Florida Cosmetic Regulations

floridaAt the 2011 HSMG Conference in Miami there was discussion amongst the many soapmakers from Florida who had concerns about a “new bill” that passed in the Florida 2010 Legislative Session. It piqued my interest and, knowing that Florida already had extensive regulations covering cosmetic manufacturers, I did a little research. Here’s what I found out …

2010 Florida legislation

The pertinent Florida legislation that passed in 2010 appears to have been resulted in Florida Law Ch. 2010-161, which makes administrative changes to the way funds and authority are handled by various Florida agencies and departments.  It also included additional wording “prescription drug distributors”.  It does not appear that it effectively changed the existing regulations concerning soap and cosmetics.

It looks like the bill requires that the administration of cosmetic permits and enforcement will transfer from the Florida Dept of Health to the Department of Business and Professional Regulation effective October 1, 2011 (although neither of their websites obviously mention it).

Current Florida soap & cosmetic regulations

The current Florida regulations that cover soap and cosmetics are covered in Title XXXIII, Regulation of Trade, Commerce, Investments and Solicitations, and particularly, Chapter 499, Drug, Cosmetic and Household Products.

What the regulations cover

In addition to drugs and medical devices, the regulations cover cosmetics, which are defined as:

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.

Note that it says “with the exception of soap“.  This is the same definition of cosmetic that is used by the FDA (although the FDA also includes the exact definition of soap).

So, using the FDA’s definition, a product that is

  • a product in which the non-volatile portion consists principally of an alkali salt of fatty acids” AND
  • makes no other claims than that it “cleanses” or “cleans”

is soap, and therefore exempt from the Florida cosmetic regulations.  However, if the soap in question makes cosmetic claims (beautifies, promotes attractiveness, etc), then is DOES fall under the cosmetic regulations.  (See my book, Soap and Cosmetic Labeling, pages 16 – 17 and Chapter 9 for more details.)

What qualifies as a “cosmetic manufacturer”?

According the the Florida statute, a “manufacturer” is defined as:

A person who prepares, derives, manufactures, or produces a cosmetic

To “repackage” is defined as:

Repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the cosmetic

A “repackager” is a person who repackages.

Anyone meeting the definition of a manufacturer, which includes soapmakers who are making soap labeled as a cosmetic, and anyone who is a repackager is subject to the Florida regulations concerning cosmetics.

Also important to note that the definition of  “cosmetic” includes an article (ingredient) that is intended to be used in cosmetics. That means that the cosmetic regulations also apply to suppliers or vendors who sell ingredients intended for use in cosmetic products.

Permits required

A permit is required for each person and establishment that intends to operate as a cosmetic manufacturer or repackager in the State of Florida.  However, if the person only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product, a permit is not required.

  • The permit may only be issued to a natural person (not a business entity) who is at least 18 years old.
  • An establishment that is a place of residence may not receive a permit and may not operate as a cosmetic manufacturer or repackager.
  • A county or municipality may not issue an occupational license for a cosmetic manufacturer or repackager unless they already have a permit from the state.
  • The current fee is a biennial fee (every two years) of $800.
  • There is an additional fee of $150 for initial applications which require a site inspection (however there is no specification as to when a site inspection is required).
  • There is a $100 fee to change the address on file on a permit, and the change must be filed prior to the actual change of address.
  • The permit must be posted in a conspicuous place on the licenses premises.

When I checked several years ago, the actual forms were available online.  However, it appears they are being revised and must be requested from the Dept of Health.

Product registration

In addition to the manufacturer registration and permits, any person who manufactures, packages, repackages, labels, or relabels a drug or cosmetic in the state of Florida must register that product with the department.

Cosmetic labelers who are not required to be permitted as a manufacturer must still register their relabeled products. (So if your cosmetic is made by someone else for you and you label it, you still must register the product.)

  • The fee to register a product is $20 per product for two years.
  • The actual labels must accompany the registration form.
  • Products that are identical except for name, size, color, or scent only require one registration. All subsequent identical products to that registration should be listed on an Identical Product Certification form.
  • To add a product to an existing registration is $20 if more than 12 months remain on the original permit; $10 if less than 12 months remain.
  • All product registration applications are to be sent to Tallahassee office for approval of certain labeling requirements.
  • A product must be registered before any sales of the product occur.

The FL Dept of Health has the application form and instructions available online.  I did note, however, that both forms mention only drugs (and are dated 1999).  There may be more updated forms available.

Certificate of Free Sale

A “Certificate of Free Sale” is a document prepared by the Dept of Health which certifies a cosmetic is registered with the department and can be legally sold in the state.

There is fee of $25 to get the actual Certificate of Free Sale document (and $2 for additional copies ordered at the same time).  Up to 30 products may be listed on one Certificate of Free Sale.  You can also get a notarized copy for an additional $10.

It doesn’t look like having the actual Certificate of Free Sale is required, but the Dept of Health is asking distributors to request Certificates of Free Sale, so if you plan to Whole Foods or other similar companies, you may need to get one.

Inspections and Enforcement

What’s not mentioned much on the websites, but is included in the statues are all the rights given to the state to inspect and enforce.  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.

If violations are found, the State may issue a warning letter and will require you to fix any issues.  They have the right to stop the sale of any adulterated or misbranded products and to seize products if they feel it is warranted.  They can issue fines as well.  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.

What’s 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;

Adulterated and Misbranded

The key factors to any cosmetic being “illegal” falls to the definitions of “adulterated” and “misbranded”.  This is true in all the US as well as in Florida. Here are the actual definitions, as defined in the Florida Statutes.  These are almost exactly the same as the Federal definitions:

A cosmetic is adulterated:

(1) If it bears or contains any poisonous or deleterious substance that is injurious to users under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual; however, this subsection does not apply to coal-tar hair dye:

(a) The label of which bears the following legend conspicuously displayed thereon: “Caution: This product contains ingredients which may cause skin irritation on certain individuals, and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness”; and

(b) The labeling of which bears adequate directions for such preliminary testing.

(2) If it consists in whole or in part of any filthy, putrid, or decomposed substance.

(3) If it has been produced, prepared, packed, or held under conditions whereby it could have become contaminated with filth or whereby it could have been rendered injurious to health.

(4) If it is not a hair dye and it is, or it bears or contains, a color additive that is unsafe within the meaning of the federal act.

(5) For the purposes of subsections (1) and (4), the term “hair dye” does not include eyelash dyes or eyebrow dyes.

A cosmetic is misbranded:

(1) If its labeling is false or misleading in any particular.

(2) If in package form, it does not bear a label containing:

(a) The name and place of business of the manufacturer, packer, or distributor;

(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; however, under this paragraph reasonable variations are permitted, and the department shall establish by rule exemptions for small packages; and

(c) A declaration of ingredients in descending order of predominance, or as otherwise required by federal law.

(3) If any word, statement, or other information required by or under authority of this part to appear on the label or labeling is not prominently placed thereon with such conspicuousness as compared with other words, statements, designs, or devices in the labeling, and in such terms, as to render the word, statement, or other information likely to be read and understood by an individual under customary conditions of purchase and use.

(4) If its container is so made, formed, or filled as to be misleading.

(5) If it is a color additive, its packaging and labeling are not in conformity with the packaging and labeling requirements applicable to that color additive prescribed under the federal act. This subsection does not apply to packages of color additives that, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes.

What does it all mean?

Well, all of us, in Florida and elsewhere in the US, have the same bottom-line requirements of not manufacturing or selling cosmetics that are adulterated or misbranded.  That’s the fundamental concept underlying all Federal cosmetic regulations, as well as those in Florida.

Unfortunately, those who live and manufacture cosmetics in Florida have an additional burden of being required to get a permit for (and possibly initial inspections of) where they manufacture, and they can’t make cosmetics in a residence. Floridians also have to register each product (although the “identical product” provisions make that a little easier).

For soapmakers, if you are just making soap, you can avoid all the regulations by packaging and marketing your soap as “soap”.

So, I hope this helps shed some light on the Florida regulations and  dispells any myths about what is, and is not,  actually required.

Comments

  1. 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. Author

        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.

  2. 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.

  3. Pingback: cosmetics manufacturer | Cosmetics For Women | Everything You Need to Know About Cosmetics For Women!

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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?

  10. 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

  11. 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. 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

  12. 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. 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. Hi John, I am replying to your comment from 2015. Are you still looking at this?

      2. Have things improved? Looking to begin the registration and inspection process soon.

  13. 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. Author

      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.

  14. 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. Author

      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.

      2. Author

        Hi Amanda,

        The Florida regulations for Drugs, Devices and Cosmetics can be found here.

        The regulation that covers Guidelines for Manufacturing Cosmetics is 64F-12.010. You should look that over to see what the exact requirements are. They are pretty general. There is no mention of a “commercial” space specifically.

        Besides registration and inspection, you also need to have your products registered, which is covered in 64F-12.016.

        An overview of the process, including a link to the application form is available here.

        I hope that gives you some help on determining how to comply with the regulations.

  15. 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. Author

      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).

  16. 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.

  17. 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. Author

      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.

  18. 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. Author

      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. Why would you have to use the address from out of state? Why couldn’t Rebecca just have “Distributed by…” on her label.

      2. Author

        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.

  19. 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. Author

      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.

  20. 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. Author

      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).

  21. 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

  22. 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. Author

      This is very good news! Good luch to you on getting the laws changed – they do need it.

    2. 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. 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

  23. 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. Author

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

      2. 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.

      3. 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.

      4. Author

        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 …)

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

    1. Author

      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.

  25. 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!

  26. 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. Author

      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?

  27. 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. Author

      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!!

  28. 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. Author

      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).

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

    1. Author

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

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

  30. 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. Author

      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.

  31. 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

  32. 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. Author

      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”.

  33. 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. Author

      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!

  34. 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. Author

      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. 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. Author

        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.

  35. 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. 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

  36. 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.

  37. 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. Author

      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. 🙂

  38. 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

    1. Author

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

  39. 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. Author

      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.

  40. 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. Author

      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.

  41. 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. Author

      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.

  42. 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. Author

      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.

  43. 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. Author

      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.

  44. 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. Author

      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.

  45. 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. Author

      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.

  46. 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. Author

      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.

  47. 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!

  48. 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. Author

      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.

  49. 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 .

  50. 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. Author

      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

  51. 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. Author

      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.

  52. 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. Author

      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. 🙂

  53. 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. Author

      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.

  54. 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. Author

      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.

  55. 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. Author

      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.

  56. 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. Author

      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.

  57. 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. Author

      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.

  58. 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. Author

      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.

  59. 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. Author

      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.

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

    1. Author

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

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

    1. Author

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

  62. 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. Author

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

    2. 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

  63. 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. Author

      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.

  64. 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. Author

      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.

  65. 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. Author

      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.

  66. 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. Author

      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.

  67. 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

  68. 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. Author

      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.

  69. 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. Author

      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.

  70. 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?

  71. 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. Author

      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”.

  72. 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. Author

      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. 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.

  73. 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. Author

      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.

    1. Author

      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.

  74. 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. Author

      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.

  75. 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. Author

      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”.

  76. 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. Author

      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.

    1. Author

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

  77. 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. Author

      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).

  78. 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. Author

      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.

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