FDA e-cigarette crackdown hits local, downstate retailers

FDA e-cigarette crackdown hits local, downstate retailers

All three of those companies compete with Juul in the e-cigarette market - but, unlike Juul, they also sell regular cigarettes, meaning a government crackdown on e-cigarettes doesn't hurt as much.

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 US Food and Drug Administration is considering a ban on flavoured e-cigarettes from Juul Labs and other companies as it grapples with an "epidemic" of youth e-cigarette use that threatens to create a new generation of nicotine addicts, the agency's head said on Wednesday.

The FDA cited research saying more than 2 million middle and high school students were current users of e-cigarettes in 2017. 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. "While teen cigarette use has hit a record low, she said, "'juuling' and vaping have become an epidemic in our schools, with products that seem targeted to get young people hooked on nicotine".

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.

"We didn't predict what I now believe is an epidemic of e-cigarette use among teenagers", Gottlieb said. The academy said Gottlieb has the authority to intervene in the market to protect minors, and any further delay runs the risk that "a generation of young people will become addicted to these unsafe products". "Appropriate flavors play an important role in helping adult smokers switch", the company said.

"FDA for years has repeatedly missed opportunities to keep tobacco products out of the hands of our children", said Chris Hansen, the organization's president. The FDA's four-year delay on that requirement has allowed the industry to flourish with little oversight.

The agency will also be increasing federal enforcement actions on e-cig sales to minors in convenience stores and other retail sites, Gottlieb said, and would look closely at a practice called "straw purchases", in which adults visit web-based stores and buy in bulk to resell to minors. As part of that plan, Gottlieb has suggested some smokers could be directed toward alternative products that deliver nicotine without the carcinogens of burning tobacco.

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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.

The agency also delivered letters to the five largest e-cigarette brands, asking the companies to tell the FDA within 60 days how they plan to curb youth access to their products.

Actions being considered - but not yet undertaken - include the immediate removal of certain flavored e-cigarettes from the market and shortening the time to market review for most cigarettes now being sold.

Officials said the move against more than 1,300 retailers was the largest coordinated enforcement action in the agency's history.

The steps announced Wednesday are just the initial elements of these new efforts, Gottlieb said.

"I certainly am in possession of evidence that warrants that", Gottlieb said.

The press released called on the FDA to immediately begin "requiring all e-cigarettes and other newly deemed tobacco products to go through the premarket review process required in the Tobacco Control Act, and removing all flavored tobacco products from the marketplace".

These levels of nicotine are highly addictive, particularly to the developing brains of children and teenagers. The brands will no longer be largely immune from regulations simply because they were already on the market in August 2016 when the FDA announced e-cigarettes would be regulated like other tobacco products.