Jarretera /
12 September 2019Big PharmaRory O'Neill

FDA cracks down on unauthorised e-cigarettes

The Trump administration has pledged to crack down on the sale of unauthorised vape products, amid growing public health concerns over the safety of e-cigarettes.

According to a  press release issued yesterday, September 11, the US Food and Drug Administration (FDA) said that it will shortly finalise a compliance policy to ensure the enforcement of premarket authorisation requirements for non-tobacco-flavoured e-cigarettes.

The government’s health and human services secretary Alex Azar said that the administration would “not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth”.

The FDA cited figures showing that flavours such as mint and menthol were overwhelmingly the most popular among young people.

According to the FDA, there are electronic nicotine delivery system (ENDS) products, such as e-cigarettes, currently on the market that “are not being marketed legally”.

The compliance policy being prepared by the FDA will target ENDS products lacking the required premarket authorisation.

The FDA said it hoped to “share more on the specific details of the plan and its implementation soon.”

Juul counterfeit action

The news comes amid growing concern over the health risks of e-cigarettes. These are particularly difficult to evaluate in the case of unapproved and counterfeit products.

Last month, leading e-cigarette manufacturer Juul filed a lawsuit against unidentified counterfeiters who the company said had been distributing dangerous versions of its products online.

According to Juul, the counterfeit vapes are not subject to any kind of regulatory oversight and posed a risk to the health of children.

The vapes are sold in “virtually identical packaging” as genuine Juul products, the company said.

In addition to infringing Juul’s trademarks, the company said that the counterfeiters had specifically been marketing to children.

In its latest announcement, the FDA said that it had, earlier this week, hit Juul with a warning letter for marketing its products to youth and giving a presentation in a school.

Acting FDA commissioner Ned Sharpless said: “Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful.

“JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” Sharpless said.

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