MoCRA Updates: U.S. FDA Allows Delay in Enforcement of Cosmetic Facility Registration and Product Listing

Facility Registration

All entities engaged in the manufacture or processing of cosmetic products for the U.S. market, regardless of their geographical location, must register their facilities with the FDA and renew such registration biennially. Foreign facilities, in particular, shall designate a U.S. Agent during registration for effective communication with the FDA.

Facilities in operation when MoCRA was enacted must complete registration with the FDA by December 29, 2023. New facilities commencing cosmetic production afterwards must be registered within 60 days after they begin manufacturing or processing cosmetics, or within 60 days after December 29, 2023, whichever is later.

Product Listing

Responsible person for cosmetics intended for distribution in the U.S., namely, manufacturer, packer and distributor of a cosmetic product whose name appears on the label, must list each marketed cosmetic product with the FDA. The product listing shall be renewed annually. Notably, a single listing submission can encompass multiple products with identical formulations or minor variations in color, fragrance, flavor, and/or quantity.

Existing cosmetic products, which were already on the market prior to MoCRA’s enactment, must be listed with the FDA no later than December 29, 2023. For new products introduced after MoCRA's enactment, the listing with the FDA should be done within 120 days from the date of their initial launch on the market.

Notes: There are exemptions for certain companies under specific circumstances:

• "Small business" with less than $1 million average gross annual cosmetics sales within the U.S. in the preceding three years, provided their products do not include mucus-membrane-contacting cosmetics, injected cosmetics, or some cosmetics categorized as high-risk.

• Enterprises whose product categories satisfy the definitions of both cosmetics and drugs. However, if these enterprises concurrently produce products solely categorized as cosmetics, this exemption is not applicable.