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Food Safety

Allergens

FDA Releases Draft Guidance

The U.S. Food and Drug Administration logo

Image courtesy of the U.S. Food and Drug Administration

September 28, 2023

The U.S. Food and Drug Administration announced updated draft guidance designed to help food facilities comply with the requirements for current good manufacturing practices (CGMPs) and preventive controls for human food. In particular, the new chapter on food allergens outlines ways to protect food from major food allergen cross-contact and ensure that the finished food is properly labeled with respect to the major food allergens.

Millions of Americans have food allergies and may experience adverse reactions to products that contain food allergens. While many allergic reactions may involve only mild symptoms, some are severe and may even be life-threatening. Earlier this year, sesame was added as the ninth major food allergen when the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act became effective on January 1, 2023. This means that sesame, when present in a food, must be listed on food labels, and firms need to implement controls to minimize or prevent sesame allergen cross-contact significantly.

With the passage of the FASTER Act, the FDA and families with sesame-allergic members hoped it would become easier for those allergic to sesame to feel more confident in their food choices with the clear label declaration of sesame. However, some manufacturers intentionally add sesame to products that previously did not contain it and label the products to indicate its presence rather than taking 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 also limits options for consumers allergic to sesame, a result the FDA does not support. The FDA encourages the industry to follow the draft guidance on significantly minimizing or preventing allergen cross-contact and undeclared allergens and review the examples provided—rather than intentionally adding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 We encourage manufacturers to follow the guidelines in the draft guidance updates released today to prevent allergen cross-contact and ensure proper labeling," says FDA Commissioner Robert M. Califf, M.D.  "We recognize there are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."

Chapter 11, Food Allergen Program, and Chapter 16, Acidified Foods, are among the chapters added since the draft guidance, Hazard Analysis and Risk-Based Preventive Controls for Human Food, was first issued in 2016.

Chapter 11 explains how to establish and implement a food allergen program that ensures food protection from major food allergen cross-contact and that the finished food is properly labeled for the major food allergens. It provides many examples of ways to significantly minimize or prevent allergen cross-contact and undeclared allergens using CGMPs and preventive controls. Labeling errors cause most FDA food allergen recalls, and Chapter 11 includes guidance on how to monitor or verify that the food allergens are declared as required, and the correct label is used for the product.

The chapter also discusses circumstances in which, despite adherence to appropriate CGMPs 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. The chapter complements the FDA's recently released Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact, reflecting the agency's risk-based and science-based approach to evaluating potential allergen violations.

Chapter 16 applies to manufacturers, processors or packers of acidified foods (such as some processed sauces, beans, cucumbers or cabbage with an overall pH of 4.6 or below). It explains how these manufacturers can use procedures, practices and processes established to meet requirements in the acidified foods regulations to satisfy requirements under the preventive controls for human foods rule.

KEYWORDS: allergen FDA guidance food safety

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