SUPPLEMENTARY INFORMATION: ( printed page 1164)

I. Background

We are announcing the availability of a guidance for FDA staff and interested parties entitled “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.” We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA 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.

In the Federal Register of April 19, 2022 (87 FR 23181), we announced the availability of a draft guidance for FDA staff and stakeholders entitled “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.” We gave interested parties until August 17, 2022, to submit comments for us to consider before beginning work on the final version of the guidance.

This guidance finalizes the approach we generally intend to take when evaluating the public health importance of a non-listed food allergen. The guidance specifies the scientific factors and other information relevant to the labeling and production of food containing the food allergen that we generally intend to consider when evaluating the public health importance of a non-listed food allergen. It also describes our recommendations for how to identify and evaluate the body of evidence applicable to an evaluation of the public health importance of a non-listed food allergen.

Food allergy can be broadly defined as an adverse health effect arising from a specific immune response that occurs reproducibly on exposure to a given food. A food allergen is the food or component(s) (often a protein) of a food that elicits specific immunologic reactions. While many different types of food allergies have been identified, food allergies that are most studied and understood clinically are those due to immunoglobulin E antibodies (IgE) that cause the body to release inflammatory chemicals. The most severe and immediately life-threatening food allergies are those that are mediated by IgE and are capable of triggering anaphylaxis, which can be fatal. The focus of this guidance is primarily IgE-mediated food allergy. However, we recognize that food allergens acting through other mechanisms may raise public health concerns. We intend to evaluate the public health importance of these allergens on a case-by-case basis. We will also continue gathering scientific data and other information on food allergens acting through other mechanisms to help inform possible future action on these allergens, which may include future guidance or communications to the public.

In general, the regulatory framework of the FD&C Act and our regulations implementing the FD&C Act broadly apply to the production of food that is or contains a food allergen through statutory and regulatory provisions regarding: (1) food labeling; (2) food production ( e.g., manufacturing, processing, packing, and holding food); and (3) the safety of substances added to food. Under section 403(w) of the FD&C Act (21 U.S.C. 343(w)), a food is misbranded if it contains a major food allergen and fails to declare that major food allergen as specified on its label using the major food allergen's common or usual name. Section 201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)) defines a “major food allergen,” in part, as any of the following: milk, eggs, fish ( e.g., bass, flounder, or cod), Crustacean shellfish, tree nuts ( e.g., almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame.

We considered all comments received during the comment period before developing the final guidance. Some comments on the draft guidance requested that we expand the scope of the guidance to cover non-IgE-mediated food allergies and to describe the potential regulatory options available to FDA. Other comments recommended that FDA define specific targets for each evaluation factor laid out in the framework. We have modified the final guidance where appropriate. Changes to the guidance include:

• Clarifying that evidence of non-IgE-mediated reactions can be useful as supplemental data in an evaluation of the public health importance of a food allergen;
• Incorporating updated text and a revised reference to reflect the recent publication of the Food and Agricultural Organization of the United Nations and World Health Organization's Expert Committee meeting report; and
• Expanding the discussion regarding prevalence data when a food is not regularly consumed in the United States.

II. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 10 have been approved under OMB control number 0910-0191. The collections of information in 21 CFR part 101 have been approved under OMB control number 0910-0381. The collections of information in section 403(w) of the FD&C Act have been approved under OMB control number 0910-0792. The collections of information in 21 CFR part 117 have been approved under OMB control number 0910-0751. The collections of information for Form FDA 3800 have been approved under OMB control number 0910-0645. The collections of information for Form FDA 3500 have been approved under OMB control number 0910-0291. The collections of information in 21 CFR 70.25, 71.1, 170.36, 171.1, 172, 173, 179, and 180 have been approved under OMB control number 0910-0016.

III. Electronic Access

Persons with access to the internet may obtain the guidance at https://www.fda.gov/​FoodGuidances, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA websites listed in the previous sentence to find the most current version of the guidance.