On September 9, 2026, the U.S. Food and Drug Administration is informing cosmetic product facilities, retailers, and industry responsible persons that the agency does not provide certificates or other documents to verify compliance for cosmetic product facility registration.
Under section 607 of the FD&C Act, as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), owners or operators of facilities manufacturing or processing cosmetic products are generally required to register their facilities with the FDA and renew their registration every two years. Additionally, the responsible person for each marketed cosmetic product must list each product with the FDA, including product ingredients, and provide any updates annually.
Cosmetic product facility registration and cosmetic product listing is neither a cosmetic approval program nor a promotional tool. The assignment of a facility registration number or product listing number does not indicate FDA approval of the facility or its cosmetic products.
The FDA has received an increased number of inquiries from individuals seeking to obtain certificates or other documents to verify compliance for cosmetic product facility registration or confirm that a person or facility is not required to register with the FDA. The FDA is aware that ecommerce platforms, such as TikTok Shop, may ask those wanting to sell their products on these platforms to provide proof of FDA registration or if they are not required to register with the FDA, a letter or email from the FDA confirming such a registration exemption.
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 a facility is registered or a cosmetic product is listed, or
- a document (e.g., certificate, letter, or email) confirming a facility or responsible person is not required to register or list cosmetic products with the FDA.
For additional information on cosmetic product facility registration and cosmetic product listing, visit:
An unofficial translation of this announcement is provided below.
翻译参考
FDA 澄清，不提供证书或其他文件以验证化妆品生产企业设施注册合规情况
2026 年 9 月 9 日，美国食品药品管理局告知化妆品生产企业、零售商及行业责任人：FDA不提供任何证书或其他文件，用于验证化妆品生产企业设施的注册合规情况。
根据经《2022年化妆品监管现代化法案》（MoCRA）修订的《联邦食品、药品和化妆品法》（FD&C Act）第607条，从事化妆品生产或加工的企业设施所有者或运营者通常须向 FDA 进行企业设施注册，并每两年延续注册一次。此外，每种已上市化妆品的责任人须向 FDA 登记产品信息，包括产品成分，并每年提交更新。
化妆品生产企业设施注册及化妆品产品登记列名，既不是化妆品批准程序，也不是宣传工具。企业注册号或产品登记号的分配，并不代表 FDA 对该企业或其化妆品产品的批准。
FDA近期收到越来越多的查询，相关人员希望获得证书或其他文件，以验证化妆品生产企业设施是否符合注册要求，或确认某个人员或设施是否无需向 FDA 注册。FDA 注意到，TikTok Shop 等电子商务平台可能要求希望在平台上销售产品的卖家提供 FDA 注册证明，如果商家无需向 FDA 注册，则可能会要求其提供 FDA 出具的信函或电子邮件，以确认其享有注册豁免。
FDA 不提供任何证书或其他文件，用于验证化妆品企业设施注册或化妆品产品登记的合规情况，包括但不限于：
- 作为化妆品企业设施注册或产品登记证明的证书；
- 声明某企业设施已完成注册或某化妆品已完成登记的验证文件，如信函或电子邮件；
- 证明某企业设施或责任人无需向 FDA 进行注册或登记的文件（如证书、信函或电子邮件）。
有关化妆品生产企业设施注册及化妆品产品登记的更多信息，请访问：
Sincerely,
Sarah McMullen
Country Director
FDA China Office
Office of Global Operations
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