R Street Comments on the FDA-CTP Strategic Plan

Food and Drug Administration – Center for Tobacco Products
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Docket No. FDA–2023–N–2873

Dear Dr. Brian King, Director of the Food and Drug Administration’s Center for Tobacco Products,

The R Street Institute (R Street) respectfully submits comments on the development of the Food and Drug Administration’s (FDA’s) Center for Tobacco Products (CTP) Strategic Plan. R Street is a nonprofit, nonpartisan public policy organization focused on advancing limited, effective government in various areas, including Integrated Harm Reduction, Criminal Justice and Civil Liberties. A foundational component of our work is a belief that health policy grounded in harm reduction has the potential to drastically reduce the negative consequences associated with various harmful behaviors while significantly relieving the burden of cost on the healthcare system. Our overall strategy stems from a simple insight well supported by decades of research and experience: abstinence-only approaches do not work at a population level for any risky behavior. Policies that try to restrict behaviors, such as smoking, via prohibition and criminalization are followed by various unintended negative consequences.

We would like to begin by commending the CTP for its desire to refine its processes and return with some key initiatives to address. Though not comprehensive, the Reagan-Udall Foundation’s evaluation identified several critical areas for CTP to focus on to improve the center’s effectiveness.[1] The five proposed goals that CTP shared as an initial step toward their 5-year strategy are essential to improving the center’s function. While important, our concerns are that these steps may have been prioritized over other, more pressing gaps and should be reconsidered to address more immediate issues that, if resolved, would have the greatest impact on public health.

I. Critical Evaluation of Past CTP Achievements Toward Historical Objectives

In 2017, the CTP identified its key strategic priorities: 1) Product Standards; 2) Comprehensive FDA Nicotine Policy; 3) Pre & Post-Market Controls: Regulations and Reviews; 4) Compliance and Enforcement; and 5) Public Education.[2] We believe that before revising new strategic goals, the CTP should reflect on its initial goals and if those have been achieved. Many would argue that most have yet to be realized due to a lack of clear definitions. There are no clear standards for tobacco/nicotine products, no clear policy on nicotine-containing products, limited effectiveness of review pathways, no effective processes related to enforcement, and unclear and non-science-based education programs.

The currently proposed goals should, first and foremost, not supersede the initial goals and priorities of the CTP.[3] There are few product-related requirements published in the Premarket Tobacco Product (PMTA) guidance documents.[4] Based on the CTP’s own admission, when the guidance was established, many questions about reduced-risk products existed and few scientific studies had been completed.[5] Due to this lack of clarity, millions of PMTAs have been processed and the overwhelming majority of them have been rejected; in fact, only 45 products have received product marketing granted orders (MGO).[6]

Though significant concerns exist with the current CTP programs, there is a need to prioritize improvement in the guidance to applicants. There is a clear distinction between where the CTP is today and when it crafted and published the initial guidance. The science around the once novel reduced-risk products has matured and the CTP has actually granted marketing orders.[7] This clearly signals that internally, the CTP has established its requirements to achieve a marketing order for electronic nicotine delivery systems, heat-not-burn products and oral tobacco products, though only a few have been approved. Clearly, whatever bar the applications had to rise above, they met the CTPs internal standards for marketing a reduced-risk product, so those standards are now known to the CTP. The FDA-CTP should follow the lead of other, more established FDA Centers and swiftly publish updated guidance that formalizes these standards, what specific studies are required and any other critical information points needed for a successful application.[8] Currently, only the most prominent and wealthy manufacturers can produce applications with a broad array of studies, hoping that some data hits the unobservable target that the CTP has set. Providing measurable standards, testing regimens and minimal research requirements will allow for process clarity to be established and open the door of opportunity for small and mid-size companies to compete in the reduced-risk product marketplace.

II. Clearly Define the CTP Mission Statement

One of the most used phrases by those that communicate for the  CTP is the legal statute, Appropriate for the Protection of Public Health (APPH).[9] The statement includes a requirement to evaluate the potential risks and benefits to the whole population when considering an applicant product. While the law is clearly weighted toward keeping harmful products out of the marketplace and encouraging consumers to reduce the use of combustible products, it also requires that the CTP allow for the marketing of less harmful nicotine products and educate consumers on the potential to quit smoking or switch to products that may replace cigarettes and significantly reduce the exposure to the toxic constituents of cigarette smoke.[10] Tobacco harm reduction policies have been an accepted (and scientifically evaluated) approach as an alternative to those that smoke but choose not to quit or are unable to quit.[11] When evaluating the whole of the nicotine and tobacco scientific literature and including the past several years of CTP activities and decisions, the APPH statement can be more precisely defined with clear measurables for each aspect of the statement.

Additional clarity should be a priority for the CTP. For example, defining the actual risks and harms of acceptable alternative nicotine products would provide a baseline against which future products can be measured. For example, when the CTP identified the uptick in the use of tobacco and nicotine products, a clear and actionable goal was identified and legislation was implemented. Tobacco 21 (T21) was a clear step forward to help protect youth from easy access to tobacco and nicotine products.[12] This addition to regulations has actively reduced the ease of access to those under the age of twenty-one that should not use tobacco or nicotine products.[13] The establishment of T21 allows for a greater emphasis to be placed on supporting and protecting the health of adults that choose to continue to use tobacco or nicotine products.

Currently, the APPH’s narrow interpretation is focused nearly exclusively on inhibiting youth access yet T21 is designed to protect youth in the same manner as other age-restricted behaviors. Instead, the CTP should focus on clarifying and identifying how the APPH is applied to the breadth of the general public (adults over the age of twenty-one) and allow products that reduce risk and provide attractive alternatives to those that smoke. The CTP need not inadvertently promote a philosophy in which adult lives are dispensable based on youth trends.

III. Clearly Articulate and Communicate a Scientifically Based Tobacco and Nicotine Policy

Additionally, establishing and publishing a transparent, science-based nicotine policy should be prioritized. Over the past decade, messaging around tobacco harm, tobacco control and harm reduction has vacillated dramatically due to unforeseen innovation and the introduction of new products.[14] The CTP has always stated that science was its north star, and that should continue to be the case.[15] The CTP should prioritize a straightforward, consistent education program that simplifies the science around smoking behavior and tobacco harm reduction.

Embracing a science-based tobacco harm reduction approach will serve dual purposes. First, it allows a potential landing zone for those who currently smoke but are either unable or unwilling to quit the use of combustible products, allowing those smokers to mitigate the harm experienced.[16] Second, for those that have concerns around cognitive function and untreated mental health issues, having non-combustible nicotine products, a less harmful option available, would allow some resolution of symptoms or improvement in quality of life.[17]

Regardless of why people choose to use a tobacco or nicotine product, demonizing and sensationalizing the behavior has not resulted in behavioral changes. A more rational, science-centered approach that allows for the continuation of similar behaviors and access to desired experiences but in a safer manner provides a roadmap that leads to a healthier population.

IV. Apply Product Standards Equally Across All Tobacco and Nicotine Products

Finally, gaps and loopholes in regulating tobacco and nicotine products must be closed. Open or closed electronic nicotine delivery systems (ENDS), disposable and reusable products, all combustible products (roll-your-own, cigars, hookah), and tobacco or synthetic oral nicotine products must have the same rules. The CTP has provided marketing orders for thousands of combustible products, yet most non-combustible reduced-risk products have failed to obtain the same result.[18] Very few ENDS products have received MGOs, but there is a plethora of nicotine-containing disposable and open ENDS products that find their way into the hands of consumers.[19] Many of these unregulated products carry the same marketing imagery (cartoons, etc.) and flavor descriptors (candy, etc) which were, at least partially, the impetus of the initial uptick in underage adoption of vaping.[20] These loopholes allow for increased risk for the population and continued confusion regarding the effectiveness of the CTP’s ability to evaluate and enforce the laws and regulations they have mandated. By holding all tobacco and nicotine consumer products, regardless of form, to the same scientifically determined and well-defined standards, transparent and enforceable policies would be possible.

V. Summary of Recommendations

1. Communicate the strengths and weaknesses of the previous iterations of the CTPs articulated goals.
2. Use the historical review and current knowledge to clearly define a mission statement and a new interpretation of the APPH standard.
3. Develop evidence-based policy goals that leverage a tobacco harm reduction posture for adult consumers and outline measurable outcomes.
4. Apply risk-proportionate product standards across and within product classifications to achieve transparency.

In summary, behavioral change is difficult, whether in an individual or an institution. For the CTP to achieve its overarching goal of protecting the health of the U.S. population, any review process or five-year plan has to be centered on three pillars: 1) A clear identification of plans to change inefficient functions; 2) A clear understanding of overarching and driving objectives; and 3) A coherent plan to provide, assess, and communicate measurable outcomes.

The R Street Institute profoundly appreciates the opportunity to comment on the proposed goals and we look forward to providing additional commentary when the complete 5-year plan is published. A well-functioning and efficient CTP is in the best interests of consumers, industry and policymakers. We hope the Center reviews this feedback and that it provides additional viewpoints that will help formalize your vision. We want to reiterate that the fewer people who smoke, the better. We believe, however, that harm reduction is a more effective way to address smoking disparities than prohibition and the negative consequences that can arise from regulating human behaviors.

Respectfully submitted,

Jeffrey S. Smith, Ph.D.
Resident Senior Fellow

R Street Institute

[1] “Operational Evaluation of FDA’s Tobacco Program,” Reagan-Udall Foundation for the FDA, last accessed Aug. 9, 2023. https://reaganudall.org/operational-evaluation-fdas-tobacco-program.  

[2] “CTP’s Key Strategic Priorities,” U.S. Food and Drug Administration, last accessed Aug. 9, 2023. https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/ctps-key-strategic-priorities.

[3] “Listening Session: Developing FDA’s Center for Tobacco Products Strategic Plan,” U.S. Food and Drug Administration, last accessed Aug. 9, 2023. https://www.fda.gov/tobacco-products/ctp-newsroom/listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023#Proposed%20Strategic%20Goals.

[4] “Premarket Tobacco Product Applications,” U.S. Food and Drug Administration, last accessed Aug. 9, 2023. https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications#.

[5]  Center for Tobaccos Products, “Modified Risk Tobacco Product Applications Guidance for Industry,” Food and Drug Administration, March 2012. https://www.fda.gov/media/83300/download.

[6] “Premarket Tobacco Product Applications,” https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications.

[7] “Premarket Tobacco Product Marketing Orders,” U.S. Food and Drug Administration, last accessed Aug. 9, 2023. https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-granted-orders.

[8] Ibid; U.S. Food and Drug Administration, “HACCP Principles & Application Guidelines,” U.S. Food and Drug Administration, last accessed Aug. 9, 2023. https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines; “Standards and Conformity Assessment Program,” U.S. Food and Drug Administration, last accessed Aug. 9, 2023. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/standards-and-conformity-assessment-program.

[9] “Family Smoking Prevention and Tobacco Control Act,” U.S. Food and Drug Administration, last accessed Aug. 9, 2023. https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-overview.

[10] Eric N Lindblom, What Is “Appropriate for the Protection of the Public Health” Under the US Tobacco Control Act?, 74 FOOD AND DRUG LAW JOURNAL (2019), 523-585. https://www.fdli.org/wp-content/uploads/2020/06/LINDBLOM-Final-1.pdf

[11] Jack E Henningfield, et al., Regulatory strategies to reduce tobacco addiction in youth, 12 TOBACCO CONTROL (2003), i14-i24. https://tobaccocontrol.bmj.com/content/tobaccocontrol/12/suppl_1/i14.full.pdf

[12] “Tobacco 21,” U.S. Food and Drug Administration, Dec. 20, 2019. https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/tobacco-21.

[13] Calvin Bryan et al., “Do State Tobacco 21 Laws Work?” National Bureau of Economic Research (December 2020). https://www.nber.org/papers/w28173.

[14] Lynn T Kozlowski & David B Abrams, Obsolete tobacco control themes can be hazardous to public health: the need for updating views on absolute product risks and harm reduction, 16 BMC PUBLIC HEALTH (2016), 1-11. https://link.springer.com/article/10.1186/s12889-016-3079-9

[15] “Research Priorities,” U.S. Food and Drug Administration, Aug. 9, 2023. https://www.fda.gov/tobacco-products/research/research-priorities.

[16] Jamie Hartmann-Boyce, et al., Electronic cigarettes for smoking cessation, COCHRANE DATABASE OF SYSTEMATIC REVIEWS (2022), 1-54. https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010216.pub2/full

[17] Paul A Newhouse, Therapeutic applications of nicotinic stimulation: successes, failures, and future prospects  § 21 OXFORD UNIVERSIT PRESS, (2019), 345-348. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6379030; Maryka Quik, et al., Potential therapeutic application for nicotinic receptor drugs in movement disorders, 21 NICOTINE AND TOBACCO RESEARCH (2019), 357-369. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6379038; Susan M Gil & Raju Metherate, Enhanced sensory–cognitive processing by activation of nicotinic acetylcholine receptors, 21 NICOTINE AND TOBACCO RESEARCH (2019), 377-382. https://academic.oup.com/ntr/article/21/3/377/5076079

[18] “Tobacco Products Marketing Orders.” https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-products-marketing-orders#Premarket%20Tobacco%20Product%20Applications%20(PMTA).

[19] Teresa W Wang, et al., Disposable e-cigarette use among US youth—an emerging public health challenge, 384 NEW ENGLAND JOURNAL OF MEDICINE (2021), 1573-1576. https://www.nejm.org/doi/full/10.1056/NEJMc2033943

[20] Jon-Patrick Allem, et al., Return of cartoon to market e-cigarette-related products, 28 TOBACCO CONTROL (2019), 555-557. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6669092