Well, well, well. It’s a big week for some of us with disgusting personal habits. On Tuesday, the Food and Drug Administration authorized the marketing of e-cigarettes for the first time ever. Officially, they told the R.J. Reynolds Company to go hog wild with three products related to the Vuse vape, after a study found its aerosols were “significantly less toxic” than combusted cigarettes. In case you glazed over that last clause, the FDA said “significantly less toxic.” Here’s what they wrote (emphasis ours):
These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes. The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies.
The authorization comes in the middle of a massive review of vaping companies by the FDA. Though E-cigarettes have been sold in the U.S. since the late 2000s with minimal regulation, the FDA announced last year that manufacturers would have to apply for authorization in order to continue selling them. According to the Washington Post, some two million companies were told to stop selling their products by Sept. 9, until their applications had been reviewed. The FDA has rejected at least 946,000 products so far, according to the New York Times.
To be clear, the authorization only permits these products to be marketed in the U.S.; it does not mean they are “FDA-approved” and/or “safe.” Surely, extended vape use will cause one million types of cancer, a conclusion not drawn from medical sources, which tend to hedge that they “don’t know” the “long term” “effects,” but from common sense. Inhaling unknown chemical cocktails will annihilate your lung capacity and probably give you diseases; anyone living in Los Angeles can back this up.
Nevertheless, the FDA authorization constitutes a fairly significant shift in the years-long debate over vaping, a controversy the Washington Post described as “fueled by criticism that tobacco companies are addicting another generation to nicotine under the guise of helping adult smokers quit.” That's a critique worth considering here; powerful corporations and trade associations with robust lobbying arms have long proved adept at convincing regulators to draw industry-friendly conclusions. Just look at alcohol.
But framing the controversy in those terms overlooks the fact that just two years ago, the debate was being fueled by something else entirely: specifically a lung condition called “vape lung” or VAPI (“vaping associated pulmonary illness”) or EVALI (“e-cigarette- or vaping-associated lung injury”). Back in 2019, two years after the introduction of Juul pushed vaping into the mainstream, state health departments in Wisconsin and Illinois received reports of incidents related to a “lung injury of unclear cause.” This pneumonia-like respiratory illness manifested as chest pain, coughing, weight loss, and “extremely rapid and labored breathing.” Its victims were predominantly male, white, and under 35.
The reports unleashed a relentless news cycle that churned out stories about mysteriously sick teenagers faster than the medical community could conduct peer reviewed studies. More than one outlet dubbed it an “epidemic,” a “public health crisis,” or a “vaping crisis.” The Centers for Disease Control and Prevention opened an investigation; the FDA and several state authorities followed suit. By September, the CDC had counted some 450 “possible cases” and at least five deaths. Around the same time, the Trump administration moved to ban flavored vapes in direct response to the outbreak.
There were already some signs that vape alarmism was verging towards moral panic. For one, there were no similar outbreaks in the E.U. or U.K., where vapes had been, as CNN reported at the time, “embraced mostly as a way for adults to quit combustible cigarettes.” In the face of the U.S. “crisis,” British health authorities stood by “their support for e-cigarettes as a cessation tool,” CNN wrote. But there were ways to dismiss that. A Politico piece on “Europe’s missing ‘vaping sickness,’” hedged that “nobody is keeping track” of possible cases. By October, however, health specialists had told Reuters that vape lung cases were largely “a U.S.-specific phenomenon.”
Why was that? Almost certainly because evidence suggested the cases were linked to a component called “vitamin E acetate,” found overwhelmingly in weed vapes on the domestic black market. E acetate, which a CDC director later identified as the “culprit” behind the crisis, is a supplement used in certain cosmetic lotions. But vape manufacturers have occasionally used the vitamin to thicken or dilute the THC liquid in their cartridges — particularly illicit-market manufacturers. According to USA Today, a 2019 study of illegal and legal THC cartridges found concentrations of E acetate in nine out of 15 illegal samples; and none in over 200 legal samples.
The connection between E acetate and EVALI was reported by the New York State Department of Health a week before the Trump administration moved to ban flavored e-cigarettes. But the ties to cannabis had been known at least a month before that. An August 2019 report from California’s Department of Public Health noted that a “reported common exposure among” a cluster of EVALI patients “is that they have been vaping cannabis or cannabidiol (CBD) oils.”
This did little to mitigate the accelerating panic over nicotine vapes, however. Walmart kicked e-cigs out of its stores. Congress raised the smoking age to 21. Melania Trump tweeted about it. This was partially because the CDC maintained well into the fall that the role of nicotine vapes could not yet be ruled out as a cause of lung issues. Still, the evidence against E acetate bore out pretty quickly. In November, a study of 29 EVALI patients revealed that they all had E acetate in their systems. By December, the CDC reported that a “health surveillance system” put in place after 9/11 had helped them determine that EVALI cases had peaked in June of 2019. As NPR put it, the “sharp spike strongly point[ed] to a single culprit.” It was E acetate.
Overwhelmingly, this culprit appeared in black market THC vapes. At a telebriefing on the outbreaks, a reporter asked the CDC’s then-Principal Deputy Director Dr. Anne Schuchat whether E acetate appeared in “non-THC vape liquid” or other “legitimately produced” e-cigarette goods. “It’s possible that vitamin E acetate in very small amounts may be used in some e-liquid material for a variety of reasons,” she said, but tested samples showed “it’s primarily been THC-containing e-liquids that have the vitamin E,” with higher concentrations in those used “for more illicit purposes.”
States began cracking down on E acetate use: Colorado banned it, Washington and Oregon followed shortly after. By February of 2020, New York Magazine reported that after CDC scientists “fingered vitamin E acetate...as the leading culprit in many of the cases,” the epidemic had been “tapering off” for months. The CDC’s updates on EVALI cases stopped just weeks later (the CDC declined to comment on the investigation).
These days, popcorn lung seems to have silently disappeared from the vape conversation. But a New England Journal of Medicine retrospective cautioned that without closer regulation by the FDA, “millions of e-cigarette users” will “have virtually no protection against the potential harms from the thousands of largely unregulated e-cigarette devices and liquids on the market.”
A spokesperson for the FDA said the on-going review of vaping companies was not necessarily related to the EVALI outbreaks. While there was greater public attention during EVALI, she said the regulatory process had “been underway” since 2016, when the Tobacco Control Act — a 2009 law that authorized the FDA to regulate cigarettes — was amended to include other tobacco products, like vapes.
The recent FDA report suggests that the “the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth.” That said, the agency still rejected ten flavored products from R.J. Reynolds — which falls in line with their order from August, calling on three vape manufacturers to pull some options like “Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.”
But at the very least, it is a small step in the war to get the doctor establishment and their media cheerleaders to admit that the hype around “popcorn lung” or “vape lung” or “EVALI” transformed real tragedy into sanctimonious moral panic, and produced an alarmism that, as the M.D. who oversaw my recent physical put it, was “misattributed to nicotine vapes.” Vaping is still bad for you, just for other reasons.
After this piece was published, a spokesperson for the CDC sent Gawker the following comment:
CDC is no longer collecting data from states about EVALI cases. However, we continue to monitor EVALI-related trends using emergency department data from the National Syndromic Surveillance Program’s BioSense/ESSENCE platform. These data do not suggest a resurgence of EVALI at this time. CDC continues to encourage clinicians to continue to report possible cases of EVALI to their local or state health department for further investigation.