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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact May 2023

Download the Draft Compliance Policy Guide (CPG) Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-1103
Issued by:
Guidance Issuing Office
Human Foods Program

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This draft guidance, when finalized, will replace existing guidance, CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens, for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.

Download the Draft CPG

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All written comments should be identified with this document's docket number: FDA-2023-D-1103.

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