Every day, millions of Americans rely on harm-reduction products to kick the deadly habit of cigarette smoking. The Food and Drug Administration has been anything but helpful in facilitating that process. Fortunately, the Trump administration is pushing back against prohibition.
According to a recent report in The Wall Street Journal, “The White House is pushing to allow more vape flavors on the market for the first time in years” even as FDA “Commissioner Marty Makary opposes the move and is blocking the plan.”
In recent testimony, even Department of Health and Human Services Secretary Robert F. Kennedy Jr. seemed open to expanding legal access to vapes. The Trump administration and the FDA could save countless lives by reversing course and allowing more reduced-risk products on the market.
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The evidence is abundantly clear: Products such as vapes are significantly less harmful than cigarettes. In 2015, Public Health England (part of the United Kingdom government) first found that vaping products are at least 95% less harmful than cigarettes and has repeatedly reaffirmed and strengthened this finding in subsequent studies. Even the FDA has said as much, albeit in a mealy-mouthed manner: “While e-cigarettes can generally be a lower-risk alternative for adults who smoke cigarettes, the use of e-cigarettes is not risk-free.”
These reduced-risk products are also extraordinarily effective in getting smokers to quit cigarettes. According to a sweeping review of the evidence involving 90 studies — 49 of which were high-quality randomized control trials — e-cigarette availability “results in increased quit rates compared to nicotine replacement therapy,” with the evidence being the strongest for vapes containing nicotine. Unsurprisingly, flavored vapes are especially effective in weaning smokers off of cigarettes, which is why flavor bans tend to increase cigarette smoking.
Instead of using this evidence to bolster harm-reduction efforts, the FDA has stood firm on prohibition. In guidance provided to vaping manufacturers on product approval, the FDA had stressed the importance of providing airtight marketing plans to prevent youth from getting their hands on e-cigarettes. The agency claimed these marketing plans were “critical” and stated in no uncertain terms that it “will review the marketing plan[s]” in making approval decisions. Then, once more than one million product applications came in the door, the FDA did a surprise switcheroo and completely ignored the marketing plans. It proceeded to deny virtually all the applications, claiming that the real key to approval was statistical evidence on switching from cigarettes to vapes.
This behavior was rightly challenged in the courts as being “arbitrary and capricious,” which refers to baseless or erratic agency actions outside the scope of the Administrative Procedure Act. Bizarrely, the Supreme Court sided with the FDA in the resulting FDA v. Triton Distribution case, though the justices did take note of the Taxpayers Protection Alliance’s arguments about the (un)constitutionality of antivaping laws.
The result of this regulatory whiplash is real-world harm for the 15 million Americans desperately trying to quit smoking cigarettes. When legal and regulated products such as flavored vapes are blocked from the market, demand does not disappear. It shifts. While prohibition prevents millions of smokers from trying reduced-risk alternatives, others will turn to illicit or unregulated products, where quality controls are nonexistent, and risks are far higher. Worse still, many smokers simply stick with combustible cigarettes — the very products responsible for nearly half a million deaths each year in the United States. This court-ordained policy framework, which makes it incredibly difficult to access harm-reduction products, is government at its very worst.
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If the FDA is serious about protecting public health, it should follow the evidence and adopt a light-touch approach to harm-reduction products. But the FDA simply will not listen unless the White House continues to push for reforms that would expand the availability of vapes, nicotine pouches, heat-not-burn devices, and similar products.
Policymakers shouldn’t cling to prohibitionist instincts that have repeatedly failed. Expanding access to reduced-risk products is a commitment to public health grounded in evidence, common sense, and compassion.
Ross Marchand is the executive director of the Taxpayers Protection Alliance.