FDA Commissioner Wants to Have It Both Ways on Vaping

Food and Drug Administration Commissioner Scott Gottlieb has rightly set out to get more people — particularly teens — to quit smoking cigarettes. However, recent FDA activity strongly suggests that the agency plans to take steps that will make it harder for people to do just that.

A news release on September 18 declares the FDA’s latest attack on e-cigarettes by announcing that the agency will revisit its “compliance policy that extended the compliance dates for manufacturers of certain e-cigarettes, including flavored e-cigarettes, to submit applications for premarket authorization.” In other words, makers of vaping products are warned that flavored pods might no longer be acceptable.

With its latest move, the FDA is specifically targeting flavored pods. As Gottlieb stated on the eve of the news release, “We know that the flavors play an important role in driving the youth appeal” and, in light of this trend, the FDA “may take steps to curtail the marketing and selling of flavored products.”

This announcement comes on the heels of a letter that the FDA sent to 1,300 online and brick-and-mortar e-cigarette retailers threatening — and in some cases exacting — fines for sales to underage consumers. At the same time, the agency demanded that Juul Labs and other major e-cigarette manufacturers either produce plans to discourage teen use or face severe consequences.

The stated purpose of these combined attacks is to reduce the number of teenage vapers. This would be a laudable goal if it were not for two troublesome facts. The first is that the alleged “epidemic” of teen vaping is  nonexistent. In fact, vaping rates have dropped among middle-school students and remained low among high-school students. The other major problem is that the campaign against vaping is conducted by those who refuse to acknowledge what the empirical data show — namely, that there is little evidence of serious harm from e-cigarettes.

Significant data point to the positive role e-cigarettes have played in reducing the number of smokers.

Earlier this year, investors were warned about e-cigarettes’ looming competitive threat to traditional cigarettes. Researchers at Citigroup and Morgan Stanley explained that e-cigarette products were disrupting what was previously a predictably steady tobacco market, and that individual stocks like those of Altria — the parent company of Philip Morris International and Marlboro — were likely to experience a challenging earnings environment. Sales trends vary by state, but the data clearly support the analysts’ conclusions: Where e-cigarette sales are strongest, cigarette sales are weaker. And with the news that Gottlieb and company are going after e-cigarette manufacturers, Altria stocks gained $8.5 billion in value.

Gottlieb’s moves against e-cigarettes are understandable given the media attention surrounding e-cigarettes, which almost invariably warns that the country is facing a disastrous health epidemic — especially among teens. This has triggered lobbying efforts aimed at persuading the FDA to do something about teen vaping. Hence, we have Gottlieb’s response: enforcing harsh rules against makers of e-cigarettes.

Meanwhile, the loudest voices pushing for extreme regulations of e-cigarettes are groups such as the Campaign for Tobacco Free Kids, which is funded by big tobacco through the 1998 tobacco settlement, and Michael Bloomberg’s Truth Initiative, which wants e-cigarettes regulated out of existence.

As oral pathologist Brad Rodu — who specializes in tobacco harm reduction research — told City Journal’s John Tierney, these prohibitionists have lost their common sense. “Like alcohol and cigarettes, most e-cigarettes used by teens are obtained from social sources, not directly from stores, so it makes no sense to go to war against retailers,” Rodu explained to Tierney. “We don’t want kids to use e-cigarettes, but many more are using marijuana and (alcohol), which are much more dangerous. We have to put these behaviors in perspective.”

Gottlieb and company at the FDA have been trying to do just that since 2016 by setting a reasonable public health goal. As Gottlieb explained in August, the FDA plans to focus on “minimizing addiction to the most harmful products while encouraging innovation in those products that could provide adult smokers access to nicotine without the harmful consequences of combustion and cigarettes.” But in this political environment, adhering to such an objective is harder that it looks.

And unfortunately, as the FDA’s imminent crackdown on what is perhaps the most effective smoking-cessation product available shows, Gottlieb seems more interested in placating prohibitionists than sticking to a common-sense regulatory standard.