The world was simpler in 2009 when Congress enacted a law that gave the Food and Drug Administration (FDA) the power to regulate tobacco. Back then, consumers’ choices were functionally limited to cigarettes and other combustible products, with little difference in risk between brands. The advent of nicotine vapor changed everything: E-cigarettes were not made by “big tobacco,” heated rather than burned their ingredients, and carried almost none of the risks of smoking. Regulations should have been amended to reflect this groundbreaking development. Now the failure of lawmakers and regulators to keep pace with innovation threatens to destroy an entire industry, eliminate a life-saving option for smokers, and put public health at greater risk.
As of September 9, 2020 all nicotine vapor manufacturers must submit an application to the FDA if they want to continue legally marketing their products. The requirement was spawned by the Family Smoking Prevention and Tobacco Control Act (TCA), enacted by Congress in 2009. Among other things, the TCA gave the FDA the power to require pre-market approval for any new tobacco products marketed after 2007. Though ostensibly intended to protect the public from new cigarettes, the TCA functionally acts as a way to protect the existing cigarette cartel by preventing new competitors from entering the market, leading some to dub it the “Marlboro Monopoly Act.” Indeed, a main reason Congress was able to pass the TCA was due to an alliance between anti-tobacco groups, like the Campaign for Tobacco-Free Kids, and traditional tobacco companies, like Philip Morris (maker of Marlboro.)
Of course, when Congress enacted the TCA, e-cigarettes did not exist. But the law also gave the FDA the power to decide what counts as a “tobacco product” that would fall under the law’s purview. Thus, despite e-cigarettes not containing any tobacco, the FDA in 2016 deemed them “tobacco products.” And, since no e-cigarettes existed on the market prior to 2007—grandfathering in date that would allow companies to bypass pre-market approval—every e-cigarette product is now required to file a Pre-market Tobacco Application (PMTA) with the FDA by September 9, 2020 or exit the market.
This set the stage for the ludicrous scenario now playing out, where demonstrably safer products must go through an onerous, expensive, and opaque process in the hope that the FDA will agree their existence is “appropriate for the protection of public health,” while big tobacco companies continue selling deadly combustible cigarettes unencumbered and without spending an extra penny.
It seems unlikely that the FDA will reject all of the vapor industry’s PMTAs, given that it has already deemed other lower-risk tobacco products, such as Snus and IQOS (Philip Morris’ heated tobacco product), and has even approved them to make claims about having lower risk than smoking. But it might not matter. How many applications the FDA will approve and how long it will take is unknown. In 2014 the FDA estimated it would receive just 50 applications in the first two years. But, with an estimated 400 million products on the market, for which companies could file applications, the final total is expected to be in the hundreds of thousands, if not more. In fact, just one company reportedly filed 333,000 applications for its 866 flavors prior to the deadline. With each application being potentially thousands of pages long (Juul’s PMTA, for example was reportedly more than 125,000 pages) it seems unlikely that FDA staff will be able to complete reviews in a timely fashion.
Most vapor companies are not nearly as big as Juul. In fact, according to the American Vaping Association, about 85 percent of the vapor industry is comprised of small, independent companies, with fewer than 10 employees. Few of these “mom and pop” vape companies will file PMTAs, since each application could cost hundreds of thousands of dollars. Most will simply close shop or try to stay open until they can’t.
With legal options already dwindling thanks to overzealous state bans, the illicit market is poised to pick up the slack. Adults who have been vaping to stay smoke free for years will not simply stop vaping just because it is no longer legal. In fact, illicit sales have already begun in earnest among former vape shop owners and international cartels. This will likely get worse as more manufacturers close and the FDA and health agencies begin enforcing the rule. It will make incidences like the illicit THC-linked lung injuries that occurred in the summer of 2019 more likely to happen again. Furthermore, it will push many adults who quit smoking with vaping, but who don’t wish to rely on the black market, back to smoking.
It didn’t have to be this way. If only the FDA had done its job as a regulator, promulgating rules that promote compliance, a vibrant above-board market, and public health, an entire industry would not face extinction, the illicit market would have been kept at bay, and FDA itself would not be dealing with a paperwork nightmare. There were numerous ways the FDA could have changed the process to encourage industry to comply with regulations: Since most products in the vapor market are similar, it could have standardized applications or issued pre-approval for certain combinations of ingredients. The FDA could have given companies a clearer idea of the requirements to meet application standards and eliminated the need for each company to include superfluous information. And it could have created the “streamlined” pathway for small manufacturers that Health and Human Services Secretary Alex Azar promised it would create in January. But none of that happened and now time is up: For regulators, for the industry, and potentially for consumers. Whatever happens now to the industry and public health as a result of the FDA’s recalcitrance is on the agency’s conscience and regulatory report card.
(This post has been updated.)