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

Thousands of vapers await their fate on the market as the FDA works past a court-ordered deadline to determine whether their benefits for adult smokers outweigh the risks of addiction for teens.

The Food and Drug Administration is still evaluating 55,000 premarket applications for e-cigarettes from Juul Labs. Inc. and other companies currently for sale, an FDA spokesperson told Bloomberg Law. The agency has been tasked with deciding, by September 9, 2021, how to regulate nearly 6.7 million such products after expanding its authority over tobacco.

Menthol-flavored e-cigarettes in particular may be helpful for adults trying to quit using combustible cigarettes, but they may also make smoking more addictive and appealing to children – a tension that is likely to cause the FDA’s delay in deciding whether or not to keep these products on the market. Marlet.

“The FDA is in a bit of a damned spot if it does, damned if it doesn’t,” said Ben Haas, partner in the healthcare and life sciences practice at Latham & Watkins LLP.

If the agency decides not to 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 Family Tobacco Prevention and Control Act 2009 (Public Law 111–31) gave the agency the power to regulate products derived from the tobacco plant, but policy analysts say it gave tobacco-free companies like Puff Bar a loophole to market e-cigarettes beyond the reach of the FDA.

The FDA said in an email to Bloomberg Law that the agency has taken action on 99% of submitted e-cigarette applications and that it “has expended enormous resources on applications for the millions of products it received”. The agency said it “continues to make significant progress in our overall actions to protect the public, especially young people.”, harm from tobacco products.

Juul declined to comment for this story. The company states on its website that “as of November 2019, we have halted all broadcast, print, and digital product advertising in the United States, suspended distribution of all non-tobacco and menthol flavored products in the United States, and fundamentally restructured our business to focus”. on the “fight against the use of minors”.

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

Decisions delayed

The FDA finalized a rule in 2016 that extends its regulatory authority to e-cigarettes, requiring vaping product makers to submit premarket applications. In 2017, the agency 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 the potentially dangerous devices on the market. A federal district court agreed and instead set a deadline of May 2020. The court then extended that date to September 9, 2020, due to the Covid-19 pandemic, giving the FDA one year after that to complete review of claims and enforce unauthorized sellers.

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

The remaining e-cigarette apps likely include “much more user flavor data, actual consumer testing in the field that the FDA will have to specifically address 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 tobacco and menthol. He said he would prioritize cracking down on unauthorized flavors that appeal to children, including fruit and mint.

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

Young vs adult smokers

More than 2 million US middle and high school students reported using e-cigarettes in 2021, though teen use of the products declined from a year earlier, according to the National Tobacco Survey in young people from the Centers for Disease Control and Prevention. Nearly 85% of young e-cigarette users reported using flavored products, with the most popular flavors being candy, dessert and menthol.

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

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

The agency must balance its goal of deterring e-cigarette use among young people with the potential benefits for adult smokers, the lawyers say.

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

A “high demand” 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, partner at Kleinfeld, Kaplan & Becker LLP which advises tobacco manufacturing groups, said.

“If you offer a safer alternative, such as a vaping product to a smoker, and the vaping product is appealing, it could benefit public health by moving smokers down the harm continuum,” he said. she declared.

Synthetic nicotine

Health groups are also calling on the FDA to crack down on children’s use of non-tobacco synthetic nicotine products, which were outside the agency’s purview.

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

Puff Bar said in an emailed statement that it does not advertise its products in “channels where our marketing would be readily available to minors, such as on television or radio.” He added that company staff “carefully check every brick-and-mortar retailer” to ensure they are following age verification procedures.

A bill (HR 6286) introduced in December by Rep. Mikie Sherrill (DN.J.) would allow the FDA to regulate any nicotine product, whether or not it is derived directly from the tobacco plant.

FDA decisions on these products could provoke backlash from manufacturers, but regulatory clarity on all nicotine devices is needed to benefit public health, Sward said.

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

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