Florida’s Cosmetic Manufacturer Exemption

In Florida, a person can manufacture certain cosmetic soaps, lotions, moisturizers, and creams in their home per Florida Statute 499.01(2)(p). These specific types of cosmetic manufacturers do not require a license, permit, or inspection of their operation.

Definitions

What is a “cosmetic”? A cosmetic is an article, except 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.

What is “manufacturing”? In this context, the term includes the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any cosmetic.

What about “soap”? Soap can be tricky since the regulatory definition of “soap” differs from the way most use the word. Most soaps on the market are not true “soaps” but synthetic detergent cleanser products. These cleansers are more popular than traditional soaps because they sud quickly and don’t leave behind residues. According to the FDA’s Frequently Asked Questions on soap, to meet FDA’s regulatory definition of soap, the product must meet three conditions:

1. What is it made of? To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye;
2. What ingredients cause its cleaning action? To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap; and
3. How is it intended to be used? To be regulated as soap, it must be labeled and marketed only for use as soap. If it is intended for moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. Or, if the product is intended to treat or prevent diseases, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug.

2021 Exemption

In 2021, Legislature amended Section 499.01(2)(p), more commonly known as the “Florida Drug and Cosmetic Act,” to provide an exemption allowing certain cosmetics to be manufactured without a permit under the following conditions:

• The person manufacturing the cosmetics has annual gross” sales of $25,000 or less;
• The cosmetic product must be packaged and sold with a label meeting the requirements of the Federal Food and Drug Administration;
• The cosmetic product is a soap, lotion, moisturizer, or cream;
• The cosmetic is not adulterated and is not misbranded as defined by 21 United States Code sections 361 and 362;
• The cosmetics are stored on the premises of the cosmetic manufacturing operation; and
• Each unit of the cosmetic product contains, in contrasting color and not less than a 10-point font, the following statement: “Made by a manufacturer exempt from Florida’s cosmetic manufacturing permit Requirements.”

Upon request, an exempt cosmetics manufacturer must provide written documentation to the Department of Business and Professional Regulation (DBPR) to verify their annual gross sales. The DBPR has the authority to inspect the premises and investigate complaints about these cosmetic products. 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 under s. 499.066. This exemption does not exempt any person from any state or federal tax law, rule, regulation, or certificate or from any county or municipal law or ordinance that applies to cosmetic manufacturing.

Further Resources

Visit the Lee County Extension Office or contact Family and Consumer Sciences Agent Jennifer Hagen at 239-533-7510 or email Jennifer here.

The Department of Business and Professional Regulation’s (DBPR) Division of Drugs, Devices, and Cosmetics – Cosmetic Manufacturer Guidance: http://www.myfloridalicense.com/DBPR/drugs-devices-and-cosmetics/cosmetic-manufacturer/

Florida Statute 499.001 (Florida Drug and Cosmetic Act): http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0400-0499/0499/0499PARTIContentsIndex.html

Is It a Cosmetic, a Drug, or Both? Or is It Soap?  FDA Guidance: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap#Soap