The U.S. Food and Drug Administration (FDA) recently released an updated list of guidance documents that the agency plans to publish in draft or final form throughout 2024. Notable guidance topics for 2024 include the following:

• Lead levels. As part of FDA’s Closer to Zero action plan, FDA intends to finalize its draft guidance on action levels for lead in food intended for babies and young children. The current draft guidance was published in January 2023.
• Arsenic and Cadmium levels. FDA also plans to publish separate draft guidances regarding action levels for arsenic, as well as cadmium in food intended for babies and young children.
• Plant-based food labeling. FDA intends to publish draft guidance titled “Labeling of Plant-Based Alternatives to Animal-Derived Foods.” This follows last year’s release of FDA’s draft guidance on Labeling of Plant-Based Milk Alternatives.
• Voluntary sodium reduction goals. FDA plans to publish the second edition of its draft guidance on voluntary sodium reduction goals for commercially processed, packaged, and prepared foods.
• FDA’s Food Traceability Rule. FDA plans to publish draft guidance in question-and-answer format to further facilitate compliance with this rule, which comes into effect in January 2026. This would expand on the agency's recent resources on the Food Traceability Rule, previously highlighted in this Update.
• HARPC: Preventive Controls for Chemical Hazards. FDA intends to publish Chapter 12 of its Draft Guidance titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food Guidance.” Chapter 12 will cover preventive control for chemical hazards.
• Cultivated meat premarket consultation guidance. FDA intends to release draft guidance regarding the premarket consultation process for cultivated meat (also referred to as Cultured Animal Cell Foods in FDA parlance).

The complete list includes possible new topics for guidance documents or revisions to existing guidance documents that FDA’s Foods Program is actively considering. FDA explains that several factors may affect the agency’s ability to issue the listed guidances, including new administration priorities and emerging public health issues, among other circumstances. FDA may also publish guidance documents on topics not included in the current list.

Perkins Coie’s Food and Beverage Regulatory team interfaces extensively with FDA and the U.S. Department of Agriculture (USDA) on behalf of our clients and is available to provide additional insights on these and related issues.

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