At the height of the United States’ experiment with Prohibition in the 1920s, the federal government took an extreme step to combat Americans’ continuing consumption of alcohol. Recognizing that bootleggers were redistilling industrial alcohol to make it potable, the government poisoned the supply to render it irreversibly toxic. People kept drinking. Thousands died, and many more were sickened. Today we look back on this episode in horror, confident that we would never endorse such a cruel approach to prohibition.
Or would we? On Friday, Sen. Dick Durbin demanded that the acting commissioner of the Food and Drug Administration ban the sale of all unapproved e-cigarettes within 10 days. Such a ban would apply to every single vaping device currently sold in the United States. That means that, overnight, e-cigarette users would no longer have any vaping options. This wouldn’t stop people from using nicotine—just as drinkers kept imbibing during Prohibition, vapers would likely return to the combustible cigarettes that still kill more than 400,000 Americans every year. Perhaps the ban would spur a few nicotine users to quit, but more likely it would force them to take their chances on the black market or go back to Big Tobacco.
The present panic is in response to a genuinely concerning outbreak of acute lung illnesses that appear to be linked to the use of vaporizers. The suddenness of these cases and their geographic clustering suggest that the cause is not something inherent to commercial e-cigarettes, which have been widely used in multiple countries for more than a decade. “Most of these severe cases, so far, appear to be symptoms that can occur when either oils or lipid-containing substances enter lungs,” says Scott Gottlieb, who recently stepped down as commissioner of the FDA. “This points to illegal products that are being cut with dangerous chemicals as a culprit.”
The FDA’s advice for consumers is to avoid the difficult-to-trace cannabis products that the vast majority of patients report using. The agency has refrained from voicing similar warnings about nicotine e-cigarettes. This echoes the advice of health authorities in England, who generally take a more pragmatic approach to vaping than their peers in the United States. “For nearly every person who vapes, the alternative to vaping is smoking,” says Paul Aveyard, professor of behavioral medicine at Oxford. “These cases are worrying and need investigating, but advice from all official bodies in the UK is that it is always preferable to vape than to smoke.”
American politicians are disregarding these sensible recommendations. Michigan Gov. Gretchen Whitmer announced that she would ban the sale of all flavored e-cigarettes. Rep. Rashida Tlaib applauded the move, saying that “we must stop repeating the lie that vaping is better than smoking cigarettes.” And then there’s Durbin, demanding that all unapproved e-cigarettes be taken off the market, full stop. These decisions contradict the advice of many scientific bodies that have studied the potential of tobacco harm reduction. But more than that, they are a gift to Big Tobacco.
Tobacco products are regulated by the FDA, but they are not regulated as a food or a medicine. The separate framework for regulating tobacco was established by legislation that was quietly negotiated and supported by Philip Morris, maker of the bestselling Marlboro cigarettes, more than a decade ago. “The name of the game was getting the bill, not getting the credit,” an executive explained at the time. One can speculate about the company’s motives, but a likely one is that it knew the law it was pushing for would create barriers to entry for potential competitors. This would position the tobacco giant as one of the few companies capable of navigating the FDA’s costly and opaque approval process. (The high barrier to entry is part of why there are currently no FDA-approved e-cigarettes on the market.)
The FDA itself has predicted that the eventual costs of compliance for e-cigarettes will be “high enough to expect additional product exit, consolidation, and reduction in variety.” The agency didn’t even release final guidance on what to include in applications until this past June. In fact, there is only one e-cigarette–like product that has ever made it through the regulatory pathway set forth for these devices, and that is IQOS, a product owned and developed by Philip Morris International that will make its United States debut in Atlanta as early as this month. Which means that if the FDA immediately bans unapproved e-cigarettes, it will be handing Philip Morris a monopoly on the American market.
One other e-cigarette maker that has expressed confidence in winning FDA approval is Juul, the company notorious for its youthful marketing and popularity with teenagers. Amid intense scrutiny last year, Juul sold a 35 percent stake to Altria, the parent company of Philip Morris USA. The move was seen as necessary for surviving a hostile regulatory environment, providing Juul with access to Altria’s scientific and lobbying expertise. Relatedly, Philip Morris International and Altria are now eyeing a corporate merger, a prospect motivated by the combined firm’s potential to dominate the market for lower-risk forms of nicotine delivery.
If all of this occurs, the independent vaping community that arose in opposition to cigarettes will be wiped out or driven underground. Today’s diverse market will be replaced by a narrow range of products made by Philip Morris, Altria, Juul, and perhaps a few other cigarette or pharmaceutical companies, rewarding those that have historically been among the most irresponsible—and sometimes evil—corporate actors.
A better approach to regulation would establish objective, transparent standards for e-cigarettes that give producers a clear idea of what will be allowed for sale. Those would take time to implement, certainly longer than the 10 days demanded by Dick Durbin. In the meantime, the FDA is already empowered to remove products from the market if it determines that they are causing illness in their users, and the Centers for Disease Control and Prevention is closely tracking the illnesses to try to understand the cause. As we wait, lawmakers should refrain from introducing rash legislation that would force the approximately 3 million American ex-smokers who now vape to go back to a product that we know for a fact is likely to kill them. Such an action would not only put smokers’ lives at risk—it would also clear the field for Big Tobacco.
