- Today, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued the first of three proposed rules that aim to update infant formula nutrient requirements. While the formal rulemaking process commences, FDA has also released new chemical contaminant testing data demonstrating that most infant formula samples showed low or non-detectable levels of contaminants, according to HHS’ press release.
- FDA intends to conduct a comprehensive review of the 30 nutrients currently required in infant formula marketed in the United States. The FDA intends to consolidate final changes to infant formula nutrient requirements into a single comprehensive final rule.
- Today’s proposed rule (phase 1 of three) would update requirements for iodine, manganese, vitamin A, and vitamin D and reaffirm existing requirements for chloride, potassium, selenium, and sodium. It would also change the units of measure for two nutrients and request public input on potential requirements for ingredients that are currently not required in infant formula but commonly added by manufacturers due to their nutritional value (e.g., arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine).
- FDA is accepting comments on the proposed rule until February 26, 2027. Keller and Heckman LLP will provide updates throughout the rulemaking process.
