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Volume XIII, Number 32

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Heavy Metal Updates: FDA Releases Draft Guidance with Action Levels for Lead and Another Heavy Metal Lawsuit Dismissed

  • This morning the FDA announced the release of draft guidance entitled “Action Levels for Lead in Food Intended for Babies and Young Children.” The draft guidance, which is part of the Agency’s effort to reduce levels of heavy metals in food, especially in food consumed by babies and young children (the “Closer to Zero” action plan), establishes the following action levels for lead in food intended for babies and children less than two years of age:

    • 10 parts per billion (ppb) limit for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single ingredient meats;

    • 20 ppb for root vegetables (single ingredient); and

    • 20 ppb for dry infant cereals.

  • These action levels reflect the levels of lead at which FDA may regard the food as adulterated. However, FDA considers on a case-by-case basis whether a food that contains a contaminant is adulterated and, when considering whether to bring an enforcement action, the Agency will also consider other factors, including its confidence in measured analytical values. Furthermore, the action levels are not the intended to be the lowest levels for industry to achieve and, consistent with its Closer to Zero action plan, FDA expects industry to “strive for continual reductions [of heavy metals] over time.” 

  • In related news, on January 19, 2023, the U.S. District Court in the Northern District of New York dismissed (Law360 subscription required) a lawsuit against Beech-Nut Nutrition which had made various claims related to allegedly dangerous levels of heavy metals in Beech-Nut’s baby food. The decision, which relies on the primary jurisdiction doctrine, is consistent with dismissals of similar lawsuits against Sprouts Foods and Gerber Products by federal courts in New Jersey and Virginia, respectively, but runs contrary to a decision by a California federal court which refused to dismiss similar claims against Plum Organics.

  • The primary jurisdiction doctrine allows a court to dismiss or stay a lawsuit when it finds that a decision is within “the special competence of an administrative body.” Applying a multi-factored test, the Court held that application of primary jurisdiction was appropriate because (1) the claims were not “garden variety” false advertising cases, but rather required the Court to make a determination as to what constituted dangerous levels of heavy metals, (2) such questions of safety were “within FDA’s authority and discretion,” and (3) a Court’s resolution of the issue without FDA guidance would result (and indeed, has resulted) in inconsistent rulings. 

  • We will continue to monitor and report on news related to heavy metals. Comments to the draft guidance are due by March 27, 2023.

© 2023 Keller and Heckman LLPNational Law Review, Volume XIII, Number 24
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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