U.S. FDA Guidelines for Addressing Color Additive Violations in Cosmetics

The Import Alert dated March 14, 2024 addresses cosmetics that appear to be adulterated or misbranded due to color additive violations. Color additives are subject to a strict system of approval under the Food, Drug, and Cosmetic Act (FD&C Act). Non-permitted, uncertified, and undeclared color additives may be relevant to adulterated or misbranded cosmetics. Divisions may detain shipments without physical examination of the products identified on the Red List of this Alert. Label examination should determine whether cosmetics are consumer commodities or non-consumer commodities. If unapproved color additives are declared, the products are considered adulterated. If valid certification lot numbers are provided, the products are considered misbranded.

Cosmetics analyzed for unapproved color additives are considered adulterated, while those found to contain undeclared permitted color additives require certification lot numbers. If a valid certification is not provided, the products are considered adulterated and misbranded. If certified lot numbers are provided, they should be confirmed by the FDA/CFSAN's Office of Cosmetics and Colors, Division of Color Certification and Technology or FDA Division personnel. Recommendations for additions to the Red List should be forwarded to the Division of Import Operations. To remove a product from the Red List, evidence should be submitted to the FDA Division compliance office.