Florida – 2021-Changes to Cosmetic Manufacturers Law

Yesterday (June 21, 2021), Florida Governor Ron DeSantis signed SB 1966 into law. Amongst many other things, it updates the Florida cosmetic regulations, making it possible for small businesses to manufacture cosmetics! This is such GOOD NEWS!

Florida Cosmetic Regulations Updated

It’s a big act, and one small bit  …(drum roll, please) …  exempts certain persons from being required to have a cosmetic manufacturer’s license!

Before this bill

Before this bill and the changes it puts in place, anyone manufacturing any cosmetic product had to be registered with the state as a cosmetic manufacturer and the manufacturing couldn’t be at a residential location. There were fees, inspections and other requirements essentially making it impossible for a small business or handcrafter to legally make cosmetics in Florida.

Who doesn’t have to get a permit?

After this bill and the changes it puts in place, if your gross sales are less than $25,000, you do not need a cosmetic manufacturer’s permit; and you can make your products at a residential location.

Limitations & Requirements

There are a few limitations and special requirements:

  1. You must have less than $25,000 in annual gross sales.
  2. You can only sell prepackaged cosmetics that have a label on them that meets the FDA requirements for cosmetic labels.
  3. You may only manufacture soap (not otherwise exempt), lotions, moisturizers, and creams1 “Moisturizers” is not defined within the act; it will probably be defined in the regulations that get created to implement the new law.
  4. You can only sell cosmetics that are stored on the premises of the cosmetic manufacturing operation.
  5. You can only sell products that are not adulterated or misbranded.
  6. IMPORTANT: The product label must include a statement “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements.” The statement must be in at least 10 point type and a constrasting color.
  7. The Department (of Business and Professional Regulation) can investigate any complaint that alleges an exempt cosmetic manufacturer has violated the law or pertinent regulations;  can enter and inspect the premises, and may require proof of gross annual sales.

What about soap?

When soap is not a cosmetic, the cosmetic regulations don’t apply. To be exempt from the definition of a cosmetic, the soap must be:

  1. The alkali salt of fatty acids (lye/oil soap) AND
  2. Sold and marketed only as “soap”
  3. Make no “cosmetic” claims (other than cleansing)

When soap IS a cosmetic, a cosmetic manufacturer’s permit is required unless the manufacturer has less than $25,000 and the limitations and requirements listed above must be met.

What if you make over $25,000 gross annual sales?

If you make over $25,000 in gross annual sales, you aren’t exempt. If you want to make cosmetics in Florida, you have to have a non-residential workspace facility, get a cosmetic manufacturer’s permit, and have your facility inspected, and comply with the manufacturing regulations.  Basically, you need to have your good manufacturing practices in place. See Florida Cosmetic Regulations for details.

What happens next?

This Act goes into effect on July 1, 2021.  It updates the Florida LAW concerning cosmetic manufacturers (and everything else it addresses).

At some point in the future, the Florida Department of Business and Professional Licensing will update their REGULATIONS with the specific details on the implementation of the law. They will also probably update their website, forms, and other information.  That may not happen right away.

You can read an unofficial copy of the bill which I downloaded and highlighted here.

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References

References
1 “Moisturizers” is not defined within the act; it will probably be defined in the regulations that get created to implement the new law.

Discussion

191 responses to “Florida – 2021-Changes to Cosmetic Manufacturers Law”

  1. Brandi Snyder

    Unclear on perfume if I need a cosmetic manufacturers license …. How about Perfume oil!?

    1. Marie Gale

      Perfume and perfume oil are applied to the human body to improve attractiveness. They are both cosmetics.

  2. MaryJo Tischler

    Hi, I didn’t see anything about salves. I am guessing they are considered cosmetic and require a license.

    1. Marie Gale

      A salve, so long as it doesn’t claim to cure or treat anything, would be a cosmetic. It might qualify as a “moisturizer” depending on how it was marketed. If so, and if the annual revenue for the business (for cosmetics) was less than $25,000, then it could fall under the exemption.

      1. MaryJo Tischler

        Thank you so much, Marie!

  3. Maria

    Hi Marie!! I have a question.. if I have an LLC and make my own moisturizing lip glosses and sell them online, would that be illegal? do i need permission for that? Lip glosses are organic.

    1. Marie Gale

      If you make moisturizing lip gloss you are a cosmetic manufacturer. In Florida (and some other states) if you are a cosmetic manufacturer, you must register with the state and get a permit (which includes fees and inspections), UNLESS you make less that $25,000 annual sales from cosmetics. In that case, you don’t need to get a permit, but you do need to put a statement on the label (see the post for details on that).

      If you are selling your products as “organic” then you need to be organic certified. You can, however, note which ingredients are organic, and the percentage.

      1. Meyi cosmetics

        Thank you for your reply. It is that my lip glosses are made of TKB brand versagel, I use fractionated coconut oil, vitamin e oil, flavoring oil and mica pigments. It would be legal to sell my homemade lip gloss having my LLC if I sell less than $ 25000 per year.
        I call the FDOH and FDA several times and they only tell me that chemicals cannot be sold without the manufacturing license. However, I have seen that many people sell them anyway without having any license.

        I have another question, I was looking for a soap base that I could buy to make soaps in my house fulfilling the requirements for it to be true soap, but I have not found any brand that sells soap base with those requirements, they all carry chemicals.
        I wonder if you know any way to make soap for example goat’s milk soap and meet the requirements.
        thank you for all your help..

      2. Marie Gale

        Lip gloss is a cosmetic, pure and simple. As I noted in response to Keynatta, the law says the $25K exemption applies to “… cosmetics that are soaps, not otherwise exempt from the definition of cosmetics, lotions, moisturizers, and creams.” Lip glosses aren’t easily included in the list of exempt items. The Florida Dept of Health has not clarified if they would accept lip gloss within the list of products that could be made in an exempt facility.

        As for the soap, you can probably find a soap base with “the bulk of the non-volatile matter is the alkali salt of fatty acids.” There CAN be other ingredients (and usually are), but the BULK must be basically lye/oil soap. For example, the SFIC goat milk soap base sold by Brambleberry lists the ingredients as “Coconut Oil, Palm Oil, Safflower Oil, Glycerin, Goat Milk, Water, Sodium Hydroxide, Sorbitol, Propylene Glycol, Sorbitan Oleate, Oat Protein, Titanium Dioxide”. That would qualify.

      3. Maria

        Thank you very much for your quick response.
        Yes, they just say you can’t sell any chemicals..
        I read that soaps containing Propylene Glycol and titanium dioxide are categorized as cosmetics so after searching a lot I found Hollys Soapmaking on Youtube, she teaches to make soaps without chemicals, only with oils, milks and sodium hydroxide.
        I say this because I know that maybe I’m not the only one who is in this situation. Thanks for everything Marie Gale

      4. Marie Gale

        Everything that goes into cosmetics is a “chemical” of one kind or another. There is no regulation or clarification about “chemicals.” Whoever told you that was either misinformed or communicated whatever they were trying to say very poorly.

        A cosmetic is something that is applied to the human body to cleanse, beautify, change the appearance, or make a person more attractive. Lotions, creams, makeup, bath bombs, soap, lip gloss, lipstick, soap, etc., etc. Soap is NOT a cosmetic IF the “bulk of the non-volatile portion is the alkali salt of fatty acids” AND it is only marketed as soap.

        In other words, if the main part of the soap is saponified lye/oil.

        Other ingredients MAY be in the soap, including propylene glycol (used for improving feel), titanium dioxide (colorant), fragrance, clays, colorants, herbs, etc. Adding those things does not automatically make it a cosmetic. It DOES become a cosmetic if you add a synthetic detergent or if you claim that the soap will do anything more than clean (such as moisturize or exfoliate, for example).

        Also, note that sodium hydroxide (lye) is most definitely a chemical!

      5. Carmen

        Hello Marie Gale, i read your article and would like to know something. I have a small online business and i want to buy soaps and makeup made in a warehouse or manufacture in Europe and also in the USA, I live in Florida and I would just label each product and send it to the buyer, I want to know if I need any permission and if there are any limits of profits? Thank you.

      6. Marie Gale

        If you purchase products and apply your own label and don’t open the package or touch the product, then you aren’t a cosmetic manufacturer. You won’t need a cosmetic manufacturer’s permit/license in Florida.

        Of course, you will still need all of the other standard business stuff.

    2. Hi Marie does this law apply to the selling of essential oils

      1. Marie Gale

        The law applies to manufacturing cosmetics. If you are manufacturing (or packaging) essential oils for sale as cosmetic products, then the cosmetic manufacturers law in Florida would apply. If they aren’t cosmetics (not intended to be applied to the human body), then they aren’t cosmetics and the law doesn’t apply. If you are just selling them, then you are a seller, not a manufacturer.

  4. Nate

    Something that I’ve been wondering for a while. How does a refillery operate legally? If someone buys a cosmetic in bulk, fills it in a large pump bottle, and allows customers to refill their own containers? Wouldn’t they be considered the new manufacturer?

    The same question applies to places that manufacture their own cosmetic’s and offers it in as a refillery option.

    Do those that have a Florida permit, be allowed to have a refillery?
    And do those that do not have a permit, how do they bypass the “pre-packaged and labeled to FDA requirements“?

    1. Marie Gale

      A refillery is not specifically addressed in the Florida regulations.

      If a company manufactures cosmetics, whether they are individually packaged or used in a refillery, then they would need a cosmetic manufacturer’s license. I would expect that the small business exemption would apply if the company has annual sales of $25,000 or less AND the product was a soap, lotion, cream, or moisturizer.

      If a Florida-based RETAILER bought a cosmetic product in bulk (that had been legally manufactured in Floria or elsewhere) and then filled the CUSTOMER’s container, the retailer PROBABLY wouldn’t be considered a manufacturer. They would still need to provide the correct ingredient information to the consumer. If they were selling by weight or fluid ounces, the measurement device would probably need to be certified. It MIGHT be treated something like buying bulk grains, herbs, or honey in a health food store.

      And, of course, there would be risks of potential contamination which the retailer would need to address.

      Keep in mind this is my opinion based on applications of other rules and regulations. I can’t for sure say how they would actually be interpreted in Florida.

  5. Isabel

    Hi Marie,

    Do we have more clarity now if shampoo and conditioner whether is solid or liquid are EXEMPT from the license? I would like to start my own business.

    Thank you!

    1. Marie Gale

      I have no additional data. However, shampoo and conditioner don’t seem like they would fit within the parameters of “soap that’s not otherwise already exempt, lotions, creams, and moisturizers.”

      1. Janice

        You can only sell prepackaged cosmetics that have a label on them that meets the FDA requirements for cosmetic labels.. I am confused , this means i cant not buy in bulk and tranfers to small containers to sell?? If i make less than 25000 with out a cosmetic license in my home?

      2. Marie Gale

        If you purchase pre-packaged and labeled cosmetics, then you aren’t a “cosmetic manufacturer” and the Florida laws and regulations that apply to cosmetic manufacturers don’t apply.

        If you are purchasing in bulk and then repackaging, you ARE considered a “cosmetic manfuacturer” and the regulations DO apply. If you make only soap, lotion, creams, and moisturizers, AND your annual gross revenue is under $25,000, AND you put the warning on the label, then you are exempt from the registration and licensing requirements.

      3. Kirsinda

        Hi, Marie so are we allowed to make bath bombs at home if our revenue is less than 25,000 a year? Thanks

      4. Marie Gale

        Bath bombs are cosmetics and a manufacturer with less than $25,000 in annual sales is exempt from the cosmetic manufacturing permit requirements. The “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements.” notice does have to go on the labels.

      5. Kirsinda

        Okay thanks 😊

    2. Janice

      Thank you 🙂

  6. Tammy

    If I make cold process soap it can be over $25,000 with no permit (of course with paying taxes)? Can I also make and sell bath bombs as long as they are under $25,000 with no permit? (of course paying taxes) Do they have to be labeled as moisturizing?

    1. Marie Gale

      Soap that is exempt from the definition of a cosmetic (that is, it is lye/oil soap and is only marketed as soap) doesn’t count in the $25,000 income cap. The $25,000 counts revenue from cosmetic products. According to the new law, you can make “soap that is not otherwise exempt, lotions, creams and moisturizers.” (Soap “not otherwise exempt” would be soap that isn’t alkali/lye soap or that makes cosmetic claims). There hasn’t been any clarification on bath bombs, but if they are intended to moisturize (and are labeled as such), they may (probably?) fall within the definition of a “moisturizer.”

  7. I just ordered your book… and am wondering what the wording ‘repels mosquitoes’ might require for a lotion?

    1. Marie Gale

      “Repels mosquitos” makes the product an insect repellent. It requires pre-approval unless it meets the federal requirement for a minimum risk pesticide. I don’t know about the Florida exemptions for minimum risk pesticide. If there are ALSO cosmetic claims, then it needs to meet the Florida cosmetic manufacturing laws.

  8. Rachel B

    If you are exempt are you also free to sell online?

    1. Marie Gale

      The exemption applies to the cosmetic manufacturing regulations and covers MAKING the cosmetics. It doesn’t matter how they are sold.

  9. Maria Perez

    Hi Marie!
    Can I sell my sugar scrub at a farmer market in Florida?
    If my earnings are less than 25,000 annually

    1. Marie Gale

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

  10. Teresa Jennings

    Where can we find examples of proper labeling? Do you offer that in a newer edition of your book?

    1. Marie Gale

      Yes. Details on how to label products are in my labeling book (at Amazon here: https://amzn.to/3eaOPSI). They are also in the new book, which contains a bunch more information as well. The new one will be available on Amazon in a week or so.

  11. Lucia Quintero

    Hello Marie. I want to ask you if you can tell us a little bit more about: not otherwise exempt from the definition of cosmetics??? I mean, we can manufacture ANY PRODUCT THAT IS CONSIDERING A COSMETIC? Like shampoo, conditioner, or maybe parfume, makeup?? Etc.. or I’m understanding wrong. I really want to manufacture Shampoo and conditioner bars, but this specific sentence it’s driving me crazy. I want to do everything just right/under the law… I’m new in the cosmetic world. And Thank you for everything that you’ve been sharing here! In my case I’m learning A LOT! 🙌🏻

  12. Narmina

    Hi, Marie! That’s incredible news! I almost gave up with the idea to open my own skincare , haircare brand… So, since reading about the changes I have a couple of questions.

    First one, about labelling of your product. If you know, could you tell me please, can I put on my creams, serums, etc, specific identification? For example, creams for oily or dry skin, serum for pores or sebum control, eye cream for puffiness, etc… Or it should be as simple as face cream or eye cream? I couldn’t find clear guidance about how to label the products outside of the exemption clause.

    Second one, if I understood correctly, I can open my own haircare products too, right? Shampoo, conditioner, hair oil, etc?… Same question like above about labelling. Can I be more specific with an explanation on the labels? Shampoo for oily hair, hair oil for damaged hairs, etc..?

    Thank you!

    1. Marie Gale

      The Florida exemptions specify “soap not otherwise exempt, lotions, moisturizers and creams.” Eye serums will probably fall under “moisturizers.” I’m not sure about how they would consider hair products.

      As for the labeling; cosmetics work on the surface to improve appearance, beautify, and cleanse. Drugs alter the function or structure of the body. If you claim that a serum will “reduce puffiness” then you are saying it will alter the function or structure of the body. If you say it will CONTROL sebum, that’s altering the function or structure; if you say that it cleanses (removing extra sebum) then it’s a cosmetic. Saying a cream is better for oily or dry skin skips around the issue. Watch the wording and consider what a consumer will think the product should be used for.

  13. Shanna

    So from what I understand, I can only sell lotions and moisturizing face washes from home if I make under $25000 in gross sales, and there’s no limit to selling soap if I don’t make cosmetic claims?
    Also would moisturizing serums with anti aging ingredients be counted as moisturizers, and can I not say anything about it having anti aging properties? Thank you.

    1. Marie Gale

      Yes, the annual income limit for exemption is $25,000. If you are within the exemption, lotions and moisturizing products can be made without a cosmetic manufacturer’s license. Soap, providing it is the alkali salt of fatty acids AND is marketed only as soap, is exempt anyway. You don’t need a cosmetic manufacturer’s license for that (and never have). Serums generally fall within the “moisturizer” group.

  14. Donata

    I have a business license in FL… Can I sell out of state from my web site or other marketing webs?

    1. Marie Gale

      If you have a Florida Business License, you need to follow the rules for that. You should be able to sell out of state from your website or other sites. Be sure you collect and report sales tax where required.

      1. Donata

        thank You

  15. mel

    Okay, I just want to be clear. I am about to buy lotion in bulk in 5 gallon containers ( I don’t manufacture the lotion itself) It’s made in another state. I will add scent to it and bottle it in my home in Florida. I know that I do need to put in contrasting color with the verbiage “manufacture exempt….” However, Do i still need to “register” the lotion with the state of Florida ( application for product registration) ” Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics ? I need some clarification regarding this.

    1. Mel

      To add to my last question. What if you buy lotion in bulk from someone else who manufactures it ( outside of Florida) you then add fragrance but the customer actually bottles it themselves… Say at markets, and pop up shop. You don’t bottle or label it. The customer does that. then how does this apply?

      1. Marie Gale

        If you are adding fragrance then you are a manufacturer. You are handling the product and could potentially adulterate it. Letting the customer bottle it won’t make a difference, and it probably just adds more possibility that the lotion could get contaiminated. Also, keep in mind that when you sell it, regardless of who puts it in the bottle, it needs to be properly labeled.

    2. Marie Gale

      Rebottling and labeling makes you a cosmetic manufacturer. If you are exempt (less than $25,000 revenue) then you only need to put the notice on the label. You wouldn’t need to register because you would be exempt.

      1. Mel

        Regarding refill lotion options: Does putting one large label on the refill container, that customers would be pumping out of into their own smaller containers, count as “labeling”?

      2. Marie Gale

        There are no provisions in the law for how to label refilled products. I would expect that providing all the necessary information on the container from which the product is filled would cover the general requirements, so long as the container is not provided by you. What WOULD apply are regulations about not selling a product that is adulterated. That means keeping in place good manufacturing practices, so you would need to have procedures in place to ensure that the product is not adulterated or contaminated in the process of refilling.

  16. Celia

    Serums would also be considered a “cosmetics”

  17. Celia

    Face masks would be considered “cosmetics”?

    1. Marie Gale

      Both serums and face masks are cosmetics, yes.

  18. Sabrina Williams

    Hello Ms. Marie, I am purchasing body butter base, body scrub base (sugar), facial cleanser base (will add oils and colorants to them) . I’m going to formulate face oils and body oils using fragrance oils also colorants to them, so does this mean I can be able to do this as long as my sales aren’t over $25,000 and I place the note on there as mentioned in the bullet point,

    1. Marie Gale

      As far as being exempt from the Florida Cosmetic Manufacturer’s Regulations: Under $25,000 and the label notice meet that requirement. Those are all cosmeticts (so long as you don’t make other claims), so that requirement is okay.

      The only thing is whether they fall under the “lotions, creams, and moisturizers” restriction. It looks like mostly they do. For the scrubs, it probably depends on if you market them as exfoliants or as moisturizing cleansers of some sort.

  19. SB

    I’m not exactly sure how I would label my product, but it consists solely of dried lavender, rose petals, and coconut milk powder intended to be poured into a bath. It is not intended to “cleanse, beautify, or alter the human body”, just add some decor to the water. Is this considered a cosmetic? Thank you!

    1. Marie Gale

      A product put in the bath is a cosmetic because it is “applied to the human body.” And if it’s in the bath, it’s part of the cleansing process. It should be labeled as a cosmetic.

    2. Erica

      Thank you for compiling this information about selling cosmetics in Florida. Just to clarify…As long as my sales are under $25,000 and I am only adding a label with the additional FL 10pt phrase, I can sell nail polish purchased from a supplier that I do not alter/open. I do not need to get a manufacturing license. But if I decide to make my own, alter what I buy from a manufacturer, or exceed $25,000, I would need to have a nonresidential space and get a permit. Right?

      Thank you!

      1. Marie Gale

        Yes, that sounds right. Note that the requirements for the $25,000 cap and the added phrase only apply if you are opening the package or are making the product yourself.

        If you just purchase and then label the nail polish, you are already exempt! No $25,000 cap and no added statement required.

  20. Suzanne

    What about something like a toner(facial mist)? Can that be considered a moisturizer?

    1. Marie Gale

      I would expect that it depends on how you market it.

  21. Maria Perez

    Hello Marie!
    Could you please let me know if some regulations exist to sell handmade bath bombs in Florida?
    Thank you!

    1. Marie Gale

      Bath bombs are cosmetics, so all of the regulations that apply to cosmetics apply to bath bombs. That includes the regulations in Florida to register and be approved for a cosmetic manufacturer’s license, unless you are exempt (make less than $25,000 per year from cosmetic sales). Additionally, there is some question as to whether bath bombs meet the criteria for what you can make under the exemption. That’s not been fully resolved yet.

      1. Maria Perez

        Thank you for your help!

  22. Sue

    Just a question on the $25,000 limit. What happens when you hit the limit. Is there a time frame given for you to obtain the permit or does all manufacturing need to stop until the permit is obtained?

    1. Marie Gale

      Nothing has been said, but I would assume that you should already be set up (registered and licensed with the state) when you cross over that $25,000 limit.

  23. Denise

    Hello Marie. Any updates on if the updated regulation includes natural deodorants? If not, a customized deodorant made by a manufacturer and shipped to me for labeling and selling online on my website should be fine?

    1. Marie Gale

      It’s unlikely that a nautral deodorant would fall under the narrow band of exemptions they have allowed. But if you have the product made and you just purchase it already packaged (and don’t open it to put on the label) then you don’t become a cosmetic manufacturer and it’s not an issue.

  24. Vickie Burkholder

    I would like to start a business in making Herbal salves, balms, and bath salts. This means I could start in my spare bedroom locked away from my cat and still be in good graces?

    If I were to put my jars and bowls on a cart and wheel it into my kitchen to clean and then wheel back into the designated room, would this be considered still under regulation and GMP compliance to start my business?

    I have been struggling with having our cat be an indoor cat, but we have a spare bedroom in our house that I can get a portable burner for!

    Otherwise I also have thought of a portable sink in replace of our kitchen, so NOTHING comes out of the bedroom unless leaving to go to the farmers market to sell (:

    What are your thoughts and advice with having our indoor cat? We can’t close off our kitchen because it is an open plan.

    1. Marie Gale

      Herbal salves, balms, and bath salts are definitely cosmetics. The rules are that you would need a cosmetic manufacturer’s permit, which cannot be issued to a business in a residence, regardless of the GMP you have in place.

      That said, IF you meet the exemption criteria (that is, your cosmetic income is less than 25,000 AND the department agrees that herbal salves, balms, and bath salts are classed as “moisturizers”) then you could make them at home.

      1. Vickie Burkholder

        So, if I make under $25,000 then I should be able to make these cosmetics in my spare bedroom?

        Do you have to have them go through your local health department? (confused when you say “department agree”)

      2. Marie Gale

        No, at this point you don’t need to go through the health department.

        The statement “if the department agrees” refers to whether they make the final determination that things like herbal salves, balms and bath bombs are exempt under the new law. The wording of the new law is a little vague; it just says you can make soap, lotions, creams, and moisturizers. So we have to wait and see what they decide is a “moisturizer.” For example, whether a bath bomb would qualify depends on how they interpret the law.

  25. Olivia

    Hello, I recently began making nail dip powder. Do you have any clarity on if this is something I can make and sale at home as a hobby. Is that something I can sale without a permit on my property? I have a detached garage I can use. Thank you.

    1. Marie Gale

      Nail dip solutions are definitely cosmetics. You would need to have a cosmetic manufacturer’s permit. Per the regulations, “An establishment that is a place of residence may not receive a permit.” I don’t know how they are interpreting a detached garage; I think it is still considered a “place of residence” since the whole property is considered a residential location. You would have to check how it’s being interpreted by the department in your case.

  26. Javier Lopez

    I was wondering if anybody can share your marketing results when a potential cutomer read the statement “Made by a manufacturer exempt.. that your product was not manufactured in a FDA approved facility. Assuming most of sales would be from online channels, how an entrepreneur would grow and scale-up when your final product will disclose you make their product in a home kitchen. Any feedback will be highly appreciated.

    1. Marie Gale

      It’s an interesting question. My suggestion would be to somehow turn this to your marketing advantage. Put a page on your website that explains the Florida requirement and that smaller companies are exempt (you don’t have to say HOW small). Make it be a PLUS that the track record for the small manufacturers is good enough that they don’t have to get inspected and licensed, and that the licensure is for large companies that have automation and such. You could also include a flier or information in your packages when you send them out so the consumer gets that information when they see the package and the statement. Also, note that it’s not “not FDA approved” it is “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements.” Which is quite a bit better!

  27. Celia Lopez

    How about scrubs/lip or body scrubs?

    1. Marie Gale

      Anything that is applied to the human body to cleanse, beautify, make more attractive, or alter the appearance is a cosmetic. Scrubs—lip or body—are definitely cosmetics. Whether they fall under the “moisturizer” exemption of the new law is still up for determination. IN MY OPINION, if they contain moisturizing components and are marketed as such, then they SHOULD qualify. BUT, remember, the final determination will be made by the State of Florida, this is just my opinion.

  28. Samaiya Balogun

    Hi Marie, what about perfume and body sprays? Are they considered cosmetic?

    1. Marie Gale

      Yes, perfumes and body sprays are cosmetics.

      1. Kalim

        Hi Maria. A bit confused about perfume. Can I make perfume at home without a permit if I don’t go beyond the 25k? Thanks for clarifying!

      2. Marie Gale

        The regulations for Florida are a bit unclear on this point and there has been no guidance issued. The law says the $25K exemption applies to “… cosmetics that are soaps, not otherwise exempt from the definition of cosmetics, lotions, moisturizers, and creams“. Perfumes ARE cosmetics, but as you can see, they aren’t easily included in the list of exempt items.

        It is my OPINION (and purely my opinion) that the legislators, in writing the law, were trying to limit the exempt items to those things they thought were cosmetics and were safe to manufacture in small quantities without permits and inspections, but they weren’t really familiar with what is included in the definition of “cosmetic”. That is, things like perfumes and bath bombs. Both of which are probably safer than lotions and creams!

  29. Ailed

    H! And thank you for sharing this great news! One question, will Natural Deodorant apply? Can I make and sell deodorant at home?

    1. Marie Gale

      There’s still no word as to what will be specifically covered in the exemption. The law change says “soap not otherwise exempt, lotions, moisturizers and creams.” Deodorant doesn’t fit within that statement exactly, but we still don’t know how they will interpret it.

  30. Mimi

    What about bath salts, face masks, and face mists? Where do you think they would be considered?

    1. Marie Gale

      I don’t know! I’ve written to the Florida State folks, but haven’t received an answser.

  31. Mel

    Hello, Marie
    I make my own products however some of them I purchase wholesale premade to re-label. The ones I relabel are considered cosmetics but I do not manufacture them myself, I am just relabeling them. How and what do I need to do as far as the FL new labeling? Do i still need to add that they were “manufactured by an exempt florida manufacture”? Do i need to add the actual manufacturer to the label somewhere? I am a bit confused on this part as I am not making the product, I am just buying wholesale “ready to re-label” items.

    1. Marie Gale

      So long as you get them already in the containers and don’t OPEN the containers, then you don’t require a cosmetic manufacturer’s permit. It’s not part of the small business exemption.

      The label should say “manufactured for …” with your business name and address.

  32. Valerie Valentin

    Im so happy to hear this !! I have a couple questions,
    1. If i don’t required a business license, what other permits or licenses i need? Do i just make my formulas and sell them without any type of state license and permit? Planning a small business and im trying to get the right information and permits.
    2. With this new law, I can describe my soap as moisturizing and still make them at home?

    1. Marie Gale

      The new law eliminates the need for a cosmetic manufacturer’s permit in the State of Florida IF you meet the requirement of less than $25,000 gross sales AND you only make the allowed products (moisturizing soap is allowed) AND you add the disclaimer to your label.

      It doesn’t negate the need for normal business requirements: registering your business, sales tax filing, and suchlike. You will also have to check your LOCAL requirements for any zoning requirements or restrictions on what type of business is allowed in a residential home. If there are any restrictions, they are usually at the city or county level.

  33. Katie

    If I manufacture my shampoo bars in another state, may I still sell them in Florida as part of my line?

    1. Marie Gale

      Manufacturing in another state implies that you have a business registered in that state that manufactures the products for your Florida company/business. If your Florida business is doing business in another state, there may be business requirements in the second state. How that would be enforced (or not) is a question that I can’t answer. However, I would suggest that you consider the implications of basing your product line and business on something that has the potential of being shut down.

  34. Brenda Kaiser

    So I CAN make solid shampoo bars and conditioners if the gross sales of them is less than $25,000?

    1. Marie Gale

      The new Florida law allows for “soap not otherwise exempt, lotions, moisturizers and creams.” A solid shampoo bar would be a “soap not otherwise exempt.” A conditioner isn’t technically on the list of things that are exempt; I don’t know how they will class conditioner in the final rules.

  35. Megan Blaker

    I have a few questions I see that you can sell lotions. I’m making lotion bars that follows on lotions right. What about lip butter balms? What about bath bombs can I sell them to. If I just label them as bath bombs no cosmetics saying on it. Can i sell them

    1. Marie Gale

      The new law says soap and “lotions, moisturizers, and creams” are allowed. How they are specifically defined is not clarified in the law; it may be clarified in later regulations or statements by the Department. I would expect that a “lotion bar” and “lip butter balms” are both intended to moisturize (so would be “moisturizers”). Bath bombs ARE cosmetics (regardless of what you say about them). They MIGHT fall under the “moisturizer” exemption depending on the purpose and function (and how they are marketed).

  36. Donata

    Where can I find out if I can sell herb sachets and neck warmers?

    1. Donata

      What about hand salves? Are they considered moisturizers ?

      1. Marie Gale

        It depends on what you say about them. If you SAY it’s a moisturizer (and it does moisturize), then it’s a moisturizer (a cosmetic). If you say it does something else (heal cracked skin, soothe redness, etc.), then it’s an unapproved new drug, not a cosmetic.

  37. Donata

    Can I sell lavender sachets and bath salts ?

    1. Marie Gale

      Lavender Sachets aren’t cosmetics; yes, you can sell them. They still need to be labeled correctly.

      Bath salts are uncertain. Under the new law they MIGHT fall under the category of “moisturizers,” but you would need to correctly market them.

  38. Morgen Stamate

    I only make exempt soap right now but my gross sales are going to hit $25k this year so I thought these changes would not apply to me. However I noticed in one of your comments you said it might just be $25k for the cosmetics part of the business? Am I understanding that right, than I can have over $25k in gross sales as long as the cosmetics portion stays under $25k?

    1. Marie Gale

      From what I understand, the income limitation is for cosmetic sales only and income from soap that is otherwise exempt from the definition of cosmetic wouldn’t count in the cosmetic income calculations.

    2. Kimberly Safi

      Maybe just keep your books very clean, keeping the two separate. I would do a set of books for the soap and another sheet for the cosmetics.

  39. Kristina Mills

    Thank you

    1. Carmen Lopez

      Thank you I live in Central Florida started making soap for sale

  40. Helen Palmer

    This is great news!!!!

  41. Kendra

    Can bath bombs be made and sold from home as well?

    1. Marie Gale

      The exemption for small cosmetic manufacturers says “lotions, moisturizers and creams.” Bath bombs are not included, although they MIGHT be considered “moisturizers” depending on what’s in them and how they are marketed.

      I expect that there will be clarifications issued by the State of Florida over the next few months.

      1. Will you be updating information once this is published?

      2. Marie Gale

        I will definitely post anything I get!

  42. Samantha

    So whipped body soap would fall under moisturizer, what about shave soap or hair soap and conditioner bars?

    1. Marie Gale

      Anything that is applied to the human body for purposes of cleansing, beautifying or promoting attractiveness (as opposed to drugs or food) is a cosmetic. Shaving soap, hair soap, shampoo, conditioner, moisturizers, lotion, cream, bath bombs, make-up, etc.

      “Soap” is exempt if it is the alkali salt of fatty acids (lye/oil soap) AND is only sold as “soap” and only intended to clean. Shaving soap (if used for shaving) is a cosmetic—not exempt soap—but would fall under the “soap not otherwise exempted” portion of the new bill. Same with “hair soap” (shampoo) and probably conditioner bars.

  43. Thanks so much for the update, Marie! I just moved to Tampa a month ago and thought I was being thwarted by Florida’s fine print. When I read this, I wanted to throw a party! I’m reading your book about Soap & Cosmetic Labels right now, and trying to figure out how I can get my shampoo bars in line with these new regulations (I am an individual handcrafter). It’s not a true soap… therefore it’s a detergent-based cosmetic… hopefully they get a little more specific about the permitted products soon.
    Cheers!

    1. Marie Gale

      Shampoo bars would probably fall under the “soaps, not otherwise exempt from the definition of a cosmetic” portion of the new bill.

      1. Got it, thanks! So my other concern is regarding the exemption statement… 10pt font?? That seems odd since most of the regulations are in terms of type size, with relation to the size of the PDP. 10pt font is really going to ruin my lip balm label, haha. (3.71875 sq. in surface area!)

      2. Marie Gale

        Yes. Normally the type size is set by the principal display panel (or, for some things, the entire amount of label-able space on the product).

        This Florida labeling requirement is—umm—unique.

      3. Can I just put a QR code on my lip balm label that leads to a web page informational panel?

      4. Marie Gale

        No. You must have the required information ON the product. If it won’t fit, you can put it on an attached card (or attach the product to a card). In either case, the CARD becomes the primary display panel for the product.

      5. Wow! I might have found a way to make it work: https://imgur.com/Ohqd8xl

        What do you think?

        This particular formulation + label might be a wash, since it contains CBD oil and that comes with more stipulations/risk than I am prepared to deal with right now. But I think this is how I’m going to proceed with the new permit exemption clause. The font is 10pt, Gloucester MT Extra Condensed. I used the same shade of orange you used in this article, but maybe blue text would look better on my product label. (Graphic design with lots of rules = fun fun FUN!!)

      6. Marie Gale

        Looks like that meets the requirements.

      7. Thank you so much for your helpful responses, Marie!! Hopefully they mean the color contrasts the background of the label, and not the other text on the label. I think I want to keep all my text black.

      8. Donata

        I know you deal only with soaps /cosmetics, but where would I find out if I can make wax melts at home and sell? Thank you

      9. Marie Gale

        As you say, wax melts are not cosmetics so they don’t fall under any requirements for a cosmetic manufacturer’s permit. As far as I know, there aren’t any state or federal restrictions on making wax melts. You MAY have zoning restrictions in your county or city that apply to what areas allow “manufacturing” or business in general. That’s something you’ll have to check locally.

  44. Monica Hayes

    Thank youn so much. I am a Floridian and have been struggling with this. This is very good news Hopefully as more folks raise questions, they will do better at redefining what’s possible. Thank you for all you are doing to keep us informed.

    1. Marie Gale

      You’re welcome! Yes, I expect things will sort out over time.

  45. AJ

    Hello! I’ve read the bill a couple of times but I’m missing the part when it only states lotion, creams and moisturizers. I do see where it states “specified products”, but nothing else. Where can I read about the Lotions creams and moisturizers being the specified products? Thank you!

    1. Marie Gale

      The addition is on page 15 of the bill. You can view a highlighted (unofficial) copy of the bill here. Scroll down to page 15. The section is midway down the page.

  46. You have helped me so much Marie! I am so happy about this!! I just have one question. What about manufacturing hair oil and hair cream?

    1. Marie Gale

      Hair oil and hair cream are definitely cosmetics. Unfortunately, I don’t think they would be included under the “lotions moisturizers and creams” limitation for exempt cosmetic manufacturers in Florida.

      1. M

        Is there a reason bath bombs & bath salts are not defined? What are the repercussions to selling them – even if you stay under the $25k rule? Is it illegal to make & sell then at this time in Florida?

      2. Marie Gale

        Unfortunatley, I was not privy to the thought processes behind the wording of the bill. I have asked for clarification and will publish any information I get.

      3. edi

        if I make no cosmetic claims Can I sell natural loofas with my soaps

      4. Marie Gale

        Soap, so long as it is the alkali salt of fatty acids (lye/oil soap) AND the only claims made about it are that it cleans, is not a cosmetic. So if that’s what you make then you are not a cosmetic manufacturer.

        Loofa in soap is normally used as an exfoliant (which, if claimed, makes the product a cosmetic). However, if you just say that there is loofa in the soap, but don’t make any statements that it will do more than clean, it’s probably still classed as a soap and exempt from being a cosmetic.

  47. Elaine Jenkins

    If I am only selling non cosmetic soap, what does DBPR require?

    1. Marie Gale

      If your soap is not a cosmetic, then the Florida cosmetic manufacturer requirements don’t apply. You don’t need to do anything—just make tons of soap and sell it!

  48. Would whipped body butters and whipped body soaps fall in this category? Also, liquid CP hand soap?

    1. Marie Gale

      Whipped body butters would likely fall under the “moisturizers” and/or “creams.” They are cosmetics.

      Whipped body soap and liquid CP hand soap would either be soap (already exempt from the definition of a cosmetic) or a cosmetic.

      You would be not be required to get a cosmetic manufacturer’s permit if the your gross annual sales (from cosmetics) is less than $25,000.

      1. Kristen

        Thank you!!

  49. Hello, when you say constrasting color, the statement “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements.” has be in color? Does that mean I wouldn’t be able to use a white label with all black wording? Or do you think that the statement itself can be bolded to stand out?

    1. Marie Gale

      It’s not explicitly stated in the new law, but using the federal labeling standards as a guide, “contrasting color” normally refers to a sufficient contrast with the background. So black on white is high contrast. They are trying to avoid people using, for example, light blue on a light green background to try to make the lettering “disappear” or make it hard to read. Black on white is the highest contrast there is.

  50. Great news!

  51. Allison

    Does this mean we still can’t make bath bombs?

    1. Marie Gale

      At the moment, it looks that way. It’s possible that when the regulations are issued there will be more clarifications as to what is considered a “moisturizer.” Possibly, bath bombs and scrubs and other similar items could be considered moisturizers. Unfortunately, we’ll have to wait for the regulations to see what’s issued.

      1. Judith

        Marie, a few days ago you mentioned that it is possible that when the regulations are issued there will be more clarifications as to what is considered a “moisturizer”. I find the current wording “moisturizer, lotions and cremes” entirely confusing. I am also hoping that bathing salts / bath bombs and such will be exempt.
        Are you planning to make another post when/if the state clarifies, or where would they publish an official statement?
        Thank you for all the work you are putting into this. I recently bought your book on labelling and wish I had done so sooner!

      2. Marie Gale

        As soon as I hear anything further I will certainly post something! If your bath salts and bath bombs are “moisturizing” in some fashion then they might fall under the “moisturizer” category.

      3. Donata

        Where can I find out if I can sell herb sachets and neck warmers?

      4. Marie Gale

        Herb sachets are not cosmetics because they aren’t applied to the human body. Neck warmers are more like pillows; I don’t think they are considered cosmetics either. Just be sure you don’t say that either product will make any changes to the body (relieve muscle tension, clear stuffy nose, etc.).

      5. Hello would foaming suger scrub fall under soap

      6. Marie Gale

        No. Regardless of what a foaming sugar scrub is made of, it is a cosmetic because it is a sugar scrub, not a soap. It would probably fall under the exemption, though.

    2. Dolly Robbins

      Make them “moisturizing”. 😉

  52. Francheska Travieso

    So, basically I don’t need any permit as long as i just make soaps and lotions, and i can work in a designated space at home?

    1. Marie Gale

      Yup, so long as you have less than $25000 annual sales from your cosmetics.

      1. What are the requirements for labeling a product ? thanks

      2. Marie Gale

        You can start with Quick Labeling FAQ. I’d also suggest getting my book, Soap and Cosmetic Labeling (link is to Amazon) for all the details.

      3. Why only $25,000? We’re old laws more restrictive? If someone wishes to make their livelihood this way, $25,000 as a ceiling seems to defeat the purpose. Is a cosmetic license expensive? Thank you.

      4. Marie Gale

        The previous law required that ALL cosmetic manufacturers get a cosmetic manufacturing permit, which mandated (amongst other things) that the manufacturing could not take place in a residential building. That made it impossible for anyone working from their home to qualify. Other than the cost of the permit, most of the other requirements were primarily getting in good manufacturing practices at the level expected from a full size manufacturer (along with the costs of doing so).

        The new law allows new businesses, just starting up and working from home, to get going without the burden of high start-up expenses or a stand-alone commercial facility. $25,000 isn’t a high number, but it does allow people to get started.

      5. Karina

        How about an LLC? Is that a requirement in Brevard, Fl? Or just a Tax sheet?

      6. Marie Gale

        As far as I can see, it doesn’t make any difference if you are an LLC for the exemption. LLC’s are not required, but if you are doing business in Florida under a business name, you need to register that with the state. You also need to register with the Sales Tax folks in Florida. I think it’s part of registering a business, but it’s been a while since I was in Florida doing any sales. I don’t know if there are any additional business requirements in Brevard County. If there are, they would probably relate to zoning and business licenses, not taxes or cosmetic manufacturing.

  53. Christa

    I’m lost on the one regulation, the one about pre-packaged cosmetics? Does this mean I can buy a lotion base, add color & scent, and label it under my business after I seal it and label it?

    1. Marie Gale

      The prepackaged means that you—as the manufacturer—must package the product before you sell it. “Pre” (before) package. Package before. And you have to package in accordance with the regulations AND add that warning to the label.

      It does NOT mean that you can only buy a base and use that.

      1. Edi

        You may only manufacture soap (not otherwise exempt), lotions, moisturizers, and creams1.
        Can you please clarify this, about only making soap

      2. Marie Gale

        Soap–so long as it is the alkali salt of fatty acids (lye/oil soap ) AND only claims to clean–is exempt from the definition of a cosmetic. If it claims to moisturize, exfoliate or do other cosmetic things, then it IS a cosmetic (not exempt). To rephrase the sentence from the law: You may make lotions, moisturzers and creams, and soap that wasn’t exempt anyway.

        Does that wording make more sense?

  54. Jaqie

    I just screamed so loud my husband almost had a heart attack!!!! This is so amazing. A bit late for me, but amazing for the rest. We just bought land in Tennessee to escape Florida laws. Congrats to everyone staying in Florida.

  55. S

    I wish this law could go into affect in CT!

    1. Donata

      What type of melt and pour soap can you make in FL ..?

      1. Marie Gale

        You can make melt and pour soap that is made from saponified lye and oils, so long as you only claim that it will clean.

        You can make melt and pour soap that is made with detergents OR that you make cosmetic claims for IF you have less than 25,000 in gross sales AND you put the required “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements” on the label.

  56. Mariana

    Can you help me understand how it is good news that folks can be making lotions, etc without regulation? We all know the need for good sanitation and good practices when making something that can grow bacteria and mold. A label does not make a product safe.

    1. Marie Gale

      True, good manufacturing practices should always be in place. It’s just that Florida has had more restrictions on small handcrafted businesses than any other state, so this is a welcome relief to those who are starting out.

      1. Alan Lefort

        It is good news because an entrepreneur trying to work hard and have a better quality of life is not regulated so much that they cannot ever get traction when starting a small business.The key word here is ” small” these products are topical and not to be consumed.Selling a moldy ot bad batch or inferior product will never survive the scrutiny of the marketplace and would just waste the time, energy and financial resources of the small business owner,in my opinion

    2. Christa

      This is Great news! Mariana you have no idea what you are talking about! I am old enough to pick where I buy from a fruit stand right? What if someone fertilizes with dog poo? I mean? They regulate that I cannot start a business and sell lotion? Or soaps? Eye shadow? I’m so glad because I am starting a business now.

      1. Should I wait for the ‘”scrubs” to interpreted or confirmed as moisturizers or can I go ahead and make the for selling ??

    3. You are right about good sanitation and good practices – but the majority of home-based cosmetic businesses follow these practices. I have a separate room in my house and keep everything sanitized and organized and use only quality ingredients. I guess it depends on the maker.

    4. Should I wait for the ‘”scrubs” to interpreted or confirmed as moisturizers or can I go ahead and make the for selling ??

      1. Marie Gale

        If you have a business or are planning to create one, it might be prudent to see what the final determinations are before creating a product line.

    5. Jackie

      Mariana, it’s good news for people who are not rich and who want to start a business. It’s as simple as that.

  57. You can only sell prepackaged cosmetics What exactly does this statement mean??? We can’t make lotions and cremes at home?

    1. Marie Gale

      From the view of the Florida regulations, it’s talking about the cosmetic products that YOU make. You have to package and label your products before you sell them.

      1. I’m assuming a sugar and salt scrubs are moisturizers, so I can make the from home , correct ?

      2. Marie Gale

        Well, I would think that salt and sugar scrubs are moisturizers. I don’t know how they are going to finally interpret the definition of “moisturizer” and what product types will qualify.

    2. Donata

      Does requirement #6 apply to soap as well ?.
      IMPORTANT: The product label must include a statement “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements.” The statement must be in at least 10 point type and a constrasting color.

      1. Marie Gale

        Yes. It applies to soap IF it is a cosmetic. That is, if the soap is made with detergents, OR you make cosmetic claims for it.

      2. Donata

        What would the soap label look like with the added info. #6?

      3. Marie Gale

        That would depend on your graphic designer. The required information on the label is the identity of the product (“soap”), the net weight, and the business name and address. There are requirements for where the information needs to be placed. See Quick Labeling FAQ

      4. Donata

        Ok, however when I read the requirements I don’t see where to out #6 statement.. front back etc….
        Please advise.. TU

      5. Marie Gale

        The new law just says it must be on the label; it doesn’t specify where on the label.

      6. Donata

        thank you!

    3. Lucia

      Thank you for all this information! I want to start my own business selling handcrafted solids shampoo and conditioner bars. So under 25k I suppose to be good selling this products?? I just want to be sure because I couldn’t find any examples about “solid cosmetics”.

      1. Marie Gale

        The law specifies that small manufacturers can make “soap not otherwise exempt, lotions, moisturizers and creams.” They haven’t clarified how they will be evaluating solid shampoo and conditioner bars.

      2. Lucia Quintero

        In facts, Shampoos bars are not allowed under the exception. I found this information. Regular shampoo bars are made with SCI, SCS, etc. those ARE NOT alkaline fat acids “lye”.. 😔

        To meet the definition of soap in FDA’s regulations, a product has to meet three conditions:

        What it’s made of: To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.
        What ingredients cause its cleaning action: To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap.

      3. Marie Gale

        There are two kinds of “exceptions” in Florida.

        The one that has always been in place is the “soap” exception. The cosmetic manufacturers registration is for COSMETIC manufacturers. Soap is not a cosmetic if it is the “alkali salt of fatty acids” AND it only claims to be soap and to clean. So someone making soap, with that definition, would not be a cosmetic manufacturer and so would not need to register. You are absolutely correct that a shampoo bar made with synthetic detergents (SCI, SCS, etc) would not fit the definition of “soap.” So someone making a syndet (“synthetic detergent”) shampoo bar would be a cosmetic manufacturer.

        The second “exception” is the one that went into effect recently. That exception is for small businesses. First requirement is that the business makes less than $25,000 in annual cosmetic sales. The second requirement is that it only applies to lotions, moisturizers, creams, and “soap not otherwise excepted”. A “soap not otherwise excepted” would be a syndet soap (doesn’t fit the already-excepted-definition) or one that claims cosmetic uses.

        A syndet shampoo bar doesn’t fit the first exception, but it DOES fit the second exception IF the business makes less than $25,000 in annual cosmetic sales.

        Note, though, that the shampoo bar would need to have the additional label statement that it wasn’t made by a licensed cosmetic manufacturer.

      4. Lucia Quintero

        Thank you very much for the detailed answer! I’m honestly so excited about the project, I’m still not sure about many things, however I’m ready to go for it! I saw that your most recent book will be on Amazon on the 15th, I will definitely have it to learn more. Thank you very much

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