The FDA Is Funding and Approving Cigarettes

With how news moves these days, it is easy to miss the drama unfolding in the tobacco world. Over the course of this year, the Food and Drug Administration announced a plan to reduce the nicotine in all cigarettes, outright ban all menthol cigarettes, and denied an application by JUUL to sell its products, only to turn around and suspend that ban as the company appealed the decision. All of this is eclipsed, however, by the fact that U.S. health agencies funded research trials for two very low nicotine (VLN) cigarette products — one of which is a menthol — that went on to receive approvals by the FDA as reduced-risk products.

It is astounding that the FDA and other agencies spent $100 million from U.S. taxpayers to develop evidence on the safety and efficacy of combustible cigarettes. Worse, these agencies then used that insufficient evidence to justify their endorsement as lower-risk, mandating labels with the marketing claim “Helps You Smoke Less” on cigarette packaging.

This is the wrong way to achieve a smoke-free United States.

But the FDA doesn’t seem concerned. Instead, it appears to be wrapped up in some magical thinking that individuals will stop smoking after using VLN cigarettes because the reduced nicotine will decrease their addictiveness. In reality, VLNs will likely exacerbate risk misperceptions among consumers. Nicotine isn’t the biggest problem; it is the combustion of burning tobacco that is most harmful to health. In other words, the FDA is approving combustible cigarettes it helped develop while rejecting more than 99 percent of vapor products from the market it did not.

Coupled with efforts to reduce the nicotine in all cigarettes, this amounts to full-scale prohibition as most brands would be removed from the marketplace for noncompliance. But the FDA-approved VLN brands would stay. The type of political wheeling and dealing indicates anticompetitive behavior, with the government trying to pick winners and losers.

History has shown us repeatedly that prohibition never works – –whether it is for alcoholopioids or flavored vapes. Further, FDA-funded research to understand the acceptance of VLNs showed that immediate reductions in nicotine resulted in more significant withdrawal symptoms and an increased likelihood that smokers might seek alternative sources.

Since the first commercially successful e-cigarettes were released, they have evolved and increased in a dramatic fashion. By 2014, the British Medical Journal documented an estimated 460 different e-cigarette brands that delivered nicotine without the harmful effects of smoking. Researchers have confirmed that e-cigarettes exist on a risk continuum, comparing them to nicotine patches used to stop smoking. Because e-cigarettes mimic the rituals of smoking, they are proven to be practical smoking-cessation tools for adult smokers. Even the Centers for Disease Control states that “more frequent use of e-cigarettes is associated with greater smoking cessation than less frequent use.” A reasonable approach to reduce adult smoking would be to increase the availability of these products.

The FDA would do well to recognize this evidence to achieve a smoke-free United States. It could start by updating the national tobacco control strategy –– the one that was published over a decade ago and doesn’t even mention vaping. It should also update the FDA’s Comprehensive Tobacco and Nicotine Regulation Plan. Created in 2017, it includes a mishmash of strategies to reduce youth use, address racial justice and eliminate smoking. Yet, much like the national tobacco control strategy, it doesn’t account for e-cigarettes as a tool to stop smoking. The FDA could also learn a bit from the comprehensive, evidence-based tobacco-control strategies of other countries like the United Kingdom or New Zealand, which have codified what a smoke-free society means for their populations.

It is important to remember that there is no safe tobacco product. Those who smoke cigarettes are encouraged to use alternatives such as reduced-risk nicotine products (like e-cigarettes) as they have become essential to helping adult smokers transition away from the deadly combustibles. Prohibiting vapes while increasing the number of reduced nicotine combustible cigarettes is as counterproductive as it is political. It doesn’t need to be.

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