Denial Is Not Just a River in Egypt: FDA Damns the E-Cigarette Market

 

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.

 

 

U.S. Preventive Services Task Force on E-Cigarettes: We Just Don’t Know!

 

The U.S. Preventive Services Task Force (USPSTF) released its updated recommendations for smoking cessation (here), and the outcome is utterly unsurprising and unacceptable: “the current evidence is insufficient to assess the balance of benefits and harms of e-cigarettes for tobacco cessation in adults.”

The task force claims that “Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.”

In fact, the recommendations are in lock-step with the policies of all other federal agencies.

The only “evidence” the task force deemed acceptable consisted of five randomized clinical trials (RCTs), and it briefly acknowledged that two showed success.  However, the report prominently notes that all trials were conducted outside the U.S., used e-cigarettes that were not available here, and “continued e-cigarette use rang[ed] from 38% to 80%. One study reported that 26.9% of all study participants were using e-cigarettes at 1 year.”

U.S. authorities are obsessed with the idea that only clinical trials can provide valid evidence that smokers can switch (here).  They are also excessively worried about continued use of e-cigarettes after smokers step away from the fire, which plays into their insistence that smoking cessation requires tobacco and nicotine abstinence.

The task force exposes its bias when discussing the “harms” of e-cigarettes, introducing four additional RCTs.  The worst symptoms reported were not serious: “coughing, nausea, throat irritation, and sleep disruption.”

In keeping with federal agency practice, this report cites e-cigarette or vaping product use-associated lung injury (EVALI), even though this pseudo-epidemic was linked conclusively to illicit marijuana products.  The task force does mention the real culprit – vitamin E acetate – but asserts disingenuously that we don’t know if nicotine e-cigarettes were involved.  They were not.

It is striking that the task force describes with conviction minor adverse effects of safer tobacco products, but feigns uncertainty about any positive effects, such as helping smokers quit or having no association with EVALI.  At least they put one honest statement at the top of their report: “480,000 deaths annually are attributed to cigarette smoking.”

The report closes with lists of “research needs.”  For e-cigarettes, this involves finding more evidence for anything negative.  For cessation, “[s]tudies must be well-designed RCTs.”  No matter how much evidence is found in government surveys (here and here), it won’t count.  Unsurprisingly, we need to know about “smoking relapse rates in adults who have used e-cigarettes for smoking cessation.”  Did the task force ever call for similar research for “FDA-approved methods”? 

Finally and most importantly, “More research is needed on understanding how to help adults quit e-cigarettes.”  For the task force, no other outcome, even for products that are vastly safer than cigarettes, is valid.