Florida Regulations – Changed 2017

Posted in: Legislation & Regulation

floridaAfter work by a number of people and groups, the Governor of Florida has just signed new legislation that makes it easier for cosmetic manufacturers in Florida.

Prior to the changes

Up until now, Florida Cosmetic Manufacturers were required to get a Cosmetic Manufacturing Permit at a cost of $800 every 2 years, and register each and every cosmetic product at $20 per product every 2 years (or when changed).

Needless to say, the costs alone were prohibitive, not to mention the burdensome paperwork associated with submitting registration paperwork including all ingredients and product labels for every product to be sold.

New Laws

The new legislation, just passed into law on June 2, 2017:

  • Eliminates all cosmetic product registration and fees
  • Changes to fees for Cosmetic Manufacturer Permits to “sufficient to cover the costs of administering the cosmetic manufacturing permit program.”

Cosmetic Manufacturer Permits

Cosmetic manufacturers are still required to get permits from the state in order to manufacture cosmetics.  That has not changed, nor have the requirements for getting said permits.

General requirements for a permit are:

  • 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.
  • Good manufacturing practices must be sufficiently in place to ensure that the products produced are safe and are not (and won’t become) adulterated.

The Florida Department of Business and Professional Regulations, Division of Drugs, Devices and Cosmetics, handles the Cosmetic Manufacturer Permits.

Florida Soapmakers

None of this changes for soap that is exempt from the definition of a  cosmetic — that is, it is the alkali salt of fatty acids, and is marketed and sold only as “soap”. No claims for the product can be made other than it “cleans”  (no moisturizing, soothing, softening, or other “cosmetic” claims).

If you are only making soap that is exempt from the definition of a cosmetic, the cosmetic manufacturer regulations don’t apply to you.




38 Comments on “Florida Regulations – Changed 2017”

  1. Mark Fuller

    I know this refers to just Cosmetic manufacturers.

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

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

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

    1. Marie Gale

      The website has probably not been updated yet.

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

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

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

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

  2. Kari Basye

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

    1. Marie Gale

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

      1. Rebecca

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

      2. Marie Gale

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

  3. Lisa Wicklein

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

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

    1. Marie Gale

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

  4. Ursula Nash

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

    1. Marie Gale

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

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

  5. Hannah

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

    1. Marie Gale

      It’s not just “medical” claims.

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

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

  6. Jacqueline Daunno

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

    1. Marie Gale

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

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

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

  7. Melinda Cusack

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

    1. Marie Gale

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

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

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

  8. Rebecca

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

  9. Katie

    Marie,

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

    1. Marie Gale

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

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

      2) You only call it “soap”

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

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

  10. Katie

    Hi Marie,

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

    1. Marie Gale

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

    1. Marie Gale

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

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

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

  11. Katie

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

    1. Marie Gale

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

  12. Javier G.

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

    1. Marie Gale

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

    2. Irina Everret

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

  13. Soon to be... Sylvia's Sweet Scrubs

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

  14. Daisy

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

    1. Marie Gale

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

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

  15. Steph Davis

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

    1. Marie Gale

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

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

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

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

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

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