Study Raises Questions About Anti-Vaping Bias at FDA

"The health care costs attributable to vaping are already substantial and likely to increase." So concluded the authors of a study just published in the journal Tobacco Control. They based this conclusion on the results of a model that compared the self-reported vaping habits and health care consumption of a few thousand participants from the National Health Interview Survey (NHIS). Exclusive use of e-cigarettes generated $1.3 billion worth of health care expenditures in 2018 alone, they found.

The study had several critical flaws, as my colleague Dr. Chuck Dinerstein noted, the most serious being “the assumption that e-cigarette use would negatively impact an individual’s health and that this negative impact would increase utilization and cost.” The authors assumed what they should have demonstrated.

That's especially troublesome because existing evidence suggests that vaping is far less harmful than smoking. Instead of boosting healthcare expenditures, e-cigarette use probably reduces the amount of money spent to treat sick smokers. In sum, the Tobacco Control paper is terrible—“a baffling piece of work,” as Peter Hajek, Director of the Tobacco Dependence Research Unit at Queen Mary University of London, put it.

While the research itself is scientifically suspect, two other troubling details have come to light in recent days. First, the Food and Drug Administration (FDA) paid for this low-quality study—then publicly denied any involvement until the paper was published. Second, the agency's actions appear to reflect a broader effort to shape the peer-reviewed vaping literature, then use it to justify excessive e-cigarette regulations.

“Completely false and inaccurate”

Last Friday, a vaping-industry trade group called the American Vapor Manufacturers (AVM) reported on Twitter that it had “received a first-hand tip that the federal government was involved in an embargoed announcement set for this evening.” [1] All AVM knew was that “the announcement was connected to federal vaping policy.” Michael Felberbaum, assistant commissioner for media affairs at the FDA, was quick to dispute AVM's report:

“This is completely false and inaccurate. There is no FDA vaping-related policy announcement on Monday. There has been no information shared with anyone because there’s no announcement to share information regarding.”

AVM deleted its previous tweet following Felberbaum's repudiation, but the Tobacco Control paper, published on Monday, May 23, clearly contradicted both of his assertions. The authors acknowledged that “This study was funded by National Heart, Lung, and Blood Institute and the Food and Drug Administration (FDA) Center for Tobacco Products (Grant number: U54 HL147127.” In a sidebar titled “What this paper adds (p 5),” the authors also explained how their work could “affect research, practice and/or policy”:

“This first estimate of healthcare utilization and expenditures attributable to e-cigarette use will provide valuable information to Food and Drug Administration regulatory impact analyses of proposed regulations that affect e- cigarette use.”

An abstract of the grant published by Grantome (a database that tracks public research funding) tells the same story:

“Healthcare costs play a central role in FDA regulatory impact analysis … The healthcare cost estimates from this project will be useful metrics for measuring the impact of tobacco use on public health, allowing a comparison of the relative magnitude of health effects of different tobacco products on specific populations.”

Anti-vaping bias at FDA?

Political influences sometimes bias the policy and messaging of federal agencies; it's neither surprising nor noteworthy that the FDA appears to have succumbed to such pressure in this one instance. What's striking, however, is the agency's overall adversarial approach to e-cigarette regulation.

At the same time it funds anti-vaping research, the FDA continues to restrict the number of e-cigarette products adult smokers can legally purchase; the few options that remain on the market are mostly sold by tobacco industry-owned brands. Documents just released via a freedom of information request (FOIA) indicate that the agency has made it a priority to review these products ahead of millions of others from smaller manufacturers.

What might explain the FDA's seemingly biased stance? A branch of economics called Public Choice Theory provides some helpful insight. Researchers this field have found that people working in government are primarily motivated by the same incentive that drives behavior in the marketplace—self-interest. According to Jane Shaw, senior associate at the Political Economy Research Center:

" Their incentives explain why many regulatory agencies appear to be 'captured' by special interests ... Capture occurs because bureaucrats do not have a profit goal to guide their behavior. Instead, they usually are in government because they have a goal or mission. They rely on Congress for their budgets, and often the people who will benefit from their mission can influence Congress to provide more funds.

Thus interest groups—who may be as diverse as lobbyists for regulated industries or leaders of environmental groups—become important to them. Such interrelationships can lead to bureaucrats being captured by interest groups. "

We can't know for certain what motivates the FDA's behavior, but there are several reasons to suspect that this capture phenomenon is in play. The agency’s Center for Tobacco Products (CTP) is funded exclusively by “user fees” from tobacco manufacturers and importers, the vaping industry's primary competition. As if written with Shaw's analysis in mind, the 2009 Family Smoking Prevention and Tobacco Control Act established the center,  legislation "crafted, in part, by the nation's leading cigarette company, Philip Morris," Boston University tobacco policy analyst Dr. Michael Siegel noted in June 2009.

The Tobacco Control Act stipulates that "the tobacco fees are only available pursuant to an annual appropriation from Congress, which provides FDA the authority to collect and spend fees." These user fees represent a staggering amount of money, the Government Accountability Office reported in 2014:

As of March 31, 2014, the Food and Drug Administration (FDA) spent about $1.48 billion (79 percent) of the $1.88 billion in total tobacco user fees it collected since fiscal year 2009. FDA spent the majority of tobacco user fees on key activities led by the agency’s Center for Tobacco Products (CTP), which is funded solely by tobacco user fees.

To sum things up thus far, the FDA funds questionable vaping research, which it uses to inform heavy-handed e-cigarette restrictions. This effort is led by the CTP, which relies on tobacco-industry user fees, as the agency itself acknowledges. That arrangement is unique to the CTP; the Congressional Research Service reported in 2021 (p 4) that FDA's other centers “are generally funded by a combination of discretionary appropriations from the General Fund and user fees.”

Shaping research and media coverage

There is clear evidence that the FDA's stance on vaping has influenced much more than this single Tobacco Control paper. The kinds of studies many academic researchers can pursue as they investigate the health effects of e-cigarettes are heavily influenced by FDA regulation. The authors of a February 2022 analysis summarized it this way:

In the US, research of EC [electronic cigarettes] as a smoking cessation aid is not permitted because EC are regulated by the Food and Drug Administration (FDA) as consumer tobacco products and not as a medical device. As a result, only harm-reduction studies are currently permitted and not cessation studies.

Additionally, due to misconceptions about safety and to avoid controversy by appealing to popular opinion, leadership at potential study sites has shown hesitancy in allowing EC intervention research to occur within their patient populations.

We also have reason to suspect that the FDA shapes how major media outlets cover vaping research. Documents acquired through another FOIA request seem to indicate that the agency has vetted entire stories published in the New York Times.

In one email chain from May 2014 (screenshot below), three FDA staffers appear to have discussed how much influence they wielded over the final text of a piece authored by Times reporter Sabrina Tavernise. “I'd so like to write them [the Times] back and tell them how much Sabrina relies on Us for her stories,” Steven Immergut, former FDA acting associate commissioner for external affairs,” wrote to his colleagues. “Quote approval?? Please..How about entire story vetting! That would be a story.”

Commentators routinely seek input from federal agencies on regulatory issues; ACSH contacted the FDA for comment on this story and received no reply. But as common sense should dictate, allowing the FDA (or any other stakeholder) to approve a story is unacceptable. For example, when it was discovered that a tobacco-industry PR firm had quietly paid for and vetted a pro-smoking story published in True Magazine in 1968, the public health establishment rightly went berserk. Yet strikingly similar behavior from a federal agency with a massive conflict of interest has engendered almost no criticism.

Conclusion

Research has shown that e-cigarettes are much less harmful than combustible tobacco and very effective as smoking-cessation tools. I haven't purchased a pack of Camels in nearly a decade thanks to vaping, and many other ex-smokers tell similar stories. But none of this seems to matter to the FDA, major medical journals, anti-smoking groups, or corporate news outlets, all of which seem committed to discouraging e-cigarette use.

So, here were are. Tobacco-related diseases continue to kill thousands of people every year. We finally have a viable intervention that could help save many of these lives, yet the institutions that should welcome this news seem to view vaping as a threat. We may never know with certainty what motivates this behavior. But if the FDA is really committed "to safeguarding the public health," it will quickly reverse course. 

[1] A Twitter user alerted us to AVM's comments about FDA support for the Tobacco Control study. We followed up with the trade group and verified the claims they made. ACSH has no financial ties to the vaping industry.