Comments on the Citizen Petition of the National Tobacco Reform Initiative

Paige C. Magness Senior Vice President Regulatory Affairs

July 30, 2020

Via Electronic Submission

Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852

Re: Docket No. FDA-2020-P-1052 – Comments on the Citizen Petition of the National Tobacco Reform Initiative

Altria Client Services LLC (“ALCS”), on behalf of Philip Morris USA Inc. (“PM USA”), Sherman Group Holdings, LLC and its subsidiaries (“Nat Sherman”), John Middleton Co. (“JMC”), U.S. Smokeless Tobacco Company LLC (“USSTC”), and Helix Innovations LLC (“Helix”),1 submits these comments to the U.S. Food and Drug Administration (“FDA” or “Agency”) in response to the Citizen Petition (“Petition”) filed by the National Tobacco Reform Initiative (“NTRI”) on March 6, 2020.

NTRI calls for an Agency refocus on the 2017 Comprehensive Plan for Tobacco and Nicotine Regulation (“Comprehensive Plan”),2 which included recognition of a “continuum of risk,” “rang[ing] from combustible cigarettes at one end, to medicinal nicotine products at the other.”3

1 PM USA, Nat Sherman, JMC, and USSTC are wholly-owned subsidiaries of Altria Group, Inc. (“Altria”). Helix is a majority-owned subsidiary of Altria Enterprises II LLC, which is a wholly-owned subsidiary of Altria. PM USA manufactures cigarettes and is licensed to sell and distribute IQOS® and HeatSticks® in the United States and JMC manufactures cigars and pipe tobacco. USSTC manufactures smokeless tobacco products and oral tobacco-derived nicotine products. Helix manufactures oral tobacco-derived nicotine products. ALCS provides certain services, including regulatory affairs, to the Altria family of companies. “We” and “our” are used throughout to refer to PM USA, Nat Sherman, JMC, USSTC, and Helix. 2 See Press Release, FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death (July 27, 2017), available at https://www.fda.gov/news-events/press-announcements/fda-announces- comprehensive-regulatory-plan-shift-trajectory-tobacco-related-disease-death; FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation, https://www.fda.gov/tobacco-products/ctp-newsroom/fdas-comprehensive-plan- tobacco-and-nicotine-regulation; Scott Gottlieb & Mitchell Zeller, Perspective, A Nicotine-Focused Framework for Public Health, New Engl. J. Med., 2017; 377:1111-1114. DOI: 10.1056/NEJMp1707409. 3 Remarks by Scott Gottlieb, M.D., Protecting American Families: Comprehensive Approach to Nicotine and Tobacco (June 28, 2017), available at https://www.fda.gov/news-events/speeches-fda-officials/protecting-american- families-comprehensive-approach-nicotine-and-tobacco-06282017.

Altria Client Services LLC 601 E. Jackson Street Richmond, Virginia 23219 (804) 335-2353 [email protected]

The Comprehensive Plan placed nicotine at the center of a regulatory approach aimed at reducing the harm caused by tobacco products.4 We have urged FDA to regulate along on the continuum of risk for more than a decade, and we continue to do so.

We have also acknowledged that curtailing underage use of lower risk products is crucial to preserving them as an opportunity for adult smokers to switch from combustible cigarettes. Congress, FDA, manufacturers, and other stakeholders have taken significant action to address the rise in underage use of e-vapor products, including raising the minimum age of purchase for all tobacco products to 21. Driving down underage vaping rates will take time and the efforts of many, but we believe the right steps are being taken.

Additionally, later this year, the marketplace for deemed tobacco products will be reset as manufacturers file premarket applications or face FDA enforcement.5 Together, these actions provide FDA the opportunity to prioritize previously stated goals, including policies that advance tobacco harm reduction.

At Altria, our 10-year vision is to responsibly lead the transition of adult smokers to non- combustible products. To achieve our vision, we are committed to advancing tobacco harm reduction and believe that stakeholder collaboration is essential to reaching that goal. As detailed below, we believe FDA should give careful consideration to many of the steps articulated in the Petition.

We organize our comments as follows:

i. FDA should regulate along the continuum of risk; ii. FDA should lead a national dialogue on nicotine and address widespread misperceptions regarding the relative risks of different tobacco products; and iii. FDA should adopt a regulatory approach that draws upon the expertise of all stakeholders.

I. FDA SHOULD REGULATE ALONG THE CONTINUUM OF RISK

NTRI calls on FDA to “[t]hink of the lives that can be saved not only in the United States but globally if we can move smokers away from combustible products by giving them consumer acceptable lower risk alternatives,”6 echoing then-FDA Commissioner Gottlieb’s 2017 pronouncement that “[w]e must acknowledge that there’s a continuum of risk for nicotine delivery.”7

4 Id. (“Our approach to making nicotine the center of our regulatory efforts needs to be accompanied by a firm foundation of rules and standards for newly-deemed products.”). 5 American Academy of Pediatrics, et al. v. U.S. Food and Drug Admin. No. 8:18-cv-00883-PWG (D. Md. July 12, 2019). 6 Citizen Petition of the National Tobacco Reform Initiative, Docket ID: FDA-2020-P-1052 (submitted March 6, 2020) at 4. 7 Remarks by Scott Gottlieb, M.D., Protecting American Families: Comprehensive Approach to Nicotine and Tobacco (June 28, 2017), available at https://www.fda.gov/news-events/speeches-fda-officials/protecting-american- families-comprehensive-approach-nicotine-and-tobacco-06282017.

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We have encouraged FDA to acknowledge and regulate along the continuum of risk since 2009, when Congress granted FDA regulatory authority over tobacco products.8 Today, a public health consensus recognizes that there is a continuum of risk among tobacco products, and that products lower in risk have an important role to play in reducing harm for consumers.9

We believe that with increasing adult smoker demand for potentially reduced risk, non- combustible products, a commitment to innovation, and an appropriate regulatory framework, we have the opportunity to make more progress on reducing the harm caused by combustible cigarettes in the next 10 years than we have in the past 50 years.

FDA should commit to regulation that advances tobacco harm reduction, consistent with the following points.

A. FDA should implement thorough and achievable product authorization pathways to create a diverse marketplace of potential reduced risk, non- combustible tobacco products

It is critical that FDA facilitate the innovation of potential reduced risk products through thorough and achievable product authorization pathways. NTRI emphasizes the importance of “developing a more flexible and adaptable regulatory framework that will allow science-based lower risk products into the market place more expeditiously, while ensuring that such products are not available, targeted or used by any children or adolescent.”10

FDA must establish achievable product pathways that provide consistency, transparency, and predictability in the review process. Recently, FDA issued long-awaited proposed rules for the Substantial Equivalence (“SE”) and Premarket Tobacco Product Application (“PMTA”) pathways. 11, 12

8 See, e.g., ALCS Comments on Docket No. FDA-2012-D-0071, “Regulation of Tobacco Products Under the Family Smoking Prevention and Tobacco Control Act” at 2-7 (submitted December 22, 2009); see also, e.g., ALCS Comments on Docket No. FDA-2012-D-0071, “Draft Guidance for Industry: Modified Risk Tobacco Product Applications” at 5 (submitted June 4, 2012). 9 See, e.g., Sherine El-Toukhy, PhD, Kelvin Choi, PhD, MPH, A Risk-Continuum Categorization of Product Use Among US Youth Tobacco Users, Nicotine & Tobacco Research, Volume 18, Issue 7, July 2016, Pages 1596–1605, https://doi.org/10.1093/ntr/ntw008; Remarks by Scott Gottlieb, M.D., Protecting American Families: Comprehensive Approach to Nicotine and Tobacco (June 28, 2017), available at https://www.fda.gov/news- events/speeches-fda-officials/protecting-american-families-comprehensive-approach-nicotine-and-tobacco- 06282017 (“[W]e must acknowledge that there’s a continuum of risk for nicotine delivery.”). 10 Citizen Petition of the National Tobacco Reform Initiative, Docket ID: FDA-2020-P-1052 (submitted March 6, 2020) at 5. 11 84 Fed. Reg. 12,740 (April 2, 2019); 84 Fed. Reg. 50,566 (September 25, 2019). 12 As early as 2011, FDA recognized that interested parties needed clarity regarding the Substantial Equivalence (“SE”) process and pledged to “initiate a rulemaking that would establish requirements and standards for SE under sections 905(j) and 910 of the [TCA].” Guidance for Industry and FDA Staff, Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (January 5, 2011), available at https://www.fda.gov/media/79702/download. In 2017, former FDA Commissioner Gottlieb stated that “[t]he foundational regulations for the tobacco program were never put in place and so we’re going to take the time to put those in place so we have a firm foundation from which to regulate.” FDA Commissioner Scott Gottlieb, Address at National Press Club (November 3, 2017), available at https://www.c-span.org/video/?436197-1/fda-commissioner- scott-gottlieb-addresses-national-press-club (time 33:15).

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The PMTA pathway is central to tobacco harm reduction. Promising, potentially reduced risk products, such as Oral Tobacco Derived Nicotine (“OTDN”) products, Heated Tobacco Products (“HTPs”), Electronic Nicotine Delivery Systems (“ENDS”), and any other future innovative products, will generally require PMTA authorization. To reflect NTRI’s goal of establishing a “more rational” regulatory framework that is “adaptable to the increased speed of innovation,”13 the rule must not be so burdensome that it prevents innovative and reduced risk products from entering the market.

In the proposed PMTA rule, FDA provides a streamlined authorization process for modified versions of products previously determined to be appropriate for the protection of the public health,14 consistent with NTRI’s call to “allow science-based lower risk products into the market place more expeditiously.”15 FDA should continue to develop additional PMTA format alternatives that “would reduce the burden associated with the submission and review of an application.”16

We urge FDA to issue final rules and implement the pathways in a manner that advances tobacco harm reduction, clarifies key terms and requirements, and avoids unnecessary review delays. There must be clear rules of the road which allow manufacturers to develop new, potential reduced risk products and invest in scientific research.

These pathways must also be backed by a viable Modified Risk Tobacco Product Application (“MRTPA”) process and other stakeholder communications, providing adult tobacco consumers with truthful and accurate messages about potentially reduced risk products to inform product choices. FDA has both an important role in providing this information and a track record of effective public health communications.17 This work should also include, as NTRI suggests, “[d]eveloping a science-based regulatory format that will allow for a variety of informational claims and statements (not just health claims) to be used that give the public a better understanding of the risks and relative risks of various products.”18

To be most effective, public health authorities, including FDA, should communicate directly. In fact, because tobacco manufacturers are barred from making modified risk claims outside of an authorized MRTPA, government public health authorities’ role as trusted communicators is critical to advancing FDA’s Comprehensive Plan.

13 Citizen Petition of the National Tobacco Reform Initiative, Docket ID: FDA-2020-P-1052 (submitted March 6, 2020) at 4. 14 84 Fed. Reg. at 50,611-13. 15 Citizen Petition of the National Tobacco Reform Initiative, Docket ID: FDA-2020-P-1052 (submitted March 6, 2020) at 5. 16 84 Fed. Reg. at 50,611. 17 For example, since 2014, FDA has used a science-based communications strategy to advance the Agency’s youth tobacco prevention efforts. See FDA, The Real Cost Campaign, https://www.fda.gov/tobacco-products/public- health-education/real-cost-campaign (“When “The Real Cost” launched in 2014, the goal was to educate at-risk teens about the harmful effects of cigarette smoking. Over time, it became clear that the campaign’s science-based approach could educate at-risk youth about other tobacco products.”). 18 Citizen Petition of the National Tobacco Reform Initiative, Docket ID: FDA-2020-P-1052 (submitted March 6, 2020) at 6.

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B. FDA should issue an Advance Notice of Proposed Rulemaking (“ANPRM”) to begin collecting scientific information and data supporting product standards for potential reduced risk, non-combustible tobacco products

As part of “[d]eveloping a more flexible and modern[] approach to regulating the growing spectrum of products,”19 NTRI suggests “establishing product standards (including the use of biomarkers) for the various categories of [tobacco and nicotine containing] products.”20 We agree that a more flexible regulatory approach, informed by product standards, would foster the innovation of potential reduced risk products.

FDA must demonstrate that proposed tobacco product standards are “appropriate for the protection of the public health,”21 when considering all countervailing effects, and are technically achievable. Product standards can serve the dual purposes of advancing product safety as well as improving pathway efficiency.

For example, we previously encouraged FDA to establish consensus product safety standards to mitigate battery safety risks in e-vapor products.22 FDA subsequently acknowledged that a product meeting a specific battery safety standard (UL 8139) “enhances consumer safety, minimizes battery-related injuries and mitigates potential risks.”23

FDA should explore product standards for a variety of non-combustible product categories, including OTDN, HTPs, and ENDS. These product standards should be class-specific and include science- and evidence-based product stewardship principles that evolve with product innovation.

Importantly, under the Guidance referencing UL 8139, FDA provided manufacturers the opportunity to modify products to comply with this standard without a PMTA submission requirement, demonstrating how product standards can inform flexible pathway execution.24 It is only a modest leap from this approach to a PMTA authorization process which expedites market authorization of new products that meet a list of product standards.

FDA should issue an ANPRM to begin the important process of engaging with major stakeholders, including industry and the scientific community. Through this process, we believe FDA can establish product standards for potential reduced risk, non-combustible tobacco products that will enhance product safety and quality and allow these products to move through the pathways more effectively.

19 Id. at 5. 20 Id. 21 Food, Drug and Cosmetic Act (“FDCA”) § 907(a)(3). 22 See ALCS Comments on Docket No. FDA-2016-N-4232, “Battery Safety Concerns in Electronic Nicotine Delivery Systems (ENDS) Public Workshop” (submitted May 22, 2017). 23 Guidance for Industry, Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products (November 26, 2019) at 3, available at https://www.fda.gov/media/133009/download. 24 Id.

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C. A nicotine standard for cigarettes must be supported by science, be technically achievable, and preceded by the establishment of a diverse marketplace of FDA- authorized non-combustible products

NTRI suggests that FDA “[m]ove forward immediately with the proposed product standard for the nicotine level of combusted cigarettes and related tobacco products.”25 As detailed in our comments to FDA in 2018,26 there are significant hurdles to implementing a nicotine product standard for any tobacco products, including combustible cigarettes. For example:

• Any nicotine product standard must conform to the law. Among other things, FDA may not adopt a nicotine standard that is not technically achievable, that bans cigarettes, or that reduces nicotine effectively to zero. • Any nicotine product standard must be supported by science and evidence. There must be a strong scientific basis to conclude that a mandatory reduction in nicotine levels would be successful, given the scope, scale, and potential risks of such a proposal. Among other things, the science needs to demonstrate that reducing nicotine will make cigarettes less addictive and that adult smokers, faced with these alterations to the product, will not change their behavior in a way that ultimately hurts public health. • Any nicotine standard must consider adult consumer choice to avoid serious countervailing effects, such as the emergence of an illicit market. • Any nicotine standard must be preceded by an established marketplace of satisfying alternative, FDA-authorized, reduced risk products, backed by stakeholder communications about the relative risks of those products, including authorized modified risk claims and evidence-based FDA communication campaigns. For a nicotine product standard to be successful, FDA must ensure that adult smokers have greater access to non-combustible product alternatives and accurate information about switching to them.

While we disagree that the necessary conditions are in place for a nicotine standard, we support NTRI’s assertion that adult smoker conversion requires a wide array of alternative products, including products with flavors.27 Flavors play a key role in transitioning adult smokers to non- combustible products. Indeed, as potential reduced risk products receive FDA authorization, and accurate information about these products is disseminated, adult smokers may migrate to non- combustible products without regard to a nicotine standard in combustible cigarettes.

25 Citizen Petition of the National Tobacco Reform Initiative, Docket ID: FDA-2020-P-1052 (submitted March 6, 2020) at 5. 26 See ALCS Comments on Docket No. FDA-2017-N-6189, “Advance Notice of Proposed Rulemaking on Tobacco Product Standard for Nicotine Level of Certain Tobacco Products” (submitted July 16, 2018). 27 Citizen Petition of the National Tobacco Reform Initiative, Docket ID: FDA-2020-P-1052 (submitted March 6, 2020) at 4 (“Today we have an array of alternative nicotine products that smokers could potentially transition to in place of cigarettes . . . There are more innovative science-based products in the pipeline. These are all products that could replace cigarettes with cleaner form of nicotine delivery.”).

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II. FDA SHOULD LEAD A NATIONAL DIALOGUE ON NICOTINE AND ADDRESS WIDESPREAD MISPERCEPTIONS REGARDING THE RELATIVE RISKS OF DIFFERENT TOBACCO PRODUCTS

We agree with NTRI that FDA must do more to provide greater clarity regarding the health effects of nicotine.28 In 2017, FDA described its Comprehensive Plan as a multi-year roadmap driven by a “greater awareness” of the continuum of risk presented by different forms of nicotine-containing products.29 As then-Commissioner Gottlieb recognized, “the nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year . . . it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine.”30

Despite a commitment from FDA to “reframe the conversation around nicotine and harm reduction,”31 adult cigarette smokers and the public remain unclear about the role of nicotine and the health risks associated with combustible versus non-combustible tobacco products. For example, a study analyzing data from the Health Information National Trends Survey (“HINTS”) found “a high prevalence of incorrect beliefs about the relationship between nicotine and cancer.”32 Specifically, the study found “[m]ost people (73%) either incorrectly believed that nicotine is the main substance in cigarettes that causes cancer or were unsure about the relationship between nicotine and cancer.”33 Potentially reduced risk products will have limited success in transitioning adult smokers until these misperceptions are corrected.

Tobacco harm reduction is no longer a theoretical exercise. According to PATH data, more than half of adult smokers are interested in satisfying, less harmful alternatives to cigarettes.34 This equates to approximately 22 million adult smokers that are interested in less harmful tobacco products. Even more may be persuaded to switch to products lower on the continuum of risk by making available appropriate relative risk communications and corresponding product offerings.

28 Id. at 8-9. 29 Press Release, FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death (July 27, 2017), available at https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive- regulatory-plan-shift-trajectory-tobacco-related-disease-death. 30 Remarks by Scott Gottlieb, M.D., Protecting American Families: Comprehensive Approach to Nicotine and Tobacco (June 28, 2017), available at https://www.fda.gov/news-events/speeches-fda-officials/protecting-american- families-comprehensive-approach-nicotine-and-tobacco-06282017. 31 Scott Gottlieb, M.D., and Mitch Zeller, J.D., Advancing Tobacco Regulation to Protect Children and Families: Updates and New Initiatives from the FDA on the Anniversary of the Tobacco Control Act and FDA’s Comprehensive Plan for Nicotine (August 2, 2018), available at https://www.fda.gov/news-events/fda-voices- perspectives-fda-leadership-and-experts/advancing-tobacco-regulation-protect-children-and-families-updates-and- new-initiatives-fda. 32 O'Brien, E. K., Nguyen, A. B., Persoskie, A., & Hoffman, A. C. (2016). U.S. adults' addiction and harm beliefs about nicotine and low nicotine cigarettes. Preventive Medicine, 96, 94-100. doi:10.1016/j.ypmed.2016.12.048. 33 Id. 34 ALCS analysis of PATH Wave 1 data, Sept. 12, 2013 – Dec. 14, 2014; Response to question – “If a tobacco product made a claim that it was less harmful to health than other products, how likely would you be to use that product?”

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FDA has the resources and a mandate to correct misperceptions regarding nicotine, and to communicate more information about the relative risks of different tobacco products to adult smokers. NTRI suggests, and we support, “[i]mplementing comprehensive labeling, marketing and educational campaigns that would reflect the risks and relative risks of the products.”35

In recent years, FDA has shared success in targeted communication campaigns.36 The Agency should apply these same principles, and coordinate with other federal agencies to apply existing resources, to help correct deeply entrenched misperceptions about the role of nicotine in smoking-related disease. A 2019 study concluded:

Findings from the current study support the hypothesis that a brief nicotine messaging intervention—similar to the messages likely to be seen on warning labels or in media campaigns—is likely to correct misperceptions of nicotine.37

Indeed, as discussed in a recent meeting of the Tobacco Products Scientific Advisory Committee, a targeted, evidence-based communications campaign is the recommended method for communicating to consumers about nicotine and the relative risks of different tobacco products.38 For tobacco harm reduction to be successful, we must empower adult smokers to make informed decisions based on science and evidence. For industry, that means we must invest in potentially reduced risk products and pursue the necessary research to justify modified risk claims. However, individuals will also look to the public health community as a credible source when assessing risks and must trust that the provided information reflects science and evidence for it to be well-received, accepted, and implemented.

35 Citizen Petition of the National Tobacco Reform Initiative, Docket ID: FDA-2020-P-1052 (submitted March 6, 2020) at 6. 36 Press Release, FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids (September 18, 2018), available at https://web.archive.org/web/20190119201459/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u cm620788.htm (“The FDA has a successful track record of using compelling, science-based public education campaigns to encourage kids to rethink their relationship with tobacco and is bringing the same approach to these new efforts to prevent youth use of e-cigarettes.”). 37 Villanti, A. C., West, J. C., Mays, D., Donny, E. C., Cappella, J. N., & Strasser, A. A. (2019). Impact of Brief Nicotine Messaging on Nicotine-Related Beliefs in a U.S. Sample. American Journal of Preventive Medicine, 57(4), e135-e142. doi:10.1016/j.amepre.2019.05.015. 38 Presentation by M. Justin Byron, PhD, Investigating and addressing the perceived risk of nicotine and very low nicotine content cigarettes (February 14, 2020), available at https://www.fda.gov/advisory-committees/advisory- committee-calendar/february-14-2020-tobacco-products-scientific-advisory-committee-meeting-02142020- 02142020. See also FDA Center for Tobacco Products, “Tobacco Products Scientific Advisory Committee Meeting” Transcript, February 14, 2020 at 216, https://www.fda.gov/media/136252/download (“[W]e know now that a broad reach, well-designed, well-funded campaign can be effective in reducing tobacco use. A campaign is recommended . . . in advance of a VLNC policy. A number[] of papers looking at perceived risk have suggested that a campaign -- so that if there was to be a nicotine reduction policy at the federal level that a campaign come out in advance to explain to people what this means and what this doesn’t mean about harm.”).

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In addition to FDA, multiple other federal agencies, including CDC, NCI, NIDA, and NIH, work to advance tobacco research and policy.39 The information consumers receive must be consistent and credible. Therefore, FDA should coordinate messaging and resources with other government health agencies, especially as the Agency begins to authorize modified risk claims. In doing so, FDA can help ensure that federal tobacco stakeholders communicate a unified message and effectively allocate resources distributed throughout the government. By aligning federal communications and committing resources to correct misperceptions, FDA can help adult tobacco consumers make product decisions informed by the role of combustion and the relative risks of different tobacco products.

III. FDA SHOULD ADOPT A REGULATORY APPROACH THAT DRAWS UPON THE EXPERTISE OF ALL STAKEHOLDERS

NTRI focused on three major stakeholders: manufacturers, the regulator, and the scientific community. We agree that these stakeholders have important, collaborative roles to play in shaping the future of tobacco harm reduction. Moreover, beyond role clarity we appreciate NTRI’s vision of civil stakeholder collaboration that could lead to a setting most conducive for tobacco harm reduction activity, in line with our 10-year vision.

Currently, we share information with the FDA through written submissions, presentations and other communications. We share the results of our scientific studies with the FDA and others through peer-reviewed journals, conference presentations, one-on-one meetings, and on the Altria science website (https://sciences.altria.com/). Like NTRI, we believe more can be gained by FDA facilitating discussions and encouraging stakeholder engagement. For example, to rapidly address emerging challenges in the dynamic tobacco category, we believe FDA should explore opportunities, by hosting stakeholder summits or by some other means, for earlier sharing of key data from national surveys (e.g. NYTS, PATH, MTF). Additionally, stakeholders, including the FDA and the editorial boards for scientific journals, should recognize the role that tobacco product manufacturers play in developing new methodologies to assess the health impact of potentially reduced risk tobacco products. To move tobacco harm reduction forward, these stakeholders should help ensure that research generated by industry is subject to appropriate scrutiny and that key learnings are shared.

A holistic approach to stakeholder engagement, that draws upon the expertise of all parties, as NTRI suggests, will provide more comprehensive information, informed in part by stakeholder insights, and better position us to achieve our common goals around tobacco harm reduction.

39 See, e.g., CDC, Office on Smoking and Health At A Glance, https://www.cdc.gov/chronicdisease/resources/publications/aag/tobacco-use.htm; Tobacco Control Research Branch (TCRB), https://cancercontrol.cancer.gov/brp/tcrb/; Nicotine and Tobacco Research Team (NTRT), https://www.drugabuse.gov/about-nida/organization/cross-cutting-research-teams-workgroups-interest-groups- consortia/nicotine-tobacco-research-team-ntrt; NIDA-Tobacco Regulatory Science Program (TRSP), https://www.drugabuse.gov/research/nida-research-programs-activities/tobacco-regulatory-science-program-trsp; NIH Research Priorities, Tobacco Use, https://prevention.nih.gov/research-priorities/tobacco-use.

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CONCLUSION

We agree with NTRI that FDA should revisit its Comprehensive Plan and prioritize regulatory policies that support tobacco harm reduction, and the goal of converting adult smokers who cannot, or will not, quit combustible cigarettes, to less harmful non-combustible products. We support NTRI’s call for efficient, rigorous authorization pathways, informed by product standards and a system of improved stakeholder information sharing.

Sincerely,

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