If the FDA determines that the products are being sold illegally, the companies could face fines, seizures or a court order to take them off the market. Friday’s move is the agency’s first large-scale action to enforce the requirement that products introduced after the August 2016 date get advance agency clearance, officials said.
Last month, FDA Commissioner Scott Gottlieb said youth use of e-cigarettes has become an “epidemic,” and he 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 that 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 that “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 R.J. Reynolds Vapor Co.; myblu Starter Kit by Fontem U.S.; and Rubi by Kandypens. 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.
A spokesman for Reynolds said that the company notified the FDA in May “that we would be making VUSE Alto nationally available and that it was a repackaged and rebranded version of a vapor product that was lawfully marketed in the U.S. as of August 8, 2016.”
The agency said that there may be situations in which 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, or might have had a different name.
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.