Vape Bans and Lung Disease: Picking Through the Feds’ Framing

    The feds have been publicly finessing their approach to vaping, amid national outcries over both an outbreak of lung disease and the impact of bans of vape flavors on former smokers. But what do their words indicate in practice?

    The latest Centers for Disease Control and Prevention (CDC) data on the outbreak of lung disease popularly associated with “vaping” indicate that 77 percent of over 800 reported cases⁠ (which have included at least 13 reported deaths⁠) involve patients who used unregulated cannabis-derived products. Just 16 percent of the patients reported using only nicotine-containing products.

    “These are self-reports, so we might want to question the accuracy of self-reports.”

    And at the Global Tobacco and Nicotine Forum—an annual Washington, DC event for regulators, tobacco and vaping industry reps, scientists and harm reduction experts that I attended on September 24-26—Mitch Zeller, director of the Food and Drug Administration’s (FDA) Center for Tobacco Products, used his keynote address to cast doubt on even that 16 percent figure.

    “These are self-reports,” Zeller emphasized, “so we might want to question the accuracy of self-reports, but some self-reports are claiming only using nicotine products.” In many US jurisdictions cannabis prohibition disincentivizes patients from reporting use of THC oils.

    Substances including vitamin E acetate or hydrogen cyanide mixed with illicit THC oils have been implicated. CannaSafe, a Californian testing firm, conducted independent analyses on 10 sample products linked by public health investigators to lung disease, and found that all contained a fungicide that could turn into hydrogen cyanide, which is extremely poisonous and flammable, when heated.

    Yet the overall picture remains muddied. “The challenge we’re facing is there’s no common thread,” said Zeller.

    Zeller’s words matched those of Dr. Anne Schuchat, principal deputy director of the CDC, at a September 26 media briefing. “Although the investigation continues, no consistent e-cigarette or vaping product, substance, additive or brand has been identified in all cases, nor has any one product or substance been conclusively linked to lung injury in patients,” she said.

    On September 25, Acting FDA commissioner Norman Sharpless had testified to a House Energy and Commerce subcommittee, offering hints at the agency’s regulatory intentions moving forward.

    “I want to assure the subcommittee that I am firmly committed to employing all of the tools at FDA’s disposal to tackle these problems,” he told the subcommittee in his written testimony, referencing “an epidemic of youth use” and the disease outbreak.

     

    Not Quite a “Ban”—But Very Much Like One

    President Trump’s rhetoric has been couched in terms of an outright national prohibition of flavored vapes. But Sharpless—like Secretary of Health and Human Services Alex Azar before him—framed the administration’s policy as a renewed commitment to the FDA’s compliance policy for premarket application approvals for nicotine products.

    “This policy would not mean that flavored e-cigarettes could never be marketed,” he said—although it would mean all of them being pulled from the shelves for an unspecified period, with no guarantee of their return.

    “If a company can show through an application to FDA that a specific product meets the standard set forth by Congress,” Sharpless continued, “then the FDA would authorize that … product for sale.”

    The fact that a long-lasting, total ban of flavored vapes isn’t guaranteed will be of little consolation to smaller manufacturers and shops.

    So reality is subtler than the headlines. Even if Trump wanted to completely ban vaping, the FDA would still, as things stand, have to formalize its Premarket Tobacco Product Applications (PTMA) compliance policy and begin enforcing it in May 2020⁠— because of a mandate from a federal judge directing this under the Tobacco Control Act of 2009.

    However, the fact that a long-lasting, total ban of flavored vapes isn’t guaranteed will be of little consolation to the smaller manufacturers and shops⁠—many of them producing in-house liquids or niche private labels⁠—on which many former smokers currently rely.

    By design, navigating the PMTA compliance policies is only a realistic proposition for large companies that can afford the costly, drawn-out process of FDA scientific review. Small-to-medium-sized companies without such resources will be excluded from the market, wiping out thousands of flavored nicotine products.

    So whether or not we choose to believe the FDA’s stated intent to entertain the re-introduction of flavored vapes at a later date, this is, at least, a de facto permanent prohibition for smaller operators.

     

    The Devastating Costs of Misinformation

    At the Global Tobacco and Nicotine Forum (GTNF), independent medical researchers who support the development of risk-reduced nicotine products condemned the prohibitionist trend in the United States.

    Dr. Konstantinos Farsalinos, a Greek cardiologist and a research fellow at the Onassis Cardiac Surgery Center in Athens, was outspoken over the prospect of a US flavor ban.  He argued this point by citing events in India, which implemented a total ban on vapes and liquid nicotine on September 18. India has over 100 million adult smokers and suffers over 1 million smoking-related deaths each year.

    “They banned the least harmful nicotine products that they had on the market,” Farsalinos told GTNF in his address.

    “That’s public health negligence,” agreed David Sweanor, an adjunct professor of law and chair of the advisory board for Health Law, Policy and Ethics at the University of Ottawa, during a panel of medical and legal experts.

    Many at the conference indicted both government and media sources for misinforming the public over the relative risks of harm reduction products. An independent evidence review published by Public Health England in 2015 estimated vaping to be about 95 percent less harmful than smoking.

    Dr. David Levy, a professor of oncology in the School of Medicine at Georgetown University, gave a similar policy assessment to those of Farsalinos and Sweanor. He also emphasized the damage caused by misinformation.

    “From my own experience raising two teenage boys and more generally from what I see, I think we need to be much more careful about the information and how we say things,” Levy told Filter. “We need to be clear that we know the risks of smoking; we know that there are some risks from e-cigarettes. We have a lot of uncertainty about that.”

    The Trump administration, conflating two different issues, seized its chance to advance a pre-existing agenda.

    A recent report from Politico encapsulated how the Trump administration, conflating two different issues, seized its chance to advance a pre-existing agenda: “A marijuana-related vaping disease outbreak gave the Trump administration the perfect opportunity to tackle another public health problem: teen e-cigarette use.”

    The public health establishment is firmly on board: It’s worth noting that the FDA unsuccessfully tried to persuade the Obama administration to ban flavored vapes back in 2015.

    Taking their cue, a raft of state governors have now implemented flavor bans. Govs. Andrew Cuomo (D-NY.), Gretchen Whitmer (D-Mi.), Charlie Baker (R-Mass.) and Jay Inslee (D-Wash.) have all implemented permanent or temporary prohibitions through executive public health actions.

    Baker and Inslee were the most aggressive, targeting both nicotine and cannabis-derived vape products. Whitmer blamed the alleged youth vaping public health crisis in her state on sweet-flavored e-liquids. Cuomo’s administration just banned flavors after he followed a similar narrative. All of these executives are lumping two separate issues together in an effort to prohibit and criminalize nicotine use.

    Of course, this whole situation simultaneously illustrates the need to end nationwide cannabis prohibition and provide people who vape cannabis with the protection of regulated products.

    People who vape nicotine have received this benefit—the vast majority of current products meet manufacturing guidelines outlined by the FDA and local public health authorities. But the current scenario, as many experts have noted, will bolster illicit nicotine markets, risking safety.

    And whatever the FDA does from here, combustible cigarettes will be left unscathed and widely accessible. Almost half a million Americans die from smoking-related causes each year, and more than half a million have been diagnosed with lung cancer at some point in their lives. And vapers are implicitly being encouraged to return to smoking.


    Photo by Vaping360 via Flickr/Creative Commons/Vaping360.com

    *The author is the recipient of a Knowledge Action Change scholarship. The Influence Foundation, which operates Filter, has previously been funded by a Knowledge Action Change scholarship.

    Correction, October 2: A previous version of this article stated that there are 41 million vapers in India; in fact, this figure is the estimated number of vapers in the world.

    • Michael McGrady

      Michael is a journalist and researcher covering alternative nicotine products and tobacco harm reduction. His work has appeared in the Wall Street Journal, the Hill and the South China Morning Post. He lives in Colorado.

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