The FDA has warned both makers and sellers of e-cigarettes about it's intentions, sending letters to some 1,100 retailers including 7-Eleven, Walgreens, Circle-K and Shell gas stations warning that the products need to be kept away from minors.
Five companies, including JUUL Labs, Inc., maker of the popular, USB-drive shaped device with nicotine flavors, will have 60 days to give the FDA a strategy on how they will curb youth use - "or face regulatory consequences", Gottlieb said.
UPI contacted two other manufacturers by phone or email but did not receive replies: Altria's MarkTen XL and Imperial Brands' Blu.
"While vaping devices have the potential to be disruptive to the combustible tobacco market, this can not be at the expense of increasing rates of nicotine addiction in young people", Ylioja said. The agency also has issued more than 135 No-Tobacco-Sale Order Complaints, which can result in retailers being prohibited from selling tobacco products for specified time periods. Such grim statistics prompted the FDA to recently propose that the level of nicotine, the addictive substance that gets people hooked, permitted in products should be brought down, either suddenly or gradually over time, to eventually wean people off smoking.
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. Flavored e-cigarettes have become a big part of the $2.3 billion e-cigarette business.
The FDA will also look closely at "straw purchases", in which adults visit web-based stores and buy in bulk to resell to minors.
Last year, the FDA announced that it would delay regulations that could have halted the sales of many e-cigarettes. Since 2017, FDA commissioner Scott Gottlieb has discussed e-cigarettes as a potential tool to ween adult smokers off cigarettes, although that benefit hasn't been proven. "We won't allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products", he said.
Federal officials called it a blitz - "the largest coordinated enforcement effort in the FDA's history" in response to concerns that e-cigarette use has become an "epidemic" among youths.
"I've been warning the e-cigarette industry for more than a year that they needed to do much more to stem these youth trends", he said. The agency issued 12 warning letters to companies they declared have deceptive marketing labels on e-liquids.
Beyond that, vaping research and development is actually costing tobacco companies as they attempt to gain market share in the burgeoning industry, Lavery said.
The FDA plans to step up enforcement actions to monitor, penalize and prevent e-cigarette sales in convenience stores and other retail sites.
"We're especially centered on the flavored e-cigarettes", said Gottlieb.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. "The FDA won't tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products".
Shares of British American Tobacco were up almost 6 percent and shares of cigarette-maker Imperial Brands PLC were up more than 3 percent. "Appropriate flavors play an important role in helping adult smokers switch", Burns said in a statement.
Ultimately, such a move could push Big Tobacco back into the lead in the e-cig market, analysts said Wednesday.
"I'm here to tell them today that this prior approach is over", he said.