[Updated September 17, 2022]
Of all the subjects I get asked about, Florida cosmetic regulations are close to the top of the list because they have the most stringent regulations for cosmetic manufacturers.
In this (very long) post, Florida cosmetic regulations are covered in detail. Read it all the way through or use the Teble of Contents links to jump to specific sections
In Brief:
- Florida cosmetic regulations require cosmetic manufacturers to get a permit to operate in the state of Florida.
- There is a small business exemption for businesses which have less than $25,000 annual revenue (from cosmetics) AND which make only certain limited products. (Jump to exemption details)
The Florida Divison of Drugs, Devices and Cosmetics handles cosmetic manufacturer permits.
Cosmetic Manufacturer Permit
Florida Law
The current Florida statutes covering cosmetics are in Title XXXIII, Regulation of Trade, Commerce, Investments and Solicitations, and particularly, Chapter 499, Drug, Cosmetic and Household Products.
What is a Cosmetic?
Directly from the Florida regulations:
(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.
FLA. STAT. § 499.003(13) (2018)
The definition of a cosmetic in Florida statutes is, for all intents and purposes, identical to the definition in US law. If it is applied to the human body to make it look better, then it is a cosmetic. Cosmetics include scrubs, creams, lotions, serums, bath fizzies and bombs, oils, bubble bath, shampoo, make-up, bath salts, bath milk, bath tea, masks, etc. For more info see What is a COSMETIC?
The definition of a cosmetic says “except soap.” Presumably, the federal definition of exempt soap is used here, which is:
- The bulk of the product is the alkali salt of fatty acids (lye/oils soap); and
- The cleaning properties come from the alkali salt of fatty acids (not from any added synthetic detergents); and
- It is marketed and sold as “soap”; and
- No other claims than cleaning are made for the product
Products which are intended to alter the function or structure of the body or to treat, mitigate, or prevent disease are drugs, even if they are in the same FORM as a cosmetic (e.g., a lotion or cream to treat acne or reduce itching). For more info see What is a DRUG?
Manufacturer
Directly from the Florida regulations:
(30) “Manufacture” means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic.
(31) “Manufacturer” means:
(a) A person who prepares, derives, manufactures, or produces a drug, device, or cosmetic;
FLA. STAT. § 499.003(30-31) (2018)
(definitions pertaining to drugs are omitted)
Repackaging, such as where you purchase a product in bulk and repackage it into smaller containers, still qualifies as a “manufacturer.”
Purchasing packaged cosmetic products for resale does not qualify as a manufacturer.
Cosmetic Manufacturer Permit
Directly from the Florida regulations:
Permits
(1) Before operating, a permit is required for each person and establishment that intends to operate as: … (p) A cosmetic manufacturer;
(2) The following permits are established:
(p) Cosmetic manufacturer permit.—A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit under this paragraph….
FLA. STAT. § 499.01 (2022)
Florida cosmetic regulations state that If you are a cosmetic manufacturer, you must get a permit.
In the explanation of the permit, it clarifies that you don’t need a permit if you don’t open the container. Therefore, if you purchase already bottled or packaged products and apply your own label (without opening the product) then you don’t need the permit.
Permit Requirements
Directly from the Florida regulations:
Permit application requirements.
(1)(a) A permit issued pursuant to this part may be issued only to a natural person who is at least 18 years of age or to an applicant that is not a natural person if each person who, directly or indirectly, manages, controls, or oversees the operation of that applicant is at least 18 years of age.
(b) An establishment that is a place of residence may not receive a permit and may not operate under this part.
FLA. STAT. § 499.012(1) (2018)
BTW, a “not a natural person” refers to a corporation or other business entity.
IMPORTANT! There is a small business exemption (implemented in 2021) which is covered further down in this post. (Jump to exemption details)
Permitting Process
The law also specifies what is required in the application. Rather than quoting the whole of Florida Statute § 499.012(4)(a), I’ve summarized the key points:
The permit must include:
- Name, business name and address, telephone number.
- Any other business or trade names used by the person.
- Type of business (sole proprietorship, partnership, LLC, etc.).
- Name and address of all business owners.
- “Any other relevant information that the department requires.”
The department will consider the following factors in reviewing the qualifications of the persons to be permitted:
- Whether the person has been found guilty of a violation of a law (in any jurisdiction) that directly relates to a drug, device, or cosmetic.
- If the person has been disciplined by a regulatory agency in any state for any offense that would be a violation of this law.
- A felony conviction under federal, state, or local law.
- Past experience in manufacturing or distributing cosmetics.
- Suspension or revocation of a federal, state, or local government of any permit currently or previously held for the manufacture of cosmetics.
- Compliance with permitting requirements under any previously granted permits.
- Compliance with requirements to maintain or make available to officials the records required.
Becoming permitted as a cosmetic manufacturer requires several steps:
- Pay the initial fees (with the application)
- Complete and submit the application
- Pass inspection
- Renew license every two years (and pay renewal fee of $800)
A total of $950 must accompany your application fee:
- Biennial (every two year) application fee, Non-refundable: $800
- Initial application and on-site inspection fee: $150
In the event that you don’t pass the initial inspection and the agent is required to return to conduct another inspection, you will likely be charged some fee for return visits. If you don’t go through with the permitting process for whatever reason, the $800 is non-refundable.
Application Form
The application form consists of 8 Sections, most of which are contact/business details or background (“Have you ever …?”) questions. Only Section 7 deals specifically with the actual manufacturing activity. The actual questions are below. They are slightly edited for readability and I have bolded and colored the questions that will probably be the most problematic:
The Division of Drugs, Devices, and Cosmetics has an official application form that must be submitted. Unlike their other forms, this one is not available to be filled out online; it has to be downloaded, printed, filled in, and mailed to them with the fees.
- Are products distributed under this permit intended for export?
- Will all required records be stored and maintained at applicant’s physical address? (If no, provide details)
- Will required records be computerized, automated or stored electronically. If yes, will you have a back-up procedure to be able to provide required records?
- Do you have labels of your products ready for inspection?
- Do you manufacture a product that has a sunscreen (SPF)? (If yes, an Over-the-Counter Drug Manufacturer permit is required)
- Do you intend to comply with all Federal and State “Current Good Manufacturing Practices”? (See Florida Regulations FL-61N-1.010 and federal Cosmetic Good Manufacting Practices.)
- Does the applicant have written policies and procedures as set forth in rule 61N-1.010(6)-(10)?
If no, provide written explanation
If yes, provide a copy of each policy and procedure - Have you obtained a copy, reviewed and familiarized yourself with the requirements set forth in Rule 61N-1.010? Failure to comply with the rule is the basis for permit application denial and enforcement action by the department.
- What date will the establishment be ready and available for inspection? This is the earliest date the application my be deemed complete.
Inspections
Once you have paid your fee and submitted the application, your facility must be inspected (and must pass!) before you can start legally making cosmetics.
The inspection criteria are based on general good manufacturing practices. The actual requirements are covered in Florida regulation, which is detailed in FL-61N-1.010 (I downloaded and reformatted the document for easier reading).
Cosmetic Manufacturer Permit – EXEMPTION
The regulations were updated in 2021 to allow for an exemption in certain cases and with some restrictions.
The good news is that you do not need to notify the Department of Business & Professional Regulation or the Division of Drugs, Devices and Cosmetics before you start making products. If you honestly believe that you meet the requirements for exemption, you can just go ahead.
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Every handcrafter’s situation is different. To work out the good manufacturing practices that will work for you, get my book from Amazon and use it.
Maximum Annual Gross Sales
Directly from the Florida regulations:
Cosmetic Manufacturer Permit… A person who manufactures cosmetics and has annual gross sales of $25,000 or less is exempt from the permit requirements of this paragraph.
Upon request, an exempt cosmetic manufacturer must provide to the department written documentation to verify his or her annual gross sales, including all sales of cosmetic products at any location, regardless of the types of products sold or the number of persons involved in the operation.
FLA. STAT. § 499.01(2)(p) (2022)
If you make less than $25,000 in annual gross sales, you do not have to get a cosmetic manufacturer permit. It has been verbally confirmed that this applies to sales of cosmetics only, not sales of other products.
The Department of Business and Professional Regulation has the right to request complete documentation of your annual sales, and if you are operating as an exempt cosmetic manufacturer, you must provide written documentation.
In addition, that means that the restriction on making cosmetics in a residence does not apply (since it is part of the permit requirements).
Exemption Restrictions & Limitations
There are some restrictions and limitations on what you are allowed to do if you are an exempt cosmetic manufacturer.
Directly from the Florida regulations:
1. An exempt cosmetic manufacturer may only:
a. Sell prepackaged cosmetics affixed with a label containing information required by the United States Food and Drug Administration.
b. Manufacture and sell cosmetics that are soaps, not otherwise exempt from the definition of cosmetics, lotions, moisturizers, and creams.
c. Sell cosmetics that are not adulterated or misbranded in accordance with 21 U.S.C. ss. 361 and 362.
d. Sell cosmetic products that are stored on the premises of the cosmetic manufacturing operation.
FLA. STAT. § 499.01(2)(p)(1) (2022)
Of the limitations above, (a) and (c) are pretty straightforward and are already included in federal cosmetic laws and regulations. Your product must be correctly labeled, and it cannot be adulterated or misbranded.
As per (b) above, the products you can make are limited to:
- soap that wasn’t already not a cosmetic (that is, it was already exempt from the definition of a cosmetic). See What is a COSMETIC?
- lotions
- moisturizers
- creams
I think they were trying to limit exempt cosmetic manufacturers from making the more risky items such as products that go on the eyes or lips. Whether things like lip balms or bath bombs qualify as “moisturizers” is still unclear.
Finially, point (d) limits sales to cosmetic products that are stored where they are made. This would limit using a distribution service, including “sold by Amazon” where Amazon stocks and ships the product.
Special Labeling
Directly from the Florida regulations:
2. Each unit of cosmetics manufactured under this paragraph must contain, in contrasting color and not less than 10-point type, the following statement: “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements.”
FLA. STAT. § 499.01(2)(p)(2) (2022)
Any cosmetic product that is made by an exempt cosmetic manufacturer must have the statement “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit requirements.” on the label, in at least 10 point type, in a contrasting color (to the background).
The law doesn’t specify where the statement must be placed on the label.
Complaints and Investigations
Directly from the Florida regulations:
3. The department may investigate any complaint which alleges that an exempt cosmetic manufacturer has violated an applicable provision of this chapter or a rule adopted under this chapter. The department’s authorized officer or employee may enter and inspect the premises of an exempt cosmetic manufacturer to determine compliance with this chapter and department rules, as applicable. A refusal to permit an authorized officer or employee of the department to enter the premises or to conduct an inspection is a violation of s. 499.005(6) and is grounds for disciplinary action pursuant to s. 499.066.
FLA. STAT. § 499.01(2)(p)(3) (2022)
Being exempt from the cosmetic manufacturing permit doesn’t mean you are exempt from the oversight of the Department of Business & Professional Regulation. They can still investigate complaints, carry out inspections, and so forth.
When you register as a manufacturer, you explicitly give permission to the state to inspect, monitor and investigate (during business hours) to ensure you are following the regulations. Of course, these are the same rights that the FDA has over ALL cosmetic manufacturers, so those who live in Florida shouldn’t think they’ve been singled out on the enforcement issues.
Since one of the main requirements is that you aren’t making adulterated or misbranded cosmetics, I expect that the main focus of any investigations would be checking for sufficient procedures in place (good manufacturing practices) to make sure the products are clean, safe, and correctly labeled.
Frequently Asked Questions (FAQ)
Answers to the most commonly asked questions concerning Florida cosmetic regulations.
What if I only sell occasionally at craft fairs or farmers markets?
There is no exemption (I checked with the state office by email). If you make cosmetics for sale, you must get a permit (unless you meet the exemption requirements).
Can I make soap without a permit?
The laws and rules apply to cosmetics, the definition of which exempts soap. The Florida statutes and rules don’t define the criteria for a soap to be exempt. Assuming Florida is using the definition provided in the federal regulations:
Permit NOT required (already exempt):
- You would NOT need a permit if you were making and selling soap that is the alkali salt of fatty acids (made from lye/oil) AND is only marketed as “soap.” (NOTE: the soap could still include additives or fragrance.)
Permit IS required:
- You WOULD need a permit if the soap were the alkali salt of fatty acids, but was marketed with claims that it would moisturize or do anything more than cleanse (the claims would make the product a cosmetic).
- You WOULD need a permit if the soap were made from detergent-based surfactants, regardless of whether you claimed it could do anything more than cleanse or not.
Note that these types of soaps fall within the allowed products under the permit exemption, so if you have less than $25,000 annual sales, you can make these types of soap (which are “not otherwise exempt”) under the permit exemption.
Are small batches really considered “manufacturing”?
Yes. If you are making and selling, regardless of the quantity, you need a permit unless you meet the permit requirements.
If I buy in bulk and repackage, is that manufacturing?
Yes. If you open the package and handle the product, then it is manufacturing.
What if I have someone make my products and deliver to me already packaged so all I have to do is apply a label. Do I need a permit?
So long as you don’t OPEN the packages, you don’t need a permit.
What if I teach classes to people to teach them to make their own products?
No, a permit is not required (unless there are some requirements for teaching in general). Of course, all your students should be informed that if they decide to go out and start a business they will need to get cosmetic manufacturer permits and they need to correctly label their products.
Do cosmetic manufacturing businesses outside Florida that sell to customers IN Florida need a permit?
No. The permits are only required for cosmetic manufacturers located in Florida.
What if I sell only online and only to people outside of Florida?
Yes, you still need a permit. It is based on making the products in Florida, not where they are sold.
Do I need to register my individual products?
The laws in Florida formerly required that in addition to the permits, every single PRODUCT had to be registered (before it was sold). The law was changed in 2017 and that portion of it was removed. Individual products no longer have to be registered.
Do I need a permit if you give away other (cosmetic) products with a purchase of soap?
Yes, probably. Generally, the rule is that if purchase is required to get the “free gift” then the gift is actually “purchased.” In that case, the cosmetics are being “sold” and a permit would be required if you are making the cosmetics in Florida.
What about a mosquito repellent?
A product that is intended to repel bugs isn’t a cosmetic, because it’s not applied to the human body to make it more attractive. Therefore, the cosmetic regulations don’t apply.
At a federal level, bug repellents are overseen by the EPA (Environmental Protection Agency). In Florida, all pesticides must be registered with the Florida Department of Agriculture and Consumer Services.
Do I need a cosmetic manufacturer’s permit to make “cosmetic” products for animals?
No, cosmetics are “applied to a human body.” However, if there is any suggestion that the product COULD be used on humans (like a shampoo, for example) then it would be a cosmetic and a permit would be required.
Are permits needed for candles, room or linen sprays, or potpourri?
No. None of those items are applied to the human body and so are not cosmetics.
Prohibited Acts
Not getting a required permit for a cosmetic manufacturing business is clearly a violation of the law, unless you meet the requirements to be exempt from the permit.
Directly from the Florida regulations:
Prohibited acts.It is unlawful for a person to perform or cause the performance of any of the following acts in this state:
(22) Failure to obtain a permit or registration, or operating without a valid permit when a permit or registration is required by this part for that activity.
FLA. STAT. § 499.005(22) (2018)
What else is prohibited?
Well, the list of prohibited activity looks long, but it’s pretty much the same as the federal regulations. Note, I’ve only included items relating to cosmetics and have removed references to drugs and devices, to which all of these items also apply.
- The manufacture, repackaging, sale, delivery, or holding or offering for sale of any cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use;
- The adulteration or misbranding of any cosmetic;
- The sale, distribution, purchase, trade, holding, or offering of any cosmetic in violation of the Florida Statutes (Section 499);
- The dissemination of any false or misleading advertisement of a cosmetic;
- The refusal or constructive refusal:
- To allow the department to enter or inspect an establishment in which drugs, devices, or cosmetics are manufactured, processed, repackaged, sold, brokered, or held;
- To allow inspection of any record of that establishment;
- To allow the department to enter and inspect any vehicle that is being used to transport cosmetics; or
- To allow the department to take samples of any cosmetic.
- Providing the department with false or fraudulent records, or making false or fraudulent statements, regarding any matter within the provisions of the Florida Statutes (Section 499);
- Failure to obtain a permit or registration, or operating without a valid permit when a permit or registration is required by this part for that activity;
- The dissemination of any false advertisement of any cosmetic. An advertisement is false if it is false or misleading in any way;
- The manufacturing, repackaging, packaging, selling, delivery, holding, or offering for sale of any cosmetic for which the advertising or labeling is false or misleading;
- The advertising of any cosmetic that is adulterated or misbranded; (See What does ADULTERATED mean? )
Other Applicable Regulations
If you have a business making cosmetics in Florida there are other regulations that apply. Just like any other state, Florida has business and tax regulations that apply to all businesses.
City or County
Depending on the city and/or county you are located in, you may need a business license.
There may also be local zoning restrictions or requirements. Make sure you check before you decide on a location in which to manufacture your products.
Florida Dept. of Corporations
If you have a partnership, LLC, or Corporation, you’ll need to register your business with the Dept. of Corporations.
Normally, if you have a business operating under some other name than your personal name, you have to file a ficticious name statement, but it looks like businesses that are registered with the Department of Business and Professional Regulation are exempt.
Florida Dept of Revenue
You will probably need to get an Employer Identification Number, even if you don’t have any employees. You can use that number for your business instead of your own social security number.
Florida collects sales tax on all retail purchases made in the state. If you are selling retail, you need to get set up with the Department of Revenue to collect and report sales tax.
in Summary
Well, there are certainly some extra requirements to establish and run a successful and profitable company manufacturing cosmetics in Florida.
If you are just starting out, you will probably meet the “less than $25,000 annual sales” requirement. So long as you limit your products to those that are allowed under the exemption (soap, lotions, creams and moisturizers), and put the required notice on your labels, you should be good to go. You can even start out making products in your own home.
If you plan to expand and grow your business, keep in mind that as soon as you hit that $25,000 mark, you ARE required to get a permit and WILL need a commercial manufacturing space outside of your home. It’s something to plan for as you are scaling up.
My best advice if you plan to have a cosmetic-making business in Florida is to take the time to start out right. Get educated on good manufacturing practices (because that’s really all they are looking for) and get them in place from the beginning. That will give you a sound footing and professional standards from the start. Then, when your business has expanded and it is time to move into a commercial space and get your permit, you will be ready and able to do it without having to re-tool your whole operation.
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