Food Allergy Labeling and Consumer Protection Act Joseph A. Levitt Hogan & Hartson L.L.P. Washington, D.C. March 2

1. Food Allergy Labeling and Consumer Protection Act Joseph A. Levitt Hogan & Hartson L.L.P. Washington, D.C. March 2005

2. Topics to Cover • Background • New Labeling Requirements • Other Provisions

3. FALCPA • Review of Legislative History • President signed into law the Food Allergy Labeling and Consumer Protection Act in August 2004 • Amended the FFDCA and establishes specific labeling requirements for the Big 8 Major Allergens

4. FALCPA • Prior to FALCPA • Complete list of ingredients • Exception for incidental additives • Generic labeling of spices, flavors, colors • Allergenic foods had to be identified by common or usual name (e.g., casein, whey)

5. Major Allergen The term “major food allergen” means any of the following: 1) milk, egg, fish (e.g., bass, flounder), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts and soybeans

6. Major Allergen (cont’d) 2) A food ingredient that contains protein derived from a food specified in paragraph (1), except: (A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil. (B) A food ingredient that is exempt under paragraph (6) or (7).

7. FALCPA Labeling • The Big 8 allergens must be labeled by common English names specific to the allergen source • FDA can modify the list by regulation • Labeling applies to ingredients derived from the Big 8 allergens that contain protein

8. FALCPA Labeling • Requires labeling for flavors, colors, and incidental additives • Contains exceptions • Highly refined oils • Refined, bleached, deodorized oils • C/U name of such oils has always required identification of source oil (e.g., peanut oil, soy oil)

9. FALCPA Labeling • FDA can exempt ingredients via • Premarket Notification • Available when scientific evidence shows that the ingredient does not contain an allergenic protein • Available when, as part of a food additive review, FDA concludes that the ingredient “does not cause allergic response posing a risk to health” • Unavailable as part of GRAS notification review

10. FALCPA Labeling • FDA can exempt ingredients via • Petition • Available for those ingredients that are ineligible for the notification • Requires data showing that the ingredient “does not cause allergic response posing risk to human health” • Petitioner has burden of proof

11. FALCPA LABELING FORMAT • Contains ____ • Must list all major food allergens in the product • Must be immediately adjacent to the ingredient statement

12. FALCPA LABELING FORMAT • Parenthetical in Ingredient Statement (“casein (milk)”) • Not required if ingredient name already identifies the major allergen • Not required if the name of the major food allergen appears elsewhere unless the other listing is for an ingredient that is exempt from the major food allergen definition

13. FALCPA LABELING FORMAT • Requires use of common English names for the major food allergens • Tree nuts must identify specific nut such as “almond,” “pecan,” “walnut” • Fish/Shellfish must identify species, such as “tuna,” “bass,” “flounder,” “shrimp,” “lobster”

14. FALCPA LABELING FORMAT • Ingredient Statement Examples Ingredients: Semolina, rice flour, rolled oats, pine nuts, tomato juice, whey, sodium caseinate, tuna gelatin, natural flavoring Contains: wheat, milk, pine nuts and peanuts

15. FALCPA LABELING FORMAT • Ingredient Statement Examples (cont’d) Ingredients: Semolina (wheat), rice flour, rolled oats, pine nuts, tomato juice, whey (milk), sodium caseinate, tuna gelatin, natural flavoring (peanuts)

16. FALCPA • A food that does not comply with the labeling requirements is deemed misbranded • FALCPA is self-executing and becomes effective for any food labeled after January 1, 2006 • FDA does NOT have to implement regulations

17. FALCPA Studies/Reports • Analysis of cross-contact issues • Review of GMPs • Review use of advisory (“may contain”) labeling • Survey of consumer labeling preferences • Review of allergen inspections conducted by FDA • Assessment of food industry and government response to cross-contact issues

18. FALCPA/Inspections • Directs FDA to conduct inspections of facilities to ensure they comply with practices to reduce or eliminate cross-contact of a food with residues of major food allergens that are not intentional ingredients of the food, and to ensure major food allergens are properly labeled

19. FALCPA (cont.) • Requires FDA to issue a proposed rule within two years, and a final rule within four years, to define, and permit use of, the term “gluten-free” on food labels • Requires FDA to collect and publish national data on the prevalence of food allergies, the incidence of clinically significant or serious adverse events, and the use of different modes of treatment for and prevention of allergic responses to foods

20. FALCPA Issues • Places the burden of proof on petitioner to demonstrate that an ingredient does not present a concern to food allergic consumer • Soy lecithin • Fish gelatin (ID SOURCE!) • Lactose • Wheat Starch • Lysozyme • Lactoferrin • Soy sauce

21. Conclusion • FALCPA imposes labeling requirements for allergens as of January 2006. • The time is now to begin FALCPA compliance

22. Contact Information Joseph A. Levitt Hogan & Hartson L.L.P. 555 13th Street NW Washington, DC 20004 (202) 637-5759 (direct) (202) 637-5910 (fax) JALevitt@HHLaw.com