The FDA has released two new chapters to the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food.

Chapter 11—Food Allergen Program—explains how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and how to ensure that food products are properly labeled with respect to the major food allergens. It provides examples of ways to significantly minimize or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices (CGMPs) and preventive controls. 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 provides options to consider in these scenarios, including the voluntary use of allergen advisory statements when appropriate.

Chapter 16—Acidified Foods—applies to manufacturers of acidified foods (such as some processed sauces, beans, cucumbers or cabbage that have an overall pH of 4.6 or below). It provides procedures, practices and processes to meet requirements in the acidified foods regulations and to meet requirements under the preventive controls for human foods rule.

Stakeholders can submit comments on the new chapters at Regulations.gov (Docket No. FDA-2016-D-2343). Comments should be submitted within 180 days of September 26, 2023, to ensure the FDA receives comments before it begins work on the final versions of the guidance documents.