FDA proposed crackdown on flavored e-cigs puts Juul on notice

Gladys Abbott
September 16, 2018

"We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people".

FDA Commissioner Scott Gottlieb called the agency's steps the largest coordinated enforcement effort in his agency's history and said it was prompted by alarming new evidence that electronic cigarette use by minors has risen to levels he called "simply not tolerable".

Fervent on an "epidemic" surge in teen employ of e-cigarettes, the highest of the US Meals and Drug Administration launched this day a "ancient action" against more than 1,300 stores and five predominant producers for their roles in perpetuating formative years access to the devices in the US. "E-cigs have become an nearly ubiquitous - and unsafe - trend among teens", added Gottlieb.

"I'll be clear. The won't tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same products", Dr. Gottlieb said.

The undercover investigation took place from June through the end of August, with the majority of violations involving the sale of products by the five manufacturers, which make up more than 97 percent of the USA e-cigarette market.

But he, too, said this can only happen if e-cigarette manufacturers are forced to remove flavored products from the market until the FDA specifically approves them, and if federal officials require manufacturers to alter current marketing practices, eliminate online sales, and take other steps to curtail illegal sales to youth. The FDA declined to publicly release the numbers, but people familiar with them said they were preliminary data from the National Youth Tobacco Survey, on which the agency and the Centers for Disease Control and Prevention collaborate.

In the absence of such plans, Gottlieb vowed "to revisit the FDA's exercise of enforcement discretion for products now on the market".

More than 2 million middle-school and high-school students used e-cigarettes in 2017.

The FDA extended an Obama era deadline that would have required e-cigarettes on the market by 2016 to be reviewed starting this year.

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Wells Fargo analyst Bonnie Herzog, in a research note, said Juul appears "most at risk" from the crackdown because of its "strong appeal to youth and the FDA's comments on flavors".

"We didn't foresee the extent of what's now become one of our biggest challenges", he said, in prepared remarks.

In its bid to wean adult smokers from traditional cigarettes, the agency has sought to make a wider range of "reduced risk" tobacco products available to consumers. They're really potent deliverers of nicotine, which is a highly addictive drug.

As part of that plan, Gottlieb has suggested some smokers could be directed toward alternative products that deliver nicotine without the carcinogens of cigarettes.

All tobacco use, including e-cigarette use and vaping, are prohibited by state law in public schools.

"While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can't come at the expense of kids", said Gottlieb.

"This may create some obstacles for adults who want to enjoy e-cigarettes", Gottlieb said. JUUL pods, which can be bought in fruit or candy flavors, contain the same amount of nicotine as a pack of cigarettes.

And to help prevent the next child from using the product. The New York Times noted in 2014 RJ Reynolds and Altria put gigantic warnings on their e-cigarette and vaping products not seen on tobacco products. If the manufacturers fail to submit plans that could halt the trend of e-cigarette use among kids, their flavored products could be pulled from store shelves.

It cited estimates from Public Health England that e-cigarettes are 95 percent less harmful than normal cigarettes.

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