麻豆传媒

Faced with a court-ordered deadline to respond to e-cigarette manufacturers' applications for their products to remain on the market, the FDA emphasized how many it had processed already, while side-stepping dealing with the market leaders.

was what the agency called its action on the "unprecedented task of reviewing applications for over 6.5 million 'deemed' new tobacco products" from some 500 companies, citing action on 93% of the total applications to date.

In August, FDA started issuing the first of flavored electronic nicotine delivery systems with non-tobacco flavors like Cinnamon Toast Cereal, which health advocates have called a driver of teen use and addiction, and applications from manufacture JD Nova's approximately 4.5 million products due to missing information. Those products had to be taken off shelves.

The agency now says involving more than 946,000 flavored products have received such marketing denials, but most are for smaller companies or vape shops bearing unfamiliar names like Mom and Pop Vapor Shop, Underdog E-liquids, and Warlock Vapes.

The top three market leaders -- JUUL, Reynolds American (maker of Vuse e-cigarettes), and NJOY Holdings -- were conspicuously missing from the list for which review has been completed.

Those omissions were "deeply disappointing," American Heart Association CEO Nancy Brown said in a statement to the press.

"The FDA's delay appears to include JUUL, which has targeted our nation's teens for years and contributed to the epidemic of tobacco use among youth," she said, adding that "its inaction appears to leave the products of JUUL and other market leaders on the market still longer."

"How the FDA could fail to make a decision on Juul products is beyond me," American Thoracic Society Tobacco Action Committee Chair Michelle Eakin, PhD, said in a press release from that society. "Juul has the largest share of the e-cigarette market and its products were a primary driver in the skyrocketing rise in youth e-cigarette use. The FDA has delayed long enough. Until the agency addresses Juul, Puffbar, and other companies that are driving the youth e-cigarette market, it is failing to do its job."

The rapid rise in youth vaping was one of the drivers in pushing the FDA to act on the authority it got in 2009 from Congress to oversee tobacco products by "deeming" e-cigarettes and other non-traditional nicotine delivery systems as tobacco products under the agency's oversight and subject to marketing restrictions.

That move came in 2016, but the has been anything but the swift action health groups have clamored for.

The FDA initially gave manufacturers 2 years to submit applications with evidence that these electronic nicotine delivery systems would be "appropriate for the protection of public health," both in terms of youth use and for traditional cigarette cessation overall.

However, a federal court order allowed products for which an application was submitted by the deadline to stay on the market until Sept. 9, 2021, at the latest pending FDA review.

FDA said it is still working on the remaining applications, which would include the top products on the market, and would issue its "decisions on a rolling basis."

"We continue to work expeditiously on the remaining applications that were submitted by the court's Sept. 9, 2020, deadline, many of which are in the final stages of review," the agency said in a press release.

FDA officials had pledged to fast-track applications of the companies with the largest market share.

One question the agency is weighing is whether to allow those companies to fruit-flavored e-cigarette cartridges, although JUUL submitted an application only for tobacco- and menthol-flavored products.

While there have been calls for a permanent ban on all sweet and fruity e-cigarettes and even a cap on nicotine concentration, FDA officials have said products will be reviewed individually , the Wall Street Journal reports.

Enforcement action against products for which the FDA has not yet completed review is at the agency's discretion.

"In the meantime, products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities," the FDA said.

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