The Atlanta Journal-Constitution
FDA now probing e-cigarette brands aimed at youth
The Food and Drug Administration, in its latest effort to curb youth vaping, is investigating whether dozens of e-cigarette products are being sold illegally, the agency announced Friday.
The FDA said it has asked 21 manufacturers and importers to provide information about whether more than 40 products were on the market before Aug. 8, 2016. Products introduced or changed after that date must receive FDA clearance before going on sale.
Last month, saying youth use of e-cigarettes has become an “epidemic,” FDA Commissioner Scott Gottlieb ratcheted up enforcement actions against retailers. He also directed leading manufacturers of e-cigarettes to come up with detailed plans for reducing underage use and warned the agency would consider a possible ban on flavored e-cigarette products or a prohibition on online sales of e-cigarettes.
Public health groups have repeatedly urged the agency to take action against what they say are new products that have not received FDA clearance. In a letter to Gottlieb in August, six health and tobacco-control organizations said “manufacturers of e-cigarette products have introduced new products at an alarming pace in total defiance of law, with no apparent concern for FDA enforcement.” It noted that one vaping website said that so many new products were being introduced that it was hard to keep up with them.
The letter, whose signers included the American Academy of Pediatrics and the Campaign for Tobacco-Free Kids, added that many of the new products appeared to be trying to capitalize on the success of Juul Labs, whose e-cigarettes have boomed in popularity among young people.
Among the products under scrutiny by the FDA action are Vuse Alto, manufactured by Reynolds American; and myblu Starter Kit by Fontem U.S. The agency said that Juul did not receive a request for information because the FDA recently conducted an unannounced inspection of the company’s corporate headquarters to learn more about its marketing practices.
The agency said there may be situations where an e-cigarette product did not appear to be on the market as of Aug. 8, 2016, but actually was commercially available and in compliance with the law. For example, a product might have been available but not publicly announced or advertised.
In cases where products are being sold illegally, however, “We will take swift action when companies are skirting the law,” Gottlieb said in a statement.