MoCRA 2024: How US Cosmetics Reform Affects Your OEM Supply Chain
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Signed into law in December 2022 and taking full effect in 2024, the Modernization of Cosmetics Regulation Act (MoCRA) fundamentally changes the regulatory landscape for cosmetics in the United States. For the first time, the FDA has mandatory recall authority, facility registration requirements, and adverse event reporting obligations β bringing the US closer to the EU model.
Facility Registration: Deadline December 29, 2024
Every facility that manufactures or processes cosmetic products for the US market must register with the FDA. This includes all OEM and contract manufacturing facilities overseas. Registration is renewed every two years. Failure to register means your products cannot legally enter the US. For Asian manufacturers serving multiple US brand clients, this registration is critical β your US clients rely on your facility being FDA-registered.
Product Listing: Every SKU Must Be Declared
In addition to facility registration, each cosmetic product must be listed with the FDA. The Responsible Person (typically the brand owner whose name appears on the label) submits the product listing, but they need specific information from you: full ingredient list, manufacturing facility registration number, and product category codes.
Adverse Event Reporting: New Mandatory Obligations
Serious adverse events (death, life-threatening experience, hospitalization, disability, birth defect, infection, or significant disfigurement) must be reported to the FDA within 15 business days. As a manufacturer, you need systems to receive and escalate adverse event reports from your brand clients.
GMP Requirements: Coming Soon
MoCRA directs the FDA to establish mandatory Good Manufacturing Practice (GMP) regulations for cosmetics. The proposed rule is expected to align closely with ISO 22716 β which many OEM facilities already follow. If you are ISO 22716 certified, you are well-positioned. If not, now is the time to start the certification process.
Fragrance Allergen Labeling
The FDA will issue a rule requiring fragrance allergens to be declared on cosmetic labels, similar to the EU’s 26-allergen requirement. This will affect every scented product in your portfolio. Start preparing your fragrance documentation now β your US brand clients will need this data.
MoCRA represents a paradigm shift for the US cosmetics industry. For OEM manufacturers, the message is clear: the era of light-touch regulation is over. Invest in compliance infrastructure now, and you will be the partner of choice for US brands navigating this new landscape.
SkincareFactoryOEM Team