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Accurate and informative labeling is critical for allergic consumers, individuals with celiac disease, and their families because they need to rely on strict avoidance of specific foods and ingredients to prevent potentially serious reactions. The Food Allergen Labeling and Consumer Protection Act of 2004 (P.L. 108-282) (FALCPA) amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and requires that the label of a food product that is or contains an ingredient that bears or contains a "major food allergen" declare the presence of the allergen as specified by FALCPA. FALCPA defines a "major food allergen" as one of eight foods or food groups (milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans) or a food ingredient that contains protein derived from one of those foods.

An important scientific issue associated with the implementation of FALCPA is the existence of threshold levels below which it is unlikely that a food allergic individual would experience an adverse effect. FALCPA provides two processes by which an ingredient may be exempted from the FALCPA labeling requirements, a petition process [21 U.S.C. 343(w)(6)] and a notification process [21 U.S.C. 343(w)(7)]. Under the petition process, an ingredient may be exempt if the petitioner demonstrates that the ingredient “does not cause an allergic reaction that poses a risk to human health.” Under the notification process, an ingredient may be exempt if the notification contains scientific evidence that demonstrates that the ingredient “does not contain allergenic protein,” or if FDA previously has determined, under section 409 of the FFDCA, that the food ingredient does not cause an allergic response that poses a risk to human health. Thus, understanding food allergen thresholds and developing a sound scientific framework for such thresholds are likely to be centrally important to FDA’s analysis of, and response to, FALCPA petitions and notifications.

FALCPA also requires FDA to promulgate a regulation to define and permit the use of the term “gluten-free” on the labeling of foods. Such labeling is important to patients suffering from celiac disease, an immune-mediated illness. Strict avoidance of gluten at levels that will elicit an adverse effect is the only means to prevent potentially serious reactions. Thus, consumers susceptible to celiac disease need accurate, complete, and informative labels on food. Understanding thresholds for gluten will help FDA develop a definition of “gluten-free” and identify appropriate uses of the term.

Section 204 of FALCPA directs FDA to prepare and submit a report to Congress. The report is to focus principally on the issue of cross-contact of foods with food allergens, and is to describe the types, current use of, and consumer preferences with respect to advisory labeling. Cross-contact may occur as part of the food production process where residues of an allergenic food are present in the manufacturing environment and are unintentionally incorporated into a food that is not intended to contain the food allergen, and thus, the allergen is not declared as an ingredient on the food’s label. In some cases, the possible presence of the food allergen is declared by a voluntary advisory statement.

Revised Threshold Report Page 12 of 108

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