The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the new federal law on cosmetic products in the United States. It has deeply changed the U.S. cosmetic regulatory framework by introducing new requirements. Among them is mandatory facility registration with the FDA by December 29, 2023. Do you produce cosmetic products? This requirement applies to you!
Who has to register and by when?
MoCRA defines a facility as any establishment that manufactures or processes cosmetic products distributed in the United States, regardless of location (in the U.S. or abroad).
- Facilities engaged in the manufacture or process of cosmetic products on December 29, 2022, must register with the FDA no later than December 29, 2023.
- Facilities starting such activities after December 29, 2022, must register within 60 days of the beginning of the operations or by February 27, 2024, whichever is later.
The registration must be renewed every two years.
Non-US-based facilities must appoint a US Agent to handle communications with the FDA. Obelis as your US Agent will do more than that, registering your facility and keeping it up-to-date, ensuring you meet all regulatory requirements and assisting you in case of inspections, adverse events, and recalls
Exemptions from the registration requirements
The following facilities are exempted from registration requirements:
- Facilities whose average gross annual sales in the United States of cosmetic products for the previous three years is less than $1,000,000, adjusted for inflation (small businesses) unless they handle the following products:
- Cosmetics for internal use or to be injected
- Cosmetics that modify the appearance for more than 24 hours and that, under usual conditions, are not removed by the consumer
- Cosmetics in contact with eye mucus membrane
- Facilities that manufacture or produce cosmetics that are also drugs, unless they also manufacture or produce products that are solely cosmetics and not drugs.
It is also important to clarify that entities solely responsible for labeling, packaging, holding, and distributing cosmetic products are not considered a facility and do not need to register.
How to register
Facilities will register with the FDA through an online portal using structured product labeling (SPL) format that will be operational as of October 2023. There will also be an alternative paper form for submission; however, electronic registration is encouraged.
As we are getting closer to the deadline, and we already know which data will be needed to register, we strongly advise you to start collecting the data to be ready to submit your application as soon as the portal opens. Furthermore, you should appoint your US Agent as soon as possible to guide you through this challenging transition. Obelis USA offers several services dedicated to cosmetic products facilities based outside the United States — Contact us to know how we can help you.
Francesca Santacatterina
Publications department
19.09.2023
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