- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition, Office of Compliance
May 16, 2023
This draft guidance, when finalized, will replace existing guidance, CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens, for FDA staff on FDA’s enforcement policy regarding major food allergen labeling and cross-contact.
The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on FDA’s enforcement policy regarding major food allergen labeling and cross-contact. See section II.B for more information about major food allergens, which are defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(qq)).
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2023-D-1103.