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GUIDANCE DOCUMENT

Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications June 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-0052
Issued by:
Guidance Issuing Office
Human Foods Program

This document describes the data that FDA’s Center for Food Safety and Applied Nutrition (CFSAN or “we”) will consider when evaluating petitions and notifications seeking exemptions from the labeling requirements of section 403(w)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding ingredients derived from major food allergens. 

This guidance is intended to address the relevant issues for most submitters, but some recommendations may not be applicable in all cases.  If a recommendation does not appear to apply to a particular ingredient or use, the submitter should explain briefly why the scientific evidence recommended here is not needed for that ingredient or use. We also encourage potential submitters to consult us before submission to discuss any questions or data needs.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance documents describe our 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 guidance means that something is suggested or recommended, but not required.

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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:

Dockets Management
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-2014-D-0052.

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