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Many e-cigarette products are attracting FDA scrutiny

Companies could face fines, seizures or court orders to remove e-cigs from the market

Quad-City Times

The FDA has asked 21 manufacturers and importers to provide information about whether more than 40 products were on the market before Aug. 8, 2016. In cases where products are being sold illegally, “We will take swift action,” FDA Commissioner Scott Gottlieb says.
Quad-City Times The FDA has asked 21 manufacturers and importers to provide information about whether more than 40 products were on the market before Aug. 8, 2016. In cases where products are being sold illegally, “We will take swift action,” FDA Commissioner Scott Gottlieb says.

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.

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, 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 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 repeatedly have urged the agency to take action against what they say are new products that have not received FDA clearance.

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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 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 is difficult 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 appear 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; myblu Starter Kit by Fontem U.S.; and Rubi by Kandypens.

The agency said 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 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 it 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.

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