FDA's Vaping 'Epidemic' Doesn't Hold Up to Inspection

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Prior to announcing his resignation last week, FDA Commissioner Scott Gottlieb had made ending teen vaping a central goal of his tenure. Determined to eliminate what he frequently termed an “epidemic,” regulators have not only exaggerated the magnitude of the problem, but also threatened retailers with regulatory repercussions. The source of the problem lies elsewhere. 

For e-cigarette opponents eager to protect children, there is no regulatory burden too big to impose. On Wednesday Gottlieb delivered on his promise of “vigorous enforcement steps” against tobacco retailers that sell to underage customers. He announced a draft compliance policy with these expectations: “some flavored e-cigarette products will no longer be sold at all…other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access… some flavored cigars will no longer be sold.”

Last week Gottlieb set the stage by calling out the management of Walgreens, as well as other national gas station and convenience stores such as Exxon, 7-Eleven, and Walmart. Using tough language, he described the FDA’s “boots-on-the-ground presence across the country,” noting the “historic milestone of conducting … one million tobacco retailer inspections” since 2010, which resulted in tens of thousands of warning letters, nearly 20,000 penalties, and 145 “no-tobacco-sale orders.”

Federal data reveals important information, however, that conflicts with the FDA announcement and the perception that teen vaping is a pervasive problem. The Centers for Disease Control and Prevention’s 2017 National Youth Tobacco Survey shows that only about 12 percent of American high school students used e-cigarettes in the past month. Even if the CDC’s observation – based on unpublished data – is correct about a vaping increase in 2018, it doesn’t confirm an epidemic. Nearly 70 percent of the students who vape – but do not smoke – used e-cigarettes five days or less during that 30-day period, a pattern called “party” or “weekend” vaping, not regular, daily consumption.

Another federal survey, dubbed “Monitoring the Future,” reveals more critical teen epidemics: alcohol and marijuana use. Thirty percent of high school seniors use alcohol and 18 percent report being drunk in the past month. Similarly, 22 percent of students report using marijuana – a level that’s remained steady since 1995. In contrast to vaping, considered to be 95 percent safer than smoking and not impacting judgment or inhibitions, teens too often die from accidents related to marijuana and alcohol consumption.

Despite the FDA’s finger-pointing at retailers, only a tiny fraction of American teens who have used e-cigarettes bought them on their own. The FDA’s own survey data backs this up. The Population Assessment of Tobacco and Health (or PATH) survey collects detailed information about teen tobacco use. It reveals that fewer than 10 percent of current teen e-cigarette users – defined broadly as having taken at least one puff in the past 30 days – “bought them myself.” In short, most teens aren’t getting e-cigarettes from retailers willing to break the law for an extra buck. Instead, they get e-cigarettes the old-fashioned way – through friends.

What’s especially egregious about the FDA’s exaggeration is that it’s based on data manipulation. The FDA claimed that 22 percent of Walgreens stores engaged in illegal sales of tobacco products to minors since 2010; and 14 other national retail chains had violations of 15 percent-44 percent. These extremely large numbers, however, are the result of cumulative math over a nine-year period. A closer look at the data reveals that there was a 12 percent violation rate nationally in 2018 – a mere 1 percent higher than in 2015-2016.  And Walgreens’ rate was 9 percent, three points lower than the national average.

While the FDA is obsessed with e-cigarettes, only 19 percent of the more than 17,500 cited violations in 2018 involved those products, a distant third place to cigars (44 percent) and cigarettes (33 percent). The focus on retailers also ignores the large variation in state violation rates, from Georgia (2.2 percent), Montana (2.7 percent), Hawaii (3 percent) and California (4.2 percent) all the way to North Dakota, Michigan, Ohio and Nevada at 23 percent. 

What’s more, the FDA ought to acknowledge different state compliance rates, and what some states are already doing to curb underage use. Seven have passed laws raising the minimum age for purchasing tobacco from 18 to 21. This kind of regulation – like a law passed in Virginia last month – addresses teen vaping by interrupting the informal black market in high schools. Right now 14 percent of American high school students are 18 years or older. They can legally purchase tobacco products and serve as the main source for all other high-schoolers. While Tobacco 21 won’t eliminate teen vaping, it creates another barrier for underage users. Teen alcohol use is still a problem, but Alcohol 21 has played a role in reducing prevalence by almost half. Tobacco 21 doesn’t restrict adult smokers’ access to life-saving, smoke-free cigarette alternatives.

We all want teens to have healthy lifestyles, but federal and state policies should be driven by facts, not by hyperbolic pronouncements. A leadership change at the FDA (Gottlieb will leave in a month) opens an opportunity to reconsider the regulatory approach to e-cigarettes. If we focus on sensible solutions, rather than onerous regulations, everyone, especially adult smokers, will benefit.

Brad Rodu is professor of medicine and holds an endowed chair in Tobacco Harm Reduction Research at the University of Louisville. Contact him at brad.rodu@louisville.edu.



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