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FDA Vapor Regulations Caught in Balancing Act With Youth Survey

Oct. 11, 2022, 9:35 AM

The FDA should consider the bigger picture of youth nicotine use as it sorts out ongoing enforcement efforts against e-cigarettes and other tobacco products, industry groups and a public health analyst say.

The latest National Youth Tobacco Survey found that 2.5 million, or 9.4%, of US middle and high school students reported using e-cigarettes. Just over 14% of high schoolers reported using e-cigarettes in the last month, an increase from 13.4% last year.

Anti-tobacco groups say the findings show the agency must act quickly to remove all flavored e-cigarettes—popular among teens—from the market. But industry trade groups were quick to point out that vaping rates among high schoolers is down 50% from 2019— context that they say is needed to inform FDA regulations and help the agency decide which products to focus its enforcement on.

“We need a complete picture, not a partial snapshot,” said Lynn T. Kozlowski, a public health professor at the University of Buffalo who has led studies on nicotine addiction, vaping, and cigarettes.

“The public health significance of the use of nicotine-containing products arises from the overall patterns of product use,” added Kozlowski, who’s also a founding member of the Society for Nicotine and Tobacco Research.

The tobacco survey, released last week by the Centers for Disease Control and Prevention, noted that the ability to compare between 2022 and previous studies is “limited” due to changes in methodology, including differences in survey administration and data collection procedures.

The CDC said in an email Oct. 7 that the full 2022 National Youth Tobacco Survey results, including updated data on cigarette and other tobacco use, will be published in a Morbidity and Mortality Weekly Report by the end of this year.

Food and Drug Administration Commissioner Robert Califf said in a statement announcing the findings that “we still have a serious public health problem that threatens the years of progress we have made combatting youth tobacco product use.” The FDA typically considers data on youth use patterns when reviewing tobacco product applications.

The FDA is overseeing multiple ongoing tobacco priorities, including an ongoing review of tobacco-based e-cigarette products, which the FDA has said it likely won’t be able to complete until June 30, 2023.

The agency recently gained authority to regulate tobacco-free nicotine, and on Oct. 6 announced it issued a formal warning to Puff Bar—which manufactures flavored synthetic nicotine products—for distributing e-cigarettes without a marketing authorization order.

Youth Survey

Lawmakers and anti-tobacco advocacy groups say the survey data warrants urgent action from the FDA to remove the products most popular among youth from the market.

Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Subcommittee on Economic and Consumer Policy, said in a press release that the data “is distressing and further highlights the need for more aggressive action by the federal government to regulate these products.”

“While I’m pleased the FDA is finally taking steps to crack down on the companies who continue to market and sell these products without marketing authorization, these actions are still simply not happening quickly enough,” he said. He criticized the FDA for not eliminating from the market all synthetic nicotine products that didn’t submit applications by a May 2022 deadline.

The FDA has yet to issue any marketing authorizations to non-tobacco nicotine products, but has sent refuse-to-accept letters for more than 800,000 products with applications the FDA said didn’t meet the criteria for acceptance.

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said Thursday that the solution to addressing youth vaping is clear: “eliminate all flavored e-cigarettes.”

“The FDA has the power to do so, but it has repeatedly failed to act and left our nation’s kids at risk,” he added.

The American Lung Association agreed, arguing that the survey data show “youth continue to be overwhelmingly drawn to flavored e-cigarettes.”

“These products, almost all of which are disposable and on the market illegally, continue to flood the market in complete disregard of the law,” said Harold Wimmer, the group’s president and CEO.

Bigger Picture

Kozlowski said more information is needed to better understand the state of youth tobacco and vaping use across the country.

“The CDC should be releasing the new data they have on what is happening with cigarette use and other combusted tobacco use by youth alongside the results on vaping products,” he said. “Previously there have been drops in cigarette smoking,” so it’s worth asking, “Is that being maintained or continuing to drop?”

The CDC has reported a downward trend of cigarette use among middle and high school students over the past decade. In 2020, nearly two of every 100 middle school students (1.6%) reported that they smoked cigarettes in the past 30 days—a decrease from 4.3% in 2011. High school students saw a decrease from 15.8% in 2011 to 4.6% in 2020.

Amanda Wheeler, president of the American Vapor Manufacturers, said in a statement that the CDC “is concealing important aspects of the latest data on youth vaping, most significantly that high school usage is still down 50 percent from its peak in 2019.” The 2019 youth tobacco survey found that 27.5% of high schoolers reported current e-cigarette use, with 10.5% of middle schoolers reporting the same.

Vapor Technology Association Executive Director Tony Abboud took aim at the FDA’s latest marketing denial orders. The FDA said Oct. 6 it denied marketing authorization for 32 Hyde e-cigarettes because the applications “lacked sufficient evidence demonstrating that these flavored e-cigarettes would provide a benefit to adult users that would be adequate to outweigh the risks to youth.”

“To say that the companies that were denied market access did not adequately demonstrate a benefit to adults that outweighs the risks to youth when 500,000 smokers per year die of smoking related disease and less then 10% of kids are using vapes ignores the role vaping plays in harm reduction and frankly puts more lives at risk,” Abboud said.

The FDA hasn’t taken an official position on vaping products as a reduced-harm alternative to combustible cigarettes, though it considers in each e-cigarette review whether the benefit it could have to current adult smokers outweighs any risks of youth smoking initiation.

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