About six months ago, the Reagan-Udall Foundation sent the Food and Drug Administration its Operational Evaluation of FDA's Tobacco Program. this is a report that the FDA itself requested in July of 2022. How is the Center for Tobacco Products (CTP) implementing the recommendations of the report to date?
I was skeptical that the report would be anything more than a whitewash, calling only for more funding and more authority for the CTP. However, the report proved me wrong: it was thorough, specific, and hard-hitting, calling for many substantive changes in how the CTP operates.
The report also accurately reflected input that the Foundation sought from internal and external stakeholders (myself included). The report summarized that input as follows:
While acknowledging the extensive work by FDA and CTP, internal and external stakeholders expressed concerns about a lack of clarity, transparency, and communication regarding CTP's priorities and its decision-making processes, particularly regarding important public policy decisions associated with applying the Appropriate for the Protection of the Public Health (APPH) standard in the TCA. These concerns affected all four of the program areas within the scope of the Panel's review (i.e., regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders). Many stakeholders expressed concern about the lack of clear, consistent, and transparent policies. For example, in 2017, the Agency announced its intention to apply a harm reduction strategy designed to move tobacco product consumers down the continuum of risk from using combustible tobacco products to noncombustible products. However, stakeholders observed the Agency's more recent marketing authorization decisions appear to reflect a policy shift—specifically a reluctance to authorize any Electronic Nicotine Delivery Systems (ENDS) other than those that are tobacco-flavored. If such a policy shift occurred, the Agency did not specifically announce it in a regulation or guidance, leaving stakeholders to glean it from documents posted on FDA's website such as a Technical Project Lead (TPL) Review of PMTAs, MDOs posted in abbreviated form, or from heavily redacted documents provided in response to Freedom of Information Act (FOIA) requests.
The report found that the CTP often operated in reactive mode, lacked a strategic plan, and "struggled to function as a regulator in part due to some of its own policy choices."
The Regulatory Transparency Project reviewed the report in a December 2022 Explainer podcast, and we discussed the FDA's initial response to the report in a more recent podcast.
In the nearly six months since the CTP received the report, little has changed.
As I predicted in the Explainer podcasts, the House Committee on Oversight and Accountability has since opened an investigation into the CTP. In a March 28 letter to FDA Commissioner Robert Califf, Chairman James Comer, wrote,
A recent evaluation of CTP by the Reagan-Udall Foundation (RUF) found that CTP has not clearly set out the most basic elements of its tobacco and nicotine regulatory programs. This has resulted in confusion, inefficiency, litigation, and suspicions of political interference. CTP has fostered uncertainty in the marketplace and has allowed unsafe and unregulated products to proliferate. Therefore, we seek documents and information regarding CTP's activities to enable transparency and to ensure the CTP is performing required functions."
Today, more than a month after Chairman Comer's April 11 deadline, the FDA has still refused to provide the documents the committee requested. So much for increased transparency.
Many legal challenges to CTP's actions continue to wend their way through the legal system.
Most recently, in March, the Fifth Circuit court maintained a stay on the FDA's marketing denial order for R.J. Reynolds Vapor menthol flavored e-cigarettes. One basis for the court's decision was that the denial order, along with earlier denials on all other flavored e-cigarettes, amounted to a de facto flavor ban. I highlighted this issue in a 2021 Regulatory Transparency Project Fourth Branch Video.
Professor Jonathan Adler's analysis of the Reynolds case is worth reading. The decision is in stark contrast with the Fourth Circuit's rulings against Avail Vapor, LLC, setting the stage for a potential showdown at the Supreme Court. This spring, Avail petitioned the Supreme Court for certiorari.
The FDA's words and actions since the Reagan-Udall report offer little evidence of either contrition or reform. But a careful reading of the agency's statements alongside a batch ofmarketing denial orders issued on May 12 for 6,500 flavored e-cigarettes gives insight into the agency's regulatory stance, as well as where it might see itself as most vulnerable in the courts.
First, CTP Director Brian King stated, "It is the applicant's responsibility to provide scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of public health." This is indeed longstanding FDA policy. However, had the agency been executing a strategic plan which followed its own July 2017 comprehensive plan for tobacco and nicotine regulation, the FDA might have acted differently. The 2017 plan envisioned moving adult smokers down a continuum of risk to FDA authorized non-combustible nicotine products. Towards that end, the agency must see applicants as potential public health partners with the agency to implement its tobacco harm reduction policy. Instead, the FDA is choosing to avert its regulatory eyes from any scientific evidence (not provided by an applicant) that nicotine e-cigarettes are more effective than traditional nicotine replacement therapy to help smokers quit smoking.
Second, Dr. King continued, "That bar of scientific sufficiency has not been met to date for any flavored e-cigarette product, including in this instance. But if an applicant were to meet that bar, FDA would authorize the product." This is a new formulation from the agency, which is famously tight-lipped about hypothetical circumstances that might give potential applicants insight into what scientific evidence should be submitted to meet the regulatory bar.
But ironically, this statement actually does nothing to give applicants specific guidance on what scientific evidence the CTP is seeking. That lack of clarity is central to not only the findings of the Reagan-Udall report, but more tellingly, to many of the legal challenges, such as the Fifth Circuit's analysis that the Reynolds marketing denial order was arbitrary and capricious. Instead, Dr. King's statement appears to be an effort to push back against the court's finding that the FDA's track record of not authorizing any flavored e-cigarettes amounts to a de facto ban on flavors.
Such a policy would have required the FDA to go through a rule-making process, which it did not do. (Interestingly, the FDA did attempt to ban non-tobacco or menthol flavors when it issued the Deeming Rule during the Obama administration. But the Department of Health and Human Services objected, and the ban was not included in the final rule.) Nonetheless, pledging that the FDA will authorize flavored e-cigarettes whose applications meet this never elucidated standard is different from actually doing so.
Another area where there's been little transparency recently is about FDA's plan to regulate premium cigars. In July 2022, the District Court for the District of Columbia ruled that the FDA's inclusion of premium cigars in the Deeming Rule was arbitrary and capricious. In my research for this article, I asked the FDA how it plans to proceed in terms of regulation of premium cigars in light of the court's decision. But the CTP did not respond to numerous inquiries on the matter. This lack of clarity leaves an entire segment of the industry in a perpetual state of uncertainty. This is the very type of situation the Reagan-Udall report admonished the CTP for nearly six months ago.
At the center of the tobacco harm reduction debate is the need to prevent the use of e-cigarettes by minors while at the same time standing up a regulated marketplace of lower-risk alternatives that would appeal to adult smokers so that they switch and reduce their risks. The crux of that debate is around the regulation of flavored e-cigarettes, which are popular among former adult smokers who use these sweet flavors to quit smoking. As it stands now, the FDA is not trying to strike a balance between these two interests, but is implementing a zero-tolerance policy against youth vaping: if kids vape flavors, flavors should be banned, no matter how much benefit those flavors play in smoking cessation among adults.
New survey results from the Centers for Disease Control and Prevention (CDC) show that only 11 percent of American adults reported smoking, an all-time low, down from 12.5 percent in 2020. At the same time, adult use of e-cigarettes has increased from 4.5 percent to 6 percent. That increase, given that it is likely that many of those new adult e-cigarette users are former smokers, is good news.
So I thought it would be telling whether the FDA shared my view that the corresponding uptake in adult vaping might be a contributing factor to the ongoing historic decline in adult smoking. I can understand how frustrated Chairman Comer must be with FDA's failure to respond to his request for information, because the FDA hasn't responded to my many requests on this topic.
One matter I thought the FDA would respond to was an issue that came up in the Reagan-Udall report process. The FDA is aware that there are misconceptions about nicotine. Between 49 percent and 80 percent of U.S. adults believe that nicotine (rather than products of combustion) causes most smoking-related cancer. In fact, research over the last two decades consistently shows that smokers in the U.S. and beyond have little knowledge of the risks of nicotine as opposed to the risks of smoking. Indeed, the Reagan-Udall Report found:
Many stakeholders stated that additional truthful and accurate information to help adult consumers make informed decisions about the role of nicotine and the risks of combustible and smoke-free products is needed. In particular, some stakeholders were interested in CTP clarifying the role of vaping, beyond warning against youth use, and communicating more clearly about harm reduction and the relative risk of tobacco products.
So I asked the FDA, in light of its stated intention to implement reforms recommended by the report, what educational plans it is developing to further reduce adult smoking through the use of e-cigarettes. Like Chairman Comer, and, more importantly, many misinformed smokers, I continue to await an answer.
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