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FDA Requests Information on Food Allergens

CFSAN Constituent Update

December 13, 2012

The U.S. Food and Drug Administration today established a Federal Register Docket requesting data and other information to determine whether the agency can safely establish threshold levels for major food allergens. 

The Food Allergen Labeling and Consumer Protections Act (FALPCA) of 2004 identified eight major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts and soybeans, which account for 90 percent of food allergies. To protect sensitive consumers FALPCA also requires that foods that contain any of the eight major food allergens carry a statement declaring them on the product label. 

If safe thresholds can be established, the FDA could:

  • more effectively determine the appropriate corrective action to unintentional allergen contamination issues;
  • better evaluate petitions and notifications for exemptions from allergen labeling;
  • better respond to situations where undeclared allergens are found in foods;
  • consider how thresholds might be used to improve consumer choices in the marketplace, while protecting sensitive consumers 

The FDA is seeking public comment on safe food allergen threshold levels from December 10, 2012 to February 7, 2013. 

To submit comments electronically go to to the docket:

  1. Choose “Submit a Comment” from the top task bar
  2. Enter in the “Keyword” space: docket number FDA-2012-N-0711
  3. Select “Search”

To submit your comments to the docket by mail, use the following address:

The Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Be sure to include docket number FDA-2012-N-0711 on each page of your written comments.

For additional information, please see:

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