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FDA Considers Changing Major Food Allergen Labeling Requirements

In response to growing concerns over sesame allergies, the U.S. Food & Drug Administration (“FDA”) is reportedly considering adding sesame to the list of major food allergens. Since the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (“FALCPA”), the original eight (8) major food allergens have remained unchanged. Currently the major food allergens include:

  • Milk;
  • eggs;
  • fish;
  • crustacean shellfish;
  • tree nuts;
  • peanuts;
  • wheat, and
  • soy.

Food Allergen Labeling

Under FALCPA and accompanying FDA regulations, major allergens must be declared in the labeling of all food products (including dietary supplements) sold in the United States. If the major allergens are not appropriately declared, companies face the possibility of detention/refusal, warning letters, and (because allergens invoke serious health risks to consumers) even recalls. Accordingly, it is important for marketers to stay up-to-date with current labeling regulations to avoid costly mistakes.

Interestingly, although the major food allergen list in the United States has some overlap with those food ingredients considered major allergens abroad, there are some distinctions. For example, in the European Union, sesame seeds are already deemed a common allergen, as are celery, mustard and other items not named on the major allergen list in the United States. Thus, as with other labeling components, it is important that importers and marketers of FDA-regulated food products are knowledgeable of FDA food labeling requirements since there are key differences for products sold in the U.S. market.

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