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The FDA is extending for 45 days the period before it will begin to consider comments on its draft guidance regarding voluntary disclosure of sesame as an allergen.

Comments should be submitted before February 25, 2021 to ensure that FDA considers them before beginning work on the final guidance.

Food Allergies

Food allergies and other types of food hypersensitivities affect millions of Americans and their families.  Food allergies occur when the body’s immune system reacts to certain proteins in food. Food allergic reactions vary in severity from mild symptoms involving hives and lip swelling to severe, life-threatening symptoms, often called anaphylaxis, that may involve fatal respiratory problems and shock. While promising prevention and therapeutic strategies are being developed, food allergies currently cannot be cured. Early recognition and learning how to manage food allergies, including which foods to avoid, are important measures to prevent serious health consequences.

To protect those with food allergies and other food hypersensitivities, the FDA enforces regulations requiring companies to list ingredients on packaged foods and beverages. For certain foods or substances that cause allergies or other hypersensitivity reactions, there are more specific labeling requirements.

The FDA provides guidance to the food industry, consumers, and other stakeholders on best ways to assess and manage allergen hazards in food. The FDA also conducts inspections and sampling to check that major food allergens are properly labeled on products and to determine whether food facilities implement controls to prevent allergen cross-contact (the inadvertent introduction of a major food allergen into a product) and labeling controls to prevent undeclared allergens during manufacturing and packaging. When problems are found, the FDA works with firms to recall products and provide public notification to immediately alert consumers. In addition, the FDA has the authority to seize and remove violative products from the marketplace or refuse entry of imported products.

Major Food Allergens

Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). This law identified the following eight foods as major food allergens:

  • Milk
  • Eggs
  • Fish
  • Shellfish
  • Tree nuts
  • Peanuts
  • Wheat
  • Soybeans
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