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.




14 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.

  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.

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