21 CFR 101 · 21 CFR 701
U.S. label requirements for products from Italy
Food and cosmetics from Italy 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: Italy
Refusal charges among the most common for Italy 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. | 14 |
| COLORLABEL-3865 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,… | 11 |
| 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. | 8 |
| 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… | 8 |
| 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… | 6 |
| NO ENGLISH-472 Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1). | 4 |
| 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,… | 3 |
| 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… | 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
- 21 CFR 101
- 21 CFR 701
- FDA Import Refusal Report (2026-10-21)
Independent private service. Not affiliated with FDA. Not legal advice.