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FDA Commissioner Scott Gottlieb Resigns

On Tuesday, March 5, FDA Commissioner Scott Gottlieb announced he would resign at the end of the month. Gottlieb, a physician and former deputy commissioner in the George W. Bush administration, was confirmed as FDA Commissioner in May 2017. The resignation was not sought by the White House, as confirmed by a senior White House official. Rather Gottlieb, who commutes weekly to Washington from Connecticut, said he wants to spend more time with his family. In a letter to FDA staff, Gottlieb noted “[t]here’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family these past two years and missing my wife and three young children.”

Unlike some former commissioners, during his tenure, Gottlieb focused much of his time on issues related to food and tobacco. For example, as part of its 2018 Strategic Policy Roadmap, FDA signaled its intent to modernize certain standards of identity (SOI) to address current barriers to the development of healthier products while making sure consumers have accurate information about the foods they eat.  Relatedly, under Gottlieb’s direction, FDA requested comments on the use dairy terms in the labeling of plant-based products. See our previous posts on SOI modernization and the plant-based products labeling debate. As for food safety, examples of FDA action include plans to modernize oversight of imported food and the investigation of several product recalls, including the November 2018 romaine lettuce E. coli outbreak. And in April 2018, FDA issued its first ever mandatory recall. Additionally, Commissioner Gottlieb dedicated his efforts to reducing tobacco-related disease and death and curtailing youth access to tobacco products and e-cigarettes. Tobacco- and e-cigarette-related posts can be found here.

Prior to his departure, Commissioner Gottlieb vowed to continue to work to cement more of FDA’s pending efforts, to secure the 2020 budget, and to help transition the agency to new leadership. At this time, Commissioner Gottlieb’s replacement has not been announced.

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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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