On September 14, the FDA Center for Tobacco Products denied Premarket Tobacco Applications from Turning Point Brands (TPB) for 525 flavored vaping liquids (here).
FDA’s letter to TPB is instructional, as it provides the rationale for ordering removal of these products from the marketplace.
The FDA acknowledges that TPB provided “clinical studies with abuse liability outcomes and a cross-sectional survey evaluating patterns of use,” but the agency judged these as “not sufficient to show a benefit to adult smokers of using these flavored [electronic nicotine delivery systems, or ENDS].” Then the regulator drops the hammer: “FDA concludes that your application is insufficient to demonstrate that these products would provide an added benefit that is adequate to outweigh the risks to youth and, therefore, cannot find that permitting the marketing of your new tobacco products would be appropriate for the protection of the public health.”
What kind of evidence does the FDA require? The kind that costs tens of millions of dollars and takes up to a decade to generate:
“All of your PMTAs lack sufficient evidence demonstrating that your flavored ENDS will provide a benefit to adult users that would be adequate to outweigh the risks to youth. In light of the known risks to youth of marketing flavored ENDS, robust and reliable evidence is needed regarding the magnitude of the potential benefit to adult smokers. This evidence could have been provided using a randomized controlled trial and/or longitudinal cohort study that demonstrated the benefit of your flavored ENDS products over an appropriate comparator tobacco-flavored ENDS.” (emphasis added)
What company is going to have the resources to fund a randomized controlled clinical trial – requiring medical-grade procedures and supervision – for one product, let alone 525? Longitudinal cohort studies are daunting. They take decades to produce results, require generations of researchers, and cost hundreds of millions of dollars.
The FDA exercises enormous power. First, it issues minimal PMTA guidance, leaving it to the companies to interpret what they need to submit. Then, if the agency believes that the benefit of any product to adult users is outweighed by the “risks to youth,” the agency can issue a market denial order (MDO).
Federal officials have for five years claimed that an entire generation of teens is being enslaved by e-cigarettes. I am one of the few researchers to have critically reviewed these claims.
As I extensively documented, our government has grossly exaggerated the so-called teen vaping epidemic (here, here, here, here), basing their case on one cherry-picked federal survey (here). They fail to distinguish between vaping nicotine and marijuana (here), and they elevate vaping over far more risky use of alcohol, marijuana (here) and other high-risk teen activities (here).
The actual risks of vaping by teens are so minuscule that prohibitionists have had to concoct the fallacious argument that “nicotine in e-cigarettes can harm brain development.” (here) Three years ago I challenged then FDA commissioner Stephen Hahn on twitter: “@SteveFDAm Please provide scientific evidence that people - not mice - show ‘impact nicotine has on [the] developing brain.’ Should be easy, there are ~90 million current/former adult smokers in the U.S. who started as teens. #vapormadness”
Three years later, I am still waiting for an answer.
In a filing to the US Court of Appeals for the Sixth Circuit (here), TPB “seeks review of the order on the grounds that it is arbitrary and capricious, an abuse of discretion…” That is an understatement.
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