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U.S. Department of Health and Human Services

Food

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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 ReceivedNotifier /
Ingredient Manufacturer
DescriptionMajor Food AllergenAgency Response
008FDA-2013-FL-0259Jan 7, 2013Unilever Ice Structuring Protein fishAgency Response, April 1, 2013
FONSI (PDF - 127KB) April 1, 2013
007FDA-2006-FL-0533Dec 7, 2006Ferrosan A/Sdeep sea fish extractfishObjection letter dated March 6, 2007
006FDA-2006-FL-0517July 5, 2006Nutraceutix, Inc.lyophilized probiotic culturesmilkObjection letter dated September 29, 2006
005FDA-2006-FL-0516 Mar 3, 2006Danisco USAanhydrous lactitol and lactitol monohydratemilkObjection letter dated May 31, 2006
004FDA-2006-FL-0192Dec 27, 2005Purity Foods, Inc.Vita Spelt®wheatObjection letter dated March 27, 2006
003FDA-2005-FL-0113 Nov 23, 2005F & A Dairy and International Media and Cultures, Inc.starter growth mediasoyObjection letter dated February 21, 2006
002FDA-2005-FL-0487 Oct 26, 2005Ross Products Division, Abbot Laboratoriesextensively hydrolyzed caseinmilkObjection letter dated January 23, 2006
001FDA-2005-N-0100Sep 30, 2005Mead Johnson Nutritionalsextensively hydrolyzed caseinmilkObjection letter dated December 27, 2005