The Challenge of Labeling Food Allergens

1. The Challenge of Labeling Food Allergens Christine J. Lewis, Ph.D. Center for Food Safety and Applied Nutrition Food and Drug Administration

2. Focus of meeting • Source or plain English labeling • Advisory labeling • Labeling of ingredients exempted from declaration (common or usual names of flavorings, spices, and colors; incidental additives)

3. Peanuts Soybeans Milk Eggs Fish Crustacea Tree Nuts Wheat Eight foods most frequently implicated in allergic reactions

4. Labeling Requirements • Food Drug and Cosmetic Act requires declaration of ingredients by their common or usual names • There are two exemptions

5. Ingredients exempted from labeling • Flavorings, spices, and colors • Incidental additives

6. Petitions to FDA • Petition from the Attorneys General of nine States • Petition from a consumer

7. NFPA’s “Code of Practice on Managing Food Allergens” • Labeling of allergens, including those in flavors • GMPs • Supplemental information • Education • Strategies to reduce the risk of consumers ingesting food allergens

8. Food Allergy Issues Alliance guidelines for food allergen labeling • Advocates plain English terms • Advocates additional disclosure of food allergens in flavors • Provides specific criteria for supplementary labeling

9. Questions on which FDA is seeking information

10. Questions on Source labeling • What plain English terms would be understandable? • What format would be most informative? • Are the formats from the Food Allergy Issues Alliance appropriate? • Are the recommendations in the States Attorneys General petition appropriate?

11. Questions on source labeling • Are multiple formats confusing? • Should source labeling be voluntary or mandatory?

12. Questions on advisory labeling • When should “may contain [name of allergen]” be permitted? • What is the impact of this labeling on consumers and manufacturers?

13. Questions on advisory labeling • Should the recommendations in the State Attorneys General petition be adopted? • Should the criteria in the Food Allergy Issues Alliance be used?

14. Questions on advisory labeling • Are there better alternatives to advisory label statements currently being used? • Do advisory statements adequately inform consumers?

15. Questions on advisory labeling • Should these statements be prescriptive? • What should be the location and prominence of these statements?

16. Questions on the labeling of flavorings, spices, and colors • Should FDA continue to address on a case-by-case basis? • Should information on allergenic components of flavorings, spices, and colors be included in ingredient lists? • Should listing of the common or usual names of allergenic components be mandatory?

17. Questions on the labeling of incidental additives • What minor ingredients or processes would manufacturers unlikely not recognize as introducing food allergens? • When products are to be further processed or repacked, is better labeling on intermediate products necessary?

18. Questions on the labeling of incidental additives • Should FDA codify its policy that allergens cannot qualify as incidental additives that are exempt from labeling?