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FDA requests federal court extend premarket application deadline on e-cigarettes to September

FDA requests federal court extend premarket application deadline on e-cigarettes to September

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The current deadline for tobacco manufacturers to file premarket applications with the FDA is May 12. It could be delayed to Sept. 9.

Tobacco manufacturers may gain a 120-day extension for filing premarket applications with the FDA for electronic cigarettes and other next-generation products.

The current application deadline is May 12, set in a federal court-mandated order, for manufacturers to be included in a 12-month review process by the Food and Drug Administration. It includes makers of nicotine liquids.

The FDA said Tuesday it filed a legal motion Monday requesting an extension to Sept. 9. It’s the same federal court in Maryland that mandated the May 12 deadline.

If the extension to Sept. 9 is established, the 12-month review process would commence at that point.

The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and non-users, particularly as those factors compare with traditional cigarettes.

If e-liquid manufacturers don’t apply, their products would be deemed as illegal to sell.

However, being in the process allows their product to stay in the marketplace.

The FDA said the request was made “solely because of the coronavirus outbreak and would not do so but for these highly unusual circumstances.”

“The agency is seeking this extension due to the challenges posed during these extraordinary circumstances.”

A coalition of public-health and anti-tobacco advocacy groups sued to require the FDA to adhere to the May 12 deadline as part of the coalition’s effort to reduce underage use of tobacco products.

The coalition said in a statement that "while we do not intend to formally oppose the FDA’s current request due to the extraordinary circumstances of the COVID-19 pandemic, any extension should be brief, and tobacco companies cannot be allowed to use this public health emergency to continue avoiding their legal obligation to submit their products for FDA review."

The coalition said in its formal response Thursday that the number of qualifying manufacturers include only those “that can show that they would have been on track to file the relevant application by May 12 but for the COVID-19 emergency.

Sandhills Strategy LLC co-founder Stefanie Miller said she expects Judge Paul Grimm to grant the request by Tuesday.

"We continue to think it’s highly likely FDA will re-assess in a couple months and re-petition for further delay if necessary," Miller said.

Miller questions whether the FDA and/or federal Centers for Disease Control and Prevention CDC "come out with formalized guidance around smoking and vaping in light of the COVID-19 pandemic."

"In the event this advice does not delineate between the risks posed by combustible cigarette use and e-cigarette use, this could increase chances that a future (premarket application) deadline extension is more selective and used in part to begin winnowing down the market to a smaller 'legitimate' group of players," Miller said.

The FDA said it “remains aware of the recent surge in youth use of e-cigarettes and the public-health imperative that these and other deemed new tobacco products undergo premarket review. The agency is committed to implementing and enforcing the premarket requirements in the law.”

“The agency strongly encourages applicants who are able, to submit applications as soon as possible.”

Lifeline or delay of inevitable

The possibility of the 120-day extension could serve as a key lifeline for some e-cigarette and vaping liquids manufacturers, but likely only delay an inevitable shutdown for others.

“It’s a little of both, I would suggest,” said Scott Ballin, past chairman of the anti-smoking alliance Coalition of Science or Health.

“Some will use the extra time to complete their work, where for others this is merely a stay of execution.”

Gregory Conley has warned members of the American Vaping Association for years that it would be possible to win a battle, but lose the war, when it comes to heightened federal tobacco regulations.

The nicotine liquids for use with open-pod e-cigarettes are available through May 12 in tobacco and vape shops — in large part because the FDA and other Trump administration officials believe those products lack appeal to individuals under age 21 and that those shops are more responsible at age-verification policies than other retail outlets.

However, the FDA also determined that makers of the nicotine liquids are manufacturers, and thus required to submit the premarket application.

“A vape shop that is in the business of manufacturing, by mixing nicotine and flavors, has a decision that it has to make about what business it wants to be in going forward,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

“If they are involved in the manufacturing process, they are subject to the law.”

Analysts, industry officials and advocates have said for years it could cost millions of dollars for each product to go through the premarket regulatory pipeline.

The FDA, meanwhile, has estimated it would cost about $500,000 per product. FDA officials are offering application assistance to small manufacturers of vaping liquids.

“An extension of the May 12 deadline by only four months would be a step in the right direction, but likely would not go far enough under the circumstances,” said Tony Abboud, executive director for Vapor Technology Association.

“Given that no one can predict the length and severity of the COVID-19 commercial shutdown, we hope that the FDA will revisit the appropriateness of a Sept. 9 deadline in the coming months.”

The association is recommending a deadline deferral of at least 180 days for large manufacturers, and at least 270 days for small manufacturers.

Regulatory delay

The May 12 deadline represents the culmination of nearly 3½ years of regulatory enforcement delay by the FDA.

The agency gained in August 2016 the authority to regulate e-cigarettes, vaporizers, cigars, hookahs (water pipes), pipe tobacco, nicotine gels and certain dissolvables.

The FDA said in August 2016 that “manufacturers of newly regulated tobacco products will no longer be allowed to introduce new tobacco products to the market without first receiving authorization from FDA.”

In January, the FDA stressed that any e-cigarette product currently available at retail “is illegally marketed” and only permitted “as an exercise of its enforcement discretion.”

Reynolds Vapor entered the FDA’s regulatory gauntlet Oct. 11 with its submission for premarket approval of multiple Vuse e-cigarette products and flavors.

Reynolds spokeswoman Kaelan Hollon has said the company “is well positioned to submit applications for the remaining Vuse portfolio ahead of the deadline of May 12.”

“The FDA guidance ... is clear that flavors can return to the entire marketplace once they have been cleared through the (premarket) process.”

Philip Morris USA said the manufacturer is “on track to complete those submissions by the May 12 deadline” or whatever timeline is imposed.

The company said it and other manufacturers requested that the FDA ask for at least an eight-week extension because of coronavirus’ influence on how employees involved with the application process are able to perform their duties.




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