FD&C Act §607 (MoCRA)
中国化妆品设施的 FDA 美国代理人
向美国出口产品的中国化妆品设施必须向 FDA 注册，并指定一名位于美国境内的美国代理人（FD&C Act §607 (MoCRA)）。在 2025-10 to 2026-09 的 12 个月内，FDA 拒绝了来自中国的 2,749 个进口条目，并有 85 项 FDA 进口警示列有来自中国的企业。
中国的 FDA 数据
数据来自 FDA 公开数据，检索日期 2026-10-21。召回数量按召回企业所在国家统计。
进口拒绝，2025-10 to 2026-09
| 被拒绝的进口条目 | 2,749 |
| 涉及注册或列名问题的拒绝 | NOT LISTED-118 · 388 FRNMFGREG-3280 · 279 |
最常见的拒绝理由
| 代码 | 数量 |
|---|---|
| TP NO PMTA-3842 This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C … | 415 |
| MELAMINE-3421 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the… | 401 |
| TP NO SE-3843 This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C A… | 396 |
| NOT LISTED-118 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on the information… | 388 |
| FRNMFGREG-3280 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on information available to FDA, i… | 279 |
列有中国企业的进口警示
至少列有一家中国企业的进口警示：85 项。近期更新：
- Import Alert 16-129: Detention Without Physical Examination of Seafood Products Due to Nitrofurans
- Import Alert 16-39: Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes
- Import Alert 45-02: Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.
- Import Alert 45-06: Detention without Physical Examination of Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts
- Import Alert 99-05: Detention Without Physical Examination Of Raw Agricultural Products for Pesticides
- Import Alert 99-08: Detention without Physical Examination of Processed Human and Animal Foods for Pesticides
法规要求
根据《化妆品监管现代化法案》（MoCRA），生产或加工供美国销售的化妆品的外国设施，必须向 FDA 注册，并提供美国代理人的姓名和联系方式。注册每两年更新一次，产品列名每年更新。
- 生产或加工在美国销售的化妆品的外国设施
- FD&C Act §612 所定义的小型企业可能获得豁免；请先核实，不要想当然
截止日期
- 新设施须在开始为美国生产或加工化妆品后 60 天内注册
- 每 2 年更新
- 每年更新产品列名
步骤
- 如果设施没有 FEI 号码，请先获取
- 准备设施、责任人及产品类别数据
- 通过 FDA 的 Cosmetics Direct 门户（或 SPL）提交
- 填写美国代理人及其联系方式
- 保留您的设施注册号码，用于产品列名
常见错误
- 将“责任人”（标签上标示的）与美国代理人混为一谈
- 错过每两年一次的更新
- 出售或购买“MoCRA 证书”：FDA 不签发此类证书
US Agent Desk 如何提供帮助
我们担任您的美国代理人，用您的语言准备注册资料供贵公司的负责人提交，在 FDA 要求时确认指定，并每天早晨查看 FDA 公开记录中与贵公司有关的内容。价格从每年 $990 起。
来源
独立的私营服务。与美国 FDA 无隶属关系。不构成法律意见。