In the 14 years since the Food and Drug Administration (FDA) was granted what it had for decades sought — power to regulate tobacco and tobacco products — it has sought to expand its reach. One way the agency has done this is by waging a misguided, years-long crusade against e-cigarettes.
FDA’s broad tobacco mandate, overseen by its Center for Tobacco Products (CTP), is to “regulate the manufacturing, marketing, and distribution of tobacco products to protect public health.” In this endeavor, the FDA claims that it “evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
Inherent in this mission statement is the underlying goal to reduce or eliminate cigarette smoking in the United States — arguably a reasonable though certainly not universally supported point of view. What is unreasonable, however, is the FDA’s regulatory record over the past several years as measured by its stated objective.
For example, CTP has in recent years approved, without any scientific review, nearly 900 new brands of cigarettes produced by dozens of companies; new brands on top of the billions of packs of cigarettes already approved for consumers. This fact alone appears completely at odds with the parent agency’s mission.
The confusion becomes bewildering when considering that, during this same period, CTP has approved less than two dozen e-cigarette products, despite acknowledging that e-cigarettes are an effective alternative to the far more health-damaging cigarette smoking.
Simply put, e-cigarettes have not gotten a fair shake in the agency’s taxpayer-funded activities, the result (to some extent) of bad behavior by a select few companies that improperly directed their marketing to young audiences.
However, the abundant volume of scientific evidence on the effectiveness of e-cigarettes in helping adults quit or reduce their smoking is nothing short of overwhelming — evidence that has been largely ignored by CTP.
One of the most credible studies, authored by Georgetown economist Robert J. Shapiro, evaluated the strength of the evidence on e-cigarettes as an effective harm-reduction and smoking-cessation tool, puts it clearly: “The single most effective way to help people stop smoking, which kills 480,000 people per year, is to encourage them to switch to vaping, which kills no people per year.”
Shapiro who, ironically has advised Presidents Clinton, Obama, and Biden, goes on to say that “this is no longer a matter of serious controversy among scientists” — unless, of course, you work at the FDA.
Under CTP Director Brian King — a career bureaucrat who was the Chief Science Officer for CDC’s highly controversial COVID-19 response – the FDA has completely squashed individual choice around e-cigarette use, and instead pointedly instructs Americans to use only the pharmaceutical products that won FDA’s self-defined stamp of approval.
The CTP’s bias against e-cigarettes is evident in the fact that of the 26 million premarket tobacco product applications presented to the Center, a miniscule 23 have been granted — a clear violation of its regulatory mandate and its commitment to public health.
The FDA pays lip service to the benefits of e-cigarettes but has simply ignored the latest science on e-cigarettes, which have been found to be more effective for smoking-cessation than FDA’s approved medicines. To justify its pinched approach, the FDA repeatedly relies on the trope that “No tobacco product is safe.”
This is disappointing, but unsurprising. Since the start of the COVID-19 pandemic, government agencies and institutions, including the NIH and the CDC (with King as its Chief Science Officer), have sought to justify their own existence and exercise control over the American public. Mask mandates, and the lie that receiving the COVID jab will provide immunity and prevent you from passing the infirmity to others, are just two critically important examples of how this approach has failed us.
To regain the public’s trust, largely lost amidst the COVID fiasco, the FDA should stop acting as a political and prohibitionist nanny, and simply regulate within its mandate. A good first step would be to start being honest and transparent with the American people about e-cigarettes being far less harmful than cigarettes.
Such transparency, based actually on scientific evidence, would be a welcome change of pace for an agency that is supposed to protect the public from the harmful effects of tobacco. It would also make for an interesting congressional oversight hearing, perhaps even garnering kudos from some Republicans.
