June 30, 2022

Volume XII, Number 181

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June 30, 2022

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FDA Issues Draft Action Levels for Lead in Juice

  • On April 27, 2022, FDA issued a draft guidance providing draft action levels for lead in single-strength apple juice and other single-strength juices. FDA states that the new levels are intended to reduce the potential for negative health effects associated with dietary exposure to lead. The action supports FDA’s Closer to Zero action plan which intends to reduce exposure to toxic elements in foods.

  • The guidance provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and 20 ppb for lead in all other single-strength juice types. As noted by FDA, the draft action levels in the guidance were determined using FDA’s interim reference level (IRL) for lead. Using this measurement, FDA estimates that a 10 ppb action level in apple juice could result in an estimated 46% reduction in exposure to lead from apple juice in children. For all other juices, an action level of 20 ppb is estimated to result in a reduction of 19% in exposure to lead from the juices in children. The Agency noted that it chose to issue lower draft action levels for apple juice because it is the most consumed juice by young children.

  • FDA is accepting comments on the draft guidance. Comments may be submitted by mail or electronically at Regulations.gov using Docket No. FDA-2019-D-5609.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 119
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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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