21 CFR 101 · 21 CFR 701

U.S. label requirements for products from Japan

Food and cosmetics from Japan 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: Japan

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

CSTIC LBLG-471 The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.	14
NO ENGLISH-472 Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).	13
NO ENGLISH-3260 Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)	13
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,…	8
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.	4
COLOR LBLG-274 The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.	2
LABELING-473 The article appears in violation of FPLA because of its placement, form and/or contents statement.	2
DIETARYLBL-2300 The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B…	2

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.