This week, a U.S. federal appeals court sided with several vaping companies whose applications to sell nicotine vaping products in various flavors were rejected by the U.S. Food and Drug Administration (FDA).

As Reason's Elizabeth Nolan Brown noted yesterday, the U.S. Court of Appeals for the 11th Circuit ruled that the FDA's decision was arbitrary and capricious because the agency ignored marketing and age-verification programs designed to prevent minors from vaping. But as Judge Robin Rosenbaum pointed out in her dissent, the manufacturer's victory may be short-lived, as the FDA appears firmly opposed to allowing the sale of vaping products in flavors other than tobacco.

This position is puzzling because ex-smokers who switch to e-cigarettes overwhelmingly prefer non-tobacco flavors, and the FDA recognizes that electronic nicotine delivery systems (ENDS) hold great promise as a harm-reducing alternative to cigarettes . But the FDA maintains that there is no solid evidence that flavor variety will make e-cigarettes more attractive to adult smokers, although it is concerned that flavor variety will make e-cigarettes more attractive to teens. So when the FDA reconsiders the applications remanded by the 11th Circuit, it will almost certainly reject them again, even though the companies are taking steps to keep their products away from underage consumers.

The FDA's opposition to flavor diversity stems from concerns about the teen vaping epidemic. But the surge in teen e-cigarette use that alarmed the FDA in 2018 and 2019 has subsided, as adults from the government-sponsored Monitor the Future (MTF) study confirm. Flavoring the ENDS market, as the FDA has yet to decide whether to allow them or to take enforcement action against them.

The data also show that teen smoking rates continue to decline as e-cigarettes become more popular. The same is true for young people: Smoking rates hit record lows as e-cigarette use among 19- to 30-year-olds continues to rise in 2021.

These trends suggest that we are seeing the kind of harm-reducing alternatives that the FDA claims to want. These data are certainly at odds with the idea that the availability of ENDS leads to more smoking. However, Judge Rosenbaum appeared to think the FDA's opposition to flavored ENDS was well-founded, denying that e-cigarettes had been shown to be a route to smoking combustible cigarettes. She did not cite any evidence to support this claim, which seems highly implausible given the continued decline in smoking rates among teens and adults.

The annual MTF survey, conducted by University of Michigan researchers under a contract with the National Institute on Drug Abuse, includes eighth-, tenth-, and twelfth-grade students. It shows that by 2021, the prevalence of nicotine e-cigarettes in the past month has fallen sharply in all three grades.

In 2020, it peaked at 10.5 percent of eighth-graders before falling to 7.6 percent last year. Among 10th and 12th graders, that peaked at 19.9% and 25.5% respectively in 2019 and fell to 13.1% and 19.6% respectively last year. Between 2019 and 2021, the prevalence of daily e-cigarettes (defined as 20 or more use in the past 30 days) decreased from 2% to 1.1% among eighth graders and from 6.8% among 10th graders dropped to 2.5%, and the proportion of Year 12 students increased from 11.6% to 5.4%.

These findings are broadly consistent with findings from the National Youth Tobacco Survey (NYTS) sponsored by the Centers for Disease Control and Prevention (CDC). The survey showed that the prevalence of e-cigarette use among high school students last month peaked at 27.5% in 2019 before falling to 11.3% in 2021. While adults can still use ENDS in a variety of flavors, the "epidemic" condemning the FDA and CDC appears to be fading fast.

Neither investigation has provided any evidence of what Rosenbaum believes is a portal. Conversely, the downward trend in teen smoking continued even as e-cigarettes rose sharply. Among 12th graders surveyed by the MTF, past-month smoking has dropped from 10.3 percent in 2011 to 2 percent in 2021. During the same period, the prevalence of daily smoking decreased from 4.3% to 0.8%. In the New York Times, the past-month smoking rate among high school students dropped from 15.8 percent in 2011 to 1.9 percent last year.

It stands to reason that, far from interfering with the decline in youth smoking, ENDS has accelerated the decline, which has accelerated with the rise of e-cigarettes. Replacing smoking with e-cigarettes is certainly an improvement in public health, and the FDA claims it is promoting it. But the agency instead described it as a serious threat to American youth. For teens, the FDA refuses to even consider the positive effects of this substitution.

A 2019 analysis of NYTS data found that frequent e-cigarette use was concentrated among teens who were current or former smokers. So far, the recent decline in teen vaping has not led to a rise in smoking rates, which would make sense if recreational users, rather than teens who vaped rather than smoke, accounted for most of the decline. But the FDA should be wary of any policies that make cigarettes more accessible than ENDS or make ENDS less attractive to people who would otherwise smoke. In the long run, the result could be more, not fewer, smoking-related deaths.

Logically, this analysis should include both adolescents and adults. But the FDA insists that the health benefits of replacing cigarettes with ENDS do not count when e-cigarette users are younger than 21. So let's consider what the MTF data tells us about the potential cost of refusing to let adults buy vaping products they clearly want.

"Smoking rates among young adults have been declining steadily since 2004, reaching a record low in 2021," an MTF report noted. "Cigarette use in the past 30 days has more than halved over the past decade," from 21.2% in 2011 to 9% in 2021. "

The decline in smoking among 19- to 30-year-olds has been accompanied by a rise in e-cigarettes in recent years. The report said: Since the first measurement in 2017, nicotine e-cigarette use in the past 30 days has almost tripled among young adults, reaching 16.1% in 2021. According to reports, nicotine e-cigarettes have increased by 21.8% in the past 12 months, which is slightly lower than the record high of 23.6% in 2019.

From 2017 to 2021, as the prevalence of vaping in this age group rose 160% in the last month, smoking rates fell 39% last month. These trends are at odds with Rosenbaum's theory that more vaping means more smoking. But they are consistent with the theory that many young people choose to vape rather than smoke.

The FDA ostensibly wants to see more. The entire premise of approving the sale of ENDS as suitable for the protection of public health—the standards FDA should apply under the Family Smoking Prevention and Tobacco Control Act—is that it will help reduce tobacco-related morbidity and provide smokers with A less harmful form of nicotine consumption to reduce mortality. However, for smokers who have made a potentially life-saving switch or who may be interested in doing so, the variety of flavors plays an important role, the FDA claims.

The FDA, paradoxically, insists that variety in flavors is important to teens. It argues that at least some of them would avoid vaping if tobacco was the only flavor they could find. Therefore, the likelihood that some teens will smoke is not included in the FDA's calculations at all. And it removes the danger of the same thing happening in adults, saying ENDS makers didn't provide enough evidence to prove it.

Contrary to its statutory mandate, the FDA has not carefully weighed the costs and benefits of its so-called juvenile protection policies. Instead, it refuses to admit that there are any costs to consider.

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