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  4. Inventory of Petitions Received under 21 U.S.C. 343(w)(6) for Exemptions from Food Allergen Labeling
  1. Nutrition, Food Labeling, and Critical Foods

Inventory of Petitions Received under 21 U.S.C. 343(w)(6) for Exemptions from Food Allergen Labeling

The Federal Food, Drug, and Cosmetic Act (the Act) governs the labeling of all foods (except meat products, poultry products, and certain egg products, which are regulated by the U.S. Department of Agriculture.) The Food Allergen Labeling and Consumer Protection Act (FALCPA) (Pub L. 108-282) amends the Act's labeling requirements for food ingredients. FALCPA's requirements apply to packaged foods, including conventional foods, dietary supplements, infant formula, and medical foods, all of which are "food" within the Act's definition, 21 U.S.C. 321(f). FALCPA requires that an ingredient (including a flavor, color, or incidental additive) that is a "major food allergen," as defined by 21 U.S.C. 321(qq), be more explicitly identified on the food label. Under FALCPA, a "major food allergen" is one of eight foods or food groups (milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) or an ingredient that contains protein derived from one of the eight. 21 U.S.C. 321(qq). "Major food allergen" does not include a highly refined oil derived from one of the eight foods or food groups or any ingredient derived from such an oil, as well as any ingredient exempt under a statutory exemption process.

FALCPA establishes a process under 21 U.S.C. 343(w)(6) by which any person may file a petition that provides scientific evidence (including the analytical method used to produce the evidence) that demonstrates that an ingredient, as derived by the method specified in the petition, does not cause an allergenic response that poses a risk to human health. FDA has 180 days to approve or deny the petition. Absent an approval or denial within 180 days, the petition is deemed denied, unless FDA and the petitioner mutually agreed on an extension of time for FDA's response.

FDA is required to post to a public site petition received under 21 U.S.C. 343(w)(6) within 14 days of receipt. The petitions received by FDA are listed below and are on display at FDA's Division of Dockets Management, 5630 Fishers Lane, Room 1061 (HFA-305), Rockville, MD, 20852.

FALP No. Docket No. Date Received Petitioner /
Ingredient Manufacturer		 Description Major Food Allergen Agency Response
009 FDA-2023-FL-2481 Jun 2, 2023 ECA Healthcare, Inc. Phosphatidylserine Soy Pending
008 FDA-2022-FL-2900 Oct 25, 2022 Guittard Chocolate Company Soy lecithin Soy Pending
007 FDA-2022-FL-2590 Sep 29, 2022 Gardenia Blue Interest Group Gardenia (genipin) blue Soy Pending
006 FDA-2021-FL-0655 Dec 15, 2020 Glycom A/S Lacto-N-neotetraose Milk Pending
005 FDA-2020-FL-1865 Jul 6, 2020 Glycom A/S 2’-fucosyllactose Milk Pending
004 FDA-2016-FL-1494 Oct 29, 2015 Archer Daniels Midland Company Soy lecithin used as release agent. Soy Agency Response (PDF) Jun 2017
Environmental Assessment (PDF)
003 FDA-2007-FL-0471 Jun 14, 2007 The Solae Company Soy lecithin used as processing aid Soy Agency Response Feb 2013
Environmental Assessment (PDF)
002 FDA-2006-FL-0384 Sep 11, 2006 The Solae Company Soy lecithin used as processing aid Soy Withdrawn by petitioner, April 25, 2007
001 FDA-2006-FL-0532 Jun 5, 2006 International Media and Cultures, Inc. Starter Growth Media Soy Objection letter dated Nov 2006

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