On July 6, the U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that will be a priority for the FDA Foods Program for the remainder of the year. This list built on the guidance agenda for 2023 that was first released in February.

The FDA added six guidance topics to the agenda, including:

1. Draft Guidance on Dietary Supplement Master Files
2. Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
3. Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
4. Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children
5. Amendment to the Menu Labeling Supplemental Guidance
6. Guidance on Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein

Rules and regulations

Notably, four of the six additions addressed food that is intended for consumption by younger consumers (i.e., infants, babies, and young children), a category that we have seen other agencies pay close attention to in the past. As we wrote in a blog earlier this year, regulators across industries — from the U.S. Consumer Product Safety Commission (CPSC) to the National Highway Traffic Safety Administration (NHTSA) and the FDA — have demonstrated an ability to move quickly on rules and regulations designed to protect children. Heavy metals in food intended for children have been a priority for the FDA, so it is likely that the draft guidance addressing arsenic and cadmium will be at the top of the agency’s list.

Ensuring food safety and advancing nutrition

Additionally, two of the additional topics specifically apply to infant formula, indicating that the FDA Foods Program has not finished with its efforts to reform how the infant formula industry operates. In March, the FDA issued a constituent update and sent a letter to key stakeholders urging the industry to “take prompt action to improve processes and programs for the protection of our most vulnerable population.” Just as industry stakeholders must address the suggested steps in the FDA’s letter and the new requirements introduced by Congress, the FDA is working through the proposed restructuring to the Human Foods Program. All of these measures have the ultimate goal of ensuring food safety and advancing nutrition.

Any draft or final guidance documents released to address the FDA Foods Program’s priorities do not impose legally enforceable requirements. However, at a time when consumers and regulators alike are viewing the food industry with stricter scrutiny, it is important that companies closely review the FDA’s guidance documents and take necessary efforts to implement their suggestions. This is especially important for companies that manufacture or sell products intended for infants, babies, or young children.

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