FDA Issues Updated Version of Allergen Guidance for Comment

FDA issued updated Q&A guidance documents (5th edition) on allergen labeling.   The original document (4th edition) was spit into two sets....one being the updated set of Q&A which is labeled as 5th ed. Draft, and the other being those original Q&A are in the document labeled 5th ed. Final.  (Why you may ask?  So the updated or Draft set of Q&A can be made available or open to comment while the Final set of Q&A is not.)

So for our discussion, the Draft version is more important as that represents new or updated thinking by FDA.  (Draft - https://www.fda.gov/media/163454/download)

Here are the primary items discussed in the Draft Guidance:
Sesame is now included, although this fact is not up for comment.
Ingredients and bulk ingredients used in further manufacturing must have allergen declarations.

Incidental allergens must be declared (soy lecithin, for example, used as a processing aid)

Spice and seasoning mixes must declare allergens.

Dietary supplements using roots, leaves stems and bark from tree nuts do not.

Genetic engineering - if allergen is produced, it must be stated.

Specific tree nuts must be listed - the entire list is provided.

The allergen statement as placed on the package is discussed.

The use on multipacks of food within a master pack.

Food ingredients that are derived from allergenic foods (highly refined oils, etc)

Incidental additives is discussed.

Also a section on Dietary supplements.


https://www.fda.gov/media/163454/download
Constituent Updates

Center for Food Safety and Applied Nutrition

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FDA Issues Guidances on Food Allergen Labeling Requirements

Today, the U.S. Food and Drug Administration (FDA) issued two guidance documents about food allergen labeling requirements to help the food industry meet the requirements to list any major food allergen on the labels of FDA-regulated foods. Food labels are a powerful tool to help protect consumers with food allergies. Consumers can avoid ingredients they may be allergic or sensitive to in a food by looking for specific allergen labeling and reading the ingredient list.

One of the guidance documents is a draft guidance titled Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry. This draft guidance updates the previous edition (Edition 4) with new and revised questions and answers related to the labeling of food allergens, including requirements in the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

The FALCPA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining the term “major food allergen” and requiring that foods or ingredients that contain a major food allergen be specifically labeled with the name of the allergen source. This law identified eight foods as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. The FASTER Act, among other things, adds sesame to the list of major food allergens effective January 1, 2023, which will make it the ninth major food allergen recognized in the U.S.

The draft guidance includes:

• New questions and answers about food allergen labeling requirements, such as the labeling of sesame, milk, and eggs; the labeling of major food allergens in the labeling of dietary supplement products; and other technical labeling issues.

• Revised questions and answers to update and clarify information presented in earlier editions of the final guidance, such as the labeling of tree nuts, fish, and crustacean shellfish.

• Images that show examples of labeling requirements.

The agency also issued a final guidance with the same title to preserve the questions and answers from the previous edition (Edition 4) that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

To Submit Comments:

Comments about the draft guidance should be submitted within 60 days of publication of the notice in the Federal Register announcing the availability of the draft guidance to ensure we consider your comment before we begin work on the final guidance. Submit comments electronically on www.regulations.gov.

If unable to submit comments online, please mail written comments to:

Dockets Management Staff

Food and Drug Administration

5630 Fishers Lane, Rm 1061

Rockville, MD 20852

All written comments should be identified with this document's Docket ID: FDA-2022-D-0099.

For Additional Information:

• Federal Register Notice of Availability

• Draft Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)

• Final Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)

• Food Allergies

• Food Allergens/Gluten-Free Guidance Documents & Regulatory Information

• FASTER Act Video - Includes basic information about the FASTER Act and helps answer frequently asked questions the FDA has received from the food industry and other stakeholders

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