Inventory of Notifications Received under 21 U.S.C. 343(w)(7) 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)(7) by which any person may file a notification containing scientific evidence demonstrating that an ingredient “does not contain allergenic protein.” The scientific evidence must include the analytical method used and the ingredient must be derived by the specified method. FDA has 90 days to object to a notification. Absent an objection, the food ingredient is exempt from FALCPA's labeling requirements for major food allergens.
FDA is required to post to a public site notifications received under 21 U.S.C. 343(w)(7). This posting is to be made within 14 days of receipt of a notification. The list below reflects the notifications received by FDA that are required at this time to be posted to a public site.
| FALN No. | Docket No. | Date Received | Notifier / Ingredient Manufacturer |
Description | Major Food Allergen | Agency Response |
|---|---|---|---|---|---|---|
| 008 | FDA-2013-FL-0259 | Jan 7, 2013 | Unilever | Ice Structuring Protein | fish | Agency Response Apr 2013 FONSI (PDF) Apr 2013 |
| 007 | FDA-2006-FL-0533 | Dec 7, 2006 | Ferrosan A/S | deep sea fish extract | fish | Objection letter dated Mar 2007 |
| 006 | FDA-2006-FL-0517 | July 5, 2006 | Nutraceutix, Inc. | lyophilized probiotic cultures | milk | Objection letter dated Sep 2006 |
| 005 | FDA-2006-FL-0516 | Mar 3, 2006 | Danisco USA | anhydrous lactitol and lactitol monohydrate |
milk | Objection letter dated May 2006 |
| 004 | FDA-2006-FL-0192 | Dec 27, 2005 | Purity Foods, Inc. | Vita Spelt® | wheat | Objection letter dated Mar 2006 |
| 003 | FDA-2005-FL-0113 | Nov 23, 2005 | F & A Dairy and International Media and Cultures, Inc. |
starter growth media | soy | Objection letter dated Feb 2006 |
| 002 | FDA-2005-FL-0487 | Oct 26, 2005 | Ross Products Division, Abbot Laboratories |
extensively hydrolyzed casein | milk | Objection letter dated Jan 2006 |
| 001 | FDA-2005-N-0100 | Sep 30, 2005 | Mead Johnson Nutritionals | extensively hydrolyzed casein | milk | Objection letter dated Dec 2005 |