FDA puts e-cigarette companies on notice over teen access


To gain clearance to return to the market, the companies would have to prove that the benefits to adults who use e-cigarettes to stop smoking outweigh the risks associated with youth vaping.

A former Trump campaign strategist says the Food and Drug Administration (FDA) commissioner has "lost his mind" after he threatened to take all flavored e-cigarettes off the US market if retailers don't do more to control use among teens.

To the extent that teenagers who otherwise would be smoking are vaping instead, that is an unambiguous gain in public health terms, since the latter habit is much less unsafe.

Gottlieb said that e-cigarette manufacturers have been given ample time to change their ways. The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end.

The FDA is also targeting retailers who have sold e-cigarettes to minors.

So in reality, e-cigarette brands are creating another generation of smokers-only this time they're a bit more high-tech. The number of regular users is much smaller, and nearly all of them are current or former smokers.

It has warned that most such products contain nicotine, which is addictive and can affect brain development. A government-commissioned report in January found "substantial evidence" that young people who use e-cigarettes are more likely to try cigarettes. "Hindsight, and the data now available to us, reveal these trends". Some experts were cautious about the results, however.

"We're especially focused on the flavored e-cigarettes".

However, Gottlieb claims e-cigarette brands haven't done enough to stop kids from using the products. But past year Gottlieb delayed the deadline until 2022, saying both the agency and industry needed more time to prepare.

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And if the trends in use that we're seeing right now continue, we're going to have to take even more dramatic actions.

The agency sent more than 1,100 warning letters and 131 fines to retailers it said illegally sold JUUL and other e-cigarette products to minors during a nationwide undercover sting including brick-and-mortar and online stores this summer.

If the plans fall short, the FDA could block sales of the products by enforcing a requirement that companies provide detailed design and health data about their products before marketing them. The FDA's delay on that requirement has allowed the industry to flourish with little oversight. But it's not clear how quickly the decision could be reversed.

Despite the fact that not one person casted a vote for Gottlieb, his board at the FDA has the future of flavored e-cigarettes in their hands. Youth tobacco prevention is a priority for our companies. British American, which produces Camel cigarettes, climbed as much as 6.4 percent in London, the biggest intraday increase in 10 years.

She said Altria could be well positioned because it has a long history of dealing with youth access to its products and has "limited/mature flavor profiles relative to Juul".

Juul Labs said it would work with the FDA on its request and is committed to preventing underage use of its product.

Now, Gottlieb is coordinating the largest scale initiative to enforce regulations against selling e-cigarettes to-date.

E-cigarettes are battery-powered devices that heat a nicotine liquid into a vapor that can be inhaled. As part of that plan, Gottlieb has suggested some smokers could be directed toward alternative products that deliver nicotine without the carcinogens of cigarettes.

"The legal standard for FDA premarket review of a new tobacco product includes consideration of whether the product would be appropriate for the protection of the public health. And they [teens] have adopted it", Gould said.