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FDA Proposes Rule to Update Infant Formula Nutrient Requirements (The Daily Intake)
: 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 ingredie[...]
Ninth Circuit Partially Revives ‘Low-FODMAP’ Labeling Suit (The Daily Intake)
: A Ninth Circuit panel has partially revived (Law360 subscription required) a lawsuit alleging that FDA and USDA nutrient content claim regulations violate First Amendment rights by preventing the inclusion of certain information about fermentable oligosaccharides, disaccharides, monosaccharides, and poloyols (FODMAPs) on food labels. The lawsuit was initially filed against FDA, USDA, and USDA's Food Safety Inspection Service (FSIS) in March 2023 after one plaintiff submitted a label to FSIS for approval. FSIS denied the approval, telling the company that it must “remove all references to digestible, gut loving, and fodmap.” According to the plaintiff, FDA had never raised concerns about the claims on labels of FDA-regulated foods. According to the Ninth Circuit, FSIS told the company that it discussed the proposed label with FDA, and FDA agreed that the FODMAP claims were impermissible nutrient content claims. The company modified the label, then filed the lawsuit along with a consumer plaintiff. The plainti[...]