On September 9, 2026, the U.S. Food and Drug Administration (FDA) notified cosmetic product facilities, retailers, and responsible persons in cosmetic industry that the agency does not issue certificates or other documents to verify compliance for cosmetic product facility registration. This clarification by the FDA aims to define the boundaries of its regulatory responsibilities and prevent misinterpretation within the marketplace.
Background
Under section 607 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), owners or operators of facilities that manufacture or process cosmetic products are generally required to register their facilities with the FDA and to renew their registration every two years. In addition, the responsible person for each marketed cosmetic product must list each product with the FDA, including the product ingredients, and provide any updates annually.
The FDA has lately been receiving a growing volume of requests from individuals attempting to secure certificates or alternative documentation verifying compliance in connection with cosmetic facility registration, or confirmation that an individual or establishment is exempt from FDA-mandated registration. The FDA notes that e-commerce marketplaces including TikTok Shop may require sellers intending to list items on these platforms to furnish evidence of FDA registration. Where registration is not obligatory, platforms may request an official letter or email from the FDA confirming this registration exemption status.
Key Points of the FDA Clarification
1. Cosmetic product facility registration and cosmetic product listing are neither a cosmetic approval program nor a promotional tool.
2. The assignment of a facility registration number or a product listing number does not indicate FDA approval of the facility or its cosmetic products.
3. The FDA does not provide certificates or other documents to verify compliance for cosmetic product facility registration or cosmetic product listing, including but not limited to:
- a certificate as proof of cosmetic product facility registration or cosmetic product listing;
- a verification document, such as a letter or email, stating that a facility is registered or a cosmetic product is listed;
- a document (e.g., a certificate, letter, or email) confirming that a facility or responsible person is not required to register or list cosmetic products with the FDA.
Implications and Recommendations for Cosmetic Enterprises
1. No FDA-issued compliance certificate exists: when e-commerce platforms or business partners request a "FDA registration certificate," enterprises should explain that the FDA does not issue such certificates, letters, or emails for facility registration or product listing, as officially clarified by the agency, and provide their own facility registration number or product listing number and related confirmation records instead;
2. Registration or listing does not constitute FDA approval: issuance of a facility registration number or product listing number is not evidence that the facility or its cosmetic products have been approved by the FDA. Marketing assertions suggesting FDA-endorsement of the facility or products are not permitted.
3. Confirm registration and listing obligations in a timely manner: owners or operators of facilities manufacturing or processing cosmetic products for the U.S. market should confirm whether they are required to register with the FDA and complete registration, renewal (every two years), and product listing (with annual updates) as required, so as to avoid compliance gaps in platform onboarding or market oversight.
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Our Services
- The United States Agent
- The United States FDA Cosmetic Facility Registration
- The United States FDA Cosmetic Product Listing
- The United States FDA OTC Drug Registration
- The United States Color Additive Batch Certification
- The United States Cosmetic/OTC Drug Labeling Review
- International Cosmetic Ingredient Name (INCI) Application
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