The U.S. Food and Drug Administration (FDA) today announced that it denied the application of Juul Labs, maker of the Juul e-cigarette, to market its products in America, with the company required to halt all sales within 30 days. The move came after months of pressure on the agency from health charities like the Campaign for Tobacco-Free Kids and members of Congress to do just that. The decision is a devastating blow to the thousands of adults who rely on Juul as a safer alternative to combustible cigarettes. Even more worrisome is the appearance that, when it comes to nicotine, the FDA and the Biden administration are basing decisions on politics rather than evidence about what would be best for public health.
Despite submitting over 125,000 pages of documentation, including evidence from more than 110 scientific studies, and an admission by the FDA that there is no evidence of “immediate hazard associated with the use of the Juul device or Juulpods,” a press release issued by the FDA cited insufficient evidence about the products’ safety profile as the reason for denying its market approval.
As Gregory Conley, President of the American Vapor Association—a trade group representing independent e-cigarette companies—pointed out on Twitter, the FDA’s rationale that Juul products lacked sufficient toxicological evidence is confusing, given that the agency has previously approved IQOS heated tobacco products and lower-nicotine content combustible cigarettes, “both of which obviously have worse [toxicological] profiles than a Juul.”
In fact, Juul products are arguably the most studied vapor product on the market, including both the company’s own clinical research and independent studies from university academics, many of whom were overtly hostile toward the products. But, as I have previously written, normal scientific standards used to evaluate the safety of products are thrown out the window when it comes to e-cigarettes. That said, the FDA has granted marketing approval for other e-cigarette brands. These products are no safer than Juul, based on the evidence, but they are also not as controversial.
Accused of marketing its products to youth in its early days, Juul has long been scapegoated as the cause of a supposed vaping “epidemic.” In response, the company has made attempts at correcting early missteps, voluntarily removing non-tobacco flavored versions of its products, clamping down on its advertising, and even developing an age-verification technology that locks devices unless users can verify they are at least 21 years old.
Moreover, youth experimentation with e-cigarettes has declined sharply since 2018, the peak of the supposed youth vaping epidemic, when approximately 27.5 percent of students reported any past-month vaping. As of the latest data, just 7.6 percent of high school and middle school students reported any past-month vaping (with Juul as only the fourth most popular brand among them). Youth smoking has also reached historic lows, a decline likely accelerated by teens substituting vaping for smoking, with just 1.5 percent reporting any past-month smoking today.
But, none of that has quelled militant anti-nicotine advocates who, since Juul submitted its premarket tobacco application, have lobbied the FDA to ban the products because of their popularity among youth. This lobbying campaign including members of Congress, who sent letters urging the agency (in not so many words) to reject Juul’s application because of the company’s alleged youth marketing during its early days. In fact, just prior to FDA announcing its denial of Juul’s application, Sen. Dick Durbin (D-IL) told Politico that FDA Commissioner Robert Califf should “step down” for failing to remove e-cigarettes, like Juul, from the market already.
Although a few e-cigarettes have managed to make it through the FDA’s premarket tobacco application process successfully, it appears the agency is intent on eliminating 99 percent of the vapor market, leaving only a handful of outdated devices and a single flavor option—tobacco—available for adults trying to break their dependency on combustible tobacco. Combined with the Biden administration’s plans to reduce nicotine in cigarettes to near zero and prohibit the sale of menthol cigarettes, the FDA’s destruction of the vapor industry is setting the stage for a public health disaster.
Millions of adults still smoke. They die, not because of nicotine, but because of the tar—the product of combustion—which, inhaled repeatedly over a lifetime, causes the illnesses and death associated with smoking. Based on principle and mountains of clinical evidence, we know that if smokers could be convinced to switch to noncombustible sources of nicotine, like e-cigarettes, it would significantly reduce disease and save many lives.
Whatever the company’s failings, Juul managed to create one of the most effective alternatives to cigarettes—not just safer than smoking but also attractive to adult smokers. Eliminating Juul isn’t a win against the companies that make cigarettes; it is a gift to Big Tobacco. Many adults will return to smoking and, should the Biden administration implement its plan to reduce nicotine in cigarettes, they will have to smoke even more cigarettes to maintain their desired level of nicotine. While that means higher cigarette sales (and more tax revenue for governments), it also means consumers will be inhaling more byproducts of combustion; it means more disease.
Some people will also turn to illicit sources to continue using e-cigarettes, full-strength cigarettes, and menthol cigarettes. Illicit markets have no age restrictions, so consumers could be exposed to additional dangers, such as adulterated products, violence, and the threat of law enforcement. And it will be the most vulnerable in our society who suffer the consequences.
This inevitable outcome should be seen as a grave failure by anyone truly interested in saving lives and improving public health. The denial of Juul’s marketing application is disappointing but unfortunately, not much of a surprise, since the FDA seems more concerned with protecting its own reputation and appeasing prohibitionists who reject any recreational use of nicotine, no matter how safe or even beneficial it might be.