The US Food and Drug Administration (FDA) unveiled two new chapters to its Draft Guidance for its Hazard Analysis and Risk-Based Preventive Controls for Human Food (PCHF) in September 2023, as provided by this JD Supra report.
These additions encompass new draft Chapter 11, dedicated to food allergen programs, and new draft Chapter 16, focused explicitly on acidified foods. Acidified foods are low-acid foods to which acid(s) or acid food(s) have been added to produce a finished equilibrium pH of 4.6 or below and a water activity greater than 0.85 to ensure its safe storage at room temperature.
The chapters were released as part of the FDA’s ongoing efforts to provide more detailed guidance on implementing preventative controls under their 2015 final rule, known as the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” at 21 CFR Part 117 (Part 117).
A broader interpretation of the guidance is instrumental for food operators to identify potential hazards tied to acidified foods, implement measures to minimize or prevent these hazards, verifying that their procedures and practices are effective, and documented record-keeping that shows the corrective measures they’ve taken whenever hazards were not adequately controlled.
Legal professionals in food manufacturing industries should consider this an opportune time to review their clients’ operations and navigate the fresh guidance, especially those dealing with acidified foods, to ensure regulatory compliance.
The FDA has been periodically introducing new details post the introduction of the 2015 rule for operators in the sector to remain updated about its implementation.