FDA Commissioner Scott Gottlieb on September 12 announced an FDA initiative to “address [the] epidemic of youth e-cigarette use.” (here) Dr. Gottlieb misbranded teen vaping an “epidemic of addiction.”
The commissioner asked manufacturers of JUUL, Vuse, MarkTen, blu and Logic e-cigarettes to respond “to the FDA in 60 days with robust plans on how they’ll convincingly address the widespread use of their products by minors, or we’ll revisit the FDA’s exercise of enforcement discretion for products currently on the market.”
Dr. Gottlieb added: “Let me be clear: Everything is on the table. This includes the resources of our civil and criminal enforcement tools.”
The commissioner’s rationale and targeting for the threatened enforcement action appear to be grossly flawed.
Dr. Gottlieb said he used “the word epidemic with great care,” but his statement that teen e-cigarette use is “almost ubiquitous” is simply wrong. The chart at left, based on University of Michigan Monitoring the Future data, shows that e-cigarette use among high school seniors is only marginally higher than cigarette use, which has been declining for decades. E-cigarette use pales in comparison with marijuana and alcohol, which are far more dangerous (hereand here).
In his remarks, the commissioner used the word “danger” three times to describe teen nicotine and e-cigarette use. This characterization is reminiscent of the “reefer madness” propaganda of the 1930s and beyond, which is well-chronicled in Mark Hay’s article, “A Brief, Paranoid History of Anti-Weed PSAs” (here).
Dr. Gottlieb’s attack on the four e-cigarette marketers may be misdirected, as FDA data show that only 10% of current teen users purchased e-cigarettes for themselves; the vast majority obtained them from social sources (here) – older siblings, friends and parents. While elimination of underage tobacco use is an important objective, focusing the full force of the agency’s civil and criminal enforcement tools on manufacturers and retailers misses the target almost entirely.
Original author: Brad Rodu