On Sept. 9, the Food and Drug Administration (FDA) is expected to announce the most significant change to America’s tobacco market in more than a decade when it decides which e-cigarettes, if any, will be allowed to remain available on the legal market. The sheer volume of applications (over 6.5 million) from e-cigarette-related companies means we may not have a decision on every product, but the FDA’s announcement will likely cover the vast majority of the vape market.
To stay on the market, every e-cigarette product must prove to the FDA that it’s “appropriate for the protection of public health,” for both users and nonusers. Unfortunately, meeting this federal requirement is wildly expensive and needlessly complex. For example, the FDA has required hundreds of thousands of vaping-related products to file separate applications for evaluation rather than have the products conform to a set of standards for e-cigarette products that protect the public. Such a process would have ensured small players in the e-cigarette industry could compete with, and offer smokers safer alternatives to, large companies and traditional cigarettes.
The bigger vape and tobacco companies enjoy a considerable advantage under the current regulatory system because they are able to focus resources and research on a small number of products. But smaller companies, many of whom may be making hundreds of different products that are sold mainly in retail vape shops, are significantly disadvantaged when trying to comply with current FDA requirements that require them to file hundreds of individual applications.
On the positive side, if the FDA approves some e-cigarettes on Thursday, it should help put to rest the arguments about whether these products are beneficial to public health. Since e-cigarettes came on the market more than a decade ago, the public health research in their favor has become overwhelming. Vaping is beyond doubt safer than smoking and has proved incredibly effective at helping people quit smoking traditional cigarettes. And research has found that teen vaping is not a gateway to smoking. Getting more people to switch from cigarettes to e-cigarettes would be beneficial for public health.
Thus, the announcement could be the first time that at least some e-cigarettes are given a seal of approval by the FDA. Going forward, policymakers and antismoking advocates trying to ban e-cigarette products or tax them at an equivalent or greater rate than cigarettes should have to explain why they are crusading against products that the FDA deems to play a role in improving public health.
While approval for some products will be an important milestone, the vast majority of e-cigarettes will likely be banned. Many of these products are the lifeblood of the vape industry. They are the devices and flavors that stock the shelves of neighborhood vape shops. If these products are banned, it will not be because they are inherently riskier than approved products. For the most part, it will likely be because the companies couldn’t navigate and comply with the FDA’s byzantine regulatory system that demands deep pockets to get each product approved.
So, what will be the consequences of shutting down a vast portion of the vape industry? In short, more smoking.
Most of the vaping products that are likely to be banned by the FDA are non-tobacco flavors that are by far the preferred choice of America’s 15 million adult vapers. Vape shops rely on selling flavored e-liquids to their customers. Without them, many, if not most, vape shops face being put out of business.
For those who believe that banning these flavors is necessary to protect young people, a recent study on the effects of San Francisco’s ban on flavored tobacco products showed an increase in high school smoking following prohibition. It should also be noted that according to research by the Centers for Disease Control and Prevention, sweet or fruity flavors are not the primary reason why youth vape.
Last month, 15 past presidents of the Society for Research on Nicotine and Tobacco (SRNT) took to the pages of the American Journal of Public Health (AJPH) to warn that the potential of e-cigarettes to save lives was being lost because of a near singular focus on youth vaping to the detriment of adult smokers. The abstract says:
The topic of e-cigarettes is controversial. Opponents focus on e-cigarettes’ risks for young people, while supporters emphasize the potential for e-cigarettes to assist smokers in quitting smoking. Most US health organizations, media coverage, and policymakers have focused primarily on risks to youths. Because of their messaging, much of the public—including most smokers—now consider e-cigarette use as dangerous as or more dangerous than smoking. By contrast, the National Academies of Science, Engineering, and Medicine concluded that e-cigarette use is likely far less hazardous than smoking. Policies intended to reduce adolescent vaping may also reduce adult smokers’ use of e-cigarettes in quit attempts. Because evidence indicates that e-cigarette use can increase the odds of quitting smoking, many scientists, including this essay’s authors, encourage the health community, media, and policymakers to more carefully weigh vaping’s potential to reduce adult smoking-attributable mortality.
Similarly, in 2019, Mitch Zeller, the director of the FDA’s Center for Tobacco Products, explained in court testimony why banishing so many e-cigarettes from the market could harm public health. “Dramatically and precipitously reducing availability of these products could present a serious risk that adults, especially former smokers, who currently use [e-cigarettes] and are addicted to nicotine would migrate to combustible tobacco products,” he testified.
Unfortunately, in the coming months, Zeller’s fears may be realized. The modern-day e-cigarette was invented almost 20 years ago and has since become the world’s greatest tool to help people quit smoking. Consumers, innovators, and small businesses, not Big Tobacco, led the vapor revolution, which has saved lives across the world.
It shouldn’t be easier to for a new cigarette to arrive on store shelves in America than it is for an e-cigarette to be legally available on the market. Unfortunately, that’s the system the FDA has set up. The sooner that U.S. public health officials embrace vaping’s potential to improve public health by reducing smoking and smoking-related deaths, the better off we’ll all be.