FDA reaches ‘difficult compromise’ in fight against e-cigarettes

The FDA plans to take aggressive steps toward limiting youth access to tobacco products and banning the sale of flavored nicotine, the organization’s commissioner, Scott Gottlieb, MD, has announced in a statement backed by Health and Human Services Secretary Alex Azar.

Gottlieb’s remarks, which amounted to a nearly 4,000-word proposal, were published simultaneously Nov. 15 alongside results from the FDA and CDC’s 2018 National Youth Tobacco Survey (NYTS), which identified a 78 percent increase in e-cigarette use in high school students and a 48 percent increase in middle school students over the last year.

According to the report, the total number of middle and high school students using e-cigs has risen to an estimated 3.6 million, and more than two-thirds of those children are buying flavored e-cigarettes. Gottlieb said the data “shock my conscience.”

“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” he wrote. “These actions are grounded in hard evidence. But they are also deeply personal.”

Gottlieb admitted he’s endorsed technologies like electronic nicotine delivery systems (ENDS) in the past, but said he’d only considered them as a facilitator in adults looking to quit tobacco. By the time he launched the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation in July 2017, youth e-cigarette use had fallen from 16 percent in 2015 to 11.3 percent.

At the time, he said, he envisioned “a world in which cigarettes lose their addictive potential through reduced nicotine levels” and “a regulatory paradigm that focused on nicotine and evaluated the diverse nicotine delivery mechanisms along a continuum of risk.”

“What I did not predict was that, in 2018, youth use of e-cigarettes and other ENDS products would become an epidemic,” he wrote.

The epidemic is one that’s growing fast and is fueled by social media. Facing complaints that their brand tailored tobacco marketing to young audiences, e-cig giant Juul shuttered its social media accounts and majorly scaled back the sale of its flavored nicotine products.

Gottlieb said he’s now directing the FDA’s Center for Tobacco Products (CTP) to revisit a compliance policy that presently allows for the sale and promotion of flavored ENDS. He’s proposing the policy be reworked to require all flavored tobacco products—barring tobacco and menthol flavors—be sold in age-restricted, in-person locations, or in highly secure online environments.

“These changes will not include mint- and menthol-flavored ENDS,” he wrote. “This reflects a careful balancing of public health considerations. Among all ENDS users, data suggests that mint- and menthol-flavored ENDS are more popular with adults than with kids. This is a difficult compromise that I’m trying to strike, recognizing the public health risk proposed by cigarettes still being available in menthol flavor.”

Gottlieb said the FDA is looking into some “potentially important distinctions” between mint- and menthol-flavored e-cigarette products, since the former flavor is popular with kids. Still, he wrote, “I continue to believe that we must recognize the potential for innovative, less harmful products that can efficiently deliver satisfying levels of nicotine to adults who want them.”

In his proposal, Gottlieb also called for a ban on flavored cigars and combustible menthol cigarettes and cigars.

The American Heart Association issued a statement Nov. 15 commending Gottlieb’s actions, particularly against combustible products. AHA CEO Nancy Brown called the move “historic and long overdue,” but she also pushed for further action.

“Limiting the sale of e-cigarettes is not enough,” she said. “The FDA should also remove flavored e-cigarettes from the market and prohibit companies from marketing their products in ways that appeal to kids.”

Gottlieb does mention targeted marketing in his proposal, promising to continue pursuing the “removal from market of those ENDS products that are marketed to children and/or appealing to youth.”

“The bottom line is that these efforts to address flavors and protect youth would dramatically impact the ability of American kids to access tobacco products that we know are both appealing and addicting,” he wrote. “This policy framework reflects a re-doubling of the FDA’s efforts to protect kids from all nicotine-containing products. They also reflect a very careful public health balance that we’re trying to achieve.”