FDA Approves an E-Cigarette for the First Time but Still Seems Bent on Banning the Flavors Former Smokers Overwhelmingly Prefer
October 13, 2021 | Tags: FDA
Seven years after the Food and Drug Administration (FDA) officially declared its intention to regulate e-cigarettes, it has finally approved one such product. But the FDA, which has rejected applications for millions of other vaping products, still seems inclined to ban the e-liquid flavors that former smokers overwhelmingly prefer. Why? Because teenagers also like them.
Yesterday the FDA announced that it had authorized the marketing of Vuse Solo, a vaping device made by R.J. Reynolds Vapor Company, along with two tobacco-flavored replacement cartridges. That decision implicitly recognizes the lifesaving potential of "electronic nicotine delivery systems" (ENDS), which offer smokers a far less hazardous alternative to conventional cigarettes. "The manufacturer's data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals," said Mitch Zeller, director of the FDA's Center for Tobacco Products.
At the same time, however, the FDA rejected 10 "premarket" applications for Vuse Solo cartridges in other flavors. The agency said it is "still evaluating the company's application for menthol-flavored products under the Vuse Solo brand."
Taken together, these decisions do not bode well for manufacturers that are still waiting to hear from the FDA or for vapers who use e-liquids with nontobacco flavors, which are much more popular among adults. According to data from the Population Assessment of Tobacco and Health Study, three-quarters of adult vapers prefer flavors other than tobacco.
R.J. Reynolds, whose Vuse products account for nearly a third the ENDS market, is a large company that had the resources to conduct the sort of expensive research demanded by the FDA. It nevertheless was unable to persuade the agency that the benefits of flavored ENDS in helping smokers quit outweighed the risk that they would be used by teenagers.
Furthermore, Vuse Solo is a "closed system" product, meaning it is not designed to be refilled with e-liquids made by other companies. The FDA seems determined to dictate which flavors vapers use in any device it approves.
"Compared to users of non-tobacco flavored ENDS products," the FDA says, "young people are less likely to start using tobacco-flavored ENDS products and then switch to higher-risk products, such as combusted cigarettes. The data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy or mint, and not tobacco flavors. These data reinforce the FDA's decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption."
Contrary to the FDA's implication, there is little evidence that vaping is a significant "gateway" to smoking among teenagers who otherwise never would have used nicotine. To the contrary, recent trends suggest that the availability of ENDS has accelerated the downward trend in adolescent smoking.
"With high-school students' smoking declining at an increasing rate since youths began using e-cigarettes, some may vape to reduce or quit smoking," David J.K. Balfour and 14 other leading tobacco researchers note in a recent American Journal of Public Health article. "If vaping causes some young people to try cigarettes, the aggregate impact must be small. A recent study estimated that if vaping increases nonsmoking youths' odds of trying cigarettes by 3.5…smoking initiation among young adults would increase less than 1 percentage point. Furthermore, US survey data demonstrate that smoking among young people has declined at its fastest rate ever during vaping's ascendancy. If vaping increases smoking initiation, other unknown factors more than compensate."
Survey data indicate that the vast majority of teenagers who vape regularly are current or former smokers, which means the FDA's concerns about an "epidemic" of adolescent nicotine addiction is also overblown. "Vaping likely addicts some young people to nicotine," Balfour et al. write. "However, the evidence does not suggest it is addicting very large numbers." That fear seems all the more misplaced in light of survey data showing that e-cigarette use by teenagers fell substantially in 2019 and 2020—a development that the FDA prefers to ignore.
Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA is supposed to decide whether approval of a vaping product is "appropriate for the protection of public health," taking into account "the risks and benefits to the population as a whole." While that collectivist standard is both morally dubious and highly subjective, it at least suggests that the FDA is expected to weigh the benefits of flavored e-liquids, measured in smoking-related death and disease prevented by the availability of those products, against the costs of the underage vaping they might encourage. But it seems clear that the FDA is not making any serious attempt to do that.
The FDA instead seems to be asking whether certain flavors are popular among teenagers. If they are, that consideration is decisive, regardless of whether those flavors are also popular among adults who have switched from smoking to vaping or might be interested in doing so. While eliminating nontobacco flavors might make vaping less appealing to underage consumers, it also would make vaping less appealing to adults who would otherwise be smoking. "While flavor bans could reduce youth interest in e-cigarettes," Balfour and his colleagues note, "they could also reduce adult smokers' vaping to quit smoking. Like youths, adults prefer nontobacco flavors, both groups favoring fruit and sweet flavors."
If the refusal to allow nontobacco flavors drives current vapers back to smoking or deters current smokers from switching, the upshot will be more premature deaths. On the face of it, the FDA is legally obligated to consider that risk. But so far there is no evidence that it is doing so.
"Flavored e-cigarettes are still extremely popular with kids," Zeller said last month. "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."
At the time, it was not clear whether "these products" meant ENDS sold by manufacturers who "target" underage consumers or "flavored" ENDS in general. The FDA's selective approval of Vuse products strongly favors the latter interpretation. The FDA seems to be taking the position that any vaping product in a flavor other than tobacco (and possibly menthol) is ipso facto targeted at teenagers, even if the vast majority of its consumers are adults.
An FDA ban on flavored ENDS will not actually eliminate those products. Where there is strong demand, there will be a supply, and the FDA does not have the resources to go after every supplier. Except for the specific Vuse products that the FDA has now approved, the agency says, every vaping device and e-liquid sold in the United States is "marketed unlawfully" and "subject to enforcement action at the FDA's discretion." Those products are still being sold anyway, and they will still be sold even if the FDA denies all the remaining applications for flavored ENDS.
That does not mean the FDA's refusal to approve these products will have no impact, however. It will compound legal risk and uncertainty for manufacturers and vape shops while driving consumers toward black-market suppliers who are less accountable and completely unconstrained by regulatory standards or civil liability. Given the recent experience with lung injuries caused by black-market THC vapes, you might think the FDA would understand the dangers of prohibition.
The good news is that the FDA is willing to approve ENDS as a harm-reducing alternative to cigarettes based on evidence that at least some manufacturers can actually produce. "The agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes," the FDA says in its press release about the Vuse Solo approval. "The toxicological assessment also found the authorized products' aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies."
Yet the same is true of the flavored cartridges that the FDA rejected: The aerosol they produce is far less hazardous than tobacco smoke. Those products have the additional advantage that former smokers demonstrably prefer those flavors, meaning they are more likely to remain former smokers. A variety of flavors also makes vaping more appealing to current smokers who might use ENDS to quit. But those considerations seem to count for nothing in the FDA's analysis.