Possible Uses of Food Allergen Thresholds

1
Possible Uses of Food Allergen Thresholds

• Catherine L. Copp, Esq.
• Policy Advisor
• Center for Food Safety and Applied Nutrition
• U.S. Food and Drug Administration

2
Food Allergen Labeling and Consumer Protection
Act of 2004 (FALCPA)

• Enacted August 2, 2004
• Requires food labels to disclose in plain
  language the presence of an ingredient that is a
  major food allergen or an ingredient derived
  from a major food allergen
• Major food allergens milk, egg, fish, Crustacean
  shellfish, tree nuts, wheat, peanuts, soybeans

3
Three Possible Uses of Food Allergen Thresholds

• Administering FALCPAs petition process
• Administering FALCPAs notification process
• Addressing the occurrence of cross-contact

4
FALCPA Exemption Processes

• Two ways a food ingredient containing protein
  from a major food allergen may be exempt from
  the labeling requirement
• Petition process
• Notification process
• Result is that the ingredient is not within the
  scope of the definition of major food allergen

5
Exemption Standard -- Petition Process

• Petitioner must provide scientific evidence
  (including an analytical method) that
  demonstrates that the ingredient does not cause
  an allergic response that poses a risk to human
  health

6
Exemption Standard Notification Process

• Notification must contain scientific evidence
  (including an analytical method) that
  demonstrates the ingredient does not contain
  allergenic protein
• NB notification may also rely on an FDA
  determination under the food additive approval
  process

7
FALCPAs Report to Congress

• FALCPA requires FDA to submit a report to
  Congress that focuses principally on
  cross-contact and use of advisory labeling (e.g.,
  may contain)
• Cross-contact results in the unintentional
  incorporation of a food allergen into a food not
  intended to contain the allergen