Confusion Clouds FDA Approach to Electronic Cigarettes



E-cigarette makers and anti-vaping groups are intrigued by the agency’s journey so far. The industry is looking for a clear path forward, while public health groups argue that the FDA’s actions have not helped reduce the appeal of vaping to teens. The agency only said it would “promptly” review the remaining vape marketing requests. And he faces potential jokers linked to legal challenges brought by pro and anti-youth vaping camps.

“I think you see the challenge of trying to apply new regulation to an existing industry,” said Scott Gottlieb, a former FDA commissioner who has devoted much of his tenure to regulating tobacco. “We’re going to get to the right end result … It’s only a challenge.”

Another former agency hand expressed confusion over the FDA’s approach. “I don’t know exactly what’s going on here,” said a former senior official with the Center for Tobacco Products at the FDA.

A spokesperson for the agency said the FDA had ruled on “over 98%” of all new tobacco applications it received by the September 9 deadline.

“The FDA is committed to completing the review of the remaining applications as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress,” the spokesperson said. “The FDA is reviewing many different applications simultaneously and intends to continue making marketing decisions as the review of the applications is completed.”

FDA regulation of the electronic cigarette market is long overdue. The agency finalized a rule in 2016 requiring manufacturers of tobacco products to submit tobacco pre-market applications, or PMTAs, for any product introduced after February 2007. In many cases, this meant companies had to apply for the authorization to continue selling their existing products.

A judge then ordered the companies to submit an application by September 2020 and the FDA to issue decisions by September 2021, after anti-smoking groups filed a lawsuit to speed up the regulatory process. But the agency finalized the PMTA’s rules for e-cigarettes this month, weeks after the deadline set to rule on business returns.

The new rules will come into effect in early November. They are demanding companies to prove that the likely benefits of their products for adult smokers outweigh the risk of enticing teens, children, or other non-smokers to start vaping. It’s similar to the standard that the FDA had previously set. When announcing the final rule, the FDA said not all pending applications would be subject to new standards.

To date, the agency has only authorized one vape and two tobacco-flavored cartridges made by Vuse, a brand owned by cigarette maker RJ Reynolds. After the FDA announced the decision on Tuesday, some public health experts questioned whether the items met the agency’s clearance criteria – especially because they contain levels of nicotine comparable to some Juul products. and disposable electronic cigarettes, both historically popular with consumers. teenagers.

Additionally, a federal survey released last month found that over 10% of high school students who vape named Vuse as their brand of choice.

“It is of deep concern that the FDA appears to have little concern about the potential for abuse [of these products]Said Matthew Myers, president of the Campaign for Tobacco-Free Kids, which sued the FDA in 2018 over the agency’s failure to require e-cigarette manufacturers to submit PMTAs in a timely manner.

“The only way for Vuse [products] could be used to reduce tobacco-related health damage if smokers switch almost completely from smoking to using the Vuse e-cigarette instead, ”Eric Lindblom, former head of the Center for Tobacco Products at the FDA, who is now a senior researcher at the Georgetown University Law Center, wrote in an email to POLITICO. “Any other use will increase the damage and risk to the health of users. ”

In the meantime, companies that have received denial-to-market orders or notices of incomplete applications may choose to reapply under the new rules. And nearly a dozen companies have filed appeals against FDA denial-of-market orders for their products.

“It’s all in the air,” said Gregory Conley, president of the American Vaping Association. “The FDA has not issued any new [marketing denial orders] since September 23, after a month of non-stop shutdown of tobacco-derived nicotine e-cigarette businesses in America. And then everything stopped.

The agency last week overturned a denial it issued to Turning Point Brands, the first company to appeal a vaping decision, regarding hundreds of its e-cigarette products. The FDA said it had uncovered “relevant information that had not been adequately evaluated” in the company’s application – including randomized controlled trials comparing tobacco-flavored vapors with fruit-flavored ones, and studies evaluating how smokers, vapers and non-smokers perceive or use its products.

This additional data deserved further scrutiny by the FDA, the agency said, leading it to put hundreds of Turning Point Brands vapes back into the review process. The agency will not punish the company for continuing to sell the products without marketing orders while it reviews them.

“It appears they did not consider parts of the request,” said the former CTP official. “When I was at the FDA… we had to do full reviews of everything and provide answers to everything the company submitted. Even if there was a fatal flaw, we still had to review the entire app, which honestly felt like a waste of resources. ”

The reviews, for the cigarette products, then lasted for several years and included several back and forth trips with the cigarette maker, the official said.

“It looks like the FDA isn’t doing it anymore,” the official added. “Looks like they’re giving companies a bite of an apple and then making a decision.” The official suggested it is the result of the one-year deadline given to the agency to render decisions on all applications.

Companies are also unsure whether their menthol products will stay on the market. The Biden administration has said that the FDA will propose a policy next year to ban menthol-flavored cigarettes.

In the meantime, the agency told manufacturers of e-cigarettes that their menthol-based products would benefit from “unique considerations,” meaning the review is taking longer. Public health groups have an open case against the FDA in northern California for its failure to regulate menthol cigarettes.

“More than half of our members have had their requests for menthols and tobacco refused by the FDA,” said Amanda Wheeler, president of the American Vapor Manufacturers Association. “The most generous interpretation is that the FDA made a clerical error in denying these products.”

Public health experts speculate that the agency wants to prevent vapers users who prefer menthol from switching to cigarettes if menthol vapers are taken off the shelves.

The FDA “says, ‘Do we need menthol e-cigarettes on the market when we ban menthol cigarettes so menthol smokers don’t turn to menthol-free cigarettes? I think that’s the big question the FDA is sitting on, ”Lindblom said.

Regardless of the reason the FDA denies vapes, menthol or whatever, outsiders fear that more companies will continue to appeal FDA denial-of-market orders to continue selling their products.

“If their product is allowed to stay in the market, they want to make this thing last as long as possible,” the former senior official said.

This concept angers anti-youth vaping advocates. “If these lawsuits delay the implementation of FDA orders, it will be the prime example of how companies have undermined and distorted regulations designed to protect the American public,” Myers said.

He admitted, however, that the agency is in a difficult situation. “I don’t think it’s as chaotic as it sounds,” Myers said. “The reality is that the vast majority of products that were turned down were flavored products that appealed to children for which no credible science was provided.”

And it makes sense for the agency to take longer to review claims from larger companies, which likely have meatier claims, Myers added, especially in the face of appeals and lawsuits from other companies. But he’s still frustrated that the pace of FDA decisions on big-company apps and menthol sprays is unclear and overdue.

Gottlieb, who has long advocated for public health restrictions on tobacco products, said this was in part due to the difficulty the FDA faces in taming a thriving vaping industry.

“CTP has done a really good job, methodically going through the different steps that they need to play the tape to put in place that proper regulatory framework, and that’s what you see unfolding,” he said. . “I’m sure there are a lot of people out there who would like things to move faster.”



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