After years facing the constant threat of extinction, it seemed the vapor industry would finally be vindicated. The evidence on e-cigarettes regarding their safety and effectiveness in helping adult smokers is strong. It is at least as strong as that for the other new tobacco products recently approved for sale by the Food and Drug Administration (FDA). Conducting an unbiased review of this evidence would all but compel the agency to admit that vaping is safer than smoking and can save lives. But, in the leadup to the FDA’s September 9 deadline to make decisions about which vapor products can stay on the market and which ones cannot, it’s becoming clear that the agency is not unbiased when it comes to e-cigarettes. More concerning, it is starting to look like the FDA cares more about saving face than about saving lives.
September 9, 2020 was do or die for vapor companies. That was the day that businesses had to submit their products for FDA approval and await a verdict. An unfavorable decision would mean having to exit the market, effective immediately. Despite shifting deadlines, a near-total lack of clarity on what the FDA wanted from applicants, and the tremendous amount of time and money required by the process, more than 500 vapor companies—the majority small, with no more than a few employees—managed to meet the deadline. Together, they submitted over 6.5 million Premarket Tobacco Applications, one for each of product, nicotine level, flavor, and even bottle size for which they sought authorization to sell.
That was far more than the than 25 applications a year the FDA initially expected when it decided, unilaterally, that it should be in charge of regulating this new industry. Perhaps that explains whythe FDA now seems intent on coming up with excuses to issue sweeping denials and whittle that number down to a size it can handle.
The first batch of denials came in early August 2021, when the FDA announced that it would not even review the 4.5 million applications from one company, JD Nova, for failing to include with each application an adequate Environmental Assessment. At the end of August, the Agency issued marketing denial orders, or MDOs, for applications related to “flavored” vapor products, 55,000 from one company and 800 from another.
Based on the press release accompanying the denials, the FDA denied these applications because the applicants failed to provide “product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.” That evidence, the FDA suggests, “would likely be in the form of a randomized controlled trial or longitudinal cohort study,” though it leaves room for other types of evidence “if sufficiently robust and reliable.”
All of this came as a surprise to the vapor industry, which, after years of requests for clearer guidance from the FDA, was never told that the agency was uninterested in more general evidence about the safety of e-cigarette ingredients, products, or their efficacy in reducing risk to adult smokers. One reason they couldn’t have known this is because it isn’t the standard to which the FDA has held other tobacco products that have successfully completed its preapproval process.
Over the last six years, the FDA has approved new tobacco products from three companies, including flavored tobacco. These include eight varieties of Swedish Match North America’s snus, the heated tobacco product, IQOS, made by Philip Morris, and combustible cigarettes with reduced nicotine made by 22nd Century Group. For these other products, the FDA was happy to accept more general evidence about the product category’s appeal to adults and youth, as well as their general risks to public health.
In its review of Swedish Match North America’s application, the FDA admitted that the company submitted no formal evidence related to the “abuse liability” of its products (use of the product in ways, or by consumers, other than intended.) But, because the level of nicotine and other ingredients was similar to other already available products, the agency noted that “the abuse potential of the proposed products is understood to be within the range of similar marketed products.” As for youth using its products, the company relied on studies about snus in general—not Swedish Match products, specifically. Again, the FDA was unconcerned since the flavors—including mint, menthol, and citrus—were similar to other already available smokeless tobacco products.
The FDA showed similar flexibility in reviewing Philip Morris’ application to market its new heated tobacco product. With regard to youth initiation, the company relied primarily on international survey data to make the case that youth were not drawn to its IQOS product in countries where it was already sold.
Not only did the FDA authorize these products for sale, it ultimately granted both approval for them to be marketed as modified risk tobacco products, allowing the manufacturers to accurately advertise that their products posed less risk to consumers than smoking combustible cigarettes.
Based on the way the FDA approached the approval process for these other products, and in the absence of contradictory information from the agency, it was reasonable for vapor companies to believe their products would be held to the same standards. Based on the same expectation, anti-tobacco activists were clearly worried, criticizing the FDA’s failure to base its decisions about products not on how many adult lives they might save, but on how youth might experiment with them and slightly, if debatably, increase their risks.
In the months leading up to the FDA’s deadline, anti-tobacco advocates, both in and outside of Congress, have attempted to pressure the agency into denying premarket tobacco applications of specific products. Top of the list of products they want the agency to deny are those made by Juul, the company they blame for the so-called “epidemic” of youth vaping (though experts disagree such an epidemic exists).
They also want the agency to ban any application to sell “flavored” e-cigarettes. Nicotine has no flavor, so all e-cigarettes are flavored to some degree, but activists want to limit the legally available flavors to those that approximate the flavor of tobacco. It is ironic that the same activists who once heavily lobbied Congress to give the FDA the power to regulate the tobacco industry now seem unwilling to trust its ability to make scientific decisions. Yet, this pressure campaign appears to be working.
There is robust evidence that non-tobacco flavored e-cigarettes help adults quit smoking. It seems their availability in non-tobacco flavors is, in fact, a major reason why e-cigarettes are at least twice as effective for smoking cessation as other nicotine replacement therapies. There is little debate, even among anti-nicotine activists, that noncombustible sources of nicotine, like e-cigarettes, are less harmful than smoking the products of combustion. For these other tobacco products, the FDA has recognized that because they afforded adult smokers a less risky alternative, they would be beneficial to public health and, as such, should be available on the market. For e-cigarettes, however, the same evidence and standards are insufficient.
The FDA has had many years and innumerable opportunities to improve its process for reviewing e-cigarette applications. A “streamlined” process for small manufacturers was even promised in January 2020 by then-Health and Human Services Secretary Alex Azar. Given that the length of previous PMTAs reviewed by the FDA had run into the hundreds of thousands (or even millions) of pages, simplifying the process would have made sense. Most e-cigarette products are similar, with only slight differences in design and ingredients, so streamlining applications would have saved both the industry and the agency a lot of time, money, and effort, without sacrificing scientific rigor. But this streamlined PMTA process never materialized.
“The FDA has known for a year which applications they planned to deny, but they waited until just before the deadline to begin justifying what would be the elimination of most of the marketplace, by continuing to provide guidance on what it would take to keep a flavored product on the market, perhaps guided by those firms they intended on approving,” one vapor industry insider with knowledge of the FDA process told me in an interview. As he explains, the move to deny most, if not all, applications of flavored e-cigarettes had little to do with science or public health. “We know this is not a decision being made by Mitch Zeller,” the director of FDA’s Center for Tobacco Products. “It’s a lot more political than that.”
But he notes that the FDA cannot now simply announce a policy of denying all flavored e-cigarette PMTAs as activists have demanded. That would qualify as an agency “rule” and make it subject to the strict guidelines and oversight of the rulemaking process. Instead, he told me, “they waited until the last minute, revised the approval standards, and are hoping they don’t get sued.”
Not being sued seems unlikely, since, no matter what FDA does now, it will anger one group or another—and it won’t be hard to demonstrate how badly the agency messed up. Maybe it was because it lacked the manpower to handle such a large category of newly regulated products. Or maybe it was due to political interference from Congress. Perhaps the career bureaucrats at the FDA are simply fearful of backlash from the media and well-funded activists should they approve any flavored e-cigarette products. Yet, the excuse hardly matters. Small vapor companies, consumers, and public health shouldn’t have to pay for the FDA’s shortcomings.