21 CFR 101 · 21 CFR 701

来自中国的产品的美国标签要求

在美国销售的来自中国的食品和化妆品，须使用英文标签，并标明产品名称（identity）、以美制和公制单位表示的净含量、成分、包括芝麻在内的9种主要过敏原，以及企业名称和营业地点（21 CFR 101；21 CFR 701）。我们的自动化标签检查（Label Check）会在几分钟内依据附有引用依据的检查清单审核您的标签设计稿。本服务不构成法律意见，也不是FDA批准。

与标签相关的FDA拒绝入境：中国

2025-10 to 2026-09期间中国最常见的拒绝入境指控中，与标签或错误标示（misbranding）相关的部分。

COLOR LBLG-274 The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.	183
COSM COLOR-197 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adult…	83
NUTRIT LBL-482 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.	81
UDI LABEL-3904 The article is a device that appears to be misbranded because its label or device package fails to bear a unique device identifier that meets the requirements of 21 CFR 801 subpart B and 21 CFR part …	76
NO ENGLISH-324 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 within the meaning of Section 403(f) of the FD&C Act in that any word,…	59
LABELING-473 The article appears in violation of FPLA because of its placement, form and/or contents statement.	30
ALLERGEN-3300 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(w) in that it appears that the label fails to declar…	28
USUAL NAME-328 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 within the meaning of Section 403(i)(1) of the FD&C Act in that the la…	19

检查清单涵盖内容

产品名称（identity）声明与净含量（位置、最小字号、美制和公制单位）
成分顺序及9种主要过敏原（英文）
企业名称和营业地点、营养成分表（Nutrition Facts）格式、原产国
化妆品：警示语、成分名称、MoCRA 美国联系人；电子产品的 FCC ID 标签

本报告为自动化检查清单，可能遗漏问题，且绝不声明标签合规。FDA 不会预先批准标签。

检查标签（$149）免费过敏原检查器

来源

独立的私营服务。与 FDA 无任何关联。不构成法律意见。