May 22, 2022

Volume XII, Number 142

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May 20, 2022

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FDA Works to Improve Supply of Formula Products

  • On May 10, 2022, FDA published a news release in which it highlighted its efforts to improve the supply of infant and specialty formula products.  This follows a warning from FDA to not use certain powdered infant formulas and a voluntary recall of those products.

  • FDA acknowledged that many consumers have not been able to access the infant formulas and medical foods that they were accustomed to using. FDA stated that it is working to ensure there is adequate product available where and when it is needed. In this regard, FDA states that it is “leveraging all the tools at its disposal” to support the infant formula product supply, including:

    • Expediting the review of notifications and manufacturing changes to help manufacturers bring safe products to market;

    • Monitoring the infant formula supply by using the 21 Forward food supply chain continuity system;

    • Expediting certificates for imports to allow for flexibility in the movement of already-permitted products into the U.S. and offering a streamlined import entry review process; and

    • Exercising enforcement discretion on minor labeling issues.

  • FDA emphasized that only facilities that are “experienced in and already making essentially complete nutrition products are in the position to produce infant formula product that would not pose significant health risk to consumers” and continues to advise against making infant formulas at home.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 132
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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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