The Modernization of Cosmetics Regulations Act (MoCRA) was enacted on 29 December 2022. This landmark legislation marks the first substantial cosmetic regulation update since the Food, Drug, and Cosmetics Act of 1938. With MoCRA, the U.S. Food and Drug Administration (FDA) has been granted significant new authority to regulate the cosmetics market.
This modernization introduces various requirements affecting all cosmetics businesses selling in the U.S., whether based in the US or not.
New registration requirements for products and facilities
From 29 December 2022, products on the U.S. market have to be listed on a newly established FDA portal. The responsibility for performing cosmetics listing falls on brand owners, identified as the responsible persons under MoCRA. However, product listing can be delegated.
The FDA holds the right to act against businesses that fail to comply with this rule.
In addition to product listings, MoCRA requires all manufacturing facilities producing cosmetics for the U.S. market to register on the FDA portal. This requirement applies globally; any facility, whether domestic or international, must register if it supplies products to the U.S. market.
International facilities also need to appoint a U.S. Agent to act as a point of contact with the FDA.
Enforcement powers of the FDA under MoCRA
The FDA can take various enforcement actions if a company or facility fails to meet regulatory requirements. These include:
- Holding products at the port of entry: Non-compliant products entering the U.S. may be detained until the FDA verifies that they meet regulatory standards.
- Product recalls: The FDA can mandate a recall of products that fail to meet MoCRA’s compliance requirements.
- Facility registration suspension: If manufacturing facilities are found non-compliant, the FDA can suspend their registration, effectively preventing them from supplying products to the U.S. market.
Documentation disclosure
MoCRA also expands the FDA’s authority to demand documentation from cosmetics businesses, including:
- Adverse events report: Companies are required to maintain records of any adverse health effects reported by consumers. This information must be available for FDA review upon request.
- Fragrance and flavor ingredient list: If there is a public health concern, the FDA can require companies to disclose detailed information about fragrances or flavors used in their products.
- Testing, studies, and investigations: the FDA may request information on tests, studies, and safety assessments conducted by companies to ensure product safety.
Non-compliance with any of these requests can lead to the enforcement actions outlined above, including recalls, port detentions, and suspension of manufacturing facility registration.
Why MoCRA compliance is essential
With the FDA’s enhanced powers under MoCRA, cosmetics businesses must prioritize compliance to avoid potential disruptions. Non-compliance can lead to severe business consequences.
Companies may benefit from expert guidance on MoCRA compliance to navigate these changes and maintain market access, especially for international businesses that need to understand U.S. regulations and establish connections with FDA agents.
Geoff Waby
Obelis US Director
Chiara Lai
Regulatory Intelligence & Innovation department
7.11.2024
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