Many Juul Vapors Left in Limbo as Teen Rates Delay FDA Decisions

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Thousands of vapors are awaiting their fate in the marketplace as the FDA works past a court-ordered deadline to review whether their benefits to adult smokers outweigh the risks of teen addiction.

The Food and Drug Administration is still assessing 55,000 premarket applications for e-cigarettes from Juul Labs. Inc. and other companies that are currently on the shelves, an FDA spokesperson told Bloomberg Law. The agency was tasked with deciding, by Sept. 9, 2021, how to regulate nearly 6.7 million of these products after expanding its authority over tobacco.

Menthol flavored e-cigarettes in particular can be helpful for adults trying to stop using combustible cigarettes, but they can also make smoking more addictive and appealing to kids—a tension that is likely causing the FDA’s delay in deciding whether to keep these products on the market.

“FDA is in a bit of a damned if they do, damned if they don’t situation,” said Ben Haas, a partner at Latham & Watkins LLP’s Healthcare and Life Sciences Practice.

If the agency decides to not approve the remaining products, the FDA “could ultimately be sued by Juul” and other companies, he said. The agency risks angering public health groups if it allows the products to stay.

Another problem is that many popular vaping brands produce synthetic nicotine devices. The 2009 Family Smoking Prevention and Tobacco Control Act (Public Law 111–31) gave the agency authority to regulate products derived from the tobacco plant, but policy analysts say that has given tobacco-free companies like Puff Bar a loophole to market e-cigarettes outside the FDA’s reach.

The FDA said in an email to Bloomberg Law that the ageny has taken action on 99% of the e-cigarette applications submitted and that it “has been devoting tremendous resources to the applications for the millions of products it has received.” The agency said it “continues to make significant progress on our comprehensive actions to protect the public, especially youth, from the harms of tobacco products.”

Juul declined to comment for this story. The company says on its website that “since November 2019, we have halted all broadcast, print and digital product advertising in the U.S., suspended distribution of all flavored products other than tobacco and menthol in the U.S., and fundamentally restructured our company to focus” on “combating underage use.”

Puff Bar said in an email that its products “are only intended to be used by adults who are at least 21 years of age who use combustible cigarettes or other tobacco or nicotine vaping products.”

Delayed Decisions

The FDA finalized a rule in 2016 that extended its regulatory authority to e-cigarettes, requiring makers of the vaping products to submit premarket applications. The agency in 2017 said companies would have until 2022 to do so.

The American Lung Association and other groups sued the FDA in 2018, arguing that the agency’s 2022 deadline would keep potentially harmful devices on the market. A federal district court agreed and issued a May 2020 deadline instead. The court later extended that date to Sept. 9, 2020, due to the Covid-19 pandemic—giving the FDA one year after that to finish reviewing applications and enforce against unauthorized sellers.

The FDA said in September 2021 that it had completed reviews on 93% of the applications. It said it had rejected more than 946,000 flavored e-cigarette products because they lacked sufficient evidence that the benefit to adult smokers overcame the public health threat for children.

The remaining e-cigarette applications likely include “much more data on user flavors, consumer testing actually used in the field that FDA will need to address specifically as part of their evaluation,” Haas said.

The FDA announced in January 2020 that it was banning the sale of most flavored e-cigarette products, except for tobacco and menthol. It said it would prioritize enforcement against unauthorized flavors that appeal to kids, including fruit and mint.

The agency is moving forward with separate plans to ban menthol as a characterizing flavor in cigarettes, and all characterizing flavors in cigars. But the ALA and other organizations want the FDA to go further by removing all flavored tobacco products from the market.

Youth vs. Adult Smokers

More than 2 million U.S. middle and high school students reported using e-cigarettes in 2021, even though teen use of the products dropped from the year prior, according to the Centers for Disease Control and Prevention’s National Youth Tobacco Survey. Nearly 85% of youth e-cigarette users reported using flavored products, with the most popular flavors including candy, desserts, and menthol.

The FDA “has the authority right now” to ban flavored e-cigarettes from the marketplace, Erika Sward, the ALA’s assistant vice president of national advocacy, said in an interview.

“While they’re making decisions on a case-by-case basis, they can look at all flavors, whether it’s all menthol e-cigarettes and alternate flavors, and understand the impact of the flavors on attracting use and, therefore, the public health,” she said.

The agency must balance its goal of deterring youth e-cigarette use with the potential benefits to adult smokers, attorneys say.

“Combustible cigarettes obviously present clear and present dangers to the user in the tobacco and the combustion byproducts,” Haas said. “You don’t have that sort of easily identifiable health risks to the individual from e-cigarettes.”

A “strong application” from a vaping company “would show that the product is less harmful than a combustible cigarette, but also helps adult smokers reduce or eliminate their use of combustible cigarettes,” Stacy Ehrlich, a partner at Kleinfeld, Kaplan & Becker LLP who counsels tobacco manufacturing groups, said.

“If you’re offering a reduced harm alternative, like a vape product to a smoker, and the vape product is appealing, that could provide a benefit to public health by moving smokers down the continuum of harm,” she said.

Synthetic Nicotine

Health groups are also calling on the FDA to confront children’s use of synthetic, tobacco-free nicotine products, which have been outside of the agency’s purview.

The agency has sent warning letters to Puff Barr and other companies for promoting youth-appealing products without prior authorization. But these companies continue selling their products, with Puff Bar named the top e-cigarette brand among middle school and high school students in the CDC’s 2021 survey.

Puff Bar said in an emailed statement that it doesn’t advertise its products in “channels where our marketing would be easily accessible to minors, such as on TV or on the radio.” It added that company staff “carefully vet each brick-and-mortar retailer” to ensure its enforcing age-verification procedures.

A bill (H.R. 6286) introduced in December by Rep. Mikie Sherrill (D-N.J.) would allow the FDA to regulate any nicotine product, regardless of whether it is derived directly from the tobacco plant.

FDA decisions over these products could prompt backlash from manufacturers, but regulatory clarity over all nicotine devices is necessary to benefit the public health, Sward said.

“We know that any time the FDA follows the law and makes the right decision for public health, the tobacco companies will sue,” she said. “But that just means that it’s all the more important that FDA act quickly and work to implement the science that will save so many lives.”

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com

Read full article here.

Celine Castronuovo – Bloomberg Law – 2022-02-10.

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