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Draft Guidance for Industry: Voluntary Disclosure of Sesame as an Allergen November 2020


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2020-D-0530

Docket Number:
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition,Office of Nutrition and Food Labeling

November 2020

We are issuing this guidance to provide food manufacturers with our current views on sesame as an allergen and to provide recommendations to voluntarily disclose sesame in certain circumstances where such disclosure is not currently required. The guidance is intended to help individuals who are allergic to sesame identify those foods that may contain sesame as an ingredient.

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

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