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AHPA seeks clarity in comments on improved FDA food hazard guidance

August 6, 2024

 

In comments submitted to the U.S. Food and Drug Administration (FDA), the American Herbal Products Association (AHPA) acknowledged changes and requested further improvements to Appendix 1 of the agency's guidance, “Hazard Analysis and Risk-based Preventive Controls for Human Food” (Appendix 1). This appendix, consisting of tables of potential safety hazards that are “reasonably foreseeable” in different food categories, had long been a source of industry concern as hazards identified in the tables were not well-substantiated. In some cases, food facility inspectors had also used the tables in Appendix 1 to require hazard controls in foods where they are not applicable.

 

In its comments, AHPA acknowledges significant improvements to the guidance (including the addition of an introduction clarifying that facilities are responsible for identifying hazards), but seeks further revisions to emphasize that the appendix is a starting point, not an enforcement tool. AHPA also requests subdivision of the “tea and tea substitutes” food category to more accurately identify product-appropriate hazards, along with several smaller changes.

 

AHPA also joined comments from the Food and Beverage Issue Alliance that sought, among other requests, greater consistency and substantiation across the entire appendix, as well as its availability in a modern online format.

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