FDA Releases Updated Draft Guidance

On the Preventive Controls for Human Food Rule, Food Allergen Program and Acidified Foods

Staying true to its promise, the FDA announced the release of updated draft guidance this week to assist food facilities to comply with the requirements for current good manufacturing practices (cGMPs) and preventive controls for human food under the Food Safety Modernization Act (FSMA). Specifically, FDA’s draft guidance provides new chapters on ways manufacturers can significantly minimize or prevent allergen cross-contact and undeclared allergens, and ensure that the finished food is properly labeled with respect to major food allergens.

As we wrote in a prior News & Insights Article “Open Sesame: Updates on Sesame Allergen Labeling,” the FDA has been concerned with manufacturing practices involving the intentional addition of allergens to foods, such as sesame, and in labeling the products to indicate the allergen presence rather than taking appropriate measures to minimize or prevent cross-contact. While manufacturers remain compliant with the laws for disclosing the presence of a major food allergen, at the same time, the FDA has advised that this practice severely limits options for consumers who are allergic to sesame and other allergens.

FDA’s Commissioner, Robert M. Califf, said “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 We encourage manufacturers to follow the guidelines in the draft guidance updates released today to prevent allergen cross-contact and ensure proper labeling.” The Commissioner also stated, “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 Updating this draft guidance with the new allergen chapter provides one tool to help manufacturers meet this goal.” 

FDA is encouraging the industry to follow the draft guidance on ways to significantly minimize or prevent allergen cross-contact and undeclared allergens and to review the examples provided in the guidance, in lieu of intentionally adding allergens such as sesame to their products to comply with the law.
Chapter 11 (Food Allergen Program) and Chapter 16 (Acidified Foods) are among the chapters that FDA has added since the Hazard Analysis and Risk-Based Preventive Controls for Human Food draft guidance was first issued in 2016.

Chapter 11 – Food Allergen Program

Chapter 11 of the draft guidance addresses how manufacturers can establish and implement a food allergen program that ensures the protection of food from major food allergen cross-contact and that also ensures the finished food is properly labeled with respect to the major food allergens. The section provides various examples of ways to significantly minimize or prevent allergen cross-contact and undeclared allergens using cGMPs and preventive controls. The Chapter also addresses situations where, despite comply with appropriate cGMPs and preventive controls, allergen presence due to cross-contact cannot be completely avoided. The Chapter presents options that a firm can consider such as appropriate use of allergen advisory statements.
FDA has also advised that while it has not established a maximum amount of any major food allergen that may be present in a labeled food product, any such published data and information can be useful to manufacturers in making decisions on appropriate food allergen controls with potential low-level exposure risk.

Chapter 16 – Acidified Foods

The Chapter on Acidified Foods, applicable to manufacturers, processes, or packers of acidified foods (e.g. some processed sauces, beans, cucumbers, or cabbage that have an overall pH of 4.6 or below), explains how these manufacturers can use established procedures, practices and processes to meet acidified food (AF) requirements to also satisfy requirements under the preventive controls rule. This includes meeting AF requirements relating to personnel qualifications and oversight, activities relating to hazard analysis controls, and records requirements.
Comments on the draft guidance chapters can be submitted within 180 days (by March 25, 2024).

For any questions on the Draft Guidance, or on other FDA regulatory matters, please contact us at

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