On September 9, 2026, the U.S. Food and Drug Administration (FDA) notified cosmetic product facilities, retailers, and responsible persons in the 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 Shops, 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 an "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.
What Can CIRS Do for You
Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services, from regulatory compliance and laboratory testing to R&D and data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.
The CIRS cosmetic team provides expert support to ensure that cosmetic products meet stringent global cosmetic regulations and safety standards.
We offer comprehensive, lifecycle-based solutions for personal care products, from early-stage cosmetic ingredient development through to final product registration. Our services include:
- Cosmetic ingredient development and regulatory strategy,
- Physical/chemical and analytical tests,
- Toxicological tests (in vivo & in vitro),
- Efficacy and claim substantiation studies (in vivo & in vitro), and
- Ingredient and product registration across global markets.
With deep expertise in cosmetic regulatory compliance and safety evaluations, our team enables brands to bring products to market efficiently and with confidence.
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
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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