The Modernization of Cosmetics Regulation Act of 2022 expanded federal requirements for cosmetic businesses. Depending on the company’s role and available exemptions, cosmetic facilities may need FDA registration and responsible persons may need to list marketed cosmetic products.
Cosmetic companies should maintain adequate safety substantiation, report serious adverse events, keep required records, and ensure the product is not adulterated or misbranded. Product identity and intended use matter: claims that treat disease or affect body structure or function may cause a cosmetic to be regulated as a drug.
Imported cosmetics are subject to FDA review at entry and must meet the same legal standards as domestic products. The importer should verify ingredient restrictions, color additive requirements, English labeling, net quantity, business identification, warning statements, and claim language.
Because cosmetic rules and implementation guidance continue to evolve, businesses should periodically reassess registration, listing, labeling, and recordkeeping obligations rather than relying on a one-time review.
APEX CS practical takeaway: Confirm the product-specific regulatory pathway before production, testing, labeling, or shipment. Requirements vary by device design, intended use, claims, market channel, and final configuration.