Florida Regulations – Changed 2017

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.

Comments

  1. I know this refers to just Cosmetic manufacturers.

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

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

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

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

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

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

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

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

      Peace out Richie

      1. Author

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

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

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

    1. Author

      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.

  3. 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. Author

      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. 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. Author

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

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

  5. 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. Author

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

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

    1. Author

      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.

  7. 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. Author

      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”).

  8. 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. Author

      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.

  9. 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. Author

      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.

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

    1. Author

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

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

      2. Author

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

  11. 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. Author

      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.

  12. 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. Author

      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.

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

    1. Author

      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).

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

    1. Author

      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.

  15. 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. Author

      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. 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.

  16. 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.

  17. 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. Author

      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.

  18. 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. Author

      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.

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

    1. Author

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

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

    1. Author

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

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

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

    1. Author

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

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

    1. Author

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

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

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

    1. Author

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

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

    1. Author

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

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

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

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

    1. Author

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

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

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

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

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

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

    would this labeling be correct for the soap?

    1. Author

      Assuming you are in Florida …

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

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

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

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

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

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

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

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

    1. Author

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

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

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

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

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

    1. Author

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

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

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

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

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

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

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

    1. Author

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

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

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

    1. Author

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

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

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

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

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

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

    1. Author

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

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

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

    1. Author

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

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

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

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

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

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

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

    1. Author

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

  38. Hello,

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

    1. Author

      It’s in the Florida Statutes, section 499.

      Section 499.01 states who is required to have a permit.

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

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

    1. Author

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

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

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

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

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

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

    1. Author

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

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

    1. Author

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

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

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

      2. Author

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

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

    1. Author

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

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

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

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

      1. Author

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

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

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

    thanks again for everything!

    1. Author

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

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

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

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

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

    1. Author

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

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

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

    1. Author

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

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

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

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

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

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

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

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