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FDA Draft Guidance for Industry Voluntary Disclosure of Sesame as an Allergen

蒋千琴 3/5/2022 浏览 256 FDA 美国

标准简介

Draft Guidance for Industry Voluntary Disclosure of Sesame as an Allergen[附网盘链接]由FDA于不久前发布，适用于美国。

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Draft Guidance for Industry Voluntary Disclosure of Sesame as an Allergen[附网盘链接]
Draft Guidance for Industry Voluntary Disclosure of Sesame as an Allergen[附网盘链接](截图)

 

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标准部分原文

Draft-Not for Implementation Voluntary Disclosure of Sesame as an 1

Allergen: Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction 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. II. Background Food allergies occur when the body's immune system reacts to certain food proteins (Ref. 1). Allergic reactions to food due to immunoglobulin E (IgE) antibodies cause the body to release inflammatory chemicals and can be particularly severe, leading to symptoms such as hives, facial swelling, vomiting, wheezing, shock, and even death. Because there is currently no cure for food allergies and approved therapeutics to avert allergic reactions are limited, allergic consumers must use avoidance to prevent allergic reactions. Successful avoidance requires, among other things, that allergic consumers and their caregivers know when allergens are present in packaged foods or in other settings, such as at retail or food service establishments. Thus, it is important that the presence of food allergens be properly disclosed and that allergic consumers and their 1

This guidance has been prepared by the Office of Nutrition and Food Labeling, Food Labeling and Standards Staff in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 3

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