FDA Approves an E-Cigarette for the First Time but Still Seems Bent on Banning the Flavors Former Smokers Overwhelmingly Prefer

If teenagers like an e-liquid flavor, the agency seems to think, adults should not be allowed to buy it.


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.

NEXT: We Have Vaccines. We Don't Need Pandemic Restrictions.

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16 responses to “FDA Approves an E-Cigarette for the First Time but Still Seems Bent on Banning the Flavors Former Smokers Overwhelmingly Prefer

  1. We should totally have more government control of our lives.

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  2. So much hand wringing over whether it stops smokers.

    The flavored ban is not about helping anyone. It's regulatory capture, pure and simple.

    That, and all the expensive approvals for each flavor, are just to keep the non-giant companies out of the market. Before there was a large cottage industry of vape juice makers, now it's just a mess with only RJ Reynolds and some mavericks who can't get action even when they submit products for approval.

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  3. This has been going on ever since I smoked my first cigarette in the late 1980s. Kids might like it, so we have to ban it! The ultimate goal is complete prohibition of tobacco/nicotine products for everyone either by law, or taxation. Then they can all cheer they did something about it and act shocked when the reality of the drug war and alcohol prohibition comes back to bite them.

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  4. Vaping with a product resulting from government graft = good.
    Vaping with something YOU choose = bad.

  5. What effect is this going to have on THC and CBD vapes? I expect the states with legal cannabis to legalize those as well. And what about flavor-only vapes? I mean vapes that don't contain nicotine, cannabinoids, or anything psychoactive? What's to prevent nicotine's or lobelline's being mixed with those?

    1. "What’s to prevent nicotine’s or lobelline’s being mixed with those?"

      Without the supervision of a government approved, toppiest of the Top, Top Man! (tm) ? Surely you jest.

  6. Regarding the FDA and questionable products it/they have allowed, I notably recall how the FDA’s then-commissioner Arthur Hull Hayes Jr. had decided (in 1981) to allow the mass consumption of the artificial sweetener Aspartame prior to his leaving the FDA for a lucrative job with the public relations firm owned by the Aspartame patent holder and producer, G.D. Searle Company. Hayes Jr. had overruled a health-expert panel that urged long-term study to ensure the chemical concoction — which was discovered accidently in 1965 while G.D. Searle Company chemist James Schlatter was testing an anti-ulcer drug — wouldn’t cause brain tumors in humans. (Feeding studies had resulted in brain lesions in test animals.)

    Assuming the news-media information I've consumed over many years is still accurate, our version of the FDA, Health Canada, allowed novelty-flavored vaping products to be fully marketed — even on corner stores’ candy counters — without independent, conclusive scientific proof that the product (as claimed by its tobacco-industry creator) would not seriously harm consumers but rather help nicotine addicts wean themselves off of the more carcinogenic cigarette means of nicotine deliverance.

    Yet, Health Canada had sat on its own research results that indicated seatbelts would save lives and reduce injury; it said it wanted even more proof of safety through seatbelts before ordering big bus manufacturers to install them in every bus (presumably because of additional cost to bus makers). It applied a double standard, in both cases favoring big business interests.

    American and Canadian governances, I've found, typically maintain thinly veiled yet strong ties to big business and its interests. I believe that the potent access corporate lobbyists have to law-makers, governing officials and regulatory agencies is unethical and immorally health hazardous to the vulnerable product-consuming public.

  7. Imagine that, a big tobacco product gets approved. Who would've guessed that. Well other than about 10,000,000 former smokers who turned ecigs into a workable substitution for smoking that is.

  8. Ever since FDA first unlawfully banned the sale of e-cigarettes in 2009 (due to lobbying by Big Pharma shills), the CDC, FDA and all other DHHS agencies (and state and local health agencies) have falsely and repeatedly claimed that e-cigarettes have addicted lots of children, are gateways to cigarettes, may be as harmful as cigarettes, and don't help smokers quit, all of which have been reported as facts by the virtually all media outlets.

    But since 2009, youth cigarette smoking as plummeted by >80%, young adult smoking has plummeted by >70%, and there are ten million fewer adult cigarette smokers in America.

    If the claims repeated since 2009 by FDA, CDC, all other public health agencies, and the news media were correct, youth and young adult cigarette smoking rates would have sharply increased, and there would be more cigarette smokers now than in 2009.

    But of course, FDA and CDC never apologize (nor are held accountable) for lying or causing diseases and deaths for many more older adult smokers (who would have switched to vapes had CDC, FDA, US SG, state/local health agencies or the news media reported the truth about vapes, which everyone involved knew to be true).

  9. The horse has left the barn. There is no possibility that the fda will ban flavored vape liquid. They may not allow the cartridges, but the vast majority of adults vaping don't use them.

  10. Censorship is telling a man that he can't have a steak because babies can't eat it.

  11. This kind of thing can pass through, doesn't it have a great impact on health

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