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  1. Food Labeling & Nutrition

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, April 1, 2013
FONSI (PDF - 127KB) April 1, 2013
007 FDA-2006-FL-0533 Dec 7, 2006 Ferrosan A/S deep sea fish extract fish Objection letter dated March 6, 2007
006 FDA-2006-FL-0517 July 5, 2006 Nutraceutix, Inc. lyophilized probiotic cultures milk Objection letter dated September 29, 2006
005 FDA-2006-FL-0516  Mar 3, 2006 Danisco USA anhydrous lactitol and lactitol monohydrate milk Objection letter dated May 31, 2006
004 FDA-2006-FL-0192 Dec 27, 2005 Purity Foods, Inc. Vita Spelt® wheat Objection letter dated March 27, 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 February 21, 2006
002 FDA-2005-FL-0487  Oct 26, 2005 Ross Products Division, Abbot Laboratories extensively hydrolyzed casein milk Objection letter dated January 23, 2006
001 FDA-2005-N-0100 Sep 30, 2005 Mead Johnson Nutritionals extensively hydrolyzed casein milk Objection letter dated December 27, 2005
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