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 Must Register and Deadlines
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 operating on December 29, 2022, must register with the FDA by December 29, 2023.
- Facilities beginning operations after December 29, 2022, must register within 60 days of starting or by February 27, 2024, whichever is later.
- 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 Registration
Some facilities are exempt from MoCRA registration, including:
- Small businesses with average annual U.S. cosmetic sales under $1,000,000 (adjusted for inflation) unless handling:
- Cosmetics for internal use or injection
- Cosmetics that alter appearance for more than 24 hours and are not easily removed
- Cosmetics in contact with eye mucous membranes
- Facilities producing products that are also classified as drugs, unless they also produce standalone cosmetic products.
- Entities solely responsible for labeling, packaging, holding, or distributing cosmetics are not considered facilities 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 the registration deadline approaches, it is crucial to:
- Start collecting necessary data to ensure readiness for submission.
- Appoint your U.S. Agent promptly to guide you through the registration process and compliance obligations.
Obelis USA offers several services dedicated to cosmetic products facilities based outside the United States — Contact us to know how we can help you.
FAQ
1. What is MoCRA?
The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 is a U.S. federal law that updates cosmetic regulations and introduces new compliance requirements, including mandatory facility registration with the FDA.
2. Who must register a facility under MoCRA?
Any establishment that manufactures or processes cosmetic products distributed in the U.S., whether located in the U.S. or abroad, must register as a facility.
3. What are the registration deadlines?
- Facilities operating on December 29, 2022, must register by December 29, 2023.
- Facilities starting after December 29, 2022, must register within 60 days of starting operations or by February 27, 2024, whichever is later.
- Registration must be renewed every two years.
4. Do non-U.S. facilities need a U.S. Agent?
Yes. Non-U.S. facilities must appoint a U.S. Agent to handle communications with the FDA. The agent can also support compliance, inspections, and recalls.
5. Which facilities are exempt from registration?
Exemptions include:
- Small businesses with average U.S. cosmetic sales under $1,000,000, unless handling injectable products, long-lasting appearance-altering cosmetics, or products in contact with eye mucous membranes.
- Facilities producing products that are also classified as drugs, unless producing standalone cosmetic products.
- Entities solely responsible for labeling, packaging, holding, or distributing cosmetics.
6. How do facilities register with the FDA?
Facilities register via the FDA online portal using the Structured Product Labeling (SPL) format. A paper form is available, but electronic submission is preferred.
7. What data is required for registration?
Key data includes facility information, product categories, and the designated U.S. Agent. It’s recommended to collect this data in advance to ensure timely registration.
8. How can Obelis help with MoCRA compliance?
Obelis acts as your U.S. Agent, assisting with facility registration, keeping records up-to-date, and supporting compliance with inspections, adverse events, and recalls.
Francesca Santacatterina
Publications department
19.09.2023
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