The FDA Is Determined To Ignore the Decline in Underage Vaping Because It Weakens the Case for New Restrictions
October 1, 2021 | Tags: FDA
According to the latest results from the National Youth Tobacco Survey (NYTS), 11 percent of high school students qualified as "current" electronic cigarette users this year, meaning they reported vaping in the previous month. That's down from nearly 20 percent in 2020 and nearly 28 percent in 2019—a 60 percent drop over two years. The Centers for Disease Control and Prevention (CDC), which conducts the survey, and the Food and Drug Administration (FDA), which regulates "electronic nicotine delivery systems," both welcomed this evidence that the "epidemic" of underage vaping is abating.
Just kidding. Since acknowledging the sharp decline in e-cigarette use by teenagers would undermine the case for new restrictions on vaping products, including a ban on the e-liquid flavors that former smokers overwhelmingly prefer, the CDC and the FDA prefer to ignore that downward trend.
The CDC emphasizes that "approximately 2.06 million youths" in high school and middle school "were estimated to be current e-cigarette users in 2021," adding that "use of tobacco products by youths in any form, including e-cigarettes, is unsafe." Since vaping products do not contain tobacco and do not burn anything, which explains why they are much less hazardous than cigarettes, the CDC's habitual conflation of them with "tobacco products" is not only inaccurate but willfully misleading. The slippery term unsafe likewise conceals a huge difference in risk.
The FDA says the latest survey results show that "youth e-cigarette use remains [a] serious public health concern." However you rate that concern, it surely is not in the same ballpark as cigarette smoking, which according to the CDC causes more than 400,000 premature deaths a year in the United States. In this context, you might think the enormous harm-reducing potential of e-cigarettes, which the FDA itself has acknowledged, would rate at least a mention alongside the alarm about vaping by teenagers.
Lest that alarm begin to fade, the CDC warns that it would be misleading to compare the 2021 NYTS results to the numbers from 2020. "The 2021 NYTS was fully conducted amid the global COVID-19 pandemic, during which time eligible students could participate in the survey in classrooms, at home, or at some other place," it says in its report on the 2021 NYTS. "Differences in tobacco use estimates by location might be due to potential underreporting of tobacco use behaviors or other unmeasured characteristics among youths participating outside of the classroom. Thus, estimates from the 2021 NYTS should not be compared with previous NYTS survey waves that were primarily conducted on school campuses."
In other words, students who completed the survey at home may have been less honest than students who completed it in school. While that's possible, it is also plausible that the enhanced sense of privacy at home increased candor. In any case, a footnote in the CDC's report notes that "15.0% of high school students who took the survey in a school building or classroom reported currently using e-cigarettes," which is still 23 percent lower than the rate in 2020 (19.6 percent) and 45 percent lower than the rate in 2019 (27.5 percent).
If "other unmeasured characteristics" explain why students who took the survey at home this year were less likely to report vaping in the previous month, the in-school number is probably misleadingly high. Furthermore, changes in methodology do not explain the 29 percent drop in "current" e-cigarette use by high school students between 2019 and 2020, which the CDC is also keen to ignore.
The FDA's take on the 2021 survey results is especially disturbing given the agency's bias against nicotine liquids in flavors other than tobacco, which are very popular among adults who switch from smoking to vaping, a change that dramatically reduces the health risks they face. "These data highlight the fact that flavored e-cigarettes are still extremely popular with kids," says Mitch Zeller, director of the FDA's Center for Tobacco Products. "The FDA continues to take action against those who sell or target e-cigarettes and e-liquids to kids, as seen just this year by the denial of more than one million premarket applications for flavored electronic nicotine delivery system products. It is critical that these products come off the market and out of the hands of our nation's youth."
While that statement is ambiguous, Zeller seems to be saying that "flavored electronic nicotine delivery system products" are intolerable because teenagers like them. That interpretation is consistent with the FDA's regulatory decisions so far. The agency has rejected or declined to accept "premarket" applications for millions of flavored vaping products while emphasizing their appeal to adolescents. It has said it will allow flavored liquids to remain on the market only if manufacturers present "robust," "reliable," and "product-specific" evidence that their benefits in helping smokers quit outweigh the risk that they will encourage underage vaping.
As a general matter, the potentially lifesaving benefits of e-cigarettes for millions of smokers easily outweigh the danger posed by underage vaping, which has always been exaggerated and now seems to be waning. It is nevertheless unclear whether even the largest manufacturers—the ones with the resources to conduct the sort of expensive studies that the FDA seems to be demanding—can satisfy the agency that approval of flavored vaping products is "appropriate for the protection of public health," taking into account "the risks and benefits to the population as a whole."
That standard, mandated by the Family Smoking Prevention and Tobacco Control Act of 2009, gives the agency a great deal of leeway to reject applications based on a collectivist calculus that is both scientifically dubious and morally objectionable. To the extent that teenagers are vaping instead of smoking, which is what recent trends suggest is happening, that substitution should count as a public health benefit. And even if some teenagers who otherwise never would have tried nicotine become regular vapers, that fact cannot possibly justify depriving adult smokers of harm-reducing alternatives to cigarettes. A flavor ban would make those alternatives less appealing, discouraging some smokers from quitting and driving some vapers back to a far more hazardous habit. The result will be more smoking-related deaths than otherwise would have occurred.
Seven years after the FDA first asserted its authority to regulate e-cigarettes, it still has not approved any vaping products, which means all of them are "marketed unlawfully" and "subject to enforcement action at the FDA's discretion." The fact that the FDA continues to hype the "serious public health concern" raised by underage vaping, without acknowledging that the evidence supporting that concern is even weaker now than it was before, does not bode well for the way the agency will choose to exercise its discretion.
"For years, enemies of vapor products and their enablers in the press have worked to the benefit [of] Big Tobacco in trying to regulate our products out of existence," Amanda Wheeler, president of the American Vapor Manufacturers Association, said in a press release. "Federal regulators routinely downplay or purposefully spin their own research to prop up an alarmist narrative based on a mirage, and deep-pocketed anti-vaping activist groups continue to ignore or conceal the large-scale public health benefits of our products. Some in our government and our paternalistic activist class seem hellbent on outlawing the single most effective smoking cessation method ever devised. It's going to drive millions of people back to smoking and cost countless lives, and frankly, it's despicable."