FDA may ban flavored e-cigarettes, cites teen use 'epidemic'

Ben Davidson
September 14, 2018

The FDA's suggestions include rigorous age verification procedures for online direct sales (which Juul, the market leader, says it already has) and "discontinuing sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months".

The FDA said on Wednesday that it is revisiting that policy and that it may reverse the extension on compliance dates if the five e-cigarette manufacturers don't meet its demands.

The FDA is also targeting retailers who have sold e-cigarettes to minors. In May, they were warned, but they are still advertising and selling the violative products.

In raw numbers, that is 3.6 million students using tobacco past year compared with 4.5 million in 2011. But, the group added, that will only be the case if the FDA acts quickly to ban e-cigarettes that have not yet been reviewed by the agency, requires all e-cigarettes to submit to immediate FDA review, and forces the manufacturers "that have fueled this epidemic" to change their marketing and sales practices. He said the impact of the rampant use of e-cigarettes "is becoming very apparent".

FDA Commissioner, Scott Gottlieb, an appointee of President Donald Trump, stated, "We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion".

Shares of British American Tobacco were up almost 6 percent and shares of cigarette-maker Imperial Brands PLC were up more than 3 percent.

"We can not allow a whole new generation to become addicted to nicotine", he said. Appropriate flavors play an important role in helping adult smokers switch.

Beyond that, vaping research and development is actually costing tobacco companies as they attempt to gain market share in the burgeoning industry, Lavery said. "Clearly the FDA knows who the industry culprits are in this epidemic and as such should exercise its full regulatory authority over these products rather than allow the industry to voluntarily self-correct".

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"Flavored e-cigarettes should be ordered off shelves immediately - ending ongoing dithering and saving another generation from nicotine addiction", said Sen.

E-cigarette makers argue the devices help adult smokers give up cigarettes - potentially saving them from related illnesses - by giving a nicotine fix without the smoke and smell of combustible cigarettes. Officials said they're investigating some manufacturers for violating rules that require regulators' approval to introduce new products after August 2016. Above that message is a link to the company's youth-prevention efforts.

Dr Gottlieb announced a number of steps the FDA plans to take.

Wells Fargo analyst Bonnie Herzog said Juul is the brand "most at risk" from an FDA crackdown and that a potential ban on the company's products would boost Altria and other cigarette makers that also sell e-cigarettes. For example, PM's is pushing to advertise its heat-not-burn iQOS devices as less harmful than traditional cigarettes, while BAT has planned to expand its e-cigarette and vaping offerings from 12 markets to 48 by 2018.

"I certainly am in possession of evidence that warrants that", Gottlieb said. Other big players are owned by big tobacco conglomerates; Camel parent British American Tobacco makes Vuse e-cigarettes, and Marlboro parent Altria makes MarkTen e-cigarettes. But it also sent letters to five leading manufacturers of "electronic nicotine delivery systems" (ENDS), insisting that they do more to keep their products away from teenagers.

These levels of nicotine are highly addictive, particularly to the developing brains of children and teenagers.

San Francisco-based Juul, which commands over 60 percent of the e-cigarette market, said it is working to prevent underage use of its products but added that flavors can help adult smokers quit cigarettes.

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