A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in Florida.
What is a “cosmetic”? A cosmetic is 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.
What is “manufacturing”? In this context, the term includes the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any cosmetic.
What is “repackaging”? The term includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the product. A few examples:
- Altering a packaging component that is or may be in direct contact with the drug, device or cosmetic. For example, repackaging from 1-liter bottles into 10-milliliter bottles.
- Relabeling, if the process involves opening the manufacturer’s sealed container. Relabeling, without opening such a sealed container, does NOT require this permit.
What is NOT a “manufacturer”? A Florida-licensed pharmacy operating in compliance with pharmacy practice standards under the Florida Pharmacy Act, Chapter 465, Florida Statutes.
Distributors – No Permit Required: Florida law does NOT require any permit for the distribution of cosmetics – only the manufacturing or repackaging. However, cosmetic distributors must keep and maintain sales and other distribution records records.
Application: Businesses seeking this permit must complete the Department’s application. Mail or deliver the application and all required attachments to:
Inspection: Passing an onsite inspection is a prerequisite to issuance of this permit, unless the applicant also holds an Over-the-Counter Drug Manufacturer or Prescription Drug Manufacturer permit at the same address.
License Term: Cosmetic Manufacturer permits are valid through the last day of the initial issuance month in the second year of licensure. Example: A permit issued on September 12, 2011 would be valid through September 30, 2013.
Fee: The application and permitting fee is $800 for a two-year permit, plus a one-time pre-permit inspection fee of $150 unless the applicant also holds an Over-the-Counter Drug Manufacturer or Prescription Drug Manufacturer permit at the same address. Make checks payable to DBPR. The inspection fee applies only to new permits.
Product Registration: On June 2, 2017, Governor Rick Scott signed HB 211 which removes the requirement to register cosmetic products manufactured in Florida effective July 1, 2017. Based on passage of the bill, the Division no longer requires cosmetic manufacturers to register their products with the Division. Cosmetic manufacturers must still meet all other licensure and manufacturing requirements established by Florida and Federal law.
NO PERMIT IS REQUIRED TO MANUFACTURER CERTAIN COSMETICS PRODUCTS
THE LEGISLATURE IN THE 2021 SESSION AMENDED SECTON 499.01(2)(p), FLORIDA STATUTES (2020) AND CREATED AN EXEMPTION ALLOWING CERTAIN COSMETICS TO BE MANUFACTURED WITHOUT A PERMIT.
A permit to manufacture cosmetic soaps, lotions, moisturizers and creams is NOT required 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 in not less than 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 to the Department written documentation to verify his or her annual gross sales.
The Department of Business and Professional Regulation has authority to inspect the premises as well as investigate any complaint received about these cosmetic products. 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.
All requests for publications, documents, forms, applications for licenses, permits and other similar certifications can be obtained by contacting the Customer Contact Center.
Walter Copeland, Division Director
Division of Drugs, Devices and Cosmetics
2601 Blair Stone Road
Tallahassee, FL 32399-1047