FDA Publishes Two New Chapters of Human Foods HARPC Draft Guidance
Wednesday, September 27, 2023
FDA Guidance Human Foods HARPC
  • On September 26, FDA announced the availability of two new chapters of the Draft Guidance for Industry: Hazard Analysis and Rick-Based Preventive Controls for Human Food. The two new chapters – Chapter 11: Food Allergen Program and Chapter 16: Acidified Foods – have been designed to help food facilities comply with the requirements for current good manufacturing practices (CGMPs) and preventive controls for human food.

  • Chapter 11: Food Allergen Program explains how to establish and implement a food allergen program that protects against cross-contact and ensures finished food is properly labeled with respect to the nine major food allergens. The chapter includes examples of how CGMPs and preventive controls can significantly minimize or prevent allergen cross-contact and the presence of undeclared allergens. It also discusses instances where cross-contact cannot be avoided despite adherence to CGMPS and preventive controls, and what options firms can consider, including the use of a voluntary allergen advisory statement when appropriate. Per FDA, the chapter complements the recently released Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact, which reflects the agency’s approach for the evaluation of potential allergen violations.

  • Chapter 16: Acidified Foods explains how manufacturers of acidified foods can use their established procedures and processes to meet the requirements of the acidified foods regulations and the requirements under the preventive controls for human foods rule.

  • Stakeholders may submit comments on the two new chapters, or the draft guidance in general. All submissions must include the Docket No. FDA-2016-D-2343 and should be submitted within 180 days to ensure the FDA receives comments before it works on the final versions of the guidance.


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