December 11, 2019

December 11, 2019

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December 10, 2019

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December 09, 2019

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Former FDA Commissioner Scott Gottlieb Calls for a Ban on Vaping Products Most Widely Used by Youth

  • On November 19, 2019, former FDA Commissioner Scott Gottlieb opined on how the FDA should proceed in regulating e-cigs to address the “youth epidemic” but also preserve the devices’ potential to help adult smokers quit cigarettes.  Gottlieb argues that “providing adult smokers with a safer alternative to cigarettes cannot come at the expense of addicting a generation of young people to nicotine with these same products.”  Gottlieb claims that the FDA must differentiate between cartridge-based e-cigs, which youth prefer, and open-tank vapes that are not popular among youth, as open-tank vapes are sold at higher prices.

  • Vaping product advocates argue that FDA restrictions on e-cigs will make it difficult for adult smokers to use the devices to quit cigarettes.  These advocates also note that regulatory action to ban flavored e-cigs, which appeal to children, could end up forcing the shutdown of small vape stores where adults shop.

  • Gottlieb argues that FDA should immediately remove cartridge-based e-cigs in order to address the youth epidemic, and once the cartridge-based e-cigs are removed from the market, companies that relaunch them would need to file FDA applications showing that they provide a net public health benefit.  He explains that this review process would allow FDA to impose additional restrictions to prevent their use by young people.  Additionally, Gottlieb notes that FDA should make the premarket tobacco product application (PMTA) process more “efficient” for small businesses that can demonstrate they are only selling products to adults, by, for example, allowing companies following common manufacturing processes to pool data and resources.  We will continue to monitor any developments.

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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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