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Sharpless: ‘No Pause’ Following Gottlieb’s Departure

  • As previously reported on this blog, Ned Sharpless succeeded Scott Gottlieb as Acting FDA Commissioner in April 2019.  Prior to Sharpless’ tenure, it was unclear whether the agency would continue Gottlieb’s efforts in the area of food and tobacco, including reevaluating certain standards of identity, modernizing the oversight of imported food and product recalls, and curbing youth e-cigarette use.

  • In remarks to the 2019 FDLI Annual Conference, Acting Commissioner Sharpless made clear that “there will be no pause at FDA,” so as to not disrupt the progress the agency made under former FDA Commissioner Gottlieb.  The agency will continue its work on the Nutrition Innovation Strategy and the rollout of the Food Safety Modernization Act (FSMA) regulations.  A strategy for food safety has already been announced, which we have reported on here.  Acting Commissioner Sharpless also referenced the agency’s continued work on labeling, as the agency rolls out the new Nutrition Facts label and looks to reevaluate certain standards of identity.

  • As a centerpiece of former Commissioner Gottlieb’s tenure, Acting Commissioner Sharpless also highlighted the Center for Tobacco Product’s (CTP) efforts to prevent youth use of e-cigarettes.  Specifically, CTP has been acquiring data on electronic cigarette products to enable the agency to reverse the use of those products by children.  Acting Commissioner Sharpless also highlighted the agency’s recent enforcement actions against companies selling e-liquids with labeling or advertising that resemble kid-friendly food products.

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 128


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...