These comments were presented before an expert panel organized by the Reagan-Udall Foundation. This expert panel was convened as part of the Reagan-Udall Foundation’s operational evaluation of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products.
I want to thank the expert panelists for including this public dialogue as part of their evaluation of the U.S. Food and Drug Administration (FDA). I would also like to make it clear that my interest in this conversation is not to advocate for or against any particular product or company. My interest is in people, the individual human beings whose lives can be drastically affected, for good or for bad, by the way government agencies approach regulation. It is people who are at the heart of the discussion about tobacco regulation and this investigation into how well the FDA is fulfilling its public mission.
While there is no shortage of debate when it comes to how tobacco products should be regulated, there is widespread agreement that the current approach adopted by the FDA is not working. The enormous challenge facing the experts on the panel is to shed light on why that is the case and what can be done to fix it for the benefit of the public. To that end, I offer the following comments, and I hope they will bring some sober clarity to a controversial issue.
The overarching message I would like to communicate is this: Unless there is a viable pathway for safer products to enter the market legally, there will be no innovation toward safer products, and we will continue to condemn the millions of current and future adults who enjoy the non-medical use of nicotine to one of two undesirable options—illicit market products or deadly combustible cigarettes.
Challenge #1: A comprehensive approach to tobacco and nicotine regulation that is principles-based, reasonable, and implemented consistently across all programs
For nearly every other risky or potentially harmful behavior, we recognize that incentives matter. It is generally acknowledged that regulation cannot prevent risk, but it can encourage markets and people to be as safe as possible. Seatbelts, helmets, electric vehicles, contraception, pre- and post-exposure prophylaxis, ridesharing, opioid maintenance therapy, and Narcan are just a few examples of how the market, unhindered by regulation, has provided means to reduce the potential harm of risk-taking behaviors, both for the individuals engaging in that behavior and for those around them.
Yet, when it comes to tobacco, the FDA, whether accidentally or not, has adopted an approach that maximizes, rather than minimizes, harm. Instead of promoting public health through a regulatory process that champions innovation, the agency has made it all but impossible for such innovation to occur or, at least, for the products of innovation to make it into consumers’ hands.
The result is that, unlike all other areas of our lives, FDA regulation has preserved and protected the most dangerous form of nicotine use, smoking combustible cigarettes, from extinction.
This is, in part, because the regulatory framework was structured around cigarettes with the goal of suppression. Unfortunately and unsurprisingly, this framework has made it impossible for truly novel products to enter the market. Many see this blockade of new nicotine products as a positive outcome, but the perverse unintended effect is that it is still easier for combustible cigarettes to gain FDA authorization than the safer products that could displace them. Worse, it leaves consumers who already rely on less harmful forms of nicotine use frustrated and most of the public confused about the relative risks and benefits of various products.
It doesn’t have to be this way and, for a moment in 2017, it seemed the FDA recognized the need to modernize its approach in response to the market’s rapid shift toward tobacco harm reduction. In that year, the agency announced its comprehensive plan for tobacco and nicotine regulation which recognized that tobacco products exist on a continuum of risk, that nicotine, while not risk-free, is not the main source of tobacco-related mortality or morbidity, and acknowledged that in the best interest of public health, the agency’s approach to reducing the harms caused by smoking required an equal effort to promote less harmful alternatives.
This plan, had it been implemented, would have likely addressed many of the challenges the FDA now must address. Unfortunately, while the agency has taken steps to reduce the appeal of combustible cigarettes, it has apparently abandoned its promise to promote the development of and consumer access to safer nicotine alternatives. And the continued failure of the FDA to adhere to any sort of comprehensive approach could have disastrous consequences. Take, for example, the FDA’s proposed prohibition on menthol as a characterizing flavor in combustible cigarettes and cigars.
The goal of the proposed menthol ban is to reduce the appeal of combustible cigarettes, used disproportionately by people of color. According to the FDA’s calculations, the ban would result in less initiation of cigarettes by youth, increase smoking cessation among adults, and lead to better health outcomes in many populations.
Those calculations, however, were based on certain assumptions about how consumers might respond to such a ban, given the other options available to them. Surprisingly, a great amount of the health benefits the FDA expects a menthol ban to produce, upwards of half, come from consumers replacing combustible menthol cigarettes with mentholated versions of noncombustible e-cigarettes. The problem with this is that few menthol smokers will have this option as the FDA has so far not authorized a single mentholated e-cigarette and has given little reason to believe they ever intend to do so.
Recommendations for FDA:
- Issue an updated comprehensive approach to tobacco and nicotine that is principles-based, reasonable, and implemented consistently across FDA programs to guide regulation and research. In addition to the 2017 plan, we suggest they refer to the Institute of Medicine’s 2001 Clearing the Smoke report.
Challenge #2: Compliance standards that are clear, transparent, and predictable
In the first public meeting the Reagan-Udall Foundation held on this topic, one of the stakeholders expressed his belief that tobacco manufacturers, including those of lower-risk nicotine products, have no interest in being regulated and have intentionally submitted deficient pre-market tobacco applications in order to slow down enforcement by the agency.
But within the nicotine alternatives market are thousands of small businesses who desperately want to understand what the FDA wants from them in order to approve their products for legal sale and reasonable regulations that would protect their companies, as well as the entire market, from bad actors.
The problem is not that the industry doesn’t want to comply with FDA regulations, the problem is that they cannot. By constructing an opaque and seemingly arbitrary pre-market authorization process and by failing to set reasonable standards, the FDA has created regulatory hurdles too high for all but the largest tobacco makers to surmount.
Recommendations for FDA:
- Set clear and consistent standards, requirements, and thresholds.
- Provide detailed definitions for critical terms like “appropriate for the protection of public health” and disclose how those definitions are calculated or determined.
- Be more transparent, cooperative, and flexible; convening meetings for public discourse, workshops, and unbiased explanations for its decisions and conclusions.
Challenge #3: A more appropriate balance between innovation, risk, and the needs of various populations
The FDA’s interest in preventing potentially harmful products from entering the market is understandable. However, aversion to this risk must not come at the expense of squashing innovation that could have a positive net benefit to public health. Nor should the agency’s aversion to the small potential risks presented by new products blind the FDA to the potential risks caused by a market that is too tightly regulated that it spurs the proliferation of illicit markets or denies consumers potentially life-saving alternatives.
Similarly, the FDA’s concern about youth experimentation and initiation with novel nicotine products is reasonable. But that concern should not lead to decisions made at the expense of current and future adult smokers. The FDA certainly has a role to play in addressing the population-level risks associated with novel tobacco products, but unlike matters such as those relating to product safety, these concerns do not justify the existing bottleneck created by the FDA’s onerous pre-market approval regime.
Challenge #4: More efficient pathways to the authorization of lower-risk products
Many of the challenges faced by the FDA’s Center for Tobacco Products (CTP) in recent years stem less from resource limitations than they do from choices regarding implementation and priority-setting.
The FDA has thus far given marketing orders to just a handful of noncombustible products, the vast majority of which are owned by large tobacco firms. This will continue to be the case so long as the approval process remains onerous, slow, and wasteful. Other nations have structured regulations based on standards and thresholds, which make compliance and, more importantly for the FDA, verification a far easier and less resource-intensive task.
The results of this standards-based approval regime are vibrant markets, with devices and flavors that meet consumers’ needs, without the problems of youth experimentation that have so vexed U.S. health authorities. Adopting a similar standards-based approach, with streamlined pathways, categories for products and components, and a substantial equivalence for novel lower-risk products would allow companies (as well as the FDA staff) to conduct more efficient reviews, ensuring that the rules encourage compliance, protect the public, and leave nobody behind.
Recommendations for FDA
- Use rulemaking power to establish streamlined Premarket Tobacco Product Application (PMTA) pathways for non-combustible products rather than forcing those products likely to be significantly less harmful than smoking to an outdated pathway even more onerous than for combustible cigarettes.
- Create a standards-based regime, with a small number of reasonable criteria for products the FDA would approve, similar to how regulation occurs in France and the United Kingdom.
- Create a substantial equivalence pathway for novel lower-risk products. This could be accomplished by “deeming” all those products which have or will receive marketing orders by the FDA as “predicate” on a rolling basis.
- Create a definition for “minor” changes as opposed to “significant” changes and created a streamlined approval process for minor changes (such as those relating to packaging, container size, and other modifications not expected to increase the potential risk of the product).
- Conduct periodic performance reviews to assess how well FDA regulation is working for consumers of reduced-risk products, based on turnaround for applicants, number of approvals for sufficient applications, and market dynamism.
- Hold public meetings with small industry participants to inform such performance reviews.