21 CFR 101 · 21 CFR 701

U.S. label requirements for products from China

Food and cosmetics from China sold in the United States need English labels with identity, net quantity in U.S. and metric units, ingredients, the 9 major allergens including sesame, and the name and place of business (21 CFR 101; 21 CFR 701). Our automated Label Check reviews your artwork against a cited checklist in minutes. Not legal advice or FDA approval.

FDA refusals related to labeling: China

Refusal charges among the most common for China in 2025-10 to 2026-09 that relate to labeling or misbranding.

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

What the checklist covers

Statement of identity and net quantity (placement, minimum type size, U.S. and metric units)
Ingredient order and the 9 major allergens, in English
Name and place of business, Nutrition Facts format, country of origin
Cosmetics: warnings, ingredient names, MoCRA U.S. contact; FCC ID labels for electronics

The report is an automated checklist. It can miss issues and never states that a label is compliant. FDA does not pre-approve labels.

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Sources

Independent private service. Not affiliated with FDA. Not legal advice.