December 9, 2018

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FDA Announces Meeting to Discuss Eliminating Youth E-Cigarette Use

On September 12, 2018, FDA Commissioner Dr. Scott Gottlieb announced FDA’s Youth Tobacco Prevention Plan in response to the perception that use of e-cigarettes has become an “epidemic”.  Dr. Gottlieb’s concern is based on preliminary data from the National Youth Tobacco Survey, expected out in November, which suggests that the number of high-school-age children reporting use of e-cigarettes increased more than 75 percent from 2017 to 2018. As part of its effort, FDA sent letters inquiring about marketing practices to five manufacturers of cartridge based e-cigarette products that are widely used by youth. The letters suggest that FDA might ban flavored e-liquids if insufficient steps to curb youth use are not taken.

On November 2, 2018 FDA announced a pubic meeting on December 5, 2018 to discuss continued efforts to curb e-cigarette use and to aid cessation amongst youth. Topics of interest noted in Dr. Gottlieb’s press release focus on cessation and include:

Potential role of drug therapies to support cessation of e-cigarettes and traditional tobacco products use (including cigarettes and smokeless tobacco) amongst youth;

Behavioral interventions to aid in cessation;

Development of cessation drugs;

Development of methods, study designs, and measures for evaluating drugs for use in youth cessation; and

Funding opportunities for research on youth use, attitudes, and cessation

A November 8, 2018 article in the Washington Post indicates that FDA may, as early as next week, impose severe restrictions on the sale of flavored e-cigarette products in convenience stores and gas stations.  The ban would only apply to cartridge-based products.

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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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