The Food and Drug Administration has released updated draft guidance designed to help food facilities comply with the requirements for current good manufacturing practices and preventive controls for human food. A new chapter on food allergens outlines ways to ensure the protection of food from major cross-contact threats and to ensure that the finished food is properly labeled.
Earlier this year, sesame was added as the ninth major food allergen when the Food Allergy Safety, Treatment, Education, and Research Act became effective on January 1. This means that the presence of sesame in food is required to be disclosed on food labels and firms need to implement controls to significantly minimize or prevent sesame allergen cross-contact.
After passage of the act, some manufacturers intentionally added sesame to products that previously did not contain sesame and are labeling the products to indicate its presence, rather than take appropriate measures to minimize or prevent cross-contact. This keeps manufacturers in compliance with the law for disclosing the presence of a major food allergen. However, it limits options for consumers who are allergic to sesame, a result the FDA shared it does not support.
The administration is encouraging the industry to follow the draft guidance on ways to significantly minimize or prevent allergen cross-contact and undeclared allergens and review the examples in the guidance rather than intentionally adding sesame to their products to comply with the law.
“The FDA is looking for opportunities that could help consumers who are allergic to sesame and other major food allergens find foods that are safe for them to consume. We encourage manufacturers to follow the guidelines in the draft guidance updates released today to prevent allergen cross-contact and ensure proper labeling,” said Robert M. Califf, M.D., FDA commissioner, in a statement. “We recognize there are challenges with ensuring products are free of allergens and we are engaging with stakeholders on this issue. The agency is interested in finding solutions, within our authorities, that meet the needs of consumers with food allergies. Updating this draft guidance with the new allergen chapter provides one tool to help manufacturers meet this goal.”
One new chapter explains how to establish and implement a food allergen program that ensures protection against cross-contact and that the finished food is properly labeled with respect to the major allergens. The chapter also discusses circumstances in which, despite adherence to appropriate good manufacturing practices and preventive controls, allergen presence due to cross-contact cannot be completely avoided and options a firm can consider, including the voluntary use of allergen advisory statements when appropriate.
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