September 19, 2021

Volume XI, Number 262

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CSPI Alleges Infant Formula Misbranding to FDA

On February 10, 2021, the Center for Science in the Public Interest (CSPI) sent a letter to the U.S. Food and Drug Administration urging it to take enforcement action against the marketing of various products labeled as infant formula but marketed for use by children over 12 months.

In its letter, CSPI argues that the Federal Food, Drug and Cosmetic Act defines “infant formula” as “a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.”  CSPI notes that because “infant” is defined by regulation as a person no more than 12 months old, infant formulas that are marketed for children over 12 months old are misbranded and should be labeled as “transition formula.”  Further, CSPI argues that any food product marketed for children over 12 months old must bear FDA’s standard Nutrition Facts label, not an infant formula nutrition label.

CSPI claims that the infant foods that are marketed for children over 12 months old are primarily composed of powdered milk, vegetable oil, corn syrup solids (or other sources of added sugars), and added nutrients, which are appropriate for infants but not toddlers.  Thus, CSPI claims that these products’ labeling may mislead consumers to believe that infant formula and/or infant formula-like products are necessary for children beyond infancy.  CSPI’s letter to FDA follows recent class action lawsuits against baby food manufacturers for allegedly failing to disclose the presence of unsafe levels of heavy metals in baby foods.  We will continue to monitor any developments.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 42
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About this Author

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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