The Food and Drug Administration Is Not Positioned to Deter Adolescent E-Cigarette Use

The Food and Drug Administration (FDA) guidance is a response to the reported sharp increase in past-month youth vaping, amounting to 3.1 million high school students in 2018—a situation characterized as an epidemic by former FDA commissioner Scott Gottlieb. This calculation was based on the Centers for Disease Control and Prevention’s (CDC’s) National Youth Tobacco Survey, but for several years estimates from other credible sources have been consistently 50% to 60% lower (http://bit.ly/3ddXwsQ).^1,2 Also, the CDC’s high school vaping numbers include legal purchasers (aged 18–20 years who served as the primary source for underage vapers), large numbers of youths who also used other tobacco products, and large numbers who used e-cigarettes infrequently (http://bit.ly/2WtIRna).

The FDA’s aim is, appropriately, to deter adolescent e-cigarette use, but the guidance is apparently laser targeted to Juul’s “flavored, cartridge-based [electronic nicotine delivery systems, ENDS] product[s]” (http://bit.ly/392zuOa) and will not affect other products appealing to youths, such as disposable Puff Bars, which are as discrete and potent as Juul and far less expensive (http://bit.ly/2x6HIHE). ³ Puff Bar sales are probably illegal, as they don’t appear to have been on the market before August 8, 2016 (http://bit.ly/2U22KQE), but the FDA has taken no action. One commenter described the situation as “a game of whack-a-mole” (https://wbur.fm/3a5e2t6), which reflects inefficient and ineffective regulation of the dynamic vapor category and marketplace.⁴

The guidance mistargets adolescent initiation, whereas the FDA slow walks authorization of safer substitutes for adult smokers. The agency, for example, took two years, about 18 months beyond its own deadline (http://bit.ly/3a61qSz), to authorize the premarket tobacco product application (PMTA) for sale of far less hazardous IQOS heat-not-burn products from Philip Morris International. During that time, while IQOS was the only product in the PMTA pipeline, 1 million Americans died from smoking-attributable diseases (http://bit.ly/2UrtPMm). After May 12, 2020, the agency will have to manage PMTAs for hundreds or thousands of vapor products from companies that will spend from $467 000 (FDA estimate)⁵ to $5 million (industry estimate; http://bit.ly/2waJSWJ) per PMTA.

The FDA’s operational deficits reflect misaligned budget priorities. Beginning in 2009, the FDA Center for Tobacco Products (CTP) has been fully funded by fees from tobacco manufacturers. In fiscal 2019, when the CTP’s budget was $714.7 million,⁶ the FDA transferred more than one third ($261.6 million) to the National Institutes of Health for scientific research.⁶ University researchers nationwide know the best way to obtain funding: meet the government’s stated objective: “to create a world free of tobacco use” (http://bit.ly/2IXyf83). This overt bias exaggerates risks and neglects the benefits of vastly safer cigarette substitutes, to the detriment of critically needed harm-reduction inquiry (http://bit.ly/2U1beYe).

The next largest CTP budget item ($159.5 million, or 22%) supports public education campaigns and communications to “reduce tobacco use” and tell “target audiences” about the “harms of tobacco product use.”⁶ In this category, “The Real Cost” Youth E-Cigarette Prevention Campaign (http://bit.ly/2IWTSWj) shows e-cigarettes invading adolescent bodies as worms and a magician converting e-cigarettes into combustible cigarettes. The FDA has acknowledged, apparently without concern, that the campaign convinces adult smokers that e-cigarettes are equally or more harmful than cigarettes, thus suppressing quitting.⁷

The CTP has a meager budget ($128.3 million, or 18%) for compliance and enforcement. It has not issued clear guidelines for PMTAs and may not have adequate resources to process them. It has not policed the emergence of new products and has not clearly communicated a plan to identify those who fail to file PMTAs. The CTP budget should be reallocated to fund less biased research, less “education,” and significantly greater compliance and enforcement activities. If broad changes aren’t made, the FDA’s guidance will not reduce adolescent e-cigarette use.