The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA's authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938. MoCRA includes new requirements for cosmetic product facility registration and product listing.
The FDA released draft guidance on cosmetic product facility registration and product listings on August 10, 2023. This guidance describes who is responsible for making the registration and listing submissions, what information to include, how to submit, and when to submit, as well as certain exemptions to the registration and listing requirements.
Who is responsible for making the registration and listing submissions?
The following individuals or entities are responsible for making the registration and listing submissions:
Cosmetic product manufacturers
Cosmetic product processors
A responsible person is an individual or entity who is designated by the cosmetic product manufacturer or processor to be responsible for ensuring that the cosmetic product complies with the FD&C Act and MoCRA.
What information to include in the registration and listing submissions?
The facility registration submission must include the following information:
Facility name and address
Contact information for the facility owner or operator
Types of cosmetic products manufactured or processed at the facility
The product listing submission must include the following information:
Product name and brand
Contact information for the responsible person
How to submit the registration and listing submissions? The registration and listing submissions must be submitted electronically through the FDA's Cosmetic Product Registration and Listing System (CPERS).
When to submit the registration and listing submissions? All existing cosmetic product facilities and products must be registered and listed by December 29, 2023. New cosmetic product facilities and products must be registered and listed within 60 days of beginning operation or manufacturing or processing of cosmetic products.
Exemptions to the registration and listing requirements MoCRA exempts certain small businesses from the registration and listing requirements. However, these exemptions do not apply to facilities that manufacture or process certain types of cosmetic products, such as products that regularly come into contact with the mucus membrane of the eye, injected products, and products that are intended for internal use.
Conclusion The FDA's draft guidance on cosmetic product facility registration and product listings provides important information to help stakeholders comply with the new requirements under MoCRA. It is important to note that this guidance is still in draft form, and the FDA may make changes before finalizing it. However, the draft guidance provides a good starting point for understanding the new requirements and preparing to comply with them. In addition to the information provided in the draft guidance, there are a few other things that cosmetic product manufacturers and processors should keep in mind: The registration and listing requirements apply to all cosmetic products, regardless of where they are manufactured or sold.
The registration and listing submissions must be updated within 60 days of any changes to the information that was submitted.
The registration for each facility must be renewed every two years.
The FDA may inspect registered facilities at any time.
Cosmetic product manufacturers and processors should review the draft guidance carefully and take steps to comply with the new requirements by December 29, 2023.