Food and Drug Administration Issues Sesame Allergy Guidance

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FDA’s Updated HARPC Draft Guidance Addresses Concerns Regarding Industry Approach to Sesame

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Friday, September 29, 2023

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As we reported previously, on September 26, 2023, the U.S. Food and Drug Administration (FDA) announced an updated draft guidance designed to assist food facilities with the requirements for current good manufacturing practices (CGMPs) and preventive controls for human food. Specifically, the new chapter on food allergens (Chapter 11) outlines ways to ensure protection of food from major food allergens cross-contact and to ensure that the finished food is properly labeled with respect to the major food allergens.
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 1st. Sesame is now required to be disclosed on food labels when it is present in a food and businesses should implement controls to significantly minimize or prevent sesame allergen cross-contact. FDA believes some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence, rather than take measures to minimize or prevent cross-contact. FDA is encouraging industry to follow the draft guidance on ways to significantly minimize or prevent allergen cross-contact and undeclared allergens and review the examples provided, rather than intentionally adding sesame to comply with the law.
Chapter 11 (Food Allergen Program) and Chapter 16 (Acidified Foods) are among the chapters added since the draft guidance (Hazard Analysis and Risk-Based Preventative Controls for Human Food) was first issued in 2016. Chapter 11 explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and that the finished food is properly labeled with respect to the major food allergens, and includes many examples. Chapter 16 explains how manufacturers of acidified foods (with an overall pH of 4.6 or below) can use procedures, practices and processes that they have established to meet requirements in the acidified foods regulations to satisfy requirements under the preventive controls for human foods rule.