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Florida Cosmetic Regulations

[Updated September 17, 2022]

Florida Cosmetic Regulations

Of all the subjects I get asked about, Florida cosmetic regulations is close to the top of the list because they have the most stringent regulations for cosmetic manufacturers.

In Brief:
  1. Florida cosmetic regulations require cosmetic manufacturers to get a permit to operate in the state of Florida.
  2. There is a small business exemption for businesses which have less than $25,000 annual revenue (from cosmetics) AND which make only certain limited products. (Jump to exemption details)

The Florida Divison of Drugs, Devices and Cosmetics handles cosmetic manufacturer permits.

In this (very long) post, Florida cosmetic regulations are covered in detail. Read it all the way through or use these links to jump to specific sections:

Cosmetic Manufacturer Permit

Florida Law

The current Florida statutes covering cosmetics are in Title XXXIII, Regulation of Trade, Commerce, Investments and Solicitations, and particularly, Chapter 499, Drug, Cosmetic and Household Products.

What is a Cosmetic?

Florida Law:

(13) “Cosmetic” means an article, with the exception of soap, that is:

(a) Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or

(b) Intended for use as a component of any such article.

FLA. STAT. § 499.003(13) (2018)

The definition of a cosmetic in Florida statutes is, for all intents and purposes, identical to the definition in US law. If it is applied to the human body to make it look better, then it is a cosmetic. Cosmetics include scrubs, creams, lotions, serums, bath fizzies and bombs, oils, bubble bath, shampoo, make-up, bath salts, bath milk, bath tea, masks, etc. For more info see What is a COSMETIC?

The definition of a cosmetic says “except soap.” Presumably, the federal defintion of exempt soap is used here, which is:

  • The bulk of the product is the alkali salt of fatty acids (lye/oils soap); and
  • The cleaning properties come from the alkali salt of fatty acids (not from any added synthetic detergents); and
  • It is marketed and sold as “soap”; and
  • No other claims than cleaning are made for the product

Products which are intended to alter the function or structure of the body or to treat, mitigate, or prevent disease are drugs, even if they are in the same FORM as a cosmetic (i.e. a lotion or cream to treat acne or reduce itching). For more info see What is a DRUG?

Manufacturer

FLORIDA LAW:

(30) “Manufacture” means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic.

(31) “Manufacturer” means:

(a) A person who prepares, derives, manufactures, or produces a drug, device, or cosmetic;

FLA. STAT. § 499.003(30-31) (2018)
(definitions pertaining to drugs are omitted)

Repackaging, such as when you purchase in bulk and repackage it into smaller containers, still qualifies as a “manufacturer.”

Purchasing packaged cosmetic products for resale does not qualify as a manufacturer.

Cosmetic Manufacturer Permit

FLORIDA LAW:

Permits

(1) Before operating, a permit is required for each person and establishment that intends to operate as: … (p) A cosmetic manufacturer;

(2) The following permits are established:

(p) Cosmetic manufacturer permit.—A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit under this paragraph. …

FLA. STAT. § 499.01 (2022)

Florida cosmetic regulations state that If you are a cosmetic manufacturer, you must get a permit.

In the explanation of the permit, it clarifies that you don’t need a permit if you don’t open the container. Therefore, if you purchase already bottled or packaged products and apply your own label (without opening the product) then you don’t need the permit.

Permit Requirements

FLORIDA LAW:

Permit application requirements.

(1)(a) A permit issued pursuant to this part may be issued only to a natural person who is at least 18 years of age or to an applicant that is not a natural person if each person who, directly or indirectly, manages, controls, or oversees the operation of that applicant is at least 18 years of age.

(b) An establishment that is a place of residence may not receive a permit and may not operate under this part.

FLA. STAT. § 499.012(1) (2018)

BTW, a “not a natural person” is a corporation or other business entity.

IMPORTANT! There is a small business exemption (implemented in 2021) which is covered further down in this post. (Jump to exemption details)

Permitting Process

The law also specifies what is required in the application. Rather than quoting the whole of Florida Statute § 499.012(4)(a), I’ve summarized the key points:

The permit must include:

  • Name, business name and address, telephone number.
  • Any other business or trade names used by the person.
  • Type of business (sole proprietorship, partnership, LLC, etc).
  • Name and address of all business owners.
  • “Any other relevant information that the department requires.”

The department will consider the following factors in reviewing the qualifications of the persons to be permitted:

  • Whether the person has been found guilty of a violation of a law (in any juridiction) that directly relates to a drug, device, or cosmetic.
  • If the person has been disciplined by a regulatory agency in any state for any offense that would be a violation of this law.
  • A felony conviction under federal, state, or local law.
  • Past experience in manufacturing or distributing cosmetics.
  • Suspension or revocation of a federal, state, or local government of any permit currently or previously held for the manufacture of cosmetics.
  • Compliance with permitting requirements under any previously granted permits.
  • Compliance with requirements to maintain or make available to officials the records required.

Becoming permitted as a cosmetic manufacturer requires several steps:

  • Pay the initial fees (with the application)
  • Complete and submit the application
  • Pass inspection
  • Renew license every two years (and pay renewal fee of $800)

A total of $950 must accompany your application fee:

  • Biennial (every two year) application fee, Non-refundable: $800
  • Initial application and on-site inspection fee: $150

In the event that you don’t pass the initial inspection and the agent is required to return to conduct another inspection, you will likely be charged some fee for return visits. If you don’t go through with the permitting process for whatever reason, the $800 is non-refundable.

Application Form

The Division of Drugs, Devices, and Cosmetics has an official application form that must be submitted. Unlike their other forms, this one is not available to be filled out online – it has to be downloaded, printed, filled in and mailed in with the fees.

The application form consists of 8 Sections, most of which are contact/business details or background (“Have you ever …?”) questions. Only Section 7 deals specifically with the actual manufacturing activity. The actual questions are below., They are slightly edited for readability and I have bolded and colored the questions that will probably be the most problematic:

  1. Are products distributed under this permit intended for export?
  2. Will all required records be stored and maintained at applicant’s physical address? (If no, provide details)
  3. Will required records be computerized, automated or stored electronically. If yes, will you have a back-up procedure to be able to provide required records?
  4. Do you have labels of your products ready for inspection?
  5. Do you manufacture a product that has a sunscreen (SPF)? (If yes, an Over-the-Counter Drug Manufacturer permit is required)
  6. Do you intend to comply with all Federal and State “Current Good Manufacturing Practices”? (See Florida Regulations FL-61N-1.010 and federal Cosmetic Good Manufacting Practices.)
  7. Does the applicant have written policies and procedures as set forth in rule 61N-1.010(6)-(10)?
         If no, provide written explanation
         If yes, provide a copy of each policy and procedure
  8. Have you obtained a copy, reviewed and familiarized yourself with the requirements set forth in Rule 61N-1.010? Failure to comply with the rule is the basis for permit application denial and enforcement action by the department.
  9. What date will the establishment be ready and available for inspection? This is the earliest date the application my be deemed complete.

Inspections

Once you have paid your fee and submitted the application, your facility must be inspected – and pass – before you can start legally making cosmetics.

The inspection criteria are based on general good manufacturing practices. The actual requirements are covered in Florida regulation, which is detailed in FL-61N-1.010 (I downloaded and reformatted the document for easier reading).

Shameless Plug!

If you are unfamiliar with the requirements for good manufacturing practices, they are covered in detail in Good Manufacturing Practices for Soap and Cosmetic Handcrafters (link to Amazon). Just one more reason to get it now!

Cosmetic Manufacturer Permit EXEMPTION

The regulations were updated in 2021 to allow for an exemption in certain cases and with some restrictions.

The good news is that you do not need to notify the Department of Business & Professional Regulation or the Division of Drugs, Devices and Cosmetics before you start making products. If you honestly believe that you meet the requirements for exemption, you can just go ahead.

Maximum Annual Gross Sales

FLORIDA LAW:

Cosmetic Manufacturer Permit … A person who manufactures cosmetics and has annual gross sales of $25,000 or less is exempt from the permit requirements of this paragraph.

Upon request, an exempt cosmetic manufacturer must provide to the department written documentation to verify his or her annual gross sales, including all sales of cosmetic products at any location, regardless of the types of products sold or the number of persons involved in the operation.

FLA. STAT. § 499.01(2)(p) (2022)

If you make less than $25,000 in annual gross sales, you do not have to get a cosmetic manufacturer permit. It has been verbally confirmed that the this applies to sales of cosmetics, not sales of other products.

The Department of Business and Professional Regulation has the right to request complete documentation of your annual sales, and if you are operating as an exempt cosmetic manufacturer, you must provide written documentation.

In addition, that means that the restriction on making cosmetics in a residence does not apply (since it is part of the permit requirements).

Exemption Restrictions & Limitations

There are some restrictions and limitations on what you are allowed to do if you are an exempt cosmetic manufacturer.

FLORIDA LAW:

1. An exempt cosmetic manufacturer may only:

a. Sell prepackaged cosmetics affixed with a label containing information required by the United States Food and Drug Administration.

b. Manufacture and sell cosmetics that are soaps, not otherwise exempt from the definition of cosmetics, lotions, moisturizers, and creams.

c. Sell cosmetics that are not adulterated or misbranded in accordance with 21 U.S.C. ss. 361 and 362.

d. Sell cosmetic products that are stored on the premises of the cosmetic manufacturing operation.

FLA. STAT. § 499.01(2)(p)(1) (2022)

Of the limitations above, (a) and (c) are pretty straightforward and are already included in federal cosmetic laws and regulations. Your product must be correctly labeled, and it cannot be adulterated or misbranded.

As per (b) above, the products you can make are limited to:

  • soap that wasn’t already not a cosmetic (that is, it was already exempt from the definition of a cosmetic). See What is a COSMETIC?
  • lotions
  • moisturizers
  • creams

I think they were trying to limit exempt cosmetic manufacturers from making the more risky items such as like products that go on the eyes or lips. Whether things like lip balms or bath bombs qualify as “moisturizers” is still unclear.

Finially, point (d) limits sales to cosmetic products that are stored where they are made. This would limit using a distribution service, including “sold by Amazon” where Amazon stocks and ships the product.

Special Labeling

FLORIDA LAW:

2. Each unit of cosmetics manufactured under this paragraph must contain, in contrasting color and not less than 10-point type, the following statement: “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements.”

FLA. STAT. § 499.01(2)(p)(2) (2022)

Any cosmetic product that is made by an exempt cosmetic manufacturer must have the statement Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements on the label, in at least 10 point type, in a contrasting color (to the background).

The law doesn’t specify where the statement must be placed on the label.

Complaints and Investigations

FLORIDA LAW:

3. The department may investigate any complaint which alleges that an exempt cosmetic manufacturer has violated an applicable provision of this chapter or a rule adopted under this chapter. The department’s authorized officer or employee may enter and inspect the premises of an exempt cosmetic manufacturer to determine compliance with this chapter and department rules, as applicable. A refusal to permit an authorized officer or employee of the department to enter the premises or to conduct an inspection is a violation of s. 499.005(6) and is grounds for disciplinary action pursuant to s. 499.066.

FLA. STAT. § 499.01(2)(p)(3) (2022)

Being exempt from the cosmetic manufacturing permit doesn’t mean your are exempt from the oversight of the Department of Business & Professional Regulation. They can still investigate complaints, carry out inspections and so forth.

When you register as a manufacturer, you explicitly give permission to the state to inspect, monitor and investigate (during business hours) to ensure you are following the regulations. Of course, these are the same rights that the FDA has over ALL cosmetic manufacturers, so those who live in Florida shouldn’t think they’ve been singled out on the enforcement issues.

Since one of the main requirements is that you aren’t making adulterated or misbranded cosmetics, I expect that the main focus of any investigations would be checking for sufficient procedures in place (good manufacturing practices) to make sure the products are clean, safe and correctly labeled.

Cosmetic Manufacturer FAQ

Answers to the most commonly asked questions concerning Florida cosmetic regulations.

What if I only sell occasionally at craft fairs or farmers markets?

There is no exemption (I checked with the state office by email). If you make cosmetics for sale, you must get a permit (unless you meet the exemption requirements).

Can I make soap without a permit?

The laws and rules apply to cosmetics, the definition of which exempts soap. The Florida statutes and rules don’t define the criteria for a soap to be exempt. Assuming Florida is using the definition provided in the federal regulations:

Permit NOT required (already exempt):

  • You would NOT need a permit if you were making and selling soap that is the alkali salt of fatty acids (made from lye/oil) AND is only marketed as “soap.” (NOTE: the soap could still include additives or fragrance.)

Permit IS required:

  • You WOULD need a permit if the soap were the alkali salt of fatty acids, but was marketed with claims that it would moisturize or do anything more than cleanse (the claims would make the product a cosmetic).
  • You WOULD need a permit if the soap were made from detergent-based surfactants, regardless of whether you claimed it could do anything more than cleanse or not.

Note that these types of soaps fall within the allowed products under the permit exemption, so if you have less than $25,000 annual sales, you can make these types of soap (which are “not otherwise exempt”) under the permit exemption.

Are small batches really considered “manufacturing”?

Yes. If you are making and selling, regardless of the quantity, you need a permit unless you meet the permit requirements.

If I buy in bulk and repackage, is that manufacturing?

Yes. If you open the package and handle the product, then it is manufacturing.

What if I have someone make my products and deliver to me already packaged so all I have to do is apply a label. Do I need a permit?

So long as you don’t OPEN the packages, you don’t need a permit.

What if I teach classes to people to teach them to make their own products?

No, a permit is not required (unless there are some requirements for teaching in general). Of course, all your students should be informed that if they decide to go out and start a business they will need to get cosmetic manufacturer permits and they need to correctly label their products.

Do cosmetic manufacturing businesses outside Florida that sell to customers IN Florida need a permit?

No. The permits are only required for cosmetic manufacturers located in Florida.

What if I sell only online and only to people outside of Florida?

Yes, still need a permit. It is based on making the products in Florida, not where they are sold.

Do I need to register my individual products?

The laws in Florida used to required that in addition to the permits, every single PRODUCT had to be registered (before it was sold). The law was changed in 2017 and that portion of it was removed. Individual products no longer have to be registered.

Do I need a permit if you give away other (cosmetic) products with a purchase of soap?

Yes, probably. Generally, the rule is that if purchase is required to get the “free gift” then the gift is actually “purchased”. In that case, the cosmetics are being “sold” and a permit would be required if you are making the cosmetics in Florida.

What about a mosquito repellant?

A product that is intended to repel bugs isn’t a cosmetic, because it’s not applied to the human body to make it more attractive. Therefore, the cosmetic regulations don’t apply.

At a federal level, bug repellents are overseen by the EPA (Environmental Protection Agency). In Florida, all pesticides must be registered with the Florida Department of Agriculture and Consumer Services.

Do I need a cosmetic manufacturers permit to make “cosmetic” products for animals?

No, cosmetics are “applied to a human body”. However, if there is any suggestion that the product COULD be used on humans (like a shampoo, for example) then it would be a cosmetic and a permit would be required.

Are permits needed for candles, room or linen sprays, or potpourri?

No. None of those items are applied to the human body and so are not cosmetics.

Prohibited Acts

Not getting a required permit for a cosmetic manufacturing business is clearly a violation of the law, unless you meet the requirements to be exempt from the permit.

fLORIDA LAW:

Prohibited acts.It is unlawful for a person to perform or cause the performance of any of the following acts in this state:

(22) Failure to obtain a permit or registration, or operating without a valid permit when a permit or registration is required by this part for that activity.

FLA. STAT. § 499.005(22) (2018)

What else is prohibited?

Well, the list of prohibited activity looks long, but it’s pretty much the same as the federal regulations. Note, I’ve only included items relating to cosmetics and have removed references to drugs and devices, to which all of these items also apply.

  • The manufacture, repackaging, sale, delivery, or holding or offering for sale of any cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use;
  • The adulteration or misbranding of any cosmetic;
  • The sale, distribution, purchase, trade, holding, or offering of any cosmetic in violation of the Florida Statutes (Section 499);
  • The dissemination of any false or misleading advertisement of a cosmetic;
  • The refusal or constructive refusal:
    • To allow the department to enter or inspect an establishment in which drugs, devices, or cosmetics are manufactured, processed, repackaged, sold, brokered, or held;
    • To allow inspection of any record of that establishment;
    • To allow the department to enter and inspect any vehicle that is being used to transport cosmetics; or
    • To allow the department to take samples of any cosmetic.
  • Providing the department with false or fraudulent records, or making false or fraudulent statements, regarding any matter within the provisions of the Florida Statutes (Section 499);
  • Failure to obtain a permit or registration, or operating without a valid permit when a permit or registration is required by this part for that activity;
  • The dissemination of any false advertisement of any cosmetic. An advertisement is false if it is false or misleading in any way;
  • The manufacturing, repackaging, packaging, selling, delivery, holding, or offering for sale of any cosmetic for which the advertising or labeling is false or misleading;
  • The advertising of any cosmetic that is adulterated or misbranded; (See What does ADULTERATED mean? )

Other Applicable Regulations

If you have a business making cosmetics in Florida there are other regulations that apply. Just like any other state, Florida has business and tax regulations that apply to all businesses.

City or County

Depending on the city and/or county you are located in, you may need a business license.

There may also be local zoning restrictions or requirements. Make sure you check before you decide on a location in which to manufacture your products.

Florida Dept. of Corporations

If you have a partnership, LLC, or Corporation, you’ll need to register your business with the Dept. of Corporations.

Normally, if you have a business operating under some other name than your personal name, you have to file a ficticious name statement, but it looks like businesss that are registered with the Department of Business and Professional Regulation are exempt (woo-hoo!).

Florida Dept of Revenue

You will probably need to get an Employer Identification Number, even if you don’t have any employees. You can use that number for your business instead of your own social security number.

Florida collects sales tax on all retail purchases made in the state. If you are selling retail, you need to get set up with the Department of Revenue to collect and report sales tax.

Summary

In Summary

Well, there are certainly some extra requirements to establish and run a successful and profitable company manufacturing cosmetics in Florida.

If you are just starting out, you will probably meet the “less than $25,000 annual sales” requirement. So long as you limit your products to those that are allowed under the exemption (soap, lotions, creams and moisturizers), and put the notice onthe label, your are good to go. You can even start out making products in your own home.

If you plan to expand and grow your business, keep in mind that as soon as you hit that $25,000 mark, you ARE required to get a permit and will need a commercial space outside your home. It’s something to plan for as you are scaling up.

My best advice if you plan to have a cosmetic making business in Florida is to take the time start out right. Get educated on good manufacturing practices (because that’s really all they are looking for) and get them in place from the beginning. That will give you a sound footing and a professional standard from the start. Then, when your business has expanded and it’s time to move into a commercial space and get your permit, you will be ready and able to do it without having to re-tool your whole operation.


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Discussion

536 responses to “Florida Cosmetic Regulations”

  1. Maritza

    Good morning, just had a question so In Florida if I were to make melt and pour soaps from detergent free soap bases or body butter from home I would be exempt? And just need to provide the label products or incorrect?

    1. Marie Gale

      By “Melt and pour soap base from detergent free soap base” I gather you mean soap that is made with lye/oil. That is NOT a cosmetic unless there are cosmetic claims made for it (moisturizing, exfoliating, etc). So the Florida cosmetic manufacturer regulations don’t appy (unless there are cosmetic claims made).

      Body butter IS a cosmetic. The Florida cosmetic manufacturer regulations do apply — UNLESS you are exempt beacuse you have less than $25,000 annual sales AND you put the notice on the label.

      You can make soap at home if it is lye/oil soap and no cosmetic claims are made (because it is not a cosmetic).

      You can only make body butter at home IF you are exempt from the regulations.

  2. Tanysha

    So I will be exempt if I create body butter at home in Florida as a moisturizer for under $25,000 in annual sales?

    1. Marie Gale

      Yes – someone who has less than $25,000 in annual sales is exempt from the Florida cosmetic manufacturer’s registration requirements. You do do need to put the notice on your product labels.

      1. Tanysha

        Thank you Queen for responding! Will I be able to make and sell body butter soap if it doesn’t have Lye in it? Will I be able to make and sell sugar/salt scrubs if I market it as a moisturizer? That’s how I was interpreting the answered questions but just wanted to make sure. 🙂

      2. Marie Gale

        I’m not sure what you mean by “body butter soap without lye” … but it sounds like a cosmetic and a “soap that is not otherwise exempt” – so it would fall under the new exemption. So would moisturizing salt/sugar scrubs as they are also cosmetics.

  3. Sydney B

    Hello, question about product descriptions on websites. I understand the label cannot describe the benefits of ingredients used, but what about the website? We make body butter and wanted to know if calling it a moisturizer in the product description would be the same as the label? How much detail can we give to product descriptions without needing a cosmetic license, we currently are exempt because we make less than $25k in profit.

    1. Marie Gale

      What goes on the actual product is a “label.” What goes WITH the product (brochures, website information, signage, etc) is “labeling.” Both are considered when determining the intent of a product.

      A body butter is always a cosmetic. You can say “moisturizing” because that is a cosmetic claim (alters appearance). You can’t claim that the product OR the ingredients will have any effect on the function or structure of the body or that they will treat, cure, mitigate or prevent disease (or any physical issues).

      If you make under $25,000 in sales, you are exempt from the cosmetic manufacturing permit. You can make body butters and claim that they are moisturizing. If you make more than $25,000 you are not exempt and you would need a permit to make body butters no matter what you say about them because they are a cosmetic.

      Also – just a note … it is $25,000 in annual SALES, not in annual profit. Big difference there!

  4. Sarah Willett

    Since I spend time in another state that doesn’t have these requirements, can I just make all my products there, label them and sell them in Florida so long as they are labeled as being crafted and packaged in other state?

    1. Marie Gale

      Douing it that way, you basically end up having a business in the other state that puchases materials, makes products and sells them (wholesale) to a business in Florida. The florida business buys finished goods and resells them. You might run into some business registration, tax and accounting issues. If you go that route you should check with an accountant to make sure you have your bases covered.

  5. Denise Jeffrey

    Hello Marie,
    I am starting my Deodorant llc. from reading the cosmetic laws in florida I am in the process of finding a company that will make my formulation. They will make, package then ship to me. I will just label them. Would my business be considered a distributor? If so, would I just need a business license to sell. What are the florida rules on that? Thank you in advance for your response.

    1. Marie Gale

      So long as you only LABEL the package and don’t open it, you shouldn’t need a cosmetic manufacturer’s permit. You will, of course, still need to register your business and get any necessary BUSINESS permits needed (depending on your city or county, usually).

  6. Maria Perez

    Hi, Marie

    I would like to know if living in Florida I can sell my sugar scrub soap in a farmer market?

    Does it fall into the category of less than 25,000 annual earnings?
    Thank you in advance!

    1. Marie Gale

      Sugar scrubs are cosmetics. Whether they fall within the allowed products under the new exemption for lessthan $25,000 annual sales is still a question. Sugar scrubs can probably be classed as “moisturizers” which would fit under the exemption.

  7. Donata M Cocks

    Can I make melt and pour soap at home and sell??…any restrictions ?
    Is MP soap a soap or cosmetic?

    1. Marie Gale

      Whether or not MP is a cosmetic depends on the formulation of the melt and pour soap base and what you say about it.

  8. Carmen Lopez

    what do i need to start selling homemade soap ,bath bomb ,shower gel

    1. Marie Gale

      Assuming you are in Florida, you can legally make soap provided it is exempt from the definition of a cosmetic. That is, it is lye/oil (cold or hot process) or MP that is made with lye/oil (not detergents) AND you don’t make any claims for it other than it cleans.

      For making bath bombs or shower gel, you need to be registered and licensed as a cosmetic manufacturer in Florida. If you make less than $25,000 from cosmetic products, you may be exempt from the licensing and registration, but you can only make lotions, creams, moisturizers and soap. There is some question as to whether shower gel or batch bombs would qualify under the exemption.

      You may also have local regulations (city or county) covering the location and permits for your business. That depends on where you manufacturing is located and what the regulations are there. And, of course, you need your business registration, tax filing and all that normal business stuff.

  9. Phara

    Thank you Marie for your time and your kindness. My question is If I buy my finished oil (for hair and body) just label them in my home and sell them online only. What license and legal document do I need as a Floridian.

    1. Marie Gale

      If you receive the containers of the haiar and body oil ready to label, and all you do is apply the label, they you aren’t considered a cosmetic manufacturer.

      If you receive the product in bulk and then repackage it into smaller containers and then label, you ARE considered a cosmetic manufacturer. In that case all the regulations apply.

      See Florida – 2021-Changes to Cosmetic Manufacturers Law for the most current info.

  10. Monica

    I am curious about bath bombs in FL with the new regulations. Can we make those as well?

  11. Donnique Mullings

    If I get someone to make soap and hair mask from a different state and I put my own label on them, do I still in a cosmetic licenses. Also, where in South Florida can I have my products made, since I can’t make it at home.

    1. Marie Gale

      If you get the product in the container it will be sold in, and you don’t open the container but only put your own label on it, then you don’t need a cosmetic manufacturers permit.

      I don’t have the names of contract manufacturers in South Florida. Google search.

  12. Kathi

    Hello Marie Gale,
    Thank you so much for putting all this work and time into answering all the questions!
    I will be opening a small retail bulk store in Florida.
    I am planning on buying bulk body and hair care products for the customer to fill them in their own container.
    So I would add a dispenser to the bulk canister but I do not manufacture, put another label on or repackage them.
    To your knowledge, would I need a license in order to do that?
    Thank you so much in advance!
    Kathi

    1. Marie Gale

      As far as I understand, I don’t think you would need to get a cosmetic manufacturers license. You may, however, need to make sure that the scale you use to determine the amount purchased is certified (like they do for produce sales in the grocery store).

      Also, be very sure you have procedures in place to ensure that the product doesn’t get contaminated in any way during the dispensing process.

  13. Teresa

    Thank you for all your insight on this craziness. I just got your label requirements book and after reading this I feel like I can’t say anything at all about my soap! It does meet the exempt requirements. I just moved to Florida and trying to sort all this out. I will need to register my business for a TIN correct? But I also need to register for an EIN even though I will be the only employee? And then I’ll have to register for my area in Florida (Bay county)? Also, on the label, I can list all the ingredients and additives (it is mostly lye, fat, and water) but I can’t say anything about properties of the ingredients is that correct?

    1. Marie Gale

      If your soap is exempt from the definition of a cosmetic … that’s right. You can’t say anything about what the soap or the ingredients do – other than clean. You can still, of course, describe the soap itself (color, scent, suds, lasting, history, etc). As soon as you say that the soap or the ingredients DO anything you have crossed into cosmetic or drug land. With the new law, however, you can make COSMETIC claims for your soap (moisturizes, exfoliates, etc) – it just becomes a cosmetic and needs to be labeled as such.

      In Florida you need to register your business name. You need to get an ID number from the Dept of Revenue (or whatever it’s called) for collecting and reporting sales tax. You MAY need to get an EIN from the IRS – but I don’t think you are required to unless you have employees. (You, as the owner, are not an employee for payroll purposes.).

      You may list your ingredients if your soap is just a soap; you MUST list your ingredients if your soap is a cosmetic.

  14. kristy keller

    hey there-what are your thoughts please- if i am making cosmetic things in my home for personal use, (florida) but others would like to try some and they give donations as a means of appreciation? i have tried to research this and can’t find any answers…. thank you 🙂

    1. Marie Gale

      Unless you are a registered non-profit, as a general rule you don’t get “donations”. Tax-wise, you might be able to claim “gifts” from people who get your products, but the IRS is pretty savvy about getting around business income. When someone gets a product and you get money … it’s a sale.

      Keep in mind, also, that if you are trying to get around having products for sale, you sort of shoot yourself in the foot because doing that will ALSO eliminate the possibility of taking the deduction of your expenses (since you don’t have a business and aren’t selling).

      If you are really looking at going doing the “donations or gifts in appreciation” route, check with an tax professional and/or a business attorney.

  15. Scott

    If I include products in my soap that have moisturizing properties but do not advertise that they moisturize am I exempt?

    1. Marie Gale

      The requirements are covered in Florida Rules 61N-1.010. My understanding is that you can’t have the manufacturing on a residential property, even if it is a separate building. However, I’ve gotten some conflicting reports on that, so you would probably want to check with the actual inspector’s office before investing time/money into a space on your property.

  16. Scott Dykes

    Hello,

    Quick question for you as an aspiring CP soap maker looking to starting a business in the next 12-18 months:

    If I manufacture CP soap that contains Castor Oil (which is in fact an oil with moisturizing properties) but do NOT list it as a moisturizing agent or ingredient and do not make any claims that the bar will provide any cosmetic benefits, will I be able to legally sell without cosmetic licensing and manufacture in my personal residence?

    Castor oil would be listed as an ingredient, but I would not make any direct claims of cosmetic features.

  17. Nancy Cavallaro

    I purchased a RV to use an office on my property, can I use this as my place of business. Where can I find the regulations of the “work space”?

    1. Marie Gale

      Honestly, I don’t know if that would work as a loophole in the regulations.

      If the Florida State inspection folks came looking, I would expect that you’d have to have some sort of proof that the products were manufactured (and packaged and labeled) somewhere other than Florida.

      In a normal circumstance, products sold in Florida but not manufactured there would be manufactured by a company that has a facility (even if it’s a person with a kitchen) that is set up as a business to manufacture cosmetics in another state. Then the products would be sold wholesale to a company in Florida for retail resale. The non-Florida business would be clearly a business from which the products were purchased. (Like any store, that’s how it works.) The documentation would be clearly in place from the accounting and purchasing (in Florida).

  18. Melissa

    If I travel, with all my tools, supplies, and ingredients, to another state (like Georgia) and manufacture, package, and label my handmade cosmetics there, THEN bring them back to Florida to sell, would I be exempt from obtaining a permit?

    Thank you!

    1. Marie Gale

      “Shampoo bars” would be considered cosemtics. Even if they CHEMICALLY meet the specifications of a soap exempt from the definition of a cosmetic, they are not being mareketed and sold only as soap, which is the second part of the requirement.

  19. vee

    hi for a lip balm business – do i need a separate license other than just registering for an EIN & Following the FDAs regulations. ? i am a little confused.

    1. Marie Gale

      Lip balms are a cosmetic. If you are in Florida, you need a cosmetic manufacturer’s license.

  20. So if salves are a cosmetic I need a cosmetic manufacturer permit and cannot make such items in my home. If it is a drug then what are my federal and Florida license requirements?

    1. Marie Gale

      No new data as yet.

  21. Marie, thank you very much for all the time and effort you have done to get this information. Are salves considered cosmetics then? I make salves from the herbs I grow such as comfrey, peppermint and lemon balm. Wading through all the regulations is NOT for the faint-hearted. I understand the labeling requirements, I think. But I am just not sure about the licensing that I need from Florida. Yes, I live in Florida. Thank you!

    1. Marie Gale

      There might be some legal ramifications if your RV is registered in Florida and you have no business or other residency in Georgia.

      But it’s worth a try! Let me know what you hear back!

    2. Patricia Rothka

      Did you ever find out?

      1. Ann seiler

        Thank you so much. Greatly appreciate your knowledge

      2. Marie Gale

        So true!

  22. Melissa

    So, I’m thinking I can drive to Georgia, rent a motel room for a few days. While there I can mass produce my bath bombs, lip balms, bubble bars, etc and bring them back to FL. Am I missing something?

    1. Marie Gale

      Making products in a random hotel room begs the question of good manufacturing practices. Can you ikeep those in and really ensure that your products are made clean and unadulterated in an environment like that? Rugs, unknown former occupants, quentionable air conditioning (when was the last time it was cleaned … it is spreading dust into your products?), no real countertops, etc.

      From a legal, business entity, tax point of view, you might have issues. Even though, technically, there’s no prohibition (as far as I know) to making products in a motel room in Georgia, you’re essentiall saying that a “cosmetic manufacturer” in Georgia made the products for your business in Florida. But that “cosmetics manufacturer” isn’t registered or legally domiciled in Georgia and there is no “proof” that it exists (or that you exist in
      Georgia).

  23. Shelly Scott

    Marie Gale, you are a saint and a treasure. Thank you so much for your knowledge and tutelage. Manufacturing in Florida is not for the faint of heart.

    1. Marie Gale

      If you are making a non-cosmetic soap — that is, a soap that is exempt from the definition of a cosmetic, then you don’t have any legal requirements or restrictions at the state level. You may need to check with your local city or county zoning ordinances about what sort of business you can have in your home.

      1. Marie Gale

        The Flordia law says:
        (r) Cosmetic manufacturer permit.—A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit under this paragraph.

        So, if you get the product and ONLY relabel it and never open the container, then you don’t need a permit.

        However, it you get the product in bulk and then repackage and label, then you DO need a permit.

  24. Holly

    Wow, this has been incredibly helpful! I like to ensure that I follow all of the rules and laws. Living near the GA border I plan to take my RV across state lines to manufacture, package, and label my products before bringing them back to Florida. Seems so crazy but I’m hoping I can avoid the craziness that Florida has. I emailed the department responsible for cosmetic oversight to ask if this would break any laws. I’ll be so sad if I can’t do it.

  25. R

    Does florida have any rules against making products from your home? I know a lot of small business make their products from home.

    1. Marie Gale

      Yes – there are rules about making cosemtics from your home in florida. It’s illegal.

      You can make soap from home if it meets the criteria to be exempt from the definition of a cosmetic.

  26. hasley

    Hi, I’m very confused about the regulations. my question is , in order to sell homemade bodybutter do I need permisitons and all of that ?

  27. Ivette

    Could I use a food truck to sell and make my body butters and scrubs in Florida instead of my home?

    1. Marie Gale

      That’s a really good question. I have no idea! I think it would depend on whether you can meet the standards for good manufacturing practices required for the inspection. If the food truck is already certified for food production, that would help, I suppose. You would need to meet the cosmetic record-keeping requirements and other stuff. I just don’t know how they would consider a food truck – whether it would be considered part of your “home” if you use your home address. You should try calling the Florida state folks and see what they say.

  28. Liubov Presman

    I did not find the exact information, please tell me. If I make soap in Florida, not cosmetics, can I make it from home? What are the requirements for the space? Thank you!

  29. Denise J

    Thank You Marie.

    1. Marie Gale

      It’s not just about the facility …. it’s also about your manufacturing practices in general and making sure both the procedures AND the facility meets good manufacturing practices. so far I ahven’t heard of anyone who got approved in a temporary (rented or shared) commercial kitchen. If you have a facility of your own, you’d just need to ensure that good manufacturing practices specifications are met for the facility and have your own GMP procedures in place.

      1. Sarah

        Hello Marie,
        I was wondering if a “Bath type bomb” that contains melt and pour (real) soap that is made with lye and oils, citric acid and baking soda would be considered a cosmetic? Or would it be considered soap since it has what is considered soap in it? Would I be able to make and sell those if I labeled it as soap balls?

      2. Marie Gale

        It sounds like you are looking at private label manufacturing. A company (with all the registration and such in place) makes the product for you, complete with seal and label. The label would have your name on it, saying “manufactured for [your company]” (which shows that you didn’t manufacture it, but you are the “responsible person”.

        In florida, so long as you haven’t don’t open the bottles or apply the labels, you are not the manufacturer. You may have to register the products, however.

        If you are working with a reputable and experienced manufacturing company, they should be able to walk you through all the requirements.

      3. Denise

        Hello!

        I’m incredibly surprised and grateful that this thread has lasted this long. I also want to mention that you have the patience of a saint by answering so many repetitive questions! I took my time to read through this thread and I have a question that I don’t think was answered. (I apologize if it was) I did read that someone wanted to give a free bath bomb if a customer purchased a certain number of products.

        My question is more along the lines of a giveaway. My business would not carry any other cosmetics, just home fragrances (candles, diffusers, room sprays, etc.) I would like to do a giveaway for massage oil candles (no purchase necessary). The entry would just be to sign up and become part of the email list. A massage oil candle is simply a candle that can be used as a massage oil once melted (which I’m assuming is a cosmetic). I just want to test out to see if I should add them to my line because after reading all of the regulations, I’m not so sure it would be worth the headache. Would I be able to do something like a giveaway?

      4. Kali

        Is it okay if I purchase ready-made soap (wholesale) to repackage and sell to customers? I found soap loaves that are pre-cut, but have to sit 2 weeks to fully cure. Then, I can separate the pieces and package them.

        Also, can I make shower steamers? They are tablets that release aromas in the shower, but are not intended for the human body.

        My other concern are spiritual businesses. In Florida, there are many establishments that sell dried herbal bags, which I know how to make, and the customer follows directions to create their ritual bath. I’ve tried to find what the laws are related to religious establishments, but couldn’t find anything.

        Under the Cottage Law, I can make my own teas, correct?

        Thanks for your help. This blog has saved me from making a big business mistake.

      5. Marie Gale

        No. Detergent-based soap is a cosmetic.

  30. Denise J

    Hello Marie. Thank You for this information. If I were to rent a place out to make my skincare products, does the location need to be in a manufacturing zone or commercial zone is sufficient?
    Also If i have an establashed manufacturer in the state of florida manufacturer my products and send to a fullfillment center or to my home for storage and shipment, I don’t need to have a lic/registration to sell online correct? The products would already be pre packaged may just have to put my label with the listed ingredients without opening the products.
    Another question. scented candels are not cosmetics, is it ok to have homemade candles to sell online?

    1. Marie Gale

      A “free gift” must be a FREE gift. If it is given with a product that is sold, then it is considered part of the sale (and therefore a consumer product) and must be properly manufacturer and labeled. In florida, for a cosmetic (like a massage candle) that would include being registered as a cosmetic manufacturer.

  31. Ericka Guy

    Only in FL, you can make soap at home and sell it, no permit is needed. But…if you want to sell accompanying lotion bars or salt scrubs, etc. where the ingredients are literally in almost everyone’s kitchen pantry, you cannot sell them without a permit and you cannot obtain a permit because you’re making them at home. Are shampoo bars considered cosmetic as well or do they fall in the soap category?

    1. Marie Gale

      While it is true that glycerine is a byproduct of saponification and that it is a humectant … once you make claims that the soap (or one of the ingredients) will do something more than clean (as in, in this case, moisturize or keep moisture on the skin) then technically the soap is no longer exempt from the definition of a cosmetic.

  32. Christopher

    I would like to share this scenario and get your thoughts. Lets assume I’m making and selling soaps from home, following all guidelines that exempt me from registering as a cosmetic manufacturer. Now I want to sell items that fall under a cosmetic definition. So I source a legal supplier, and simply re-label for my business. I know that I must not make any claims or use any descriptive language on the soap that I am actually manufacturing but am I allowed to make claims and use that language on cosmetic items that I’m simply “relabeling”?

    1. Marie Gale

      The only thing that is exempt from the definition of a cosmetic is a product that is primarily the alkali salt of fatty acids (lye/oil/water soap) AND is marketed and sold only as “soap”.

      So even if a bath bomp is made with “real” soap, if it is marketed as a bath bomb it is a cosmetic.

      Also, a bath bomb is probably primarily other ingredients than the soap, so it wouldn’t be exempt from the definition of a cosmetic because of that as well.

      1. Marie Gale

        In Florida, for the SOAP it depends on whether it is exempt from the definition of a cosmetic. If it is made up of the alkali salt of fatty acids (lye/oil/water soap) AND it is only marketed as “soap” with no cosmetic claims (ie exfloiating, moisturizing, etc), then you don’t need to be registered as a cosmetic manufacturer (since it’s not a cosmetic).

        Shower steamers are somewhat questionable … I don’t know how the State of Florida interprets them generally. I think it would depend on how they are marketed – the “steam” definitely gets on to the body, but the biggest factor would be what the intended use is. If it is intended to “promote attractiveness or beautify or cleanse” then it would be a cosmetic. Perfumery is also a cosmetic, if there is any intent for that. If it’s just a “room freshener” and only there to make the SHOWER smell good, you might have an argument that it’s not a cosmetic.

        Spiritual businesses aren’t a thing. There can be products which are used as part of a religious practice, and the PRACTICE and USE of those products may be covered by religious freedom. The MANUFACTURE of those products probably still falls under regular regulations applicable to the type of product. So a bath tea, since it is used in the bath, is applied to the human body. Under normal circumstances it would certainly be a cosmetic product. Even when used for a religious purpose, it still may be considered a cosmetic (make the body “more attractive” in a spiritual way). It gets into some pretty interesting law there! My guess is that regardless of the potential religious use, the manufacture would still be goverend by cosmetic manufacturing regulations (so a cosmetic license would be requried).

        I can’t address teas for consumption in Florida as I am unfamiliar with the food laws (cottage or otherwise). However, if you are making the tea for YOURSELF it’s probably okay … it’s generally when you start selling to others that the laws kick in.

  33. Delinda

    I am interested in possibly developing my own skin care line marketing mostly to people with sensitive skin and eczema such as myself. I am new to Florida and live in an apartment, so a separate building is not possible at this time. I would appreciate any advice on where I could manufacture my products, such as a commercial kitchen or some other space. TYIA!

    1. Marie Gale

      Shower steamers are sort of borderline. Could be considered either a cosmetic (because you’re in the shower and the steam is in contact) or a room freshener (as you say). I haven’t seen anything specific about how they are being addressed, either in Florida or at a federal level.

      Personally, i wouldn’t start a business based on shower steamers being a non-cosmetic because there would be too much of a possibility that some government official at a state or federal level could interpret the laws/regs in a way that would shut me down.

  34. Zach

    I have a question. I am starting a natural soap and cleaning supply business (laundry soap, stain remover and so on) what are the laws on the cleaning supplies? I know the soap part about cleaning only, but what about the others?

    1. Marie Gale

      If you are creating oils for pain and other purposes, you are making unapproved new drugs. If they are just for cosmetic purposes, you’d need a permit. If you advertise or sell them to heal or treat, you have crossed into illegal territory. Loose organic tea would fall under food regulations. I expect there is a permit needed for it – but I don’t have the information on food products in Florida.

  35. Lauren

    Hello! Thank you for all of this info. Is it acceptable to state on a soap website that glycerin is a natural byproduct of saponification, and that glycerin is a humectant that draws moisture to the skin? Thank you in advance.

    1. Maura Yurkins

      Food for thought! Thank you!!

    2. Luna Mari

      I make herbal products. I create oils for pain and other purposes. I also make salves for different purposes. Would I need a permit? I don’t advertise or list my products as cosmetic items.
      I also sell loose organic tea.
      Any permits needed for these things?

      1. Marie Gale

        Cleaning products are not applied to the human body, so they are not cosmetics. As for any business, you need to register your business name iwth the state of Florida, arrange for collecting sales tax for local retail sales and all that. You may have local zoning regulations pertaining to where a business is located. But don’t need a cosmetic manufacturers license to make cleaning supplies.

  36. Hi! Thank you so much for making things easy to understand! I have a question about foaming soap base. Since it is soap would that be considered soap? What about additives such as salt or sugar. It’s majorly still the soap base?

    1. Marie Gale

      If you are moving to Florida, you need a cosmetic manufacturers license to make and sell cosmetics – which includes body sprays, lotions and roll on perfume. A cosmetic manufacturers license is not issued to any business located in the home.

      Soap, if it is exempt from the definition of a cosmetic, and candles are not cosmetics and do not need a cosmetic manufacturers license.

      In most other states, no license is needed.

  37. yami

    I want to start my own handmade natural bath bombs from my own home do I need a business license or anything also I have gone to school for beauty as a full specialist license so I have is a nail/skin specialist license from the state im in Florida is my license would be okay to start my own bath bomb business its that I want to sell online on etsy im not sure what to do

    1. Marie Gale

      Bath bombs are a cosmetic. In order to manufacture bath bombs in Florida you must be registered and licensed as a cosemtic manufacturer. A cosmetic manufacturer cannot make consemtics (including bath bombs) in a residence.

  38. Shaye

    I’m curious has there been any attempt to petition a change in Florida? The fees are ridiculous for anyone looking to start a small business especially if its home based. I think so many can benefit changing the requirements and manufacturing rules and generate more business within the state.

  39. Martika Hooper

    What about shower steamers? Technically, they are not applied to the skin. You throw them in the shower for an aromatherapy experience.

    1. Marie Gale

      It depends on how the soap is made. If the soap in the soap base is made from detergents (not soap from saponification of oils with lye) then it is a cosmetic.

      Note, however, that some soap bases state their ingredients are “sodium olivate” or “sodium palmate” — and those are the result of saponification of oil with lye – even though there is not “lye” in the ingredient list.

      You need to understand the ingredients in the soap base in order to determine – or check with the supplier.

      1. Marie Gale

        That looks like soap that is made from oil/lye/water. Keep in mind that the ingredient list shouldn’t have “explanatory” text (the stuff in parenthesis). Add that to the label content if you want to explain.

  40. Kenya Pinkston

    So i just want to be clear, I can’t make any cosmetics from my home and sell them online. I can however make soaps and candles from my home, sell them on my website WITHOUT a permit. I’m I on the right track so far?

    1. Marie Gale

      So long as you are making finished cosmetics for sale to consumers (or wholesale and then to consumers) then you are not a cosmetic manufactuer. Also, if you are making soaps, that are the alkali salt of fatty acids and are only marketed as soap, they are exempt from the definition of a cosmetic and therefore not cosmetic manufacturers license would be required.

      1. Marie Gale

        I re-checked both the law and the regulations. The LAW says that drug manufacturers that apply labels must register, but it’s not specifically stated (that I could find) that applying a lable to a sealed package of cosmetics requires a manufacturers permit. HOWEVER, the regulations say “all persons who manufacture or relabel cosmetics in Florida”. So I think you probably DO need to be registered even if you are only relabeling (I’ve updated the page accordingly).

        If you purchase labeled products, then you are just selling – so that’s not an issue as far as I can tell. It’s just like any other business that buys and sells products.

      2. Alex

        Thank you Marie for being so knowledgeable and sharing it with us. 🙂

      3. Marie Gale

        The determining factor is whether the product is the alkali salt of fatty acids (that is, soap that is made from lye/water/oil) AND the only thing it claims to do is clean AND it is only called “soap”. If it meets those criteria, then it falls under the definition of soap that is EXEMPT from the definition of a cosmetic (it’s not considered a cosmetic) so you wouldn’t be a cosmetic manufacturer, so no cosmetic manufacturer permit and license is required.

        Note that claims include not just what is on the package label, but also what is stated in any marketing material or on your website promoting the product.

      4. Megan

        Thank you! Do you know how these batch tests are done? Do they need to be sent off to a facility to be tested or is it something you do yourself?

      5. Marie Gale

        Soap is exempt from the definition of a cosmetic IF:
        1) The bulk of the non-volitile portion is the alkali salt of fatty acids (that is, made with lye/oil/water, not a detergent)
        2) Is marketed only as “soap”
        3) Only claims to clean

        The Stephenson soap base you are using may qualify (you’ll need to check the ingredients or check with them) but is also depends on how you market the it and what you say about it.

      6. Marie Gale

        The actual definition, for a soap to be exempt, is that the “bulk” of the non-volatile matter is lye/oil soap. So you could put in additives (clay, herbs, etc) and the bulk of it would still be the soap. (The “volatile” part is usually the fragrance.)

      7. Synthia Myers

        how i just learn alot just by finding your page! Thank you so much Marie Gale for your knowledge and for you to take the time to share them with us.

  41. Jackie Glinkie

    Do I need a permit in Fl. if I am rebottling and relabeling sample sizes of essential oils and fatty oils to be included in a class, not selling them individually? I would not be putting the products together, I would be teaching people how to do it.

  42. Daniela

    Hello, I want to start making and selling my own brand hair products that will initially include shampoo, conditioner and keratin treatment, I already have the manufacturer that will make the products for me, I will only sell my own brand of cosmetics online. My house will only serve as an office because the products will be stored in a company that will take care of all the logistics once sales are made (Warehouse, packaging and shipping). My company is already created and I have the EIN and
    1. I would like to know if I need to apply for the Cosmetic Manufacture?
    2. If I am going to sell them only online, they may also be sold internationally, will I need another the Application for Certificate of Free Sale?
    3. Do I need to have a registration with the FDA, because my manufacturer told me there is no pre-market FDA approval process, so there are no FDA certificates for cosmetics?
    3. To start selling online, do I have to have a special permit or Licence?
    Regards

    1. Marie Gale

      Assuming you are in Florida … I don’t believe that you need a manufacturers license as you are not manufacturing in Florida and the products are being completely managed elsewhere. You should verify that with the companie(s) that are making and drop shipping them for you. they should also have information if you are selling the products internationally … that’s more a factor of the countries you are selling INTO rather than US regulations.

      For cosmetics, you do not need any FDA registration.

      You do not need special permits or license to see online. You should make sure you are following the sales tax regulations for your state and any other the states you sell INTO if that is an issue.

  43. Monique

    Marie,
    1. Do I need a license If I purchase Lip Gloss Base from different state and its shipped to me here in FL in a 30 pound container, then package the lip gloss bass in a smaller jars (no label on the jars) and sell them online. (the lip gloss base is uses to make lip gloss)
    2. Do I need a license to sell Empty Lip Gloss Tubes? These tubes are used so other people can put lip oil or lip gloss in it. (the people buying the empty lip gloss tube will more than likely make their own products). (I would just be selling the empty tubes).
    3. Would I need a license if I decide to make my own lip gloss or lip scrub and sell them online? If yes, I would eliminate this from my plan for sure.
    4. Do I need a license if I purchased lip gloss that is already branded, and I am just purchasing it wholesale to resale online? (I am assuming I do not because, I am buying something that was not open and just reselling it)
    I asked these questions because based on what you tell me and recommend, I would know what should not probably sell. I do not want to go through the hassle of the DBPR. So, I will focus my business on what does not need a license. I have my LLC and resale license already, however, this just put a wrench in my planning. If you can so kindly answer my questions, I would be so grateful, and I am so glad this thread is still active after all these years.
    I am so surprised of Florida rules because, so many people are now selling lip gloss and lip gloss base and it’s all over the internet, you tube and Esty. I am sure they do not have a license. So many people probably do not know this rule exist.
    I look forward to your reply to the 4 questions. I know other people will also benefit from this as well.
    If I can do any of the 4 based on licensing, I may focus on selling soap and candles and the supplies needed to make them.

    Thank you again for this blog!! this is making me do things the correct way,

    1. Marie Gale

      If you package or relable a cosmetic product, you need a manufacturer’s license.

      If you make your own cosmetics to sell, you need a cosmetic manufacturer’s license.

      If you purchase products wholesale (cosmetic, lip gloss containers or anything else) that are already packaged and ready to sell, you are just a store, reselling products, not a cosmetic manufacturer. If you buy lip gloss containers (or other non-cosmetic products) in bulk and then sell them in smaller quantities, you are not a cosmetic manufacturer.

      I hope that helps.

  44. Seems to me the easiest thing to do for someone who doesn’t want to open a factory in Florida would be to contract for your product’s manufacture. There are contract manufacturers who’ll use your formula confidentially to make and package what you want. No muss, no fuss, they’re the ones with the permits (if they’re in-state — but they could also be out-of-state) and who deal with inspectors, it’s all out of your hands. Some of them will even warehouse for you. Drop-shipping, that you’d probably have to arrange separately for.

    They have their own quality control, but of course you can and should always inspect your own product. You can still do all the fun experimentation at home, and when you get your formula the way you want, you send it to them. Many of the ingredients they’re dealing with in large enough quantities that they can purchase cheaper than you could.

    1. Marie Gale

      Yes, this is a good way to do it.

  45. Nicole Bauer

    This is very helpful! Question: I am interested in making a skincare product for the face. If i work with a FDA approved manufacturer facility that will help to create the product I desire, will i still have to do anything as far as permits? Trying to figure out, before I contact them. Also, if i am selling the product on say: etsy, would their name go on the product label, or would it be the name i create?

    1. Marie Gale

      That’s very interesting! Where did you get that information?

      1. Marie Gale

        Yes, salves are cosmetics, when they are applied to the human body for cleansing, beautifying or promoting attractiveness.

        Keep in mind that if the intended use of the product or the ingredients is to treat, mitigate or prevent disease or to alter the function or structure of the body — based on any statements you make about the product or the ingredients — then the product is a drug.

  46. Sarah Moors

    Following up on this comment:
    What if I have someone make my products and deliver to me already packaged so all I have to do is apply a label. Do I need a permit?
    No. So long as you don’t open the containers and only apply a label, you don’t need a license.

    Would this person need to register their product?

    What if I myself go to another state and manufacture there, and then come back to FL and sell?

    1. Marie Gale

      If you aren’t making any cosmetics, then the cosmetic regulations (including not making cosmetics from your home) don’t apply to you.

  47. Ndewana

    What is required if I want to start a lip scrub business. I have a hair braiding license, do I need another license to sell lip scrub. I will make them myself. Can anyone help?

    1. Marie Gale

      For a lip scrub business, you are looking at two different issues.

      First is SELLING the lip scrub, which is just like any other store or business. Make sure you are registered with the state, correct business name, any local license to occupy a business space, etc.

      Second is MAKING the product. Since this comment is about Florida Cosmetic regulations, I assume you are in Florida. So – in Florida, in order to make (manufacture) cosmetics — and lip scrub is a cosmetic – you must get a license as a cosmetic manufacturer from the state, pay the fees and get inspected. The inspection covers good manufacturing practices. You can’t have the manufacturing in a residence.

      If you are just starting out with making cosmetics, I suggest that you get very familiar with how to make them, formulating and keeping in your good manufacturing practices … BEFORE you try to get a license.

  48. Tammy Ellingson

    What about making essential oils to sell

    1. Marie Gale

      Generally Essential oils for sale fall into the cosmetic category (perfume/scent). Since they are a cosmetic, the cosmetic manufacturing regulations in Florida would apply.

  49. Heather

    Hi. Thank you for all the information! So if I’m understanding correctly as long as my soap is lye and oil based I can add whatever I want so long as I make no claims other than it cleans. Is that correct? Listing ingredients I’m hoping is ok?

  50. Mary

    So, if I want to make soap from soap base that does not contain lye, that would be considered a cosmetic?

  51. Reni

    Has the regulations regarding detergent-based soap changed?

    1. Marie Gale

      In order to be exempt from the definition of a cosmetic it must be an oil/lye/water based soap AND marketed and sold only as “soap”. No cosmetic claims – no claims that it will do anything more than clean. Adding oil, flavor, dye and color additives doesn’t make a soap a cosmetic.

      1. Marie Gale

        Bath salts are a cosmetic. If you don’t already have a cosmetic manufacturing license, you would need to get that from the state.

        I don’t know about using CBD in Florida. With the passage of the Farm act legalizing growing of hemp (non-THC), there is a big gray area. CBD has already been approved as a drug, so it can’t be in any ingestible product or nutritional supplement. There is no specification in the regulations for cosmetics, so that’s gray. Most certainly you CANNOT make any claims that the product will mitigate, treat, diagnose, prevent or cure a disease (an in any physical issue) NOR that it can alter the function or structure of the body — that would make the product an unapproved new drug.

  52. donna

    I am making beer soap. With the ingredients of beer, lye, oils and clay. Is there any regulation for adding beer into the soap?

  53. Hi Marie!
    I was relieved to find this thread has stayed alive for so long, as I found the information you’ve provided very informative; not only in the article itself, but throughout the comments section as well! Not only immensely helpful, you’re extremely patient with the help you’ve offered so many crafters and artisans too, as I’ve read MANY redundant questions (ie: Are bath bombs cosmetics?) which you still took the time to answer for each individual! In truly hoping to not make this a repetitive question myself, I read through as many comments/answers as time would allow me, but I still want to apologize in advance if this is a question you’ve previously addressed and I missed it…
    My husband is active military, so we get moved around quite frequently. For the last 4 years, we’ve been residing in Florida, where I make and sell cold process soaps under my registered LLC. with no cosmetic claims. These soaps are sold almost exclusively on my website. However, for the months of December through January of every year, as well as late May, I return to my home state of Arizona to visit and stay with family. My question is: Since Florida regulations pertain to the manufacturing of cosmetics, would I be able to make my lotions & body butters exclusively in the state of Arizona, then list and sell them on my website when I return home to Florida? If so, would I need to clearly specify in the product’s listing on my website that these items were made/manufactured in the state of Arizona? My reasoning for this is that I myself only purchase (through online purchases) handmade skincare products, and currently I order all my facial creams from a handmade crafter located in New York. This leads me to the belief that BUYING and receiving handmade products (made elsewhere) within the state of Florida is no problem, it’s the MANUFACTURING of these products within the state of Florida where these regulations apply.
    In a nutshell, in your excellent knowledge of this subject, do you feel I would be permitted to resell handmade cosmetics (lotions & butters) which I made in Arizona, so long as this were specified with the product’s listing on my website?
    Thank you so much for your time and help, and again, my sincerest apologies if this is the same, or similar, to a question already asked and answered.
    Wishing you a beautiful day!

  54. Hello Marie, so if I decide to make just soaps (not cosmetic) am I able to make it from my home or must it be at a physical business location?

    1. Marie Gale

      There are several different kinds of tests that can be done – both onsite and by a third party testing facility. I don’t have any products or services that I recommend at this point. Getting a professional third-party text of your final formulation to verify the preservative system is a very good idea. Then from there you could probably do in-house testing with a kit to make sure there aren’t any issues from batch to batch.

  55. Are natural liquid soaps required to have a permit?

    1. Marie Gale

      Per good manufacturing practices, you should test sufficiently to know that what you are finally selling is safe and uncontaminated (and will stay that way for a sufficient time after you package it). If you open the gallons and are handling them, they have a chance of becoming contaminated.

      In a large company each batch would be tested and one completely packaged unit would be kept aside.

      In a small company, you should completely document your procedures for adding the fragrance oil, filling and labeling and then document the safety. You’ll need to make a judgement call on how often you should test and hold aside units for future testing and verification. For small batches, it’s always a balance between testing everything and the real economics of it all.

      1. Erica Kolh

        I buy melt and pour soap base, would that be cosmetic or not? It’s from Stephensons if that helps any

  56. Megan

    So say you’re ordering gallons of lotion and only adding fragrance, do you have to batch test each gallon?

    1. Marie Gale

      You should probably do some research into the chemistry of soap. ALL real soap contains lye – it’s part of the chemical reaction and what makes soap SOAP. To be exempt from the definition of a cosmetic, the bulk of the product must be the alkali salt of fatty acids … the end result of the reaction of soap and lye.

      The product ingredients that you listed would probably make a cream or a lotion – it’s a recipe pretty similar to old school cold cream … the oil and water being emulsified with the castile soap (which is made with oil and lye). It would definitely be a cosmetic.

  57. kerri

    Hello, you have provided some very valuable information. Have you heard of anyone being able to rent a commercial kitchen and use that space to be licensed as a cosmetics manufacturer?

    1. Marie Gale

      It really depends on how you market the tattoo balm and what it is intented to be used for. It if is to treat, mitigate or prevent disease (which would include anything antibacterial or that reduces the chance of infection), or it is intended to alter the function or structure of the body (heal faster, less scarring, less pain, etc), then it would be a drug.

      If it is just to moisturize and make the tattoo LOOK better (improve appearance) then it would be a cosmetic.

      1. Marie Gale

        If you have a business in Florida then you need to be registered with the state. There may be a business tax, but I don’t think so. Florida does have a tax of some tangible property (there’s a form to fill out each year) and they have SALES tax (which you have to collect if you selll products in Florida). But there isn’t an INCOME tax in Florida.

        If you are starting a business to sell soap (or for any other thing) I strongly suggest that you get with an accountant to get your financial stuff set up and in proper order.

      2. Marie Gale

        If you are purchasing products that are made somewhere else, and you don’t open or repackage them before you sell them in Florida, then you are not a “manufacturer”. That is, you aren’t actually MAKING anything in Florida. In that case you would be more like a distributor or retailer.

        You can get the products made for you with your name on the product – you would just need to put that it was “manufactured for … ” or “distributed by ” … your business and address in Florida. That way it’s clear to anyone looking that you are responsible, but you didn’t make the product (in florida).

  58. Kyle H

    If I were to make a liquid soap that contains no Lye, but contains oils and xanthan gum as a thickening agent, would this still be classified under soap? Or would this now fall under the Cosmetic classification? For example, the recipe contains: Olive Oil, Shea Butter, Vegetable Glycerin, Xanthan Gum, Water, Castile Soap, and fragrance oil.

    Thanks in advance !

    1. Marie Gale

      Zoning restrictions are usually handled at a city or county level. Determine if the property is within city limits and then check with the city (usually the Planning office). If it’s not within city limits, check with the county.

      Depending on how technically savvy the city or county is, you may be able to find a zoning map and the regulations for each zone on their website.

  59. How do you check zoning restrictions before renting a commercial place to manufacture cosmetics?

    1. Marie Gale

      I did a quick check and only found that California has additional VOC regulations. However, if you are making products that contain a high percentage of alcohol, nail polish remover, personal fragrance products (perfumes, cologn, etc), shaving cream or gel, deodorant, or hair styling products (spray, mousse, gel, shine, etc), then you should make sure you meet the federal standards.

  60. JUDITH DEAN

    EXCELLENT SOURCE OF INFORMATION

  61. Liubov

    Ingredients soap base: Olive Oil (Grade A Extra Virgin), Coconut Oil, Palm Oil,Safflower Oil, Glycerine (Kosher, of Vegetable Origin), Purified Water, SodiumHydroxide (Saponifying Agent), Sorbitol, Propylene Glycol (Made from VegetableGlycerine), Sorbitan Oleate (Emulsifier), Oat Protein, Titanium Dioxide.

    1. Marie Gale

      Yes – if the product remains sealed and all you do is apply a label, then a manufacturer’s license is not required.

      I don’t know about the liability as a distributor of a manufactured product. I doubt that it would fall to you … unless, MAYBE, somebody went on a serious warpath about the product and tried to sue everyone in the supply chain.

      In determining if the large company in Florida is licensed, keep in mind that they might be getting the products made for them by a contract manufacturer … that is VERY common.

  62. Liubov

    Hello! Tell please, if I do soap from soap base and add in it oil, flavor, dye, mica and’m pouring in different forms, I still can to do his homes and this will nazyvatsya soap? My state is Florida. Thanks!!!

  63. Liubov

    Hello! Tell please, and if soap has flavor orange or the other flavor, i.e. it not has properties aromatizatsii, and simply has flavor, then such soap becomes cosmetic product? Thanks!

    1. Marie Gale

      Bath Bombs are a cosmetic. In Florida you must have a cosmetic manufacturers license if you MAKE them, OR if you receive them naked and LABEL them.

      If you receive them already made, packaged and labeled, you do not need a cosmetic manufacturer’s license.

    2. Nicole S

      Just curious about this.. I am looking that the Florida Drug and Cosmetic Act, section 499.01 under permits, and section p says the following: “Cosmetic manufacturer permit.—A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit under this paragraph.”

      Wouldn’t that mean that you are exempt from a permit if you are labeling (changing the label) of a cosmetic as long as it is sealed?

      Also, I recently discovered that a few bath and body products that I am selling (as a distributor not as a manufacturer or as white label) are manufactured by a large company in Florida that doesn’t seem to be licensed. Am I liable as a distributor?

      1. Marie Gale

        I have not seen anything in the cosmetic regulations concerning beer. In general, when it comes to alcohol, the typical rule is that if it is no longer consumable for the alcohol content, you are okay to use it.

        If you are over 21, buying retail, and not giving access to minor who may imbibe, should be good. There are additional regulations for purchasing without the alcohol tax for reuse in other products – but those regulations are generally pretty strict as they are designed to ensure people don’t buy tax-free consumable alcohol and then drink it.

  64. Denise

    Please, the state of Florida has specific VOC limits for cosmetics or Florida follows the National EPA limits? Thanks in advance!

    1. Marie Gale

      A product, handmade or not, that treats or relieves itches, burns, bites, etc is a DRUG. It is intended to alter the function or structure of the body and/or to mitigate, prevent or treat “disease”.

      Any product that makes those claims that is not otherwise approved by the FDA is an unapproved new drug.

  65. Kellie Stobie

    Thank you so much for your hard work educating us. I do have a question that hasn’t yet been asked. I am close to becoming a certified Aromatherapist. My plan was to make blends of essential oils, repackage bulk orders of oils as well as lipids and solid butters. Since these are applied to the skin, I am assuming that they would be considered cosmetic because I won’t be making claims about what they can do. Is this correct? I would’t be making things per sey, but mostly decanting.

    1. Marie Gale

      Some states have regulations about buying and selling alcohol for non-beverage use (such as a room spray). I couldn’t find anything on the Connecticut websites, but I did find some information here: https://organicalcohol.com/permits/connecticut. Apparently this company sells alcohol for non-beverage uses. If you CAN get non-beverage alcohol, you are probably going to be much better off business-wise because you won’t be paying the retail alcohol tax (which is about $5.40 per gallon in Connecticut). That tax can really up your product costs.

      As far as claims, stay away from anything physical (colds, flu, sinus issues, anti-bacterial) or that is specifically “mental health” (depression, insomnia). Metaphysical type claims will probably work, depending on what they are.

      1. Eve

        I was inquiring at an insurance company for coverage for room sprays and they stated that I would have to see if my state (Florida) restricts room sprays that are made with alcohol, because if the state does, they won’t cover me. If they don’t they will. I’m not sure where to get a definitive answer on this and I keep going in circles on the Florida sites. The one I use is SDA 40B 200 proof perfumers alcohol.

      2. Marie Gale

        Room sprays aren’t cosmetics, so the cosmetic regulations (and Florida cosmetic permit requirements) don’t apply. As far as I know, Florida doesn’t have any direct restrictions on them specifically.

        HOWEVER, if the room spray is made with 200 alcohol, then it probably is flammable and as such does have some restrictions as a hazardous substance. That’s federal, although there are probably also comparable state laws. Flammable products require warning labels. They also have shipping restrictions. Florida may also have restrictions or permitting requirements on using denatured alcohol in bulk.

    2. Tom

      How does one make bath bombs in Florida legally and what permits would I need? Could I have someone from out of state ship them to me and then label them or would that be a nono?

      1. Marie Gale

        Where you sell really depends on your business plan and marketing program. Generally, the most usual ways to sell are online (through a website), local or regional events (crafts shows, farmers markets), or through wholesale sales. If you haven’t already, put together a business plan, and do the necessary research to see where and how to sell your products. If you are looking to sell locally, check your local library for any books or publications that list local events or farmer’s markets and contact them.

  66. Daisy

    Hello,
    I am currently making soap but want to include room sprays and linen sprays to my list of products. Are the sprays considered cosmetics?
    Thank you so much for all your help!

    1. Marie Gale

      Room and linen sprays aren’t cosmetics unless you say they can be used on the human body. You dont have to register as a cosmetic manufacturer for non-cosmetic products.

  67. Betsy Schwartz

    If a handmade product is used for itches, burns, bites, etc.. and no claims to heal or beautify the body.. what category does that fall under? it is not a cosmetic and not a drug.

    1. Marie Gale

      To be considered a soap, the whipped soap must be made from lye/water/oil (not a detergent-based soap base or MP) AND can ONLY claim to clean.

      If you make it an exfoliant (no matter what the soap base is made of), or have any claims that it will do anything more than clean, then it is a cosmetic.

  68. Vanessa

    Are whipped soaps considered soap or cosmetic and if I add an exfoliant would that change it in any way?

    1. Marie Gale

      Yes, bath salts and sugar scrubs are cosmetics.

      The way the change is worded, they MIGHT fall under the “moisturizer” part of the exemption …. IF they are intended to moisturize.

  69. Stamatia

    I understand you can not make cosmetics in florida from your home, but are you able to have a building on your property that is solely for making cosmetics and follows all the good manufacturing guidelines?

    1. Marie Gale

      There is conflicting information on this point. The Florida statutes (499.012(1)(b)say:
      “An establishment that is a place of residence may not receive a permit and may not operate under this part.”
      (The definition of “part” in this case is Part 1 of Chapter 499 of the statutes).

      Obviously that means making the products in your HOME is not acceptable. As noted, there is conflicting information on whether a completely separate building on a residential property is acceptable. I have heard that it has gone both ways. That may be due to the interpretation of the inspector, or it may have to do with the actual facilities.

      I would expect that IF it were possible at all, the building used for manufacturing would have to be completely self-sufficient (bathrooms, sewer, water heater, materials, storage, access, etc.) It would probably also need to be fully permitted as a building from the building inspectors and codes for the county and state, and would need to be legal for manufacturing (allowed use on a residential property for zoning purposes). Some areas don’t allow a buisness on a residential property; some allow some types of businesses, but not all.

      Carefully do your research.

      1. Are bath salts and sugar scrubs a cosmetics?

      2. Marie Gale

        So long as YOU aren’t making the statements about your ingredients or products you aren’t specifically linking to statements about the properties from your product or ingredient descriptions, you should be okay.

      3. Scott

        Thank you for the quick response. I wanted to be absolutely sure that inherent properties of oils used (as in statements verified by the FDA about specific oils) wouldn’t automatically classify my soaps as cosmetics.

      4. Marie Gale

        It’s what you SAY about the product in order to tell the consumer the intended use. What you put in the product doesn’t determine the intended use.

  70. I just want to say THANK YOU SOOOOOOO MUCH for putting all this very useful information on here. I was literally super confused about what I can and can’t do at home and when I spoke to someone regarding what license I would need to sell my products I specified that I wanted to sell from home and she said absolutely nothing about it. Thank GOD that I found this page because now I know I can’t and I am going to have to definitely fins a warehouse so I can manufacture my products.

  71. Sorry if I missed this question being answered already, I skimmed through most of the comments and didn’t see any questions on it. But do you know what kind of requirements there are for a manufacturing space in FL? Or where we can look for more info on what they are looking for during the inspection? I have been looking into how I can legally start expanding my product line and a local business that does massages/acupuncture and other holistic health related things has offered that they may have space available for me to use for manufacturing once I find out the requirements. But I’m sure their space wouldn’t be any sort of commercial kitchen…I have seen some people mention using commercial kitchens but is that actually a requirement? I think I have also seen people in other blogs mention that they have even had their guest homes registered to start manufacturing in as ling as they weren’t using it as a living space? If that’s the case for FL I can’t imagine space in a local business (that isn’t a commercial kitchen) would be out of the question…

    I intend to read your good manufacturing practices book, but I wasn’t sure if that would give me info on what they are looking for in the inspections?

    1. Marie Gale

      I am in the process of writing another blog post about Florida Regulations to bring the information up to date – it should be ready in a week or two.

      Meantime, I will say that the criteria for the space and the inspection are generally based on good manufacturing practices. The whole point is to ensure that the product won’t become adulterated because basic GMP isn’t in place. A commercial kitchen covers many of the requirements – but not all. A retail space would probably have more issues.

  72. I’m curious if this applies to products designed for animals, such as sunscreen, paw protectants, etc. Do you know anything about the licensing and manufacturing issues related to these products?

    1. Marie Gale

      Starting a handcrafted cosmetic business in Florida can be a challenge. It can be done – but it’s a challenge.

      Before investing a lot of MONEY, I’d suggest you invest all the TIME needed to thoroughly research what it would take in terms of financial investment and time committment. Then decide if it’s something that you want to undertake.

      1. Marie Gale

        If the soap is exempt from the definition of a cosmetic, then you don’t need to register as a cosmetic manufactuer. Only cosmetic manufacturers are limited to not making products in a residence.

      2. Marie Gale

        I expect that the State of Florida puts their attention on regulating the larger manufacturing companies. Most State agencies (and even the FDA) don’t have the resources to go after every violator … so they concentrate on those that make the most impact if they are in non-compliance – the ones that make a lot of product used by a lot of people.

        BUT, that doesn’t negate the law or the regulations. Our society is set up so the laws and regs are in place and people are expected to follow them voluntarily – not follow them only if they are “caught” not doing so. Once too many people are in violation of some law or regulation, the typical path is that it starts getting enforced “before the fact”. Most countires require that cosmetics are registered BEFORE sale, or are approved BEFORE they can be sold (like drugs in the US).

        So, I always recommend that people voluntarily follow the law and regulations – DESPITE what others may be doing. The more people who are in compliance, the better the argument for not making stricker laws. Conversely, every time someone is “caught”, it gives the regulators one more reason to put stricter laws in place.

        If we play by the rules, the rules are less likely to be made tougher.

      3. Marie Gale

        I believe there are some that are licensed and officially registered, but I don’t know the names. Sorry, I can’t help with that.

  73. Sherry Meade

    Thank you Marie for sharing all your knowledge. Can you please tell me where I can find the cosmetic manufacturing requirments for Tennessee? I bought a building in Florida and Tennessee for the manufacturing of creams, lotions and bath bombs. Florida requirements just seem to be beyond my abilities to obtain, so I think Tennessee may be my only option. I have called every office in Tennessee and everyone is telling me I don’t need a license? Can you please help me? Does anyone really get approved in Florida or id this just a myth?

  74. Leina

    I have read through this and found it to be extremely helpful so thank you so much! I am thinking of making my tattoo balm to sell, but am not sure where it falls in that fine line of cosmetics to medical. I am not claiming that it cures or heals anything (I use it while tattooing to lubricate the skin) and I feel it would fall within the cosmetic area. But am just not positive and am finding it to all be very confusing!!!!

    1. Marie Gale

      If your soap is exempted from the definition of a cosmetic, then you don’t need to be registered as a cosmetic manufacturer. To be exempt, it must be the alkali salt of fatty acids (made with the reaction between lye and oil), and marketed and labeled only as “soap”.

      A CP soap that is called “soap” and only claims to clean would meet that definition and be exempted from the definition of a cosmetic.

      1. Marie Gale

        So long as your soap isn’t a cosmetic, then you are not a cosmetic manufacturer.

        In order to be exempt, soap must be the alkali salt of fatty acids (that is, made with lye and oil) AND all you can say about it is that it is soap and it cleans. If you say much else about it, then it will probably become a cosmetic.

  75. KELLIE

    Shared commercial kitchen space

    1. Marie Gale

      That could work.

  76. mary glynn

    Marie, love your site and you are so helpful and patient with people … very impressed. I am in Florida and would like to make and sell lotions and potions that would be considered cosmetic, but the cost makes that impossible for at this time. What specifically can be done, or possibly is being done, to change these regulations? Florida is such a great place for year-round farmer’s markets and fairs it seems so unfair to make the regulations so strict for these small businesses. My understanding from your information is that other states take a much more realistic stance on the regulations. I would like to see about getting this changed if possible, or at least try. Can you tell me if a movement has been started somewhere that I can join or if maybe you can point to a state with reasonable regulations whose policies we can propose to the powers that be in Florida? Thanks for your time.

    1. Marie Gale

      I haven’t seen anything definitive from the State of Florida. Most reports I get are like you said – confused and often conflicting.

      The actual statute says, “An establishment that is a place of residence may not receive a permit and may not operate under this part.” The regulations that implement the statute don’t seem to have anything more specific.

      It apparently comes down to how “establishment” and “is” (as in “is a place of residence”) are being defined. And THAT seems to be somewhat arbitrary based on who you are talking to. Could be the BUILDING, could be the PROPERTY.

      Keep pushing to get a clear answer …. and let me know what happens!

  77. Brenda

    This article has been very informative, and you’re graciousness to answer questions in the manner that you do, doesn’t go unnoticed. I live in Florida. I make homemade lye soaps. Hot process, cold process and detergent free melt & pour. Where are all of the locations and ways to sell, not requiring the licensing, permits, fees, (being exempt)? i.e. farmer’s markets, festivals, online, local stores, etc? Thank you kindly for your time and help! You’re a gem on here for us!! Blessings

    1. Marie Gale

      No, I haven’t heard anything. I specifically asked about a year ago and was informed that there were no exemptions for small/cottage business allowed in the law.

      The (federal) Food Safety Modernization Act that went into effect several years ago DOES have some provisions for small businesses and farms that make food products (especially from produce they grow), but it doesn’t apply to cosmetics at all.

      1. Marie Gale

        You’re welcome! I’m glad the book was of help.

  78. Melissa Carmel

    Wow! Such great information! We are trying to get information on producing Bath Salts- and not the drug kind! Just basic salt blends for soaking in the tub with herbs, botanicals and essential oils- Specifically with CBD isolate, but I know that comes with completely separate licensing. We’ve called the state numerous times and no one seems to know how to answer our questions! We are assuming salt blends are cosmetic, but if you have any info, either with or without CBD, we would really appreciate it!! We have a commercial production space for our soap production already, but wondering if we can legally expand our product line. Thank you!!!!

    1. Marie Gale

      In answer to your first question – I don’t know what the State of florida would think about your manufacturing in AL. My GUESS is that if they decided to come after you, it might be hard to prove that you are not a “Florida manufacturer” if you don’t have some sort of legal presence in AL as a cosmetic manufacturer. Of course, the point could be argued either way.

      If you had a business entity in AL, and THAT entity manufactured and then sold the products to your Florida business, it would more clear-cut. But much more complicated for the paperwork, taxes and such. I’m sorry I can’t be more help — possibly an attorney in Florida could give you some guidance.

      On the other point – the acutal makeup of “soap” to be exempt from the definition of a cosmetic is that “The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds.

      Sodium Cocoate, Sodiuym Myristate, Sodium Laurate and Sodium Stearate all all alkali salts of fatty acids. However Glycerin and Prop. Glycol, Coconut Oil and Triethanolamine are the largest percentage ingredients. And then – some detergent properties would come from the Sodium Laureth Sulfate, which is a synthetic detergent. Without knowing the actual percentages, it would be hard to say if the “bulk” of the nonvolatile matter meets the definition. I rather think not, but I can’t be sure.

      1. Marie Gale

        That’s right – anything that is applied to the human body is a cosmetic … except soap, if it fits the definition and is ONLY marketed as soap. Pretty much Florida regulations suck for handcrafted soap and cosmetic makers.

  79. Sierra North

    Trying to do some research into the legalities of selling my homemade room spray. I know as a room spray it is not cosmetic. I have heard that I need to look into the local legalities of selling products that contain alcohol. My recipe uses vodka. However I cannot seem to find any info for CT. Where should I ask? Also wondering if I have any more range in how I market it as any claims would be in the area of metaphysical benefits not physical healing or body claims? Thank you! Your article has been the most helpful so far!

    1. Marie Gale

      The requirements have their basis in Good Manufacturing Practices and ensuring that the product won’t become adulaterated or misbranded. You can read the actual requirements in Florida Rule 61N-1.010. From the lined page, click on the “Final” version – it is available as a Microsoft Word document.

      1. Marie Gale

        The full definition is “the bulk of the non-volatile portion is the alkali salt of fatty acids”.

        So the vast majority (“bulk”) of it needs to be oil/lye/water soap (the “alkali salt of fatty acids”). Putting in fragrance, color additives (mica, pigments, etc), other additives (herbs, plants, extracts, etc) and even “fillers” (clay, etc) is all fine … so long as the BULK is true soap.

  80. Michael

    Great info. Wondering if I have to follow same laws and regulations if im only using my products on my clients aa an esthetician during facials and not selling them? What is your opinion. Thank you

    1. Inessa

      Hello Marie, is there any source I can look up to learn about building’s coding, zoning, age, conditions, or other requirements for a cosmetic manufacturing facility in Florida? The only info I could find that a facility could not be the residential type of property. There are plenty of retail spaces, standing along office buildings, and warehouses that can be repaired to comply with GMP … but I could not find anything on the Florida state prerequisites for that matter. Thank you so much!

  81. Erin

    This is a great idea! I’m just getting started and had no idea Florida was so strict. I’m located in the panhandle and would love to look at sharing a space to reduce costs! If interested, lmk!

  82. Emma

    Do you know if the soapmaker pay tax in Florida?

  83. Corinne

    Hi Marie, I just moved to FL a few weeks ago and after pouring over everything I could find, your page here seems to be the most informative. Before moving here I just started making and selling salve. I was so excited to start fresh here in FL and actually build my business but it’s sounding like the $$ involved in the uber expensive permits/licenses and the added expense of outside (the home) workspace on top of the cost of starting a business and product costs… I’m feeling like this is the end of the road, before it truly ever started. Am I being a Debbie-downer here or am I being realistic and saving myself and my family from losing tons of money?

    1. Leonardo Blanco

      Yes, This is how I make soap PURE soap. But can I make soap (for Cleansing) from home and sell it from home?

  84. sandy

    can i make CP soaps and sell it labeled as soap and that it cleans, nothing else and still be exempted

  85. Elizabeth

    Hello, I am also new to the whole soap, bath bombs, bath salts, etc. making thing. I’ve read just about every comment on here and have learned so much – thanks, Marie!! To recap a bit, if I am making TRUE SOAP (according to FDA requirements), I can make soap ONLY from out of my residence. Is that correct?

    1. Marie Gale

      For soap to be exempt from the definition of a cosmetic (and thus the cosmetic manufacturer regulations) the bulk of the product must be the alkali salts of fatty acids (that is, it is made from the saponification of oils with sodium or potassium hydroxide) AND it must be marketed only as “soap” AND it can only claim to clean.

      You can’t state that the soap will do anything else.

      If you say that it will moisturize, or do anything other than cleanse, then it is no longer exempt from the definition of a cosmetic.

      So long as it’s exempt from the defintion of a cosmetic, you can make it in your home and sell it.

  86. heather

    Hi Marie,

    I make bath bombs and soaps. I had no idea of the laws in FL until I started researching on what legal steps to open up bath buisness. I am trying to find a way around not being able to produce my products at home. Would I be able to rent a commercial kitchen space and make/package and label from there? I am not able to rent out a store at this time and really don’t want to give up on this.

    Thank you

    1. Marie Gale

      It’s in the Florida Statutes, section 499.

      Section 499.01 states who is required to have a permit.

      Section 499.012(1)(b) states “An establishment that is a place of residence may not receive a permit and may not operate under this part.”

      1. Karen L

        In Florida, registered businesses can be search online (Sunbiz). Does this satisfy the requirement of having an online listing, to be able to leave off the street address from labeling?

      2. Marie Gale

        I don’t have much on Tennessee – what I do have is on my States page. Scroll down to Tennessee. As far as I know, there aren’t any requirements.

        There may be general business requirements (business name registration, local (county level) business license and such). But I don’t see anything specificto cosmetic manufacturing.

  87. Carnesia

    Firstly, I love that everyone’s questions was answered! Furthermore, I am wanting to sell Shea butters for skin and hair… but mostly as body products using essential oils and natural products, would I have to be licensed for this in Florida? Yes, I will be buying ingredients wholesale and will repack my products. I will also plan to get certified as an aromatherapist as well.

    1. Marie Gale

      Yes – in order to do what you are describing, you would need to be licensed as a cosmetic manufacturer in Florida.

  88. Julie

    Hi Marie,
    To your knowledge has there been any clarification on whether or not we can manufacture with a cosmetic license out of a separate building on our residential rural property? Assuming, of course, that it meets inspection and is GMP compliant.

    I know calling the state to ask has previously gotten confused and conflicting answers. Thank you for your help!

    1. Marie Gale

      That would be most likely. However, keep in mind the determination is based on the intended use, which is partly from what you call it, but also partly from all the other things you might say about it. If it came to an inspection, it would be up to the inspector to determine if the product was “true soap” and only claimed to “cleanse” …. or if it has the intended use to improve appearance or beautify in other ways than just cleansing.

  89. Lyuda

    Hi Marie,
    I understand of soap not falling under cosmetic quidlines, I have 2 questions, adding essentials or fragrances does it considerate as cosmetic? And second, I didnt quite understand, even just “soap that cleans” I can’t make at home?

  90. Karen

    Maria-have you heard anything about Cottage industry being set up in Florida for soaps, lotions and the like? I think there is one for jams, Jellies, honey, breads. In Florida.

  91. Stacy

    Due to the manufacturing restrictions and regulations, not to mention the exorbitant costs associated with licensing in Florida, I am looking to manufacture scrubs, as well as couple other products in Ohio and ship them to here for resale. I will be labeling here in Florida, but not manufacturing. Any suggestions on doing this? I already have already registered as a fictious name here in Florida, but don’t really know what I need to do in Ohio to make this work?? Thanks in advance for any assitance you are able to provide…it is greatly appreciated!

    1. Marie Gale

      I don’t believe there are any restrictions on manufacturing cosmetics in Ohio, so that should work. If you are doing it as a business in Ohio, then you’ll need to do whatever is needed to have a business in Ohio. If you are living in Florida, and have an “office” of your business in Ohio that is manufacturing, you might want to check with an accountant to make sure you have all the accounting and taxes figured out.

      From the Florida end of things, you should be okay since the Florida statutes state:

      A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit. (see: http://flrules.elaws.us/fac/61n-2.002

  92. Perry

    So much great info here and helpfull links!

  93. Hey Marie, I wanted to thank you for being so responsive on this long thread, it’s really answered a lot of my questions before I asked them. Here’s mine, since I haven’t seen it yet. We live in Florida about 30 miles from the AL state line. We work from home and don’t want to rent a place solely to manufacture bath bombs. So, I was thinking we could just rent a place in AL on the weekend maybe once a month or so and manufacture/package all of our bath bombs while we are there. I would be sure to document it all so that there’s evidence that it’s not being done in FL whatsoever. Do you think this would work out? I’m thinking this is pretty safe, but just wanted more opinions.

    Also second question, I read where the SFIC M&P soaps were OK to use, and I found another site with ‘detergent free’ M&P, but I was wondering if the base M&P that I want to use (cost efficiency) would qualify as a real soap as well? Here’s the ingredient list. Glycerin, Prop. Glycol, Coconut Oil, Triethanolamine, Sodium Cocoate, Sodium Myristate, Sodium Laurate, Sodium Stearate, Sorbitol, Sodium Laureth Sulfate, Purified Water.

    thanks again for everything!

  94. Margarita Goodman

    I am in the same predicament in which I want to make hair oils for African American hair, I am literally just mixing oils and just starting out with no real customers, Florida requires you to act as if you are a big business. I am looking to see if there are facilities that allow people to share rent wise to make products. I also want to do hair shows for which I can mix the product on the spot, which is an issue as well. I was told if I provide the bottles and allow the customers to mix the oils then technically I do not have to have a license. However, I also am mixing butters which is where the problem lies. It is just very frustrating that soap is literally applied to your body but not regulated and everything else is. Nonetheless, I am wondering if we can work in someone else’s manufacturing facility or start a group facility ? Any takers?

    1. I have heard similar horror stories. The biggest threat is the high cost of operating a home-based soap-making business IMHO. Forcing small businesses to flee the state to support ourselves and families makes no sense at all for Florida. That size “operation” pays taxes, fees, and generates other types of income producing activities for the state. Thinking of tourists, travelers, boutiques, hair salons, health “food” stores, etc. I still own property in Wisconsin and I maintain my business registration, etc there. That way I “manufacture” my products in another state. Florida requires the business register here, so they can potentially collect sales taxes for products sold retail within the state. (I probably over simplified that, but you get my drift – no doubt).

  95. Dana

    Do you know what is legally considered an acceptable facility for manufacturing or is it just anywhere that is not a residence?

    1. Marie Gale

      I believe the determining factor would be the suitability of the premises rather than where it’s located.

  96. ximena

    Hello, I understand we cannot Manufacture bathbombs, lotions, scrubs etc. in Florida without all the proper requirements. Could you have your items made out of state and shipped to you and then you sell them? They would carry your label etc. Then would it be legal since your not actually manufacturing? Also, would the person making them in the other state need any permits etc? They would be in New York. They will not be getting paid or benefiting in any way. They would just be making the products to help out. Since they cannot be made in the state of Florida. Would this be a OK?

    1. Marie Gale

      It’s the BULK of the non-volatile portion. Bulk = Most of; high percent of. You can put in additives, and as long as MOST of the non-volatile part is the alkali salt of fatty acids, you are okay.

      1. Marie Gale

        Since salves are applied to the human body, they are either a drug or a cosmetic – in Florida and everywhere else.

        If it’s used to “beautify or improve appearance” (soften, moisturize, exfoliate, etc) then it’s a cosmetic.

        If you make any claims that it treats, cures, prevents or mitigates disease or changes the function or structure of the body (for bruises, sprains, sore muscles, cuts, burns, etc), then it is an unapproved new drug (and illegal).

        Even if you don’t say anything about it, but it is applied to the human body, then it would at LEAST be a cosmetic.

        In Florida, to legally make the product you must be a registered cosmetic manufacturer.

  97. Leonardo

    Hi, So If I only make SOAP, I can run my soaping business from home?

  98. Richie

    Hello I live in Florida I want to make a face oil for myself and friends and give it away just to see how well it does. However if I wanted to start selling privately to friends and family only how would I go about doing that? I am not a professional cosmetologist or anything I just want to make something for me and my friends and family for now before I actually start a business. However I would like to sell it for very cheap just enough to keep ordering the supplies I need. Please help. Thank you

  99. Gwen

    Thank you SO MUCH for working through all this stuff to make it easier on us!

    1. Marie Gale

      Yes, mild is okay.

  100. Denise Ohle

    If I make soap with goat milk at my home, can I sell it at craft shows as soap and not get in trouble?

    1. Marie Gale

      The regulations for cometics say the street address may be omitted if it is listed in a “phone or city directory.” The last word from the FDA to the HSCG said “online phone directory” was acceptable. Technically, Sunbiz isn’t a “phone directory”.

      On the other hand, it IS a searchable directory and is easily publicly available and findable and the FTC determined that that would meet the requirements of the Fair Packaging and Labeling Act. The HSCG has a petition in to the FDA to allow it.

      You’ll have to make your own judgement call as to whether you want to go with the existing regulations … or go with a possible future change. If you get inspected by the FDA there’s no telling how it would go, although you’d probably have an arguable position.

      Florida doesn’t require labels to be submitted for cosmetics, but they may have an interpretation as to whether a listing in Sunbiz would be sufficient for omitting the street address.

  101. Carolyn

    Has anyone used commercial kitchen space for this? I’m referring to commercial kitchens that rent out the space on a part-time basis. Is this allowable in FL? Are there any places that would be open to this? I’m assuming that I could still make soap in my home so no worries about lye in a food-prep environment, but scrubs, oil blends, etc. would be made in the commercial space.

    Also, a question about out of state manufacturing. From what I understand, if I make a large batch of product out of state but then put it into smaller containers in FL, that constitutes “manufacturing” (at least by their definition).
    Thank you.

    1. Marie Gale

      I don’t know how Florida regulators deal with renting a commercial kitchen for manufacturing. It’s not just the kitchen space – it’s also all of the other things that go into good manufacturing practices (so things like material storage, finished product storage, record keeping, etc).

      Out of state manufacturings is fine — but the product can’t be opened and repackaged in Florida. So you would need to get the product packaged in the finished containers. You could label them in Florida without a manufacturers license – just not open the containers.

      1. Carolyn

        Thanks, Marie. Appreciate the feedback.

  102. Gwendolyn

    Thank you for all of the information.

  103. Dee

    Hello,

    Hello, Your blog is very informative. I have been searching for the FL regulations. Where does it say specifically that cosmetics can’t be made in your home and require a separate facility?

    1. Marie Gale

      Assuming you are in Florida …

      For the soap, if it is not detergent based (is lye, water, oil), then it is not a cosmetic and you don’t need to be licensed as a cosmetic manufacturer, PROVIDED you only call it soap and you don’t make any other claims than that it cleans/cleanses.

      Bath bombs, lotions, scrubs, and bath salts are all cosmetics. You do need to be licensed as a cosmetic manufacturer to make those products in Florida.

      The labeling you described is basically correct. You also need your business name and address (including the street address unless the business is included in an online listing).

  104. Mimi

    Great information, thank you for this. So if I make a facial soap and I label it “soap for the face” would that be ok as well? Thank you, Marie.

    1. Marie Gale

      From what I heard, the price for registration isn’t going to change — it’s just that the listing of individual products (and the costs associated with that) are supposed to go away.

      The Florida Cosmetic Manufacturers page has been updated since the last time I looked at it (not much information there right now). It says to call the Drugs, Devices, and Cosmetics Program Office at 850.717.1800 if you have questions.

      1. Marie Gale

        In Florida, as with the FDA at a federal level, soap can be exempt from the definition of a cosmetic. If you are in Florida and are just making soap, since it’s exempt from the definition of a cosmetic, the cosmetic regulations (including licensing) don’t apply. There are no restrictions on making soap in your home and selling it.

        Good manufacturing practices are not REQUIRED (and no one will be checking what you have in place) but they are still a good idea. In fact, assuming that your soap is clean and your are being watchful as you make it, you probably already have many of the the GMP basics in place. I suggest you get the book, Good Manufacturing Practices, so you can gradually work toward getting your own GMP in place. (The link goes to Amazon.com and opens in a new tab or window.)

  105. Mimi

    Could I give my shampoo bar, which is a CP soap, an alternative name, such as “hair soap” or “soap for the hair” to avoid FL cosmetic laws? Also, where does dog or pet soap fall within these regulations? Thank you so much.

    1. Marie Gale

      Bath bombs ARE a cosmetic. The only product that goes ON the human body for cleansing or “beautification” that can possibly be exempt from the definition of a cosmetic is a “true soap” – that is, a soap where the bulk of the non-volatile portion is the alkali salt of fatty acids. It must be an oil/lye soap, not a detergent based product.

      That being said, if you are purchasing the products packaged, and are selling them under your own label, you don’t qualify as a cosmetic manufacturer in Florida.

      Keep in mind that since the bath bombs are a cosmetic, you will need to include the ingredient declaration on the label. Check the soaps you are purchasing, if they are detergent based (some melt & pour soaps are), then they wouldn’t qualify as “soap” and would also need the ingredient declaration on the label. Your supplier should provide you with the information you need to correctly label the finished product for sale.

  106. Jessica

    I am getting ready to move to Florida soon. (Currently in Ga) I am looking to set up a separate building on our residential property. Could I use this as my shop/place of manufacturing or will it still count as our place of residence? Here in Ga I have a separate studio but it is attached to the house. I know that will not work in the state of Florida.

    1. Marie Gale

      I’ve heard differing reports on whether a separate building on a residential property is acceptable for cosmetic manufacturing license. I would suggest that you check with the Florida licensing folks for a definite answer.

      Also keep in mind that if you are manufacturing on a residential property you may have zoning issues with your city or county — that’s purely local, so you should definitely check that as well.

  107. Vita

    True soap is oils, water and lye. What if I add Fragrance oil and micas? Is it ok in FL? I need to stick to the regulations?

    1. Marie Gale

      Bath bombs are cosmetics and to legally manufacture them in Florida, you need to be licensed as a cosmetic manufacturer (unless, of course, you are making them for yourself and not selling them). That’s true even if you give them away with another purchase — you are still manufacturing them and the consumer still has to purchase something in order to get them.

      1. Marie Gale

        If you want to make cosmetics in Florida, you need to register with the state. You’ll need your good manufacturing practices in place and probably a location outside the home to manufacture. I believe the fees for REGISTERING your products have been waived, but I don’t think the actual registration and inspection fee has been waived.

        You should contact the state for additional information if you are planning to go ahead.

        Also note that you might need some sort of local business license depending on what your city and/or county require. If you are using a business name other than your personal name, you’ll need to register a ficticious name with the state as well. And Florida has sales tax, so if you are selling retail, you’ll need to get a sales tax license (or whatever they call it in Florida).

      2. Marie Gale

        In order to be exempt from the definition of a cosmetic, and there fore exempt from the cosmetic manufacturing regulations in Florida, the “bulk of the product must the the alkali salt of fatty acids” AND it must be marketed and sold only as “soap”. No cosmetic claims for the product OR the ingredients. No other surfactants (detergents) used.

        Whipped soap, so long as it fits the definition of a “soap” to be exempt, is still soap.

        If you are using any MP soap in your products, make sure they are the alkali salt of fatty acids, and not using some other synthetic detergent base. Any detergent-based soap is automatically a cosmetic – no exemptions.

      3. Marie Gale

        The FDA doesn’t approve cosmetic facilities … Is your friend located in Florida? Were you referring to approval to manufacture cosmetics in Florida?

  108. BL

    PS
    I ordered your labeling book from Amazon and I finished it in one day it was extremely helpful and enlightening thank you so much for putting the book together

  109. BL

    Hi Marie
    First thank you so much for putting this information together and responding to everybody so thoroughly. What I find difficult to believe is that every single vendor at the numerous events around the state are all either from out of state or have followed all the rules for the state of Florida and have manufacturing of what is considered cosmetics outside of their homes. In researching there were at over 100 businesses at events I’ve attended in the last six months who sold what are considered cosmetics and resided in the state of Florida ….when asked said “they whipped it up in the kitchen” or something to that effect. There was also a huge gap in labeling of the products.

    Is it just hit or miss, fly under the radar til they are caught…or is there possibly a complete lack of knowledge with regard to the regulations? Is there a lobby or special interest group that we can join to push further changes in these Machiavellian cosmetics regulations in Florida ?

    1. Marie Gale

      A shampoo bar is generally considered a cosmetic because it is “shampoo” not “soap”. If you just market and sell it as “soap” with no other claims (including that it’s “shampoo”) then it could be exempt from the definition of a cosmetic. But as soon as you call it a shampoo bar, and say that it does anything at all for hair, then you have crossed over into making it a cosmetic.

      The good news is that all you need to do is add the ingredient declaration and you are good to go. All the other requirements, identity (“soap” or “shampoo”), net contents and business name and address are required regardless of whether it is a cosmetic or not.

      1. Marie Gale

        I looked at several bath whip bases online and both were detergent based. I don’t think there is a “true soap” whipped soap base (it would be extremely difficult to do). If the product you are using contains Disodium Lauryl Sulfosuccinate, then it is a detergent-based product. It would be a cosmetic.

      2. Marie Gale

        It’s not just “medical” claims.

        In Florida you can make soap that is exempt from the definition of a cosmetic (so the cosmetic rules don’t apply).

        In order to be exempt from the definition the soap must be the alkali salt of fatty acids (that is, made with lye/oil/water – not a synthetic detergent) AND it must be marketed and sold as “soap”. That means the only claim can be that it cleans – no claims that could make it a cosmetic (moisturizing, soothing, otherwise changing the appearance) … for the product itself OR any of the ingredients. (For example, you can’t say that it contiains “moisturising” shea butter. (Shea butter, yes, but not “moisturizing”).

      3. Marie Gale

        I believe the regulations just say “in a residence”. It’s my understanding that a separate building has been approved, but I don’t know if an attached unit would be acceptable. You’d have to check with the inspector.

  110. Tania

    So even if you make no claimes whatsoever, even if it’s just called skin cream or just sugar scrub….. it’s a cosmetic? So really we can’t make anything but soap in Florida. The thing we absolutely do rub on our body.

    1. Marie Gale

      If you MP soaps are “soap” — that is they are the alkali salt of fatty acids (made with lye and oil), then they are exempt from the definition of a cosmetic and you don’t need to get registered as a cosmetic manufacturer in Florida. If they are DETERGENT based, then they ARE cosmetics, and you must jump through all the hoops to be a cosmetic manufacturer. In that case, I expect it would be much easier to change your base than to become a registered cosmietc manufacturer in Florida.

      1. Marie Gale

        Nothing has changed as far as I know. It’s actually in the Florida LAW about no residential cosmetic manufacturing (not just agency regulations). What shutdowns and the pandemic have done to enforcement is unknown, however restrictions have lightened up in Florida, so that may not be much of an issue.

  111. Hi,
    I started years ago in Florida, but the regulations forced myself and several other body care businesses out. We all left Florida.

    The state searches for you, or competitors would report you to the state, then you get that knock on the door, and I had a separate facility. They were there taking photos, going through all my supplier invoices, it took them about 5/6 hours to totally comb over things, then they hand you a cease and desist notice. Production had to immediately be stopped. I had about 1100 orders waiting to be filled. Had to refund everyone and move my home, my facility, my family out of state.

    It was a competitor that reported us. No other state I ever worked in was like Florida’s regulations.

    I do wish Florida would at least go with the federal laws, and be as easy as all the other states I’ve worked in.

  112. Niurka

    Hi Marie,
    I wish to start produce and sell “soap” in Florida.
    I got that to produce soap where the bulk of the non-volatile portion is the alkali salt of fatty acids don’t need permission and don’t fall in “cosmetics” matter.
    I want to be sure that this true even if I add some ingredient like parsley or avocado or honey or whatever but don’t claim for their properties.
    Thank you,
    Niurka

    1. Marie Gale

      Talking apples and oranges here. Since you are making detergent-free MP soap, you are exempt from laws, regulations and licensing for cosmetic manufacturers. There are still plenty of other things that you have to take into account when starting a business and selling products. A local business license may be required (depends on the city and county in which you live). A federal tax id is required if you have employees, if your business is not a sole proprietorship, or if you don’t want to use your personal social security number for your business. A state tax id is probably required if you sell retail (for collecting and reporting sales tax) – that’s what craft fairs normally required. Ficticious name filing with the state is required if you are doing business as something other than your personal name. Your bank may require additional documents for a business account, and your accountant or tax person may need you to keep specific records for tax purposes.

      Check the Business and Finance portion of the HSCG How-To Library – there is a whole section on business start-up.

      1. Marie Gale

        I have heard rumors that enforcement is changing in Florida, but you should check with Florida State for the current information and to find out if they are allowing any exceptions.

  113. Danielle

    thank you! ill hold off on the shaving soap (only make it for the family for now) and thank you for your quick reply! the only reason I put the ingredients on my products is that as a buyer of handmade soap I prefer to know what I’m putting on my body and I assume others would want to know as well =]

  114. Danielle

    thank you for your reply!
    i have a couple more questions.

    im going to hold off on all the other stuff until im able to get everything needed.

    my questions are.
    am I able to make shave soaps? or does that fall in the lines of cosmetic?

    and can I make face bars if labeled
    Face Soap with ingredients listed on the back

  115. Hi,
    I have learned so much reading all of this, so thank you.
    I definitely decided to stick to making soaps, but I was wondering if I could describe the soap as mild?

    1. Marie Gale

      It’s unfortunate that regulations often don’t make sense! Maybe they were based on a good idea at the beginning – but it rarely stays that way.

    2. Irina Everret

      Dear Javier,
      Did you try to open cosmetics manufacturing in Florida? Do you know requirements for facility where you can manufacture cosmetics in Florida. I am trying to find information about cosmetics manufacturer compliance and how to open cosmetics manufacturing facility in Florida.

      1. Marie Gale

        Rebecca – could you have your friend email me? I’d be very interested in her story!

      2. Marie Gale

        Thanks for that info! Please keep me updated as you find out more about what they will and won’t allow.

      3. Vicky

        Could I get more information and what licensing or requirements did she have to maintain? Thank you very much.

      4. Rebecca & Marie – hi! I’m wondering if I could get a clarification as far as your friend goes, Rebecca? Moving to FL this summer and would like to continue my soap business from home as well 🙂 Thank you so much!

      5. Marie Gale

        Cosmetics are defined as products that are applied to the human body … so products for animals are not cosmetics and don’t fall under the cosmetic manufacturing laws. Keep in mind, however, that sunscreen is considered a drug as are “skin protectants.” I’m not sure if paw protectants would fall under the same category. If a product is intended to alter the function or structure of the body it’s a drug … and the FDA regulates animal/veterinary drugs the simiarly as they do human drugs.

      6. Michael

        Did anything come up on this as of late? Be interested to see what enforcement and residential restrictions looks like given the pandemic.

      7. Marie Gale

        Body butter is a cosmetic. If you make it in Florida to sell, then yes, you need to be registered as a cosmtic manufacturer. You can’t have your manufacturing in your home.

      8. Marie Gale

        Whether the location of your manufacturing facility needs to be in a manufacturing or commerial zone is normally a factor of the local (city or county) requirements. You’ll have to check locally to see what ordinances apply.

        If your products are manufactured for you and all you do is label them, without opening them, you shouldn’t require a manufacturer’s license.

        As you said, candles aren’t cosmetics. There aren’t any additional federal regulations covering them; I don’t think there are any additional regulations in Florida (but I haven’t checked in depth). If you are making and selling candles, I HIGHLY recommend that you have product and general liability insurance. The Handcrafted Soap and Cosmetic Guild has good insurnace options available.

  116. Danielle

    so I’m wanting to start selling
    bath bombs
    bath salts (maybe)
    lotion bars scrubs (salt and sugar)
    and melt and pour soaps (colors and fragrance oils added only) not detergent based

    what do I have to do to sell these legally?
    if I understand correctly i can make the soap in the home and sell no problem.

    just not sure about the other products.
    since its just frangrance oils and colors added to the soap with no claim that it makes the skin soft or heals.

    i would list everything thats put into the soaps and other products
    for example
    *name of soap*
    soap
    weight
    on the back listed ingredients***

    would this labeling be correct for the soap?

    1. Marie Gale

      I can understand your concern. You should write the governor of Florida, Ron DeSantis, and tell him that you were planning to move there but probably won’t be doing so because the small/home business restrictions.

      I don’t know how people are doing it. I expect there are quite a few flying under the radar.

  117. Cindy

    Hello, I live in Florida. Could i make bath bombs and label them to be used for “FUN in the Tub purpose”. Ive called the FDA and they said it depends on the intent of the product that determines if its a cosmetic or not. But i feel like its a very grey area and would like a clear answer.

    1. Marie Gale

      Tis is the official and legal definition of a cosmetic:

      The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

      The definition includes things like make-up, shampoo, lotions, creams, lipstick, lip gloss, beard oil, shaving cream, bubble bath, etc.

      A bath bomb is a cosmetic. In order to make them in the state of Florida, you are supposed to be registered as a cosmetic manufacturer.

      Of course, a bath bomb could be a drug — if the intent was to cure or treat some disease (say, as a soak for sprains or to clear a stuffy head).

      1. Is a bath bomb a “cosmetic” if it’s not for cleansing, beautifying, promoting attractiveness, or altering appearance? If it’s just to fizz in bath water and feel nice, that doesn’t look like it fits the definition of “cosmetic” any more than pool maintenance chemicals would. Seems like it would have to be intended to leave something on your skin to be a “cosmetic”.

      2. Marie Gale

        Yes – it is a cosmetic. It is applied to the human body – generally for cleansing or for perfuming. Either way, that’s a cosmetic.

        If you were to classify it under the concept that it changes the way your feel (your mental state) AND it is applied to the human body, then it would be a drug (but, of course, it would need to go through the clinical trials to prove effectiveness in mood improvement).

  118. Katie

    Hello,

    Are there any new updates regarding cosmetics?

    1. Marie Gale

      There’s legislation in the works, but no changes to the cosmetic laws or regulations at this time.

  119. I just went on the site to see if they have updated any information as of yet. I am still waiting to see how much that it will cost. Would you happen to know a number that I could call to get the information ? The application still has not been updated. Thank you.

    1. Jackie

      Hi there, Thank you so much for all your hard work and comments and keeping us updated. I just have a question in regards to soap making/selling. If I were to create solely “soap”, the lye and oils definition, would I still need to have the safe practices in place ie. not created in my home? I have been soaping as a hobby and many of my friends have encouraged me to start selling but I’m not sure what is all required. It would only be marketed as soap, so then would I be able to sell the soaps that I create in home here in Florida? Thanks so much!

      1. Marie Gale

        A suitable space in a commercial kitchen would probably work for the physical space requirements. Keep in mind that in addition to the space, is making sure that basic good manufacturing practices are in place is a hefty portion of what they look at. All the things necessary to making sure that your products won’t become adulaterated or misbranded. It includes things like batch records, batch numbers, retain samples, proper handling of raw materials, written procedures, etc. If you don’t have my book on GMP, it would be a good place to start. You can get it at Amazon.com here.

  120. Allicia Dean

    I will be purchasing soap bars/loaves (cleansing purposes only!; non-cosmetic and non-drug) and bath bombs (cleansing purposes only) from a wholesaler and labeling items as my own to sell online. The items will be labeled as “soap” and “bath bombs”. Do you need a license, permit or insurance through your department or agency? The items would be delivered to me, I would put labels on them and mail them to purchasing customers. Again, the soap and bath bombs will not be considered cosmetic or drug; cleansing purposes only. I will be only putting the soap and bath bombs in shrink wrap and placing the label on the items.

  121. Margarita Goodman

    HI, I hope this thread is still live.
    The question I have is I am wanting to sell hair oils and essential oils (that can also be used as lotion), however my twist is the customer mixes the oils themselves. I originally was going to set the business up as me mixing the oils, but with all the regulations around it I was wondering if I would still need a manufacturing license if I allow them to mix it themselves. I would have jars of different oils and essential oils for them to mix themselves with a percentage recipe for them to follow. I also want to sell this online and it seems with the manufacturing rules, I would still have to get a license and a place.
    I was then thinking of a small store front that I can use the front to sell the oils and the back to make the online orders, hoping that would work. It is just hard as a person just starting out who does not have the funds for all the fees required, as well as getting a store front and not knowing if it will pass inspection.
    Any suggestions for my dilemma?

    1. Marie Gale

      If you are mixing up the product for the customer, then it definitely falls under cosmetic manufacturing (although it’s really a stretch to call it “manufacturing” when you are making products one at a time … the regulators really don’t get our industry!).

      I’m not sure how it would work if you had a store front and the customers mixed the products. I expect that someone would want to make sure that you had good manufacturing practices in place to ensure that the products didn’t get contaminated — especially if the customers are handling them. You should probably check with the state inspectors office to see what they ahve to say about that.

  122. Joan

    Hi Marie, I live in Florida and make lye soap. I was wanting to add salt scrubs and bath bombs to my inventory to sell. Am I allowed to make and sell these products without a permit? I’m only using household ingredients like baking soda, salt, oils, etc.. Also, I was going to make bubble bars but I use SLSA sometimes and Cocamidopropyl Betaine (Coco Betaine) which is made from coconuts. Its a bubbling agent. I’m sure the bubble bars fall into the cosmetic area. If I can’t sell these products, may I give them away? Like buy 3 bars of soap and get a bubble bar free?
    Thank you, Joan

  123. Joan

    Hello, I have a question. I make lye soap and was going to add salt scrubs and bath bombs to my line. Am I ok to sell these products? They only contain basic household ingredients. Baking soda, corn starch, salts, oils. Etc… I make no claims. Also, was going to sell bubble bars but they have Cocamidopropyl Betaine ( Coco Betaine) which is made from coconuts and is for bubbles. I’m sure this falls into cosmetics? Can I give them away instead of selling them and not need a permit? Like buy 3 soaps and get a free bubble bar? Thank you
    PS : I live in Florida also.

    1. Marie Gale

      Correct – no cosmetic license if you’re not making cosmetics (and lye/fatty acid soap is exempt from the definition of a cosmetic — unless cosmetic claims are made).

      The OTHER things you need (licenses, etc) aren’t about soap, but arer about your BUSINESS (same as most any other business). You need to register your business, get a tax license/id, collect sales taxes, etc. Your local city or county may require that you have a business license in order to do business in their jurisdiction (that just depends on the local laws). Also depending on your local city or county, you may have zoning requirements for manufacturing (soap or anything else) – some places have stricter rules for what can be done in residential or downtown areas. I don’t know of any place that requires a “professional license” for soapmakers (like a hairdresser or masseuse, for example).

      In Florida, much of that is managed at https://dos.myflorida.com/sunbiz/. They also have general information on starting a business.

      1. According to the state, the commercial kitchen can only be used for cosmetic manufacturing, no food commercials kitchen qualify.

  124. Diane Riley

    I have searched myfloridalicense.com for many soap companies who I know make creams in Florida, either in their home or store. I am unable to find one company that has a Florida Business license. I’ve found them on sunbiz.org with a dba registration, but can’t find any with a state license. Can you help….I feel like I must be doing something wrong in my search. Is it possible to give me one example of a small soap company making their own handmade soaps and creams with a state license?

    1. Jessica

      Oh Florida.
      So I understand that if I’m making soap from lye and fatty acids and /or using mp bases that are not detergent based, I don’t need a cosmetic liscence. But do I need another liscence to sell the soap? That’s what I can’t find a clear answer on. What do I need to do to legally sell soap?

      1. Marie Gale

        I have heard of several people considering this option, but I don’t know if anyone has actually been approved.

  125. Dana

    Is shampoo bars considered cosmetic ? Could it be label d as shampoo bar? Being made via cold/hot process without making any claims other than soap

  126. danii

    I just moved to Fl and made soap mostly for myself and family members… do i need to register or do anything if my soaps are melt and pore base nothing added but color and scents?
    what about other processed soaps? i dont really add anything into them other then scents and color. sorry as i stated i just moved here my old place didnt have any laws regarding soap making

  127. Steph Davis

    I make salves. I want to sell them at the market with my herbal teas. Nothing I find really talks about what salves are really considered. I personally wouldn’t consider them cosmetic but I’m thinking the state of Florida might consider them that. I really don’t have the funds right now to rent a commercial space to do all this. Any insight???

  128. Daisy

    Hello Marie,
    I am so confused. I live in florida. I make only detergent free M&P soap. I understand i can make this at home and sell without a problem. However, if i am not required to registered/licence, and if i get insurance (to protect myself) would that be sufficient? By the way, do i still need to get a tax id #???? Some craft shows required tax id # to participate.
    Thank you so much!!!!
    Daisy

    1. Lourdes

      Marie,
      Is there anything new based on this question? We are starting our soap and scrub business and were unaware of the restrictions here in FL. Just wondering if there are exceptions and what we need to do to get the correct licenses and permits to make the scrubs in our home.
      Thanks for all the great info!

      1. Marie Gale

        You must meet three main criteria for you soap to be EXEMPT from the cosmetic laws:

        1) The main portion (bulk) of the soap must be the alkali salts of fatty acids (in other words, made with lye and oil). If you are mixing up the soap from lye and oil, it meets this criteria. If you are using melt and pour soap, check the ingrediets to make sure they are primarily lye and oils (or are listed as “sodium ____ate” i.e. “sodium olivate” or “sodium palmate” etc).

        2) You only call it “soap”

        3) You only claim that it cleans/cleanses. No other claims about what it will do (moisturize, soothe, etc). Just cleans.

        If your soap is made with a detergent (some MP soaps are) OR you call it something else (“shampoo” for example) OR you say it will do anything more than clean … then it falls under the cosmetic rules.

      2. Marie Gale

        The Florida Cosmetic Manufacturer information has been updated to reflect that cosmetic products no longer need to be registered (based on the bill that was signed on June 2nd).

        The current permit (updated 2017) still has the $800 two-year fee. I guess it’s more complicated for them to figure out how much is “sufficient to cover the costs” of administering the program.

      3. Marie Gale

        Tricky. I don’t exactly know how Florida interprets their laws in this case.

        At a federal level, the labeling is for products that are being marketed and sold – if it’s for personal or professional use, they don’t apply.

        I would think that if you are just “mixing up beneficial components” for each customer individually at the time of the facial, it wouldn’t really be considered “cosmetic manufacturing”. Although it’s possible that some officious official could say otherwise, your’re probably okay.

  129. Soon to be… Sylvia’s Sweet Scrubs

    In my humble opinion, since I used to help customers open businesses and register licenses that have to deal with state, city and/or county licenses and fees; if you are selling a product that customers will either consume or apply to their body, we should have such regulations. Other wise who knows what will be sold to the public and who knows what their reactions might be if they’re not inspected or regulated? I look at it as if it were a restaurant, and believe we should all be inspected and regulated. And as far as the fees go, well if there is a $950 application fee, it should be worth your while other wise don’t sell or make that product. Again, my humble opinion.

  130. Javier G.

    Hi Everyone,
    From my point of view, Product registration is nothing compared with the actual facility requirement. For all of you that are just starting out, this is the end. The setup costs, insurance, GMP compliance, permits.. will kill all your initial capital and without selling a jar. The same way that a kitchen can be authorized for commercial purposes, a home can qualify to be in compliance with GMP (I know what I’m talking about). Regulation just doesn’t make sense.
    Javier

    1. Marie Gale

      If the appraiser considered it a commercial outbuilding and the county is taxing it as such, you might have good grounds for getting okay to manufacture cosmetics there. I expect it would be up to the inspector to determine if it is still “residential” or not. Can’t hurt to try!

      1. Elizabeth

        Oh, sorry, one more question about the last soap statement in this section! Do you still need a business permit to make soap in your home that you intend to sell?

  131. Katie

    What about using a foaming hand soap base and adding our own fragrance? Is that also considered a cosmetic?

    1. Marie Gale

      Yes, hard to deal with Florida — I don’t think they realized there are so many small manufacturers that are covered by the law … they don’t want the headache. Even so, the regs are the regs.

      As far as I have been able to determine, even a separate building on a residential property is not acceptable — but there has been conflicting information on this. It depends on whether the regulation is interpreted to mean “not IN a residential home” or “not ON a residential property”.

      As for selling products that are made and packaged in another state — I believe that would be like purchasing products from somewhere to resell … the “florida cosmetic manufacturer” regulations apply to manufacture IN florida. You should (mind you, this is my un-lawyer opinion) be fine.

      1. Marie Gale

        If you are labeling them in-house in Florida, then you are a relabeler, which needs a cosmetic manufacturing license as far as I can tell.

  132. Katie

    Thank you Marie!

  133. Katie

    Marie,
    So what is my next step if I wanted to sell as a business? Did they waive all fees yet?

  134. Katie

    Hi Marie,

    I use a foaming bath whip base to make whipped soap. I will post the Ingredents later so you can help me decide. Unless you kbow what I’m talking about. Thank you for all the help.

  135. Katie

    Marie,

    I need help. I started making soap and I am afraid it may fall under the cosmetic law. Can you pleasee help me too see how I can figure this out. What do you need from Me? Just my Ingredents? I am in Florida.

  136. Rebecca

    For everyone worried about making soap in your home. Unless they let my friend slid by the “rules” she is making soap and other products IN her “residential home”. She makes bath bombs, lotions, chapstick, soaps, hand soaps, shampoos and other things as well. She upgraded her license and was approved just recently.

    1. Marie Gale

      Whether a shower gel is a “soap” that is exempt from the definition of a cosmetic depends on what it is made from. The laws for small cosmetic manufacturers recently changed in Florida – see Florida – 2021-Changes to Cosmetic Manufacturers Law.

  137. Melinda Cusack

    Thank you Marie! Appreciate all your hard work keeping us informed!

  138. Melinda Cusack

    I tried calling them yesterday…we’re not helpful.. almost argumentative. I had 2 simple questions l wanted clarification for and did not have an answer. If l produced, packaged and labeled in another state and just brought back to sell could l get in trouble….no answer? I read the law like 10 times…seems like it would be legal? And if a separate bldg on a rural property would be acceptable….why can’t it be in your own property….l would obviously do and follow all the requirements…..so confusing…..l should not have moved here l guess before checking back these laws. I had no idea….so disappointed in Florida!!

  139. Marie

    I just want to resell 100% therapeutic grade essential oils. The small .05 oz. Already have a Homemade Organic / Natural soap business in Florida and our customer are always asking about EO’S. These are unopened and still sealed from manufacturer I would just have a assortment on the table with out any explanation for use. I’ve been looking for a issue on line and have not been able to find one. Are you aware of an issue?

    1. Marie Gale

      So long as you are not manufacturing, you don’t need to deal with the regulations covering cosmetic manufacturers in Florida. You can purchase and resell just like any other “store”.

  140. Patty

    Hi Marie,

    Thanks for all the information you’ve provide to all of us. I just want to clarify after so much reading, that if I want to make/sell CP soap in FL, I cannot make the soap in my residence but need a separate licensed commercial facility? The CP soap is not a cosmetic and therefore doesn’t fall under the Florida cosmetic regulations.? BUT the minute I add a lotion or sugar scrub to my product line, those products do fall under the Florida cosmetic manufacturing regulations?

    Hopefully I am understanding this correctly? If I am, it’s sad because I want to produce handcrafted soap for online, craft fairs, etc, but don’t have the income to rent a commercial facility.

    Thank you!

    1. Marie Gale

      The regulations in Florida apply to cosmetics, and require a separate licensed facility.

      Cold process soap, provided it is marketed and sold only as “soap” (with no other claims than “cleansing”) is not a cosmetic. You can make and sell soap without going through the cosmetic manufacturing facility registration.

      But, as you said, the minute you add a lotion or sugar scrub to your line (assuming you are making it yourself) you DO fall under the Florida cosmetic manufacturers regulations and must operate out of an approved facility.

  141. Thank you for your wonderful work and information on your blog. I currently make handmade soap in Florida and was wondering if I can sell whipped soap legally in Florida if I don’t make any other claims other than that it is soap in a “whipped” form. All of these regulations are so confusing. Thank you so much for your help!

    1. Rebecca

      Marie I have a friend who just a few months ago got her FDA approval to make soap, creams and other products which are made in her home.

      1. Angela

        Hi Marie, Are shower gels ok to make in your home in the state of Florida. Do they fall under “soap”

      2. Marie Gale

        It’s what you SAY about the product in order to tell the consumer the intended use – so if you SAY castor oil is moisturizing, then that would make the intended use “moisturizing” … which makes the soap a cosmetic. What you put in the product doesn’t determine the intended use.

      3. Marie Gale

        For drugs (federal and Florida) there are two issues:

        First, for a drug to be entered onto the market it must be approved as safe and effective. There are two types of approvals – over the counter and new drugs. The new drug approval process is long, complex, and expensive (think about how much a company goes through to get any new drug on the market. Even the covid vaccines, being rushed through and skipping many of the testing/safety requirements, took months and months and millions of dollars. Over-the-counter drugs are ones that already have safe specifications and the product must meet those specifications for active ingredients and exactly what can be said about it. For example, a product with a certain percent of salicylic acid may be sold as an OTC acne treatment, provided only certain statements are made. Each OTC drug has a “monograph” which details the allowed active ingredients and the claims that may be made.

        Second, the facility must be licensed, registered and approved as a drug manufacturing facility. The good manufacturing practices are specified in regulations and they must be met in order for the facility to stay in business. The GMP is at the level that would be required to manufacture ANY drugs so – as you can imagine – they are very detailed and exact.

        Drugs are approved (and the OTC specifications set) at the federal level. Drug manufacturing facilities must be registered and approved at both the federal and state level. Neither of these things are within my area of expertise, so if you want to go down that path, you should find a consultant that specializes in drug manufacturing.

    2. Bobbi

      If I were to buy bath bombs private label outside of Florida and just put my label on them, would I need a permit?

      1. Marie Gale

        The key for FLORIDA regulations is that cosmetic manufacturers must register and get licensed. If you aren’t actually making (or repacking) the cosmetics in Florida, then no manufacturing license is needed. Any business can purchase packaged cosmetic products to sell on their website, in person, to stores, etc.

        Since you have a registered business in Florida, you probably already have your basic business requirements in place (taxes, filing, accounting, business registration and all that). You could purchase product from any company – or make anything that is legal for you to make – to sell in your business.

        If you go to Arizona and make the products, you essentially end up having a business in Arizona that makes cosmetic products (under the laws of Arizona) and then transfers them to your company in Florida. You may run into a BUSINESS issue (for which you may need accounting and/or legal assistance) having to do with your corporate structure and taxes. Are they the same business, with offices in two states and registered in one state as an “out of state corporation”? Are they two different businesses, one selling to the other – in which case you probably need business registration in EACH state, with taxes and such (and the Florida business buying from the Arizona business)? There may be other scenarios that work as well … again, that’s something you should work out with an accountant and/or attorney to figure out what is best

      2. Marie Gale

        Yes, if the products are applied to the human body (to beautify or make more attractive) and you are NOT making any claims that they will alter the function or structure of the body, then they be considered cosmetics and be subject the the laws and regulations that apply to cosmetic products.

  142. Shannon

    I just want to sell soap. What do I need?

    1. Marie Gale

      Soap, so long as the bulk of it is the alkali salt of fatty acids (lye/oil/water) AND it is marketed and sold only as “soap,” isn’t a cosmetic. It is not covered by the Florida cosmetic manufacturer regulations. As far as I know, there aren’t any restrictions in Florida on making and selling soap. You might have some licensing or zoning issues in your town or county (for example, having a business in residentially zoned area). You should check that out as well.

  143. Alhisson Cartagena

    Hello, I’m planning on opening an Organic skin care product online business. I will be preparing, shipping, manufacturing, and producing them. They are 100% Organic and handmade. I would like to know if I need a License or any permits for either the product itself or my business location in Miami Florida, please.

    1. Marie Gale

      If you are making products in Florida, you will need to be licenses ($800 for 2 years), inspected ($150) and approved by the State of Florida as a cosmetic manufacturer. You’ll need a facility outside your residence (and if Miami has zoning restrictions, it will need to be in a correctly zoned building). If you want to say the products are “organic” you probably need to be a certified organic producer under the National Organic Products program (under the USDA). I’d also suggest general and product liability insurance.

  144. Pam Birtolo

    Hi Marie,
    I met you at the HSCG annual conference this year and we chatted while you signed books for me. Thanks for all you are doing for the industry! With the new Florida law, I am still a bit confused about what I need to do to sell my homemade ‘lotions and potions’ here in FL. I have read the bill content and then I did go to the DBPR website. I learned about what I no longer need to do, but I sure would like to know what all we still must do. Any advice?

    1. Marie Gale

      You still have to register your facility (currently $800 for 2 years), get it inspected ($150) and approved before you can manufacture cosmetics. The main requirements have to do with making sure that you have sufficient good manufacturing practices in place to make sure that your product won’t be adulterated or misbranded. The facility can’t been in a residence, although it looks like it MIGHT be acceptable if it is on a residential property, but in a separate building. You may also need to check local zoning regulations to see if there are any restrictions on where “manufacturing” can be located.

      1. shelly asbury

        Just as an FYI – I reached out to “the powers that be” in Florida regarding a separate building on residential property and I was sent a response with a big fat NO – that is not allowed. The facility/space has to be totally located in a different area than the residential property.

        Even though they have loosened the regulations a little bit, they are still making it difficult on the small business soap, etc. makers. 🙁 However, I can make food (certain types) out of my house and sell it to you without regulation.

  145. Hannah

    So in Florida is it legal to make just soap in my home and sell it? (without making “medical” claims)
    Is there anything I should know or do first?

  146. Ursula Nash

    The $800 bi-annual fee and inspection fee of $150 are on the updated cosmetic manufacturing permit effective July 1, 2017.

    1. Marie Gale

      That sounds about right!

  147. Lisa Wicklein

    Marie, the Florida Statutes still state thus far that the permit costs “may not be less than $250 or more than $400 annually” (https://goo.gl/VKv6iW), and the DBPR seems to have removed the online application version. The paper-based application still reflects the old fees. Being that this just went into (official) effect on July 1st, 2017, I’d say it’s safe to presume that it will take many administrative hours to update all connecting documentations and forms with the new information that just passed.

    In a private Facebook Group specific to FL-based soapmakers, some of the members were sharing phone call experiences to the DBPR on the topic of whether the place of manufacturing to be permitted can be on your residential lot, or not (and not attached to the residence). So far, there have not been clear-cut answers, as a clear-cut answer seems to possibly impede on each county’s Zoning Laws enforced (for example, one person stated that the location to be permitted needs to be Zoned for Manufacturing only and cannot be Zoned for Commercial). This is one part of the bill that is so utterly confusing, vague, and undefined, and mixed answers from the DBPR do not seem to inform callers inquiring of this information with specific answers. However, I would also presume defining the “permitted location” may negatively impact small businesses already permitted.

    1. LeeAnne Williams

      I called today 2-19-2020 & was told the fee is $800

      1. Marie Gale

        I don’t know of any campaigns to change the registration regulations. There was recently a successful move to remove the requirement (and cost) of registering all products, but removing the registration … not that I know of.

        There has been FEDERAL legislation in previous years that might have had an effect — but anything has to be reintroduced in the new legislative session and we’ll have to wait and see what comes.

  148. Kari Basye

    Thank you Marie for all the hard work you do to keep us all informed ❤️

    1. Marie Gale

      The website has probably not been updated yet.

      The actual bill changes the wording of the cost of registration permit.

      It used to say the cost of the permit “may not be less than $250 or more than $400 annually.”

      With the change, the regulation will say the cost “shall be sufficient to cover the costs of administering the cosmeting manufacturer permit program.”

      My guess is that it was a compromise since they are losing the revenue from the individual product registrations. At this point it is unknown what the actual registration permit fee will be.

    2. Im confused please help. Im a skin specialist been making my own products to use on my skin clients at my spa in Colorado. I dont sell or charge for product just usage . i make custom for each facial .. Moved to fl. Question if im not selling or charging do i still need to register as a manufactor and what are my guide lines for only using not sellinh. Please help

  149. Kari Basye

    I’m wondering if a residence had an attached apartment that was it’s in “dwelling”, if that would meet proper qualifications. The only entrance is from the outside of the apartment.

    1. Marie Gale

      Actually, cosmetic ARE regulated by the FDA … they just don’t have a lot of requirements outside of the basics of labeling and the mandate that products may not be adulterated or misbranded.

      The labeling regulations cover the misbranded part.

      Implementation of good manufacturing practices is considered to be the way to ensure that products don’t BECOME adulterated.

      Florida has gone a step further by requiring licensing for cosmetic manufacturers — the standards for which are the same as the basic GMP guidelines for cosmetics.

  150. Nancy

    I don’t see anywhere that the $800 permit fee has been removed.

    1. Marie Gale

      I assume when you are talking about the “FDA” here, you are referring to the State of Florida licensing for cosmetics?

      You are right about cosmetics just getting tagged onto the drug regulations … that’s where all the GMP requirements come from. It was in place well before the current Personal Care Products Safety Act, though. If the PCPSA goes is approved with the preemption section intact, it may make it much easier in the states (like Florida) that have more difficult regulations.

    2. Regina

      Cosmetics are NOT regulated by the FDA, so why does the building need to be of FDA standards? Seems like they want to be of some say but not want the total responsibility for regulating Cosmetics.

      1. Marie Gale

        If you are working under a business name, then you’ll need to register that with the State of Florida (don’t have to if it’s in your own name). If you are starting a business, you’ll need all that stuff in order to have a bank account in your business name. The Handcrafted Soap and Cosmetic Guild How-To Library has a good section on business and business start-up requirements.

        Business permit or license depends on the city and/or county you live in. Some cities say you can’t have a business in your home – some limit the KIND of business that can be in a home — some don’t care and don’t have any permit or license requirements. You’ll have to check locally.

      2. Marie Gale

        Technically, as soon as you start selling, you are a “cosmetic manufacturer” and would need to fulfill all of the cosmetic manufacturer regulations. Probably not something you want to attempt until you have decided if you want to go into business or not.

        If you are just market testing, don’t sell it – give it away. But if your friends or family wanted to help you buy some of your supplies because they love you….

      3. Marie Gale

        In Florida, a shaving soap is probably considered a cosmetic because the intended use isn’t to CLEAN, it’s to make it possible to SHAVE. Soap can only be marketed as sold as “soap” AND can only claim to be cleansing.

        “Face soap” – so long as it is intended only to CLEAN (and not to moisturize or do anything else) is a soap.

        Ingredients aren’t required for soap (although they may be included); they are required for cosmetics.

  151. I know this refers to just Cosmetic manufacturers.

    What I found interesting was these two requirements;
    -An establishment that is a place of residence may not receive a permit and may not operate as a cosmetic manufacturer or repackager.
    -Good manufacturing practices must be sufficiently in place to ensure that the products produced are safe and are not (and won’t become) adulterated.

    The first would eliminate manufacturing at a home. Of interest would be a clarification if a separate segregated space would suffice or must they locate to a separate building or location.

    The second outlines a duty to follow cGMP. Inherent to that is a requirement to have programs into place and to record compliance. If this is a wek area for you, I would purchase a copy of Marie’s book on Cosmetic cGMP (available on Amazon).

    1. Florida Regulations physical facility requirements of smooth floor and smooth ceilings. A smooth ceiling requirement can FDA approved ceiling tiles that are waterproof which can simply replace the common used the suspended ceiling tiles, and be bought online. From what I been seeing a case of 10 2 x 4 drop in tiles are about 110. 00 a case. The smooth floor is a totally different story. The material used must be FDA approved and from what I am finding its an epoxy. The thing about a smooth floor is that it has no seems. A seamless linoleum floor could be a cheaper alternative but not sure if its FDA approved.

      The FDA also wants all your corporate information so send them copies with your application to save some time. They also want copies of your product labels. From what I was told, all labels must be FDA approved first before selling the product. I asked the time period to have labels approved but never got that answer and was told I need to be more specific with the question. There is also an application received wait period from 22 – 28 days for your application to be review. Also application page 8 section VII Manufacturing Activities requires written policy procedures to be included in the filing of the application.

      There is a whole lot going on here in Florida especially when it seems they just tagged soaps cosmetics as drugs to appease lobbyist of senator dianne feinstein of California and senator susan collins of maine with the origination of the Personal Care Products Safety Act. The President said he wants to bring manufacturing back to made in USA so its time to become a personal lobbyist and petition the President and the over the top regulations to sell some soap and lotions.

      As for me, I am trying to figure out how to get exempt from the FDA smooth floor requirements with different easy to clean flooring since their regulations has very little to do with the harmless nature of soaps, cosmetic and or repackaging.

      P.S. I hope i didn’t discourage anyone out there
      P.SS. I was thanked for my 950.00 payment to the FDA
      P.S.S.S If all else fails I just might write my own soap and cosmetic bill that’s logical, doable, and sensible for all the handcrafted entrepreneurs and then press the politicians with it, and to boot a simple comprehensive internet tax plan to keep the IRS off our backs.

      Peace out Richie

      1. Marie Gale

        Those are all cosmetics. So you’d have to be licensed as a cosmetic manufacturer in Florida.

        I doubt you can give them away with soap, because purchase is “required” in order to get the product … so they are essentially buying the product. Again, that would make you a commercial cosmetic manufacturer.

      2. Marie Gale

        Again, it depends on what the hand soap is made of and how you market it. In order to be exempt from the cosmetic manufacturing regulations, it must be “true soap”, and only marketed as “soap” without any other cosmetic claims. Otherwise, it’s a cosmetic and the cosmetic manufacturing regulations apply.

      3. Missy

        As lifelong Texans, recently relocated to Florida (forced to relocate by jobs), just the simple act of building our shop (aka to Floridians, “shed”), was a feat. We had to have an engineer draw up the design for the slab alone. We decided to have our home reappraised recently after spending a considerable amount on our shop, outbuilding, shed, etc., and they had to appraise it under a “commercial outbuilding” because of the specs…nothing else in the vicinity to compare it to (2K sq. ft). SO I am wondering….could this be our out?? we are DIYers and want to make soap (lye-based), AND lotion bars, etc, but I also had an Etsy shop. Why can’t I make what I want and sell wherever I want (and if I have to, not ship anywhere in FL??). Does this make sense?

      4. Marie Gale

        The key is the definition of “soap” from the regulations – it has two parts:

        1) If the “bulk of the non-volatile portion is the alkali salt of fatty acids” (that is, it is made with lye & oil) it is considered soap. Note that it’s the “bulk” of it …. so adding fragrance, color or even some additives (clay, herbs, etc) would still leave the “bulk” of it as soap.

        2) It can only be labeled and marketed as “soap” and only claim to CLEAN.

        Soap becomes a cosmetic if either of those things are violated —- for example:

        If the soap is made with detergents (not lye/oil)
        If the soap claims to moisturize.
        If the soap claims to make your skin softer, smoother, brighter, happier, etc.

        In Florida, a COSMETIC manufacturer must be licensed and inspected and cannot make the product in a residence.

        When the product is a SOAP that is exempt from the definition of a cosmetic, then no licensing is necessary and it CAN be made at home.

      5. Marie Gale

        The Florida definition of a cosmetic is just about the same as the FDA definition. From the Florida statutes [499.03]:

        (13) “Cosmetic” means an article, with the exception of soap, that is:
        (a) Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or
        (b) Intended for use as a component of any such article.

        They don’t define “soap” in the statute, and I didn’t see it in the regulations that I have reviewed. I expect they use the same definition that the FDA uses [21 CFR 701.20(a)]:

        (a) In its definition of the term cosmetic, the Federal Food Drug, and Cosmetic Act specifically excludes soap. The term soap is nowhere defined in the act. In administering the act, the Food and Drug Administration interprets the term “soap” to apply only to articles that meet the following conditions:
        (1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and
        (2) The product is labeled, sold and represented only as soap.

        So long as the product is “soap” and meets the definition of soap, it is likely to be exempt from the definition of a cosmetic.

        As for pet products – the definition of a cosmetic is for articles applied to the human body … so pet soap is not a cosmetic. It may be regulated under some different regulation (I haven’t researched Florida regs for pet products).

      6. Barbara

        I am so bummed out about Florida regs I am planning to move to Florida and I make soap and body butters. I don’t know if I want to live there if I can only make soap. I live in the northeast and we dont have these restrictions. Considering another state. This is just too costly for a small home-based business. How are people making out with these regs and cost. This would be prohibitive for me.

      7. Marie Gale

        If the soap you are making is exempt from the definition of a cosmetic, then it isn’t a cosmetic and you don’t have to get a cosmetic manufacturing license in florida. So you are not limited by the requirements of the cosmetic manufacturing license… and can make the product in your home (provided there aren’t any other issues).

        In order to be exempt, the bulk of it must the the alkali salt of fatty acids, and it can only be labeled, marketed and sold as “soap”. So that means no claims other than it cleans.

  152. dee

    FINALLY- As of 6/2/2017, these fees and regulations are null and void. The governor signed HB 211 into law to start 1 July 2017. Cosmetic manufacturers will only need a permit. This is a short article to read- http://saintpetersblog.com/rick-scott-signs-bill-loosening-regulations-florida-cosmetic-manufacturers/

    Here is the HB 211 law in full-https://www.flsenate.gov/Session/Bill/2017/211/ByVersion

    Click on the hyperlinks “PDF” or “2017-51”

    1. Marie Gale

      This is awesome news! Thank you!

  153. Roxie Guillen

    Marie, thank you for taking the time to answer our questions. I am planning on manufacturing cosmetics soon, and understand they cannot be done in my home. My husband is planning on building a steel building on our property where our home is for his business and was going to build a room in it for my stuff. Because it is at my home address, would this still be considered AT my home, even though it would be a separate building? Our property is zoned as agricultural land because of our grapefruit grove, if that plays any factor into it.

    1. Marie Gale

      You should check with the state for the requirements. My understanding is that the facility cannot be on a residential property … but there might be some exceptions and/or “discretionary enforcement”.

  154. Alba

    What about if I have a true soap that I would like to call “Sugar Scrub Soap” because I put sugar in it but I’m not claiming it as an exfoliant?

  155. Alba

    Thank you so much! You had help me a lot with this information. So, if I live in Tampa, Florida and I make just make melt and pour soaps, (goat’s milk and honey soap bases), with no detergents, that means that I don’t need to contact the Florida Cosmetic Regulation Department for anything. Right?

    1. Marie Gale

      So long as your soap is “true soap” – that is, the bulk of the product is the alkali salts of fatty acids, AND it is identified and marketed only as “soap” then it is exempt from the Florida cosmetic regulations. Keep in mind that if you say the soap can do ANYTHING more than clean, and you say that in a brochure, signage or on your website, then it is no longer exempt and would likely fall under cosmetic regulations.

  156. Susan Pollak

    I’m in Florida and I have a second home in Georgia. I plan to make soaps, lotions, scrubs, etc… I want to sell online, etsy and at craft shows. I’m incorporated in Florida right now, but I’m going to open the business in Georgia once I’m ready to get started. My question is this.. If I make everything in Georgia – the only way I will be selling in Florida is loading up the car and going to craft shows and farmer’s markets. I won’t have a store in Florida. Do I just need to get a business license to collect sales tax in Florida when I’m physically here selling?

    1. Marie Gale

      If your business in Georgia is legally making the products, then the product are legal to sell in Florida. If you set it up so your business in Georgia makes the products and then sells them wholesale to your business in Florida, your business in florida is just like any other retailer, selling products it purchases to resell. You’ll have to be wary of the rules for craft shows that require the vendor to make the product but otherwise so long as you are registered to sell products in Florida and collect (and pay) the correct taxes, based on the regulations I’ve read, you should be fine.

  157. Javier

    Hello everyone!
    Please, do’t be afraid of GMP and SOPs… inspectors won’t do anything unless you’re already in trouble. GMP guidelines are free on FDA official page, same for SOPs and Quality manual, everything is available for free on internet. The bad news, all your GMP and procedures MUST describe your current operations activities, so don’t copy / paste. A complete GMP program for your new facility can be created in 1 month if you have some technical writting skills and background in Quality. Javier Guandalini, Product development & Quality Engineer Pharmaceuticals. Feel free to contact me if you need some help. Regards, Javier

  158. Michael

    Hello
    I loved reading all of the post. I am a liscensed cosmetologist in fl, i make my own skin care products do use on my facial clients, i make on the spot to use on them at that moment< i do not sell any products just for my use on there skin at that moment am i violating any florida laws.
    Thank you

    1. Marie Gale

      I honestly don’t know whether the products you are making would qualify you as a cosmetic manufacturer. I think, since you are using them in a purely professional capacity and are not selling, then the regulations that apply wouldn’t be those of cosmetic manufacturers, but of cosmetologists. I don’t know what if there are any restrictions that apply to professional products used and/or made by cosmetologists in Florida.

  159. Cindy

    This is all so confusing. My daughter lives in New Orleans and makes homemade soaps, lotions ,bath bombs etc. She doesn’t know a lot about marketing or have the time to do the shipping and labeling. (she has 3 beautiful children). I told her that I would handle her online marketing and sell the above products for her on Etsy etc. if she would mail me the products once a month. Is this ok as long as she already has them boxed and sealed?

    1. Marie Gale

      If you are only selling and delivering the products that come to you all ready to go, then you are not a cosmetic manufacturer. You’re not MAKING … you are SELLING.

  160. Hi Marie!
    First, let me say that I am grateful for your website and collection of information and the fact that you share it openly with the community. It took me some time, but I have read through this whole post and all of the above comments…I have even contacted John about the Florida Cosmetics Manufacturers Coalition.
    I am in the process of opening a cosmetics manufacturing company in Ormond Beach, FL and to say the fees and process so far is frustrating is a complete understatement. I have finally been able to send out the application to the Department of Business and Professional Regulation, but I haven’t heard anything back just yet (it’s still early). I feel totally unprepared for the inspection and after reading through everything here, I feel more nervous than ever.

    I have a few questions that you may be able to help me with…

    1. I have big plans to grow my business, but I am starting with the lean start-up method so I am launching with essential oil roller bottles only – I have 15 variations. I have registered submitted to register one product with 14 “duplicate” products. We will see how the state feels about that. So, my question here is around me growing my business. The inspection will be taking place with one, simple product that I am manufacturing, but I definitely plan on adding more – should I expect that the state is going to come out and inspect my office more after I start submitting more product registrations?? It just seems RIDICULOUS to me the idea that I would jump through all of these hoops to prove that I have a clean facility and a GMP system for a single product, but that they might not care at all about what I’m doing after that first inspection…and yet that’s what it seems like at this point – one inspection and I’m done??

    2. My second question is around policy and procedure forms. I submitted my application and stated that I didn’t have any typed procedure forms because I am a one-woman show and I don’t need to write down what I’m doing because I’m not going to forget. I have cards that have the details of my formula for each product and I only make one formula at a time. After reading through the comments here I feel like I definitely need to write down the procedures for making the products – do you have any helpful information or guides for creating these policies/procedures?

    3. Is there a community that you know of that can help connect other people in Florida that have actually gone through the whole process and might be able to share their experience and help others that are just getting started? I feel lost in the crazy rules in Florida, I’ve found some people that charge a hefty hourly fee for consultation but I simply cannot afford to pay it!! I’m just hoping that there might be a group of people that might have some mentoring advice. 🙂

    Thank you so much for your help and all of the time and care that you have spent answering these questions!!!

    1. Marie Gale

      to answer your questions …

      First, I don’t know if they state is likely to inspect each time you submit additional products. I expect not, but they could. They might want to come and take a look if your products change to more complicated ones (like lotions or creams) to make sure you have safe manufacturing in place.

      Second, you definitely need procedures and forms WRITTEN DOWN. That’s part of good manufacturing practices – a major part. While you SAY you won’t forget, sometimes it is easy to just lose your place on what you are doing. And GMP requires logs of incoming ingredients and batch records with ingredients tracked. The exact specifications for what Florida expects are in their regulations, which are here: https://www.flrules.org/gateway/ruleNo.asp?id=61N-1.010. You should also check my book on GMP which gives some pretty easy record-keeping ideas, from Amazon, here.

      Third, I highly recommend you join the Handcrafted Soap and Cosmetic Guild. Not only will you get excellent information and support, there is a Facebook group for members, and local chapters are in process – one of the first of which will be Florida.

  161. Tammy Haas

    Great article! One question though, where can one find what the State of Florida requires in a facility when doing an inspection for cosmetic production? I’ve searched and searched.

    1. Marie Gale

      The requirements are in the Florida Rules. Go to https://www.flrules.org/ and then search for “Cosmetic”. You’ll have to wad through the list (it’s not long). The different sections are in Word documents that need to be downloaded separately. There are about 6 of them. The main on is rule 61N-1.010, Guidelines for Manufacturing Cosmetics (amended 2015). It’s basically general good manufacturing practices in place.

  162. Mikey

    I use to manufacture all natural products. I had a line of soap, lip balms and lotions. I went through the entire licensing process and registration of all the products. The state looks at everything from good manufacturing processes to the manufacturing area, storage area all the labeling and they do read the entire label so that needs to be setup correctly. They even looked at the product name to make sure I wasn’t adding any types of drugs. The department of health in Florida views manufacturing the same way they view pharmacutical manufacturing. You must have a complete SOP manual for all details of running your business. From manufacturing to emergency response. I spent 8 hours with the inspector going over all of my documents. I needed logs for temperatures, logs for FIFO process, batch code logs etc. It is a difficult process but dosble. I registered 63 products and spent over $2000 just to get it done. That is good for 2 years. Than you have to do re-register . My mistake was not staying with just soap. I put no claims on anything, but still did it legal. I was the only soap producer at the time that did this and it use to make me mad that the state didn’t enforce it for everyone. I’ve read the 499 rules backwards and forwards . Good luck to anyone trying to do it legal in florida. Oh yeah if your thinking of doing it part time, just throw your money away now in florida.

    1. Marie Gale

      That’s very interesting. It certainly gives an idea of what the process entails!

    2. John Ray

      Mikey – I would welcome the opportunity to talk with you about your experience with Florida’s cosmetic regulations and regulatory agency. We are leading an effort in Florida to make Florida’s cosmetic laws and regulations more business friendly. Best, John Ray, Florida Cosmetic Manufacturers Coalition jray@johnrayconsulting.com

  163. Stephanie

    Thanks! Are things like bath teas, bubble bars, & bath bombs cosmetics too? Adding bubbles to bath water? Lol these laws are sooooo confusing.

    1. Marie Gale

      Yes – all those things are cosmetics – they are “applied to the human body” and are intended to “cleanse, improve appearance or beautify”.

  164. Stephanie

    Does perfume oil fall under the cosmetics? Simply scent and oil that doesn’t “beautify or improve appearance”?

    1. Marie Gale

      Yes, perfume is a cosmetic. It is intended to “promote attractiveness” 🙂

  165. Roberta

    thank you. I will talk with an accountant.

  166. Roberta

    Hi. I live in NJ and moving next month to Florida. I make soaps, scrubs, lips balm, lotions, etc….
    I just find out about the laws in Florida is different then NJ.
    I am thinking keep my business name (register) in NJ make products here and bring to florida to sell.
    My question is. Do I have to have two business. One that I already have in NJ and open another business in Florida just for sale . Or I keep just one in NJ and pay all sales taxes to NJ state.
    Thanks

    1. Marie Gale

      The company that manufactures the products needs to be in a different state – and I assume that it would need to be all legally set up in that state.

      If you are selling in Florida, then you would at least have a way to collect and report the sales tax.

      You should probably consult an accountant about setting it up… if the business from Florida is purchasing the products from the business in New Jersey, that would have some tax ramifications in both New Jersey and Florida. Luckily Florida doesn’t have income tax, but I don’t know what other taxes in Florida and/or New Jersey would be applicable. Plus it may be affected by where you actually live. Best to get an expert opinion on the legal and accounting side of things.

  167. Pam

    I have 2 questions:
    I understand not to make cosmetic claims (makes you beautiful; leaves your skin soft) or medical claims (soothes itchy skin; cures pimples) but can I say it makes you Feel prettier? (would that be a cosmetic claim?)
    Can I say using it feels like going to a spa or feels like a walk in a garden? (would that be a medical claim?) How about it’s the most fun anyone can have in the tub (c)?
    Can I mention it removes dirt and grease without drying the skin, or removes odors from the skin (like onion or root rot) or is that a cosmetic/medical claim too? I am starting a new soap making business and I have some very specific marketing planned for my soaps, but now I am wondering if some things would be considered cosmetic or medical claims.
    Can we make soap at home? It says cosmetics must have a separate facility, but does not address location of soap making, which leads me to think a clean kitchen is acceptable.

    1. Marie Gale

      Cleansing ONLY is a soap claim.

      Beautifying or improving appearance, including removing odors – is a cosmetic claim.

      Claims to make you feel better (like (“a walk in the garden”, “fun in the tub” “like going to a spa”) are either cosmetic claims (better “feelings” which would make you look better) or they are just plain marketing claims and don’t affect the intended use at all. — UNLESS they address named “mental illnesses” which are considered “diseases”).

      Making soap is not covered by the Florida cosmetic regulations, so there are no applicable provisions about where you can (or can’t) make it.

  168. Jill

    Just want to make sure I am right. I can sell my soap here in florida without much hassle. But, my scrubs and such I will be ok if I make in my 2nd home out of state and label as such?
    Thank you so much, florida is a pain in the tookas

    1. Marie Gale

      The cosmetic products would need to be manufactured and packaged out-of-state by an out-of-state company. The label could say “manufactured for” or “distributed by” a Florida based company, however.

  169. Bernice

    Thank you so much. I read the section on melt and pour and from what I understood soap must be free of detergents?
    Now regarding the naming of the soap I have one I named first crush. Is that ok?
    Thanks again I really appreciate your advice

    1. Marie Gale

      For melt & pour to qualify as a “soap” (and be exempt from the definition of a cosmetic), it must be from oil/lye/water saponification. Use of detergents would make it a cosmetic.

      “First crush” doesn’t include an ingredient or make a claim.

  170. Bernice

    Hi Marie
    This info you’ve provided is so informative thank you for explaining it all. My question is can you give me an example of what to label soap. I saw you suggested not calling it like “peppermint soap” so what would you be allowed to call it? I make melt and pour soap and add fragrance and essential oils so I’m curious to know.

    1. Marie Gale

      Glad it’s helpful!

      First, you need to make sure that your melt and pour soap qualifies as soap. See my blog post, , for details on that.

      Second, you can only identify the soap as “soap” – without using the name of an ingredient in the identity unless the ingredient is present in “significant and functional amounts” (that’s per the FTC regulations on the statement of identity).

      Third, you can’t make any claims that the soap will do anything more than clean (otherwise the intended use would be as something different than soap, which puts you under the Florida cosmetic laws).

      So, to name the product, you could use some sort of creative name “Peppermint Passion”, for example. Or you could forego a “name” and just say that it is “Peppermint scented” or “scented with Peppermint essential oil” or something similar. The name is not required and you have free reign for marketing text (such as the scent) … so long as you don’t make any cosmetic (or drug) claims.

  171. Diane

    Folks need to know that if they “relabel” or “repackage”an item, they can do this without a permit. As long as they don’t “open” the item. So if the item has a seal on it, they can relabel it without a permit. ” Relabeling, without opening such a sealed container, does NOT require this permit.” Here is the law.

    COSMETIC MANUFACTURER
    A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in Florida.
    What is a “cosmetic”? A cosmetic is an article, with the exception of soap, that is: (a) intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance; or (b) intended for use as a component of any such article.
    What is “manufacturing”? In this context, the term includes the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any cosmetic.
    What is “repackaging”? The term includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the product. A few examples:
    • Altering a packaging component that is or may be in direct contact with the drug, device or cosmetic. For example, repackaging from 1-liter bottles into 10-milliliter bottles.
    • Relabeling, if the process involves opening the manufacturer’s sealed container. Relabeling, without opening such a sealed container, does NOT require this permit.
    What is NOT a “manufacturer”? A Florida-licensed pharmacy operating in compliance with pharmacy practice standards under the Florida Pharmacy Act, Chapter 465, Florida Statutes.
    Distributors – No Permit Required: Florida law does NOT require any permit for the distribution of cosmetics – only the manufacturing or repackaging. However, cosmetic distributors must keep and maintain sales and other distribution records records.
    Requirements:
    Application: Businesses seeking this permit must complete the Department’s application. Mail or deliver the application and all required attachments to:
    Florida Department of Business and Professional Regulation
    Drugs, Devices and Cosmetics Program
    1940 North Monroe Street
    Tallahassee, FL 32399-0783

    1. Marie Gale

      Yes, that’s true. If someone gets product made and receives it in the finished containers and then only adds a label, then it is relabeling and no permit is required. Keep in mind, though, that this does not apply to purchasing a base, adding scent and/or color and then packaging. If you “touch” the product, then you are a manufacturer or repackager. If the product is never touched, then it is just relabeling and a permid is apparently not required.

  172. Shauna

    Marie,

    I see so many people at farmers markets, flea markets, online selling homemade bath bombs, lotions, and scrubs. I am almost positive all of these people don’t have the proper licensing. They make them at home just like the rest of us but decide to sell them with their soap.
    Is it risky to do this? I really want to sell these things also but I’m not willing to go through the Florida cosmetic hassle.

    1. Marie Gale

      They probably don’t have proper licensing. All they are doing is making it more likely that there will be tougher enforcement and regulations for the rest of us.

      Risky? Probably not too risky right now … it’s the long term effect on all of us that is really the issue. And, of course, if you get caught you’ll probably have a MUCH long road to getting finally certified and approved. Don’t know what potential fines or other problems there might be.

  173. Jessica C.

    Hi Marie! Thank you so much for all of this information! I’ve been doing research for days and have not ben able to find a clear, concise answer for anything. We just moved to Florida, my mom & brother own a craft beer/wine shop and have been wanting me to make beer soap and other products for sale. SO many shops sell homemade soaps, lotions, scrubs, serums without proper labels, let alone proper registration and licenses. I’m not willing to take that risk though.

    So, I just want to make sure I am understanding correctly. I can make soap (water, lye oil) and add whatever I want to it & bypass all of this mess just by labeling it as soap, making absolutely no claims. Now, I could scent the soap with citronella and call it Citronella Soap, same with Beer Soap, Lavender Soap, Peppermint Soap – making absolutely zero claims. Now when people ask about it, I could tell them “citronella makes a great bug repellent” or “lavender is very relaxing” – but that claim is nowhere on the label, it’s only verbal. Is this correct?

    Also, could I make room sprays (that could be used on the body, but are just labeled as room spray)? Could I make bath bombs but just call them “scent bombs” and store them in a clear glass container in the store and people can pick out a few – they will just have a sign that says “scent bombs” – I can tell people you can drop them in your toliet, or your bath tub to release the fragrance.

    Could I make lip balms and just label them as “lemon stick” or “peppermint stick” and write a disclaimer saying “for scent purposes only not for cleansing, beautifying, promoting attractiveness, or altering the appearance of the user” – I can tell people I like to use it as lip balm, but the label will not say lip balm, or make any claims.

    I assume none of these regulations are valid for candles or potpourri?

    Thanks so much!

    1. Marie Gale

      Yes, Florida is tricky and there are a lot of people who are trying to get around the laws.

      If you make just soap, label it as soap and only claim that it cleans, then you are okay. Remember, that “label” includes the “labelING” which is ANY content that goes with or on the product. That includes signage, website, facebook, brochures, (and, yes, even verbal statements). Best approach is to put the ingredients on the package and tell people they should research any soap or cosmetic ingredients before purchasing (if they are unfamiliar).

      As an additional note, the FTC regulations state that the identity of a product (“soap” in this case) may not include the name of an ingredient unless it is present at “substantial and effective amounts”. You might want to consider naming the product with something other than the ingredient name (not “citronella soap”), and then say “scented with citronella” or “contains citronella” as a marketing statement that is separate from the identity of the product.

      Any product that is NOT intended to be applied to the human body is regulated the same as soap. That would include candles, room spray and potpourri.

      A product that IS intended to be applied to the human body … or COULD be applied to the human body … would be a cosmetic. Can’t make those in Florida. That includes “scent bombs” that could be used in the tub with a person, or any product that is applied to the body for scent/perfume purposes.

      Keep in mind that the inspectors are pretty savvy. Not easy to try to get around the regulations by being “tricky” with the labeling. 🙂

  174. Mary

    Hi,
    I have a part of my residence that I used to rent out. I have renovated it. May I Use t hat area as a place to make bath bombs for resale.

    1. Marie Gale

      I doubt it; the regulations prohibit cosmetic manufacturing in a residence. If it’s part of your residence, I think it’s still considered residential even if you rent it out. (Unless it is a separate building, possibly classed as commercial?)

      You could check with the licensing department, though – they could probaby give you a more specific answer.

  175. Shauna

    Hi Marie!

    Can you just briefly tell me what the requirements are JUST to sell soap with no other claims? I am wanting to start a handmade vegan soap business, but am confused on how it legally has to be packaged or what licenses I need. Thanks in advance!

    1. Marie Gale

      If you are selling soap …. that is, a product is 1) primarily made from oil, lye and water (added stuff okay); AND 2) is identified as “soap”; AND 3) is marketed as cleansing (no other claims), then it is not a cosmetic and none of the cosmetic regulations in Florida apply (or at the federal level).

      The product still must be packaged and labeled with the identity of the product (“soap”), the net weight and the name and address of the business.

      You may have other requirements in Florida for your BUSINESS, but not for the product. (For example, registering your business name, local city/county business license, sales tax collection, etc).

      Marie

  176. Francisco Diaz

    Good afternoon ,

    I would like to know more information on opening a location that I have that I will be using to fill cosmetics .

    I also want to know how to get a free sale certificate for a cosmetic product that I have .

    1. Marie Gale

      You need to contact the Florida Department of Licensing. Information on cosmetic licensing can be found here: http://www.myfloridalicense.com/dbpr/ddc/CosmeticManufacturer.html

  177. Veronica Scott

    I’m located in Florida and am attending an event where people will be buying and selling. I planned to make mosquito repellent using essential oils to sell. I am making various sized bottles and was just going to label them “Bug Spray” and list the ingredients. I didn’t planned on saying “spray on clothes and body”. The oils are mixed with distilled water and one or two other ingredients. Would they be considered “cosmetic”? I have a Facebook page for the essential oils as a distributor. I do not have a website yet.

    I love your website and have learned a lot. Thanks for sharing your expertise.

    1. Marie Gale

      Actually, bug repellants – whether applied to the body, clothes or just the air around – are governed by the Environmental Protection Agency (EPA) at the Federal level, and usually some state agency at the state level. Bug repellants require advance approval at a federal level, unless they meet the strict the requirements for Minimum Risk Pesticides. Some states have similar exemptions, but you’d have to check the the Florida version of the EPA.

  178. Kathy

    Well just the fact that I have to purchase them instead of making them myself is soooo wrong! Complying to regulations can be done in my dedicated “business” space just the same as complying in a “leased business” space. It simply has no merit. Makes you wonder how and why they came up with that nonsense.
    Thanks for the response Marie!

  179. Kathy

    Just to be sure I understood all of that:
    I can open a business making soap in my home (garage), but only soap as it is my residence. I can sell my homemade soaps online, farmers markets, etc., without registration of each soap…because it’s just soap. I could also purchase handmade lotions wholesale from someone else in another state and be allowed to sell them here in Florida with my handmade soap. Is that correct? Yea, that makes alot of sense. Seems like it would be beneficial to the state to be able to come to my residence & inspect, etc. , rather than me selling someone else’s handmade products. Did I get this right Marie?

    1. Marie Gale

      That is basically right. Remember, when you are making soap (so long as it doesn’t have cosmetic claims), then you’re not making cosmetics … so the cosmetic manufacturing regulations don’t apply.

      If you purchase products to sell (handmade, homemade or not), then you are just reselling product like any store or business … so the cosmetic manufacturing regulations don’t apply.

  180. Courtney

    Hi Marie,

    Thank you for all of the great info! I plan on making auric sprays for home use. However, I also wanted to make other products that I want to clarity on in regards to whether they’re considered cosmetic:

    1. auric sprays that are SAFE for the body (but not necessarily “meant” for body use)
    2. shower bombs for aromatherapy (that don’t go directly on the body)
    3. oil candles (also safe for the body)

    1. Marie Gale

      Products that are APPLIED to the human body are cosmetics. If the products say that they COULD be used for the body, that implies that one of the intended uses is to be applied to the human body … which would make them cosmetics. (massage candles, for example).

      If the product is clearly NOT meant to be applied to the human body, then it would not be a cosmetic.

  181. Dawn

    I called cosmetology dept in Tallahassee to clarify about homemade salt scrubs as I emailed 2x with no response. Cosmetology said they don’t regulate salt scrubs, call my local county office. I called my county tax assessor on 2/23/16 and they told me to call the dept of agriculture, called them who referred me to the dept of sales/ farmers market. The woman there said she can answer my question. She said yes I can sell salt scrubs without a license/permit. I then asked about homemade deodorant, she has to get back to me on that. I did document names, dates and times. She said she didn’t think it would be an issue but will check into that one. So I will call next week since after 2 days she hasn’t called me back.

    1. Marie Gale

      The Departement of Cosemtology would cover hairdressers, nail techs, barbers, etc. They don’t cover cosmetics (although the names are very similar). The correct department is the Florida Department of Business and Provession Regulation, Division of Drugs, Devices and Cosmetics, Cosmetic Manufacturer.

      According to their webpage and the regulations, salt scrubs and deodorant are cosmetics and WOULD require a Cosmetic Manufacturer’s license.

  182. Vernetta Holman

    Setting up a separate business division for manufacturing only in another state is acceptable? Or setting up a totally new business with a different name for manufacturing is acceptable? I moved to FL a few months ago, started this business now I’m stuck. I buy soap wholesale but want or make my other products. I’m ok with going back to Pa once a month and setting up business there for making product.

    Thanks

    1. Marie Gale

      If your business in Florida is purchasing items for resale, then it is a distributor and does not require a cosmetic manufacture’s license. In THEORY, if you owned another business in a different state that made the products and then sold them to your Florida business, then the manufacturing regulations and laws that would apply would be those of the state in which the manufacturing business is located. A lot of big companies get around local regulations like that … credit card companies have moved their headquarters to certain states because they can charge more interest there.

      That said, you should be VERY careful if you are going to attempt to do this and realise that you will have the expense of registering and running two completely separate companies in two different states … with registration, bank accounts, check, accounting, income tax, sales tax and other issues for each. It would only be worth all that time, expense and overhead if your sales are significant.

  183. Catherine Alzate

    Hi, I’m wondering…. If I make and sell soap I can do it at home in Florida correct?

    If I make the Lip balms, bath salts & scrubs and don’t sell them but give them away to buyers who purchase certain amounts. Would that be legal?

    scrubs

    1. Marie Gale

      You’d probably need to check with an attorney. However, I seem to recall there is some legal concept that if you are only giving something away when something is PURCHASED, then it’s like you are selling it. Like if you give away a lip balm, but ONLY give it away when someone buys a soap, then it could be considered that they are “purchasing” the soap AND the lip balm. Again, definitely have to check with an attorney on that one.

  184. Jackie

    Hi, what’s your opinion on this… what if I teach classes to the public on how to make infused oils, body butters, lip balms, etc. and I would supply the materials needed to make them and we all make it together. Like and arts and crafts party. I won’t sell what I make. I just provide the materials so they can make it. Also for example, I’d research the ingredients, explain what the ingredients are, the benefits, contraindications. Do you think that’s illegal? I’m researching this online and think I need to speak with someone, I don’t know whom that would be, to ask the question. If you know who the specific department to ask that question I’d appreciate that. Thank you for your time!

    1. Marie Gale

      As far as I know, there’s nothing illegal about giving classes and teaching people how to make products for their personal use. If the people you teach think they are now versed enough to sell their products, they should be informed of the laws and regulations; in any event, you should should VERY clear that the products they are making are for personal use only – not for sale. Be watchful of the “benefits” for the products you are having them make, and limit those to cosmetic benefits; otherwise you are stepping into the drug area. The Florida Departement of Licensing – Cosmetics, would be the right place to ask.

  185. We are wanting to to sale lip balm. So my question is this… I am a Florida Resident, can I sale my lip balm if I make it at a high end suite/hotel with kitchenette in Georgia or South Carolina and maintain proof of hotel stay to show it WAS made at that location.

    1. Marie Gale

      If your company is ONLY located in florida, you might run into issues if you just go out of state to manufacture and then bring the stuff back to package, market and sell. If you are going to go that route, it might be better to have a separate company in another state that MAKES the product, and then your company in Florida purchases the finished product.

      If you’re going to try to get tricky in going around the laws, you should consult an attorney to ensure you are staying on the right side of the law and regulations.

  186. Miguel

    I just wanted to start off with thank you for doing what you do Marie. It’s unfortunate that the rules and regulations are not only unfair and pretty unnecessary, but how UNCLEAR all the rules and regulations are when you go to different government websites that say one thing and then you go to another that says the opposite. So I truly thank you for clearing everything up.

    So I started making my own beard oils and balms. I launched at 2 different festivals in Florida and I have just now learned about these ridiculous rules and regulations. My product is going to be manufactured outside of the country soon for easier shipping within that country and its surrounding neighbors. My recipes are being kept within my family – my cousin is helping me with everything down there. She’s dealing with all the paperwork and stuff down there. I believe she finished it all within a day or two. I should be fine as long as I’m following the laws of that country, correct? On my label, it only states that my product is made in the USA/product of USA. I don’t specify WHERE in the USA, but after reading through this article and all the comments, I might just move back to California.

    I currently rent out a space where we highly sanitize everything with rubbing alcohol before use, new pipettes for every batch, etc. No bathroom or sink, since it’s a storage unit, but after the batch is done, all the dirty dishes (which are strictly for making the balms) gets taken home and washed very thoroughly with its own special soap.

    I’m going to try and find any information in regards to cosmetic regulations in California and possibly using a California address as where my business is operated. If I have my products manufactured there and sent here, would I need to prove every detail of every package sent over?

    Wouldn’t be surprised if these regulations of cosmetics were made by the giant corporations who already have all the money to protect their empire from falling. Honestly, it makes sense.

    Thanks again for everything you’re doing Marie!

    1. Marie Gale

      As far as I understand, if you are a cosmetic manufacturer, manufacturing IN florida, then the regulations about registering and all that do apply. But if your products are manufactured elsewhere and you are just selling, then I don’t think they do apply. Keep in mind that if you are manufacturing OUTSIDE THE US, then the FDA will scrutinize the products when they are imported.

      Also, there are very specific rules about “Made in the USA” … so if the product is made outsside the US or using ingredients from outside the US, then you should be careful of the Made in the USA claim.

  187. Shelly

    Hi. Do you have any thoughts of the website question I left? Thank you

  188. Layla

    I really wanted to know the answer to Maries Skilling question, as well.

    1. Marie Gale

      Sorry I didn’t get Marie’s question answered. It was a good question – I’m answering it now.

  189. Shelly

    Hello
    Two people recently told me that the can make ‘butters’ and scrubs in Florida for resell at markets and events as long as they do not have a website. They said the regulations only apply if you do not sell on line and they can make these products from their home and resell locally in their community. I do not believe this is correct, but can you clarify if anything changes with website sales? Thank you

  190. Carolyn

    I just moved to FL. I was making some products–which would be classified as “cosmetics” by this definition–in my prior home in NJ. I was only selling it in NJ to one company.

    I’ve been researching setting up my business as a FL company, but after reading all this, I’m also looking into setting up a workshop at the company in NJ. It might actually be cheaper for me to fly to NJ a few times a year to make a bunch of product.

    Here in FL, I could still test and experiment to my heart’s content, couldn’t I? As long as I’m not selling it. Along that line, when I make a new product, or variation of a product, and I give to friends test, that would be outside of FL regulations, correct?

    1. Marie Gale

      I believe the manufacturing regulations apply to facilities that make cosmetics for sale. If a florida-manufactured cosmetic is going to be SOLD, then it needs to have a Certificate of Free Sale (registering the cosmetic, ingredients and label), and it has to be made is a registered facility. But if you’re just fiddling around and doing R & D, making stuff for personal (and free to friends/family) use … I shouldn’t think any registration is needed.

      But, disclaimer-disclaimer, I’m not an attorney and this is my opinion based on what I’ve read of the regulations and the definitions. 🙂

  191. Ruby

    Thank you

  192. Conchita

    Thank you for all your help. I understand that in order to not be a cosmetic, my soap can only be advertised as soap, do I need to add the word “cleans or cleansing” anywhere on the label or just “soap” will be enough?
    Thanks again.

    1. Marie Gale

      Just “soap” is sufficient.

  193. Denis

    I am looking for a Chemist to start a hair cosmetic company in south Florida.
    I have very large experience in product testing, hair, contacts all over Europe, South America, worked many years in international hair cosmetic company , sales, Marketing, create success full trending products, also i have best contacts to the clients.
    Maybe somebody can help me to start my hair cosmetic company or knows someone who can be partner entering with low budged.
    I would be so thank full if there is somebody who can guide,help or orientate me.

    Sincerely

    Denis

    1. Vit

      Hi Dennis. I’ve got some ideas for you, since you’re looking for a cosmetic chemist. If you’re still looking forward to openning the company, please, e-mail me back. Thanks, Vit

  194. My husband and have started and run several businesses but nothing has been as confusing as this. I have always loved natural products and over the years have made products for friends who have always encouraged us to begin to market them. The first is potpourri which thankfully, doesn’t get sucked into any of this mess. The other two, that we plan on starting with however, are essential oil blends and soaps. The oil blends are just that, various blends if essential oils in roll on bottles or dropper bottles for use in a vaporizer. The soaps make no claims but do not contain lye as we use only water, coconut oil, oils, etc. Do those items fall under the cosmetic manufacturing requirements? I am in Central Florida by the way and thank you for everything that you do.

    1. Marie Gale

      In Florida, like at the national level, soap MAY be exempt from the definition of a cosmetic IF it is 1) the alkali salt of fatty acids (made of lye and oils/fats/butters), AND 2) is identified as “soap” AND 3) only claims to clean. If you are making soap that fits that definition, then it does not fall under cosmetic registration requirements in Florida. I note you say your soap will have only water, coconut oils, etc and “not lye” … if you have soap that is not make with lye then it is detergent based and IS a cosmetic (all exempt soap is made with lye).

      Essential oil blends that are applied to the human body as perfumes or to “beautify or improve appearance” are cosmetics. If you make medical claims, they are drugs. Essential oils used in a vaporizer as a home scenting device (to perfume the home) are not cosmetics (not applied to the human body). But if the purpose is as a decongestant or other medical reason, then it is a drug. Drug manufacturing has even stiffer requirements than cosmetics – even in florida – so you probably don’t want to go there.

      1. Ruby

        So if u make a soap that has (FO)(EO) in it is it cosmetic how bout if u make one with clay and / or pumice coffee grounds ect? I still c it as soup but does the law in FL c it as cosmetic ?

      2. Marie Gale

        The full definition of “soap” is:

        The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent
        properties of the article are due to the alkali-fatty acid compounds

        Adding a scent (EO or FO, or an additive such as clay, pumace, coffee grounds, oatmeal or a color additive) doesn’t change the fact that the BULK of the nonvolatile matter is soap. Unless you call it something other than “soap” (shampoo bar, exfoliating bar, etc) OR you make cosmetic claims for it, it should still be classed as soap, not a cosmetic.

  195. Marie Skillings

    Thank you for this explanation. It clears a few questions up for me. So just to make sure I understand this correctly… I can add milk, exfoliates, and whatever else my imagination comes up with to my handmade soap but the label can’t say that it moisturizes, exfoliates, helps with acne etc. The label states “soap” and it cleans.
    Now lets say I make a soap with Shea butter. Would it be possible to put somewhere on the label that Shea butter is known to moisturize? I’m not saying my soap is moisturizing but the shea butter in my soap is moisturizing.
    Am I pushing my luck here?? I’d like to think I’m being creative.

    1. Marie Gale

      Yes, you can add additional ingredients to the soap (exfoliants, milk, color, scent, etc). That doesn’t change that the soap is still primarily soap. And correct – you can’t say that it has any cosmetic aproperties (moisturizes, exfoliates, etc). “Helps with acne” is a drug claim, which would make the soap an unapproved new drug … best not to go there.

      As for making claims for the ingredients – the FDA (federal, not the state of Florida) has often cited claims made for ingredients as claims for the product itself. So if you say that “shea butter is known to moisturize” you potentially change what the consumer considers is the intended use from “cleansing” (soap) to “moistursing” (cosmetic) because of the claims for the shea butter.

      Yes pushing your luck 🙂 The state and federal agencies are pretty hip to most of the possible ways to get creative with the labeling and claims!

  196. Natalie

    Hi Marie,

    I’m curious about the specific regulations applied to soap. From what I’ve read I can make soap using water, lye, and oil from my home and sell it in the state of Florida. Can I do the following without needing a cosmetics license:
    1. Add other ingredients to the soap like essential oils and/or fragrance oils, and list them as having aromatic properties, relaxation properties?
    2. Add exfoliants?
    3. Add milks?
    4. Add decorative micas, colors?
    Please explain what is going to cause my soap to go from being homemade without a cosmetics license, to needing to be made in a separate commercial facility with a cosmetics license. It seems like a fine line.

    1. Marie Gale

      The Florida regulations (499.003 Definitions of Terms) defines Cosmetic as:

      “Cosmetic” means an article, with the exception of soap, that is:

      intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or alterint he appearance or

      intended for use as a component of any such article.

      The definition for soap is not defined in the Florida regulations, but since the definition of cosmetic is essentially the same as the Federal definition, I assume they are using the Federal definition of soap (21 CFR 701.20), which is:

      A product in which the non-volatile portion consists princapally of an alkali salt of fatty acids AND the product is labeled, sold and represented only as soap.

      So if your soap is lye, water and oil, then the “non-volatile portion consists principally of an alkali salt of fatty acids”. Additng colors, scents and specialty ingredients (such as milk or other liquids) doesn’t change that.

      If you are adding EXFOLIANTS, and you STATE that they are exfoliants, then your soap is more than just soap and is doing more than just cleansing … it’s exfoliating, which makes it a cosmetic. (Same with “moisturising” or any other claim than just “it’s soap” and “it cleans”.

  197. Terri

    Thank you for your response much appreciated.
    If I sell soap can I give away other products (bath) with a purchase of soap? Is that illegal? Thank you

  198. Terri

    So here in Fl I can’t make or repackage any bath product except soap? Does that include melt and pour soap? Do I have to have license for every single kind of soap: ie: goats milk, olive oil, oatmeal, aloe Vera bases? This is crazy! You can make food in your , kitchen cottage food reg., without crap but not repackage and scent a lotion? Thanks

    1. Marie Gale

      Florida regulations cover cosmetics. Soap is exempt from the definition of a cosmetic, IF it is 1) the alkali salt of fatty acids (made with lye and oil), AND 2) is identified as “soap” AND 3) only claims to clean. Melt and pour soap may or may not be a “true soap” (and meet the exemption criteria) – you’d have to check with your supplier for the formulation of the soap you use. Some MP soap is “true soap” and some is not.

      If you are selling COSMETICS, then you must be licensed, have your facility inspected, and register each product for a Certificate of Free Sale.

      Nothing says it is fair or right …. that’s just the way the regulations are at the moment. There are people working to change the regs.

  199. Wendy Powell

    Just checked and some links and prices have changed as of March 2015:
    State of Florida – Product Registration Form
    http://www.myfloridalicense.com/dbpr/ddc/documents/productregistrationcosmetics.pdf
    New cost: $30.00 per product
    Product you manufacture and this also applies to purchasing from someone else and repackaging…

    1. Marie Gale

      Thanks very much for the update!

  200. shelly

    Hi
    Does any of this still pertain if you are only selling at farmers markets?

    1. Marie Gale

      The florida regulations apply to all cosmetic manufacturing in Florida – regardless of where you sell.

      1. Shelly

        Thank you so much for this information! You have been VERY helpful. Please continue to update us.

  201. Lisa Smith

    Thank you so much for this blog! I think I am more confused than before. I want to make & sell bath scrubs, salts & bath bombs. I live in Fl. Does this mean I need to license each product individually as well as license a business? Also do I need to make the product outside of my house?

    1. Marie Gale

      According to the regulations, if you are making bath scrubs, salts and bath bombs, you are a “cosmetic manufacturer.” In Florida, that means you need to have a license as a cosmetic manufacturer, which includes an inspection to ensure that you can safely make the products (generally, that means having and following good manufacturing practices). The facility can’t be in a residence.

      In addition, all of the indivudal products must be registered with the state, including the ingredients and labels. You must get a “Certificate of Free Sale” for each cosmetic product you make in Florida to sell.

      Information can be found on the Cosmetic Manufacturer License page (from http://www.MyFloridaLicense.com, under the Drugs, Devices and Cosmetics section).

      1. Lisa Smith

        Thank you so much!

  202. Teresa Jennings

    So basically if I want to make like bath salts, and body butters I have to rent a spot to make these? If so will a ventilated storage shed work? Technically it isn’t in my home its on my property.

    1. Marie Gale

      Bath salts and body butters are cosmetics, and under the FDA regulations can’t be made in a residence. There seems to be some consensus that they will allow a separate building on a residential property, but that’s not written in the regulations so may be up to interpretation by the inspector.

      Remember, it’s not just “ventilated” … it must be suitable for good manufacturing practices and provide a clean, safe production site that is set up in a way that product is unlikely to be adulterated when made or stored there (and ingredients are unlikely to become adulterated when waiting to be used). Keep in mind that the regulations are for cosmetic AND DRUG manufacturing facilities — so the inspector may have high standards. I certainly wouldn’t CALL it a “storage shed” when talking to them!!

  203. Kari

    Hello Marie!! I just have a quick question. I completely understand having to have a separate facility to manufacture in, my question is this, although we technically can not manufacture cosmetics within the residence, can we have a small facility set up on the same property unattached? Thank you very much!!

    1. Marie Gale

      The Florida statutes (499.012(1)(a) says:

      “An establishment that is a place of residence may not receive a permit and may not operate under this part.”

      “Establishment” is defined as: (499.003)

      “Establishment” means a place of business which is at one general physical location and may extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under common operation and control. Where multiple buildings are under common exclusive ownership, operation, and control, an intervening thoroughfare does not affect the contiguous nature of the buildings. For purposes of permitting, each suite, unit, floor, or building must be identified in the most recent permit application.”

      Not being an attorney, and not having some insight into how the State of FL is interpreting it, I don’t really know whether a separate unattached building on the same property as a residence would be considered “a place of residence” or not. I can see it going either way. Best bet would be to call the state and see how they are interpreting it. Having these two statutes might help in the discussion.

      Once you find out, let me know, okay?

  204. Thank you! I see now that I can probably use some of your labeling suggestions and be well within the regulations here in Florida. I appreciate your assistance! Thank you!

  205. Kathi

    How about aromatics? If I am selling essential oils for use in diffusers would this be under the same laws?

    1. Marie Gale

      Products that are not applied to the human body are not cosmetics. Aromatherapy diffusers fall into a “home scent” type category and aren’t considered cosmetics.

  206. Thank you for this great information. I hope you can help with my question. I am a licensed massage therapist and often blend massage oils and lotions with different essential oils to use in my sessions. I’ve been asked by clients if they can purchase these blends for home use. I’d like to start creating some oil blends and bath salts and selling them to customers. Would this application fall under this law? Any advice?

    1. Marie Gale

      You can create any sort of essential oil blend you want, and put it in oils, bath salts, lotions, or any other cosmetic product. You just can’t make any CLAIMS that the essential oils, the blend or the product with cure, mitigat or prevent any disease. If a customer loved your “blend #1” in massage, you can make and sell “blend #1” for them. (Unless you’re in Florida, where you would have to be a licensed cosmetic manufacturer).

      If you’re in Florida … I’m not sure, but I’m guessing that sent the customer home with FREE products for at-home use you MIGHT be okay, under the fact that the products are not being sold. There is probably also some sort of exemption for massage therapists that blend their own massage oils, so it might be an extension of that provision. I’m pretty sure that if you charge extra for a massage “with take home products” then it would be considered charging for the products – but if all your massages of the same kind and length were the same price (regardless of take home products) then it wouldnt’ be considered charging for the take-home products. THIS IS MY GUESS ON HOW IT MIGHT WORK. If you decide to pursue this approach, PLEASE be sure to read the regulations carefully and/or check with an attorney.

      1. Do massage oils fit the definition of “cosmetic” in Fla.?

      2. Dawn

        From my understanding, the oils are not considered “cosmetic” but lotion is. This is where I’m getting confused.

      3. I think I know where the confusion comes from. The criterion “for cleansing, beautifying, promoting attractiveness, or altering the appearance” is used in the federal statutory definition as well as that of many (maybe all) states, and you can see that’s not what massage oil is for. However, manufacturers & marketers of a lot of products for application to the human body that aren’t for those purposes — including massage oils, sexual lubricants, some aromatherapy products, some bubble baths — have voluntarily been complying with cosmetic regs in the knowledge that:

        (1) they’re not very onerous;
        (2) FDA can simply act on the assumption that anything is in their jurisdiction, and make you go to court to get your seized product back; and
        (3) given #2, if there’s any possibility that labeling the product as if it’s a cosmetic will mean it’s NOT treated as a topical drug or a medical device (although nothing says it can’t be that as well, and some products indeed are), then take the cosmetic route, like a plea bargain.

        In other words, people have been acting as if anything to be smeared on the body is a cosmetic if it has no drug purpose. They’ve been treating the “cleansing, beautifying, promoting attractiveness, or altering the appearance” part of the definition as if it weren’t there, and they’ve been just as happy.

        However, that is NOT the case now w.r.t. Fla., because the difference in regulation there between “cosmetic” and not-a-cosmetic is enough to make people decide not to be in the cosmetic biz AT ALL. Therefore I expect people there to take seriously the “for cleansing, beautifying, promoting attractiveness, or altering the appearance” phrase and start marketing products with disclaimers of cosmetic purposes. Like, this massage oil or sex lubricant is for lubricant purposes only, this bath foam or fizzie is for amusement only (or prevention of bathtub ring), this aromatherapy product is only for its sensation in the user’s nose, this powder or lotion is only for the comfort of the user — not for cleansing, beautifying, promoting attractiveness, or altering the appearance of the user.

      4. Xebi

        I’m a massage therapist (MT) in FL. All of the insurance I’ve looked into will only cover massage oils/creams used DURING the massage. Something sent home with the client is not covered under MT insurance. If the client has an allergic reaction and you’ve sent them home with something, insurance won’t cover the claim. If the cream was used only during the massage, it is covered.

      5. Marie Gale

        That’s interesting! It may have to do with product liability, since you are making the product and sending it home with the customer … that’s just a guess on my part. You might want to look into insurance that covers a little more broadly. The insurande fromthe Handcrafted Soap and Cosmetic Guild would provide coverage for the product sent home (I’m pretty sure – you might need to check). And I think that Veracity Insurance Solutions, which provides the insurance offered to HSCG members, also has a program for Massage Therapists. You might check that.

        Lastly, you’d need to be sure that you aren’t in violation of the Florida laws for making cosmetic products (don’t think so if you are providing them professionally … but …)

  207. John

    I am working with a group of Florida cosmetic manufacturers to change Florida’s laws, to improve and make Florida’s comsmetic manufacturing regulations more streamlined and business-friendly. Right now, Florida’s laws and regulations for this industry are costly, burdensome and, in many instances, unnecessary. We are organizing ourselves as the Florida Cosmetic Manufacturers Coalition. Please contact me to learn more about this important initiative. We need your stories and accounts ( all confidential) of how tough and confusing it is to be a cosmetic manufacturer in Florida. You can reach me at jray@johnrayconsulting.com or 850.445-5044.

    1. Marie Gale

      This is very good news! Good luch to you on getting the laws changed – they do need it.

    2. Kari

      Hello John!! would it be ok if I shared this info with other Florida soapmakers? What you are doing is a breath of fresh air to us all. Florida makes it almost impossible to have a successful business in this industry. I understand that there were consequences that led to these very stiff and unfortunate regulations, but it wasn’t crafters that caused it and to me that is so unfair. Pharmaceutical compounding regs should have nothing to do with handmade cosmetics and/or soap, but you know they say, it rolls down hill and it landed right on us lol. Again, thank you for all you are trying to accomplish.

      1. John

        Kari – that would be fine, as our effort needs to learn more how and to what extent Florida soapmakers have gotten ensnarled Florida’s complex and burdensome cosmetic regulations. Would it be possible to setup a quick phone call or email exchange to understand more fully some of these issues? John

  208. Marina

    Hi Marie,

    It so good to have your site! May be you can help me with the Form DBPR-DDC-229 Application for Drug Registration. I am new with Florida regulations. There are two fields: Establishment Permit Number and Product registration Number. Where can i get this information?
    I appreciate any your help
    Thank you in advance
    marina

    1. Marie Gale

      When I looked at the Florida licensing website, under Cosmetic Manufacturer, the link at the bottom took me to DBPR-DDC-206, Application for a Cosmetic Manufacturer. You might be using the wrong form.

  209. I am curious about shaving soap — Is it considered a cosmetic? can laundry soap bars be made and sold as soap?
    Thank you!
    Donna Lee

    1. Marie Gale

      Shaving soap is a cosmetic. It’s intended for more than just “cleansing” – that makes it a cosmetic.

      Laundry soap bars are not cosmetics – they’re household goods, not intended to be applied to the human body. (They still need to identity of the product, the net weight and the name and address of the responsible party on the label, in accordance with the Fair Packaging and Labeling Act).

  210. Donna

    Can I make and sell shaving soap in Florida? Not sure if it’s considered a cosmetic…
    What about laundry soap? I’m not making any claims!

    1. Marie Gale

      Shaving soap is a cosmetic.

      Laundry soap is a household product. It’s not a cosmetic because it is not applied to the human body.

  211. Rebecca

    I have a home in Georgia(main resident) where I make my products, soap, lotions, salts, bath balms, salves etc etc. We also have a home in Florida, ( we are in florida 4-5 months out of the year) If I make and label all my products in Georgia, can i sell them in Florida?

    1. Marie Gale

      As far as I know, the Florida regulations apply to products MADE in Florida. Just make sure that the name and address you use for your business (and put on the product label) is the one in Georgia … and don’t make any products in Florida!

      1. Marney

        Why would you have to use the address from out of state? Why couldn’t Rebecca just have “Distributed by…” on her label.

      2. Marie Gale

        If Rebecca has a business in Florida that is distributing the product, then “Distributed by” with the Florida address could work. However, there’s probably less liklihood of confusion with the State of Florida if the products are clearly labeled as manufactured by a business located in Georgia – then there is no question that the Florida manufacturing requirements wouldn’t apply.

  212. Liz

    I run a clothing company and just formed a separate LLC to start manufacturing body butters. I had planned to work from the same space because I rent an office/workshop space outside my home to design my line and make clothing samples. I have a big work room in a sort of a warehouse style space with fabric and sewing machines and a large cutting/work table. For the next 12 months, we plan to do hand made lots of our products and will only set up our manufacturing equipment (portable induction burner, roll up silicone work surface cover, dedicated kitchen tools, etc) once a week or so to make a new lot of product between working on other, non-cosmetic products with our main s-corp (separate from the body product llc). The body product equipment and ingredients have dedicated storage space and containers when not in use.

    We set up our equipment on the main work table and have set up and breakdown/clean up procedures in place. We use good manufacturing practices, note our lots, clean work space and equipment etc – but how do we prepare for an inspection since the manufacturing set up is a temporary event. What is the inspection looking for? I haven’t found any information other than we are subject to inspection while I’ve been working out the rest of the permit/licence/etc information. It’s a large fee for the permit and I want to be sure we are properly prepared to go into this line of business. Is there a do-over for an inspection that doesn’t go well?

    1. Marie Gale

      I am unfamiliar with the workings of the State of Florida with regards to the cosmetic facility inspections, but here’s some info that should help.

      The FDA has a GMP Inspections Checklist, which is supposedly what they look for when they do inspections. I would assume that Florida either uses the FDA’s checklist as a guideline or has a similar checklist that they use for their inspections. Either way, they are going to be looking for things that could cause your products to become adulterated or misbranded.

      You can use the Inspection Checklist and also the FDA’s newer Draft GMP Guidance document as a starting place for making sure you have everything set up right. And, chances are that if you don’t get a “pass” on the first inspection, they will tell you what you need to do and then reinspect (probably with a fee).

      As for scheduling, I don’t recall that the inspection for your initial permit approval is “surprise inspection”, so they’ll probably call to set up an appointment so you should be able to work with them so you have your production area set up when they come by.

  213. A company I was a supplier to, [name removed], was sold to someone in Georgia. I think this issue had something to do with it, because while they were in Fla. they had to stop making the other toiletry products they’d been making before the new law and make only soap.

  214. Deborah

    Hi Marie,
    Man, am I glad I found your website. You really are wonderful to spend so much of your time helping others. I had just finished getting all my labeling stuff and shipping info together, when I decided to give the Fl. Dept of Health a call to make sure everything was OK to sell a home made / handmade facial cleanser on Etsy. It seemed that it wouldn’t be a problem as so many others were doing just that with home made looking labels and all. I was shocked to find out what was required if you live in Florida.

    Of course this means that I will not be able to sell my cleanser on Etsy or anywhere else, but I was wondering if I could manufacture my cleanser (it’s only four ingredients) in my cousin’s house in North Carolina, have her send me the unlabeled jars, and then just label and sell them here from my home on the internet. Would she have to put on a rudimentary label so that I would have to “re-label it? Thanks so much again for all the other info you have provided through your web site.
    Deborah

    1. MarieGale

      If I recall correctly, the regulations in Florida don’t apply to a business that only applies labels to products and doesn’t open or repackage the items – although you should check that to verify. And, of course, if you purchase or receive products that are ready for resale and sell them, it’s just like any other store in Florida that buys items wholesale for retail sale (brick and mortar or internet).

      There are some FDA regulations that apply to sending unlabeled cosmetics though interstate commerce between companies (covered in my book, Soap and Cosmetic Labeling, on page 124).

  215. Susanna Jordan

    Hello,

    I am so glad I found your site Marie! I’ve been planning to set up shop selling natural bug spray, hand sanitizers, body butters, etc. on Etsy. The Florida regulation puts a damper on things since I live in Central Florida. I read in a previous post that the governor was planning on making some changes. I tried searching for information about the changes online and cannot find anything. Have you heard anything new since the original post? Thanks so much for your books and this amazing site!!

    Susanna

    1. MarieGale

      I’ll do some checking and see what I can find out.

      Well – I did some research. I wasn’t able to find anything that indicates that there have been any changes in the rules and laws governing the manufacture of cosmetics in Florida. In January 2011, Governor Rick Scott announced a plan (as part of the budget) to “grow jobs by streamlining government, reducing burdensome regulations” and part of that included moving the licensing of cosmetics from the Department of Health to the Department of Business and Professional Regulation.

      That apparently went into effect, because the information on cosmetic manufacturer licensing is now listed on the Florida Department of Business and Professional Regulation site (www.myfloridalicense.com). Unfortunately, it doesn’t look like the requirements have changed — and I didn’t see anything that exempted “handcrafters” when it comes to making cosmetics.

      Of course, there could still be something going on in the background that isn’t posted to their website yet.

      I suggest that you write to the Governor’s office and ask if anything is being done about it. You can find the Governor’s contact information here: http://www.flgov.com/contact-governor/

      1. I’ve been scouring the Internet trying to find details, to avoid trying to contact anyone with the state. Here are my questions that I can’t find an answer to:

        1. What exactly are the requirements to be met for the facility during inspection in FL?

        2. If I live at one address and rent a tiny studio apartment at a completely different address and use that studio solely for manufacturing, is that OK? Or does it have to be in a true commercial space? It’s hard to find spaces that have a sink outside of the bathroom (which I am assuming is a requirement during the inspection, but I don’t know, since I can’t find the requirements).

        I am hoping that I can get away with renting a studio that is used SOLELY to store my ingredients and manufacture my products, and avoid trying to find a commercial space, which are considerably more expensive per sq ft.

        Thanks for any help you can offer! This is a great article, and I’m excited to look at the rest of your site in more depth.

  216. ursula

    Can you sell a home made handcrafted cosmetic in FL that was made and packaged in another state like New Jersey that doesn’t require special licensing for home cosmetic makers that sell directly to consumers? I believe cosmetic distributors are not required to be licensed in FL only manufacturers and repackers. So if your labels say made in NJ are you good to go to sell in FL?

    1. MarieGale

      The regulations apply to manufacturing cosmetics. Selling cosmetics that are already packaged is a completely different thing. It’s the same as a retail store selling cosmetics that are purchased from a wholesaler.

  217. Rachael

    Fla is the hardest place to try to work from I think. I used to live and work there, and even had a facility to make the products in and the state of Fla came in, and gave me a cease and desist. They wanted batch samples of everything (asked about it), were there for 2 days, took tons of photos, wanted files on the suppliers, invoices to show what you bought, receipts, and every single item you make, you have to get a license (or is it register?) it (the product) and you cannot even sell it, until they approve it (and they are sloooooooooow)

    It’s not worth it. We left the state. I had to break my lease, go to court for that, move..it was horrible, but Fla made it so difficult..the paperwork they required was crazy.

    We heard a year or so ago, the governor said it was a mistake…and they were working on reversing the law (sorry if I am not explaining this in the way they said it, lol), but they were saying how badly it impacted the Fla economy, because the small businesses couldn’t afford the fees, understand how to follow all these guidelines, the paperwork, etc…so people left and moved, and went to states that were easier to work with.

    I know I called at least 20 states during this time, and none of them cared what you did. You needed a business license, your LLC and they said yes, you can make soap, bath fizzies, lotion bars, lotions, anything. One state just said you needed a mail order certificate. But, you DO work under the “good faith” standards (on a federal level) where everything you make, your ingredients are correct, etc, etc

    But, Florida? Forget it. We did everything we thought was right and they shut us down…because of all the paperwork and this was right before Christmas (years back), but he said he was sorry (the agent that came out), but it really affected us. Our employees lost their jobs, our landlord lost us as a tenant, we left our home…everything, and had to leave Fla just to work.

    1. Wow, that is a really awful tale. That’s good to know that they are thinking about reversing the law. I know there were changes made, but they don’t really make it much easier for cosmetic manufacturers (especially little ones).

      I hope you were able to set your business up somewhere else and continue with it.

      Marie

    2. This is really ridiculous ! where did you end up moving?

    3. John Ray

      Rachael – if you have time, please contact me as I would like to learn more about your unfortunate Florida story. We are trying to improve the situation for cosmetic manufacturers in Florida and I believe some things could be learned from your story. Thanks. John Ray

      1. Marie

        Hi John, I am replying to your comment from 2015. Are you still looking at this?

      2. Rhiannon

        Have things improved? Looking to begin the registration and inspection process soon.

  218. Angela

    Okay so though about it, it was a stupid question, if I would be making the products in Florida I would still have to follow Fl regulations and law.

    1. Angela

      Sorry my pc keys stick, I meant “thought” but I have two more questions if you would please answer if you can. One is my store is set to open next month where I would have been making my natural and organic lotions, etc., is on the beach and is a row of buildings with just a suite number, from what I read above this would not be allow, it would have to be a stand alone building? The second and last question is, if I buy wholesale and leave their labels I can just open and sell as planned? Wow my nephew just opened a bakery here in Florida and did not have to go through half of this and we eat that stuff, not even all natural or organic, but sure is good 🙂 Thank you so much Marie for sharing all of this!

      1. Hi Angela,

        You’d have to check with the state office that needs to approve your facility for manufacturing cosmetics … I don’t recall seeing anywhere that it has to be a stand-alone building, just that it can’t be in a home.

        The provisions for the approvals and registration have to do with manufacturing (so that’s the mixing and filling). If you purchase products wholesale that are already labeled, you’re just like any other store. It makes you a retail outlet (like a gift store or Wal-Mart), not a cosmetic manufacturer. I believe that applies even if the products are private labeled for you, but you might want to check on that point to make sure.

        If you purchase lotion or cream, for example, in bulk quantities and then repackage it into smaller bottles that have your label, I believe you still fall under the overall label as a “manufacturer”, but again, check on the regulations to be sure.

        You ought to be able to find someone in the right department at the state capitol who can help with these things. (Hey, if you find out who it is, please email me so I can pass on the information to other people who have asked!)

        Marie

  219. Angela

    This may sound like a stupid question, but what if I start a website and only sell products on line as an internet business would I still be required to follow all the above State regulations? Thanks.

    1. Hi Angela,

      It is my understanding that you would still have to follow the Florida regulations as the product is being MADE in Florida … it doesn’t matter where it is being sold.

      Marie

  220. Jocelyn Moore

    I was curious about selling body lotions or creams. Do you really need to find a place outside the home to manufacture them if you are not making claims that would identify them as a cosmetic per the terms you posted? I mean, if I don’t say anything about beautifying or cleansing or anything else, are they really a cosmetic?

    1. Hi Jocelyn,

      Any lotion or cream IS a cosmetic, regardless of what label claims are made about it. Only soap (true soap, made with oil, lye and water) MAY be exempt from cosmetic regulation, but only if no cosmetic claims are made.

      So, technically, yes, in Florida, in order to manufacture lotions or creams for sale, you must have a registered facility outside the home and have your products registered with the state. It’s an unfortunate law for the small handcrafted soap/cosmetic maker.

      Marie

      1. How do we go about receiving a copy of the Webinar. My life can be prttey unpredictable, and it would be great to have a copy to watch at my leisure and share with all who may be interested. We have to get the word out to people who have no clue what they are doing to their bodies. Any advertising that we can do on a personal level other than spreading the word verbally?

  221. I’m curious what limitations there are for businesses outside of Florida to sell to Florida residents. It’s my understanding that we have to have permits too, no?

    1. It’s my understanding that the Florida regulations only apply to products MANUFACTURED in Florida. If you manufacture elsewhere, you can still sell within Florida as far as I know.

      Marie

  222. Irma

    Hello Marie,
    I printed an application for a permit, and on one of the questions it asks:
    Have you included evidence of $100,000 bond security required by 499.012 (2) a or c
    Does this mean that the cosmetic manufacturers have to post a bond as well as a fingerprint card?
    I called Florida DBPR but could not talk to anyone. Do you have any information on this ?
    Thanks
    IB

    1. I don’t have any info on it, sorry. I did notice that the forms they had (not sure if they are still using them) were for both cosmetics and pharmacies. I can see a pharmacy needing a big bond and fingerprinting — but cosmetics?? Try continuing to call the department, but also send a letter or a fax. If that doesn’t work, try going to your local state representative to see if you can get some help.

      Marie

  223. Ariel

    Hello Marie;

    I want to open a business in Miami, my goal is buy powder tint for hair (ready to use) and re-pack it into personal amounts.

    My questions is: if there is anyone here in Miami that can guide me on all the legal procedures to make this proyect a reality.

    Thank you for your atention.

    1. Ariel,

      Powder tint for the hair would be a personal cosmetic, so the cosmetic regulations apply. I don’t know of anyone in Miami specifically that would be able to help you. I would suggest contacting the state agency and seeing if you can get a helpful person to talk to you about what’s needed. You might even be able to talk to the inspector and find out exactly what the requirements are for getting your facility approved.

      Also check with the City and County you are in to see about any licensing regulations that they enforce.

      Good luck with your endeavor!

      Marie

  224. L Lorenzo

    I want to open a business in FL to offer workshops of soap making, lotions, mist, etc. for personal use, and supplies for the clients. Does the FL regulation applied for those to teach too?

    1. I’m not sure what the regulations are for those who teach in Florida; the regulations I was discussing have to do with cosmetics manufactured for sale. If nothing else, you should make sure you have professional liability insurance (available through the Handcrafted Soapmakers Guild), make sure you inform your students of the regulations, and check on any local licensing regulations for teaching.

      Marie

  225. alexandro braga

    Hello, I’m from Brazil and would like to ride a
    small cosmetic factory in USA.
    I wonder if in Florida, to have the license to manufacture, you need a professional (chemical or pharmaceutical) is required? or just have knowledge of manufacturing?

    thanks,
    Alexandro Braga

    1. Yes, in Florida you must have your facility registered and licensed. You don’t have to be a certified anything in order to manufacture cosmetics, although you must show that you can manufacture cosmetics safely.

  226. […] The guidelines for how they go about enforcing are somewhat vague, and are supposed to take into account the level of the violation, if there have been previous violations, what’s being done to resolve the issue(s) and other factors. It seems to be up to the department at the time of the inspection. Read more on Cosmetics Manufacturer […]

  227. vladimir velazquez

    Hello. I’m interested in making my own shampoo and conditioner hair product. What are the legal steps that I have to take? Can I make it out of my own house? Thanks.

    1. If you are making products for your own use, you can do pretty much whatever you want.

      If you are SELLING the product, then all of the FDA regulations apply, as well as any regulations in your state. If you are in Florida, FL Regs say you can’t manufacture cosmetics (which includes shampoo and conditioner) in your home – if you are going to sell it. In most other states you CAN make cosmetics to sell in your home.

    2. Mercedes Strickland

      Hello Marie, My question is do I need any kind of license to do Makeup on clients and can I operate out of a salon without one? The department of health has told me that they do not regulate Makeup artist. Is this true?

      1. Marie Gale

        I found the following in the Florida Statutues at 477.0135(11):

        A license or registration is not required for a person whose occupation or practice is confined solely to makeup application, which includes, but is not limited to, application of makeup primer, face paint, lipstick, eyeliner, eye shadow, foundation, rouge or cheek color, mascara, strip lashes, individual lashes, face powder, corrective stick, and makeup remover; but does not include manual or chemical exfoliation, semipermanent lash application, lash or brow tinting, permanent makeup application, microblading, or hair removal.

  228. Jesse Wilson

    I am just starting out my business in Florida. I also attended the recent soap makers conference. My questions are these:

    1. I attended the Batch versus Manufacturing class. I am a batcher and not a manufacturer. My batches are not going beyond three pounds at a time, this includes my soap loafs. So does the ‘manufacturing’ section really apply?

    2. I want to make lotion bars, lip balms, bath bombs. Yet again, not in a large quantity. So I cannot make these in my kitchen?

    Thanks for doing some research on our behalf!

    1. Cosmetic “manufacturer”, in the legal terminology, means anyone who is manufacturing a cosmetic product – regardless of how it’s done. The difference between “batch” and “manufacture” as defined in the class is more of a practical definition – both fall under “manufacturing” in the legal sense.

      Correct about manufacturing at home – if you make any cosmetic product (lotion bars, lip balms, bath bombs, lotion, cream, bath salts, etc.) in Florida, you need to be registered and you can’t be registered to make them in a residence.

      Marie

    2. I would like to make body scrubs, bath soaks. and bath bombs. I also would like to buy in bulk and resale and re package the products in smaller quantities. Also do I have to get a place of business to repackage? Should I keep their names on the products? Or can I use my companys name? What about essential oils? Can I buy them in bulk and repackage in smaller quantities if I use the companys name that manufactured them?

      1. Marie Gale

        From what I understand, in florida if you are opening the packages that you receive and changing or repackaging, then you qualify as a cosmetic manufacturer. Doesn’t matter if you keep the other company name on the package (which they probably would not appreciate, if you are repackaging). You should check with the Florida agency covering cosmetic manufacturing…. but I’m pretty sure you need to get registered, inspected and approved for any of the actions you mention.

    3. coconut wax candle can be used as massage. Do I need a certification?

      1. Marie Gale

        Anything that is applied to the human body for beautification, promoting attractiveness or changing appearance is a cosmetic. A wax candle that is promoted for use in massage becomes a cosmetic because the intended use (or at least one of them) is for it to be applied to the human body — it becomes a massage oil. If you’re making a massage oil, you’re making a cosmetic … so in Florida you need a registered cosmetic manufacturing facility unless you fall under the new exemption.

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