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FDA Issues Guidance on Submission of Petitions and Notifications for Exemption from Allergen Labeling

Melvin S. Drozen
Keller and Heckman LLP - Washington Office

Eric S.C. Lindstrom
Keller and Heckman LLP - San Francisco Office

Evangelia C. Pelonis
Keller and Heckman LLP - Washington Office

May 27, 2014

Previously published on May 16, 2014

On May 8, 2014, the Food and Drug Administration (FDA) released draft guidance for industry with instructions on how to obtain a food allergen labeling exemption through submission of a petition or notification to FDA.[1] The Food Allergen Labeling and Consumer Protection Act of 2004 (FACLPA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by rendering any food containing a major food allergen ingredient misbranded unless the label declares the presence of the allergen.[2] Notably, however, FALCPA also explicitly provided that any person may submit a notification or petition to FDA requesting an exemption for an ingredient containing allergenic protein from the labeling mandate.[3]

More specifically, a person may submit a petition for exemption from the labeling requirement demonstrating that the food ingredient, as derived by the petitioner, does not cause an allergic response that poses a risk to human health.[4] Alternatively, a person may file a notification if the food ingredient does not contain allergenic protein or if FDA has previously granted a petition and determined that the ingredient does not cause an allergic response.[5] To date, only three petitions and eight notifications have been submitted to FDA, and industry has been largely unsuccessful at obtaining FDA approval.[6] Therefore, to better inform industry of the required components of a successful allergen petition or notification, FDA released the draft guidance with recommendations on submission content.

FDA’s draft guidance provides that a successful petition or notification should include an environmental assessment (or claim of categorical exclusion) and scientific evidence with information on the:

(1) ingredient description (including the name, source, properties, standards/specifications, and composition of the ingredient);

(2) ingredient preparation and manufacture (including physical, chemical, and temperature treatments, growth conditions, and any bioengineering processes (if relevant));

(3) ingredient protein characterization;

(4) ingredient application (including intended use level, technical effects, and method of incorporation of the ingredient into food); and

(5) method(s) used to obtain the scientific evidence.

In addition to the aforementioned information, the draft guidance clarifies that a petition should also contain one of two forms of scientific evidence used to demonstrate the ingredient does not cause an allergic reaction:

(1) clinical testing, either through oral provocation or skin prick studies, or

(2) risk modeling using data on consumer exposure to the ingredient, and published data on the distribution of minimal eliciting doses in the population.

Although FDA will accept comments on the draft guidance at any time, commenters wishing to ensure that FDA considers their viewpoints must submit comments by September 5, 2014. Keller and Heckman LLP attorneys have considerable experience preparing a variety of regulatory petitions and notifications to FDA and will continue to monitor developments related to the food allergen labeling exemption draft guidance.

[1] Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications, 79 Fed. Reg. 26435 (May 8, 2014). The draft guidance has been posted to FDA’s website, click here - http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm395494.htm 


[2] Food Allergen Labeling and Consumer Protection Act, Pub. L. No. 108-282, 118 Stat. 905 (2004). The major food allergens are “[m]ilk, egg, fish (e.g., bass, flounder, or cod), [c]rustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. FD&C Act § 201(qq)(1), codified at 21 U.S.C. § 321(qq)(1).

[3] FD&C Act §403(w)(6)-(7), codified at 21 U.S.C. §343(w)(6)-(7).

[4] FD&C Act § 403(w)(6)(C), codified at 21 U.S.C. §343(w)(6)(C).

[5] FD&C Act § 403(w)(7)(A), codified at 21 U.S.C. §343(w)(7(A).

[6] Food and Drug Admin., Inventory of Notifications Received under 21 U.S.C. 343(w)(7) for Exemptions from Food Allergen Labeling, click here - http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm076656.htm 
Inventory of Petitions Received under 21 U.S.C. 343(w)(6) for Exemptions from Food Allergen Labeling, click here - http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm076631.htm


The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.

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