With a new round of legislative hearing looming ahead there is no doubt that vaping—and various prohibition strategies—will be at the forefront of national policymakers’ agendas in 2020. The first hearing of the new decade held by the District of Columbia’s Committee on the Judiciary & Public Safety, which I attended on January 2, serves as a harbinger of what’s to come.
In discussing proposed zoning, sales and flavor restrictions, witnesses and councilmembers provided insight into the mental gymnastics required to endorse prohibitions of products that are not only far less dangerous than those readily available, but can actually prevent early death and disease.
Those of us who advocate for sensible regulation of e-cigarettes—including controlled but reasonable access, and availability of flavors other than those that are already found in combustible cigarettes—are well aware of the challenges we face in public hearings. It’s always an odd feeling to watch some witnesses get a pass on the misinformation—and sometimes outright lies—about the roots of the vaping illnesses or the harms of e-cigarettes, while others have to justify their very existence.
At the DC hearing, claims abounded once again that the recent spate of vaping-associated illnesses were a consequence of e-cigarettes, or that e-cigarettes are uniquely dangerous for adolescents.
But there is no evidence that e-cigarettes are uniquely dangerous for adolescents when compared to cigarettes. More importantly, vaping illnesses have not been linked to nicotine-containing e-liquids. And there is a reason for that: As a water-soluble chemical, there would be no reason to add an oil to nicotine. Doing so would make it difficult to keep nicotine in a solution that can be vaped.
He referenced the National Academies of Sciences, Engineering and Medicine report—only to be criticized by the chair for “cherry-picking” evidence.
Meanwhile harm reduction advocates get their academic and professional credentials called into question if, for example, they cite a report from the nation’s most respected collection of scientists and medical professionals.
Providing testimony on January 2, Gregory Conley, president of the American Vaping Association*, referenced The Public Health Consequences of E-Cigarettes by the National Academies of Sciences, Engineering and Medicine—only to be criticized by Councilmember Charles Allen, the chair of the committee, for “cherry-picking” evidence.
Chairman Allen went on to question Conley’s academic background, suggesting he is not qualified to make public health arguments because he holds a Juris Doctorate and not a master’s degree in public health. It is worth noting that Matt Meyers, president of the anti-vaping Campaign for Tobacco-Free Kids, provided testimony earlier in the day and was not questioned on his academic background, despite also not holding a public health degree.
The National Academies’ report states: “The net public health effect, harm or benefit, of e-cigarettes depends on three factors: their effect on youth initiation of combustible tobacco products, their effect on adult cessation of combustible tobacco products, and their intrinsic toxicity.”
So how are we doing by those measures?
Youth smoking rates have been consistently declining over the last decade (and are at their lowest yet). E-cigarettes have shown to be more successful as quit aids than their pharmaceutical counterparts. And vapes’ intrinsic toxicity is minimal compared to their combustible counterparts.
One can only conclude that e-cigarettes confer a net public health benefit by being available to replace cigarettes
The DC council members seemed to have missed that the FDA largely agrees with this report. Former FDA Commissioner Scott Gottlieb previously stated, “A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine–while highly addictive–is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”
Furthermore, this continuum of risk is central to the FDA’s roadmap of the future of tobacco. Regarding the steps the FDA is taking to address youth use, the Commissioner stated that “While it’s the addiction to nicotine that keeps people smoking, it’s primarily the combustion, which releases thousands of harmful constituents into the body at dangerous levels, that kills people. This fact represents both the biggest challenge to curtailing cigarette addiction‒and also holds the seeds of an opportunity that’s a central construct for our actions. E-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products.”
However, the FDA has maintained that ensuring that adolescents are not uniquely driven to pick up nicotine when they otherwise wouldn’t is also a top priority. Even in 2018, the Commissioner stated that they seek to strike a balance between protecting underage and non-users from addiction to nicotine while keeping safer products available to adult smokers to enable them to transition away from combustible cigarettes.
This is exactly why one consideration for approving new nicotine products, including heat-not-burn, snus and even e-cigarettes, is the so-called “public health test” that takes into account the risks (increased tobacco or e-cigarette use) and benefits (decreased smoking to the population as a whole)—to both users and non-users of these products.
This ongoing process is why state and local governments should be wary of implementing prohibitions until the FDA has had the opportunity to review
What might not be obvious is what’s required to achieve approval through the FDA’s Premarket Tobacco Application, or PMTA, process. This approval process is necessary for any manufacturer looking to sell novel nicotine or tobacco products, including e-cigarettes, after May 2021. While there has been a lot of back-and-forth, the final deadline for manufacturers to submit applications is May 2020 and the FDA has until May 2021 to review the applications for final approval—failing which, they will be removed from the market.
Manufacturers must specify every aspect of their product, including obvious things, like nicotine strength and flavors, but also things that aren’t as obvious—like data on population and individual health impacts of each individual product. All of these factors are taken into account to determine if the existence of the product would be an overall benefit to society. Clearly, the impact on adolescents and non-users will be a top consideration.
This ongoing process is why state and local governments should be wary of implementing prohibitions, including those on flavors, until the FDA has had the opportunity to review applications.
While it’s likely that the FDA will take an extreme approach to protecting adolescents— to the detriment of those who would benefit from e-cigarettes—it’s also likely that the products and flavors that they do approve will have large-scale benefits.
Across the US, too many bills to restrict or prohibit e-cigarettes and flavors have been filed to count. So it’s probably unrealistic to hope that lawmakers will table these proposals for another year. But we ought to expect more from our elected officials than behavior witnessed in past hearings.
Bullying of witnesses who don’t fit the perfect mold or refusing to acknowledge even the possibility that e-cigarettes might be a part of the solution to a much bigger problem isn’t going to help anyone. The simple truth is, a public health degree is not required to read academic reports that support the basis of a harm reduction approach to smoking; nor does having one give the recipient permission to ignore such evidence when creating policy.
* The R Street Institute, the author’s employer, previously provided a restricted grant to The Influence Foundation, which operates Filter, to support production of two reports on harm reduction topics.
* The nonprofit American Vaping Association has also previously provided grants to The Influence Foundation.