21 CFR 101 · 21 CFR 701

U.S. label requirements for products from Spain

Food and cosmetics from Spain 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: Spain

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

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.	34
COLOR LBLG-274 The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.	28
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,…	9
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…	8
NO ENGLISH-472 Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).	6
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…	4
FLAVR LBLG-258 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an artificial flavoring 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

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.

Check a label ($149) Free allergen checker

Sources

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