Selling Cosmetics & Skincare in the US: MoCRA Guide

MoCRA created new obligations for cosmetic brands selling in the US: (1) Facility registration: All facilities that manufacture or process cosmetics for US sale must register with FDA. Deadline for existing facilities: December 29, 2023. Biennial renewal required. (2) Product listing: All cosmetic products must be listed with FDA. Responsible person must submit product listings including ingredient information. (3) Safety substantiation: Brands must maintain records demonstrating their products are safe — a significant change from the previous self-regulatory framework.

Product listings must be submitted to FDA within 120 days of a product being first marketed in the US (or for existing products, by July 1, 2024). Each listing requires: product name, responsible person name and contact, facility where manufactured, cosmetic category, list of ingredients (using INCI names), and whether the product is for children under 11. Listings are submitted electronically via FDA's Cosmetics Direct electronic portal.

Under MoCRA, the responsible person must ensure each cosmetic product is 'adequately substantiated for safety' and maintain records to demonstrate this. Records must be available to FDA on request. Adequate substantiation typically includes: ingredient safety data (toxicological profiles, NOAEL data), finished product safety testing (dermatological testing, patch testing), preservative efficacy testing (where applicable), and review by a qualified cosmetic safety professional.

US cosmetic labels must comply with FDA 21 CFR Parts 701 and 740. Required elements: product name, net quantity (in US customary units with metric equivalent), ingredient list in descending concentration using INCI names, name and address of manufacturer/distributor, warnings as required by FDA regulations. Drug products (OTC sunscreen, acne treatments, dandruff shampoos) have additional requirements under OTC drug monographs. Foreign-language labels may be supplemented with English but English must be included.

MoCRA requires responsible persons to report serious adverse events associated with cosmetics to FDA within 15 business days. Serious adverse events include: events requiring medical treatment, disfigurement, hospitalisation, or death. Responsible persons must also maintain records of adverse event reports for 6 years. This requirement applies to all US cosmetic brands including importers of international brands.