Some e-cigarettes may need to halt sales after latest FDA move

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Some e-cigarettes may need to halt sales after latest FDA move


Oct 12 2018 16:47
Anna Edney, Bloomberg


U.S. health officials dialed up their efforts to halt an epidemic of underage electronic-cigarette use, warning tobacco companies including British American Tobacco that their products may be violating the law and could need to come off the market.

The Food and Drug Administration on Friday sent warning letters regarding 40 e-cigarette products to 21 companies, asking them to prove that they haven’t run afoul of an exemption that let the industry continue selling vaping devices after the agency began regulating them in 2016.

Vaping among teenagers has increased dramatically over the past year, prompting FDA Commissioner Scott Gottlieb to change his stance on devices he has viewed as tools that could help adults quit smoking cigarettes. Last month, Gottlieb told e-cigarette makers to find ways to clamp down on youth use of their products or face curbs on sales of flavored tobacco pods that appeal to children. He has also said he could explore banning online e-cigarette sales.

“Through these actions – and with more to come in the weeks and months ahead – we’re committed to doing all we can to reverse the disturbing trends of youth tobacco use, especially e-cigarettes,” Gottlieb said. “I’ll do everything I can to curb the epidemic of youth use.”

Congress gave the FDA the authority to regulate tobacco products in 2009, and the agency extended that oversight to e-cigarettes in 2016. The agency has permitted companies to continue selling only vape devices that were on the market prior to August 8, 2016, while preparing applications for the agency to review the products by 2022. The FDA is concerned that some may have new features, flavors or formulations that disqualify them from the carveout.

The letters sent on Friday target companies that may have introduced new flavors or altered their product in ways that violate the exemption. They include Logic Technology Development and Fontem U.S.

Juul Labs, the maker of the most popular vaping product among teens, didn’t receive a letter. The FDA conducted a surprise inspection of Juul’s headquarters in San Francisco last month and seized documents that could help determine whether the company violated the exemption.

Anti-tobacco and health-advocacy groups including the American Heart Association and the Campaign for Tobacco-Free Kids sent Gottlieb a letter in April accusing Juul of introducing its mango and cool cucumber flavors in 2017.

The FDA confirmed that youth vaping jumped 75% in the past year as teens were increasingly drawn to Juul. In 2017, more than 2 million middle and high-school students used e-cigarettes, according to the Centers for Disease Control and Prevention.