One of the many changes introduced by MoCRA is the mandatory registration of cosmetic products to the FDA. The Responsible Person must register the products already on the market by December 29, 2023. Conversely, new products must be listed within 120 days of their entering the US market.
The old system
Due to the new MoCRA requirements, the FDA had to dismantle the previous system: the Voluntary Cosmetic Registration Program (VCRP). In March 2023, the FDA announced that it no longer accepts submissions to the VCRP and that the information there will not be transferred to the new MoCRA system.
The FDA established the VCRP in 1972 to obtain information on the cosmetic products available on the US market. The registration was voluntary, so the database did not provide a complete picture of cosmetic products in the US; however, it represented a good estimate.
The registration through the VCRP database did not constitute approval by the FDA, as only the brand is responsible for ensuring compliance with the law. Furthermore, it did not apply to cosmetics for professional use only and products not for sale (samples, gifts).
MoCRA requirements for the registration of cosmetic products
MoCRA strengthens the role of the FDA in regulating cosmetic products: mandatory products listing is one of the ways to achieve this.
The law provides that the registration by the Responsible Person includes the following data:
- The commercial name of the product
- Ingredients list, including fragrances and flavors
- The cosmetic product category
- Details of the Responsible Person
- Registration number of the facilities where the product is manufactured or produced
In case of changes to that information, the Responsible Person must update the registration annually.
Moreover, MoCRA exempts small businesses (with average gross annual sales for the prior three years of less than 1 million dollars) from the registration requirements unless they manufacture the following categories of cosmetics:
- Products in contact with the mucous membrane of the eye
- Injectable products
- Products for internal use
- Products that alter the appearance for more than 24 hours.
This is what we know, but many points are still uncertain. As a matter of fact, the FDA is still developing the registration system; thus, we expect further updates in the coming months. However, the December 29 deadline remains firm and beauty brands should start getting ready.
MoCRA deeply reshaped the regulatory framework for cosmetic products in the US. Obelis is here to help you keep up with the changes. As your US Agent or in-country regulatory consultant, we smooth the compliance process.
Don’t let regulatory changes hold your business back. Contact us today to learn how we can help you stay ahead of the game.
Francesca Santacatterina
Publications Department
20.06.2023
References:
- FDA. (2023). Voluntary Cosmetic Registration Program. Retrieved on 20.06.2023
- FDA. (2023). Modernization of Cosmetics Regulation Act of 2022. Retrieved on 20.06.2023