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 |