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Recall of Deficient Infant Formula

  • Designed By Nature announced June 14, 2021 that it is recalling its Goat’s Milk Powder, Cow’s Milk Powder, and Base Milk Powder formulas with an expiration date between May 1, 2021 and June 11, 2022 because they are deficient in several nutrients required for infant formula.  Furthermore, the products were not tested for the presence of Cronobacter.

  • The current product label indicates the product was “developed for all life stages.”  However, the company will be changing its labeling to make clear that the products are not intended to be used for infants 12 months and younger.

  • Products marketed as infant formula must meet certain minimum nutrient requirements, and manufacturers must notify FDA prior to marketing a new formula.  According to the recall notice, Designed by Nature’s formulas were not approved by FDA.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 168
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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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