Re: Docket No. FDA-2026-D-1817 (91 Fed. Reg. 11980, Mar. 11, 2026) – “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk”

RAI Services Company (“Reynolds”) submits this response to the Center for Tobacco Products’ (“CTP”) draft guidance named “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk,” 91 Fed. Reg. 11980 (Mar. 11, 2026) (“Draft Guidance”).¹

The draft guidance doubles down on a flavor-prohibitionist playbook that harms Americans by handing over the marketplace to unregulated Chinese manufacturers whose illicit products evade FDA review and endanger youth. Today, these illicit Chinese products constitute about 86% of the market—and worse, they explicitly target youth by, among other things, incorporating popular cartoon characters and built-in video games. This bears repeating: 86% of the American vape market is comprised of illicit Chinese vapes. The guidance does nothing to correct this. Instead, it entrenches the exact failures it purports to address.

The guidance is a gut punch to American companies committed to playing by the rules. Responsible American manufacturers languish in a regulatory purgatory, whereas foreign companies that evade FDA and flood the market with illicit products have thrived. The path to protecting youth is enforcement against illicit products—not severely restricting American products. The draft guidance gets this exactly backwards.

In addition, FDA has a historic opportunity to help adults quit smoking. FDA can help move adult smokers away from combustible cigarettes to less risky ENDS products—and it should make this transition easier, not harder. But the guidance gets this backwards as well. Studies show that adult smokers who use flavored ENDS products like vapes and e-cigarettes are significantly more likely to quit smoking than those who use tobacco-flavored ENDS or no ENDS at all. Flavors drive the switch, and steer adult smokers away from smoking combustible cigarettes. But FDA and its guidance get in the way of that switch. The guidance doubles down on a so-called “comparative efficiency standard,” which is an unscientific bureaucratic fiat that requires companies creating flavored vapes to meet a heightened standard: They must prove that their non-tobacco flavored ENDS products statistically outperform tobacco-flavored products in head-to-head switching studies. This is the wrong comparison, and it leaves the vast majority of the public health benefit on the table. Millions of smokers who would switch for a fruit flavor will never switch for tobacco, and the comparative-efficacy standard writes them off as if they do not exist. FDA should make it simpler—not harder—to get these products to adult smokers who want to stop smoking cigarettes. Unfortunately, the draft guidance endorses an approach that makes it harder. In fact, it makes it virtually impossible, as demonstrated by the near-universal denials for non-tobacco flavored ENDS products. If Congress had wanted to ban such products, it would have said so. But Congress did not, and it is not for a regulatory agency to substitute its own judgment and policy preference for that of Congress.

Reynolds is committed to ensuring that no youth ever uses a tobacco or nicotine product, but the draft guidance does nothing to achieve that goal. Reynolds offers these comments to make the case for a regulatory framework that protects youth through aggressive enforcement, while giving adult smokers access to the flavored products that maximize their chances of quitting combustible cigarettes for good.

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¹ RAIS submits this comment on its own behalf and on behalf of its affiliated tobacco companies. RAIS coordinates regulatory compliance for the subsidiary companies of °µÍř˝űÇř Inc. (RAI), including R.J. Reynolds Tobacco Company; American Snuff Company, LLC; Santa Fe Natural Tobacco Company, Inc.; R.J. Reynolds Vapor Company; and Modoral Brands Inc. References to “RAIS” or “Reynolds” in this letter may refer to RAIS itself and/or its affiliated RAI subsidiaries, as applicable.

For more than 150 years, the °µÍř˝űÇř organization has been an enduring part of American industry. Today, the organization continues to invest in the communities where employees live and work, train the next generation of American workers, and support farmers across six states. The feature explores the critical role °µÍř˝űÇř plays across North Carolina and Tennessee economies.

°µÍř˝űÇř is transforming and modernizing its innovation and manufacturing capabilities to accelerate toward a predominantly smokeless business. Continued progress, however, also depends on a regulatory environment that keeps pace with innovation and prioritizes access to innovative alternative smokeless products that meet adult smokers’ preferences.

Explore to learn more about Reynold American’s investment and transformation and discover how the organization is growing a Smokeless America here.

The feature explores how Reynolds is navigating one of the most significant evolutions in its history, transitioning from a combustible-products business toward a predominantly smokeless trajectory while remaining grounded in science, responsibility, and long-term investment in the U.S.

Through a conversation with °µÍř˝űÇř Inc. President and CEO David Waterfield, the article examines what has sustained the organization for a century and a half and how Reynolds aims to commit approximately $3.2 billion to its U.S. operations by 2030. These investments span science, advanced manufacturing, workforce development, and agricultural partnerships to support continued progress.

The piece also underscores Reynolds’ commitment to responsible growth, including ongoing investment in research and development, advanced manufacturing technologies, and efforts to prevent youth access to tobacco and nicotine products.

As Reynolds enters its next chapter, the feature offers a behind-the-scenes look at how the organization is balancing heritage with transformation by investing in people, science, and technology to support long-term progress.

Readers are invited to explore the full article and learn more about Reynolds’ vision for Growing Tomorrow.

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For generations, tobacco farming has been central to the livelihoods of families across North Carolina and beyond. Chris Dixon, Vice President of Leaf Operations, notes, “It is not merely a crop you choose, but a heritage that chooses you.” Today, Reynolds’ farmer network spans ten states, with growers diversifying their operations to meet evolving market demands.

The organization’s commitment extends beyond agriculture. Reynolds has played a significant role in supporting local communities, creating jobs, and contributing to the economic development of Winston-Salem, N.C. Mark Owens, President & CEO of Greater Winston-Salem Chamber of Commerce, states, “The Reynolds organization has led the way in unification, innovation, and growth in Winston-Salem from the very beginning until today.”

Reynolds’ focus on workforce development and sustainability is evident through initiatives such as the Future-Ready Workforce Alliance with Forsyth Technical Community College. Kara Calderon, Head of Sustainability and Community Engagement, emphasizes, “You really get that agility to collectively work together for the betterment of the entire community.”

Innovation remains a cornerstone of Reynolds’ strategy. The organization has invested over $200 million in manufacturing and $100 million annually in research and development, leading advancements in smokeless products and responsible growth. Wade Huckabee, Senior Vice President of Strategy and Transformation, comments, “Regulation in its purest mission is to ensure that the alternative products adult tobacco consumers have available to buy are appropriate for the protection of public health, that they are of high-quality standard and responsibly marketed.”

As Reynolds looks to the future, its commitment to growers, communities, and responsible transformation remains steadfast. The company’s legacy demonstrates how tradition and innovation can work together to drive progress.

To learn more, click to the link to read the full POLITICO article highlighting °µÍř˝űÇř’s journey and vision for the future:
 

In a recent episode of podcast, Kara Calderon, Head of Underage Access Prevention at Reynolds, and Stephanie Sikorski, CEO of TruAge, spoke about the collaborative efforts to prevent underage access to tobacco and nicotine products.

The conversation highlighted how partnerships between manufacturers, retailers, and technology providers are contributing to lower rates of underage tobacco use. Reynolds enforces strict marketing protocols and maintains contractual obligations with nearly 183,000 retail outlets, requiring age verification at point-of-sale to ensure products are sold only to legal-age consumers. TruAge, a nonprofit, mission-driven organization, offers a universal age verification solution that supports responsible retailing across the convenience industry.

“We are now at record lows of underage vapor usage,” Kara shared, citing 2024 data from the National Youth Tobacco Survey. “Middle school usage is down to 3.5%, high school usage to 7.8%, and underage cigarette use has dropped to an all-time low of 1.4%.”

Stephanie added context from the retail environment, noting that convenience stores process over 54 million age-restricted transactions daily, with more than 40% of those involving age-restricted products. TruAge’s technology helps retailers verify age securely while providing actionable insights into carding rates and ID validation.

Despite the progress, both leaders acknowledged a growing challenge: the rise of illicit disposable vapor products, often flavored and marketed in ways that appeal to youth. Kara cited a 2,200% increase in youth use of these unregulated products, calling it the biggest hurdle facing underage access prevention today.

Stephanie emphasized the importance of proactive solutions like TruAge, which not only verify age but also help shift the narrative around convenience retailing. “TruAge was built to show proof points,” she said. “We want convenience to be in the headlines for the right reasons, showing how to do responsible retailing right.”

Listen to the full episode to learn more about how Reynolds and TruAge are working together to protect youth and support responsible retailing:

To learn more about Reynolds’ Underage Access Prevention efforts, click here.

Through THR, we aim to create A Better Tomorrow by Building a Smokeless World—one where adult nicotine consumers have access to smokeless product alternatives that are potentially less risky than combustible cigarettes.

Our latest clinical research on oral nicotine products is a key milestone in that journey. The study, published in , analyzed how adult nicotine consumers engage with nicotine pouches and examined patterns such as consistency of use and nicotine uptake. The findings build on a growing body of evidence showing that smokeless products can serve as potentially less risky alternatives for adult smokers.

This study evaluates how adult nicotine consumers interact with nicotine pouches—across different nicotine strengths and flavors—and finds consistent patterns in how they are used. The findings reinforce why nicotine pouches are increasingly considered viable as potentially less risky product alternatives for adult smokers. They contain no tobacco leaf, involve no combustion, and produce no emissions. The data, now peer-reviewed and under FDA scientific review, strengthens the growing evidence base supporting the role of smokeless product alternatives in potentially reducing the public health impact of smoking.

RELATED: Fostering Transparent Collaboration to Reduce Tobacco Harm

This isn’t just about publishing science. It’s about putting our principles into practice.

We believe the success of THR depends on three things: expanding product choices, advancing scientific understanding and acceptance, and building solutions grounded in real-world behavior. This study supports all three. It adds to the growing body of evidence regulators rely on, reinforces the importance of science-based decision-making, and demonstrates that adult nicotine consumers benefit from access to a wider range of potentially less risky product alternatives that better suit their preferences. Most importantly, it reflects the kind of rigorous, transparent engagement we see as essential to driving the THR conversation forward.

While smoking rates are at historic lows, at least 30 million Americans still choose to use combustible cigarettes. Expanding the range of high-quality, science-backed, non-combustible product alternatives is essential to potentially reducing the public health impact of smoking.

What makes this research especially meaningful is not just what it shows about the use of nicotine pouches—but what it reflects about our approach: a commitment to clinical science, behavioral research, and proactive engagement with public health stakeholders. This study is one of many efforts to build understanding around THR. Through research like this, we aim to demystify smokeless product categories, address their misperceptions, and support informed choices for adult nicotine consumers concerning these products.

Our commitment is clear: we’ll continue to publish, share, and engage—because helping adult nicotine consumers make informed choices about alternative products is how we move toward A Better Tomorrow.

To learn more about our approach to Tobacco Harm Reduction, visit the Reducing HarmĚýpage onĚýReynoldsAmerican.com.

RELATED: The Path to Tobacco Harm Reduction

The global BAT organization has a mission to create A Better Tomorrow by Building a Smokeless World and aims to reach 50 million adult consumers of its smokeless products globally by 2030.

In the video above, Susie Gharib, senior special correspondent at Fortune Brand Studio, interviews BAT’s chief financial officer Soraya Benchikh about BAT’s role in advancing Tobacco Harm Reduction.

for the original interview with Benchikh in the Fortune Brand Studio.

Every stakeholder – from policymakers, regulators, and advocacy groups to those in the healthcare and scientific communities – plays a significant role in working to reduce the harm associated with smoking. This also includes the tobacco industry, which is why we’re committed to collaborating with those who share the common goal of improving public health outcomes.

The tobacco and nicotine industry generates the largest body of rigorous science on Tobacco Harm Reduction but is excluded from important scientific and policy forums where constructive discussion is needed. Allowing the industry to share research and perspectives can lead to greater trust between stakeholders and more innovative solutions to overcome one of the most important public health challenges.

RELATED: The Path to Tobacco Harm Reduction

Collaborations between the public and private sectors are crucial in offering potentially less harmful alternative products to adult smokers. When government, public health, and industry stakeholders collaborate to bring regulated, potentially reduced risk alternatives to market, we see positive results. For example, Sweden’s smoking rate has dwindled to 5.3% percent due to effective collaboration among key stakeholders with the shared goal of reducing the harm associated with combustible cigarettes. That’s less than half of the smoking rate in America today!

In the U.S., transparent collaboration is essential to advance tobacco harm reduction. Effective partnerships between stakeholders can drive solutions to offer adult smokers with potentially reduced risk alternatives.

We’re committed to ensuring adult smokers who are uninterested in quitting tobacco products altogether have access to innovative, potentially less risky alternatives to combustible cigarettes. To those who share a common ambition to reduce harm, Reynolds invites dialogue and collaboration.

To learn more about Tobacco Harm Reduction, and Reynolds’ commitment to creating A Better Tomorrow by Building a Smokeless World, visit the Reducing Harm page on ReynoldsAmerican.com.

THR is an approach to improve public health outcomes by focusing on what we believe is one of the most important movements for America’s health agenda – reducing the harm associated with smoking combustible cigarettes.

Our commitment to our mission of creating A Better Tomorrow^TM by Building a Smokeless World necessitates an even stronger commitment to pragmatic solutions that help advance paths to reduce the health impact of our operating businesses.

There are over one billion smokers worldwide and 30 million of them live right here in the U.S. In any group that large, there will be a wide spectrum of opinions and priorities. Some adult smokers are uninterested in quitting tobacco altogether. Those adults deserve access to science-backed information about potentially reduced risk options available today.

RELATED: Fostering Transparent Collaboration to Reduce Tobacco Harm

So, what exactly is THR? It’s a public health strategy that creates opportunities to improve health outcomes in America. By empowering adult smokers with knowledge about potentially reduced risk alternatives, they can make informed decisions regarding their consumption of alternative nicotine products.

Public misperceptions surrounding potentially reduced risk products pose a challenge in reducing the health burden of cigarette smoking. Our focus is to address these misperceptions by educating and engaging with key stakeholders on the scientific evidence supporting the potential benefits of potentially reduced risk products as compared to combustible cigarettes. THR accounts for where the tobacco and nicotine markets are today, where the market is heading, and for the innovative technology that has become more commonplace in the last few years. From modern oral products, like nicotine pouches, to tobacco heating products and e-cigarettes, there are more options than ever for those adults who want to continue to use tobacco and nicotine products while exploring alternatives that have potentially reduced risk compared to combustible cigarettes.

Why now? Smoking is at a near historic low. Adult smokers are embracing these potentially reduced risk alternatives, and they deserve the information about potentially reduced risk products that allows them to make the best choices for themselves. In fact, since 1970, the rate of adult smoking has fallen more than 70%, but of adults that still smoke tobacco products, including non-combustible products, more than 79% use combustible cigarettes. This number will likely remain higher than it could be if there is a lack of access to alternatives with potentially less risk for adult smokers who are uninterested in quitting tobacco altogether.

Nothing happens in a vacuum, which is why our approach to Tobacco Harm Reduction has four key pillars, all of which are crucial to having a positive impact on America’s public health:

1. Better Regulation: Using guidance grounded in science to foster sensible regulation that keeps pace with innovation.
2. Better Alternative Choices: Continued innovation allows the industry to bring new, potentially reduced risk alternatives to adult smokers who are uninterested in quitting tobacco products altogether something other than traditional combustible cigarettes.
3. Better Solutions: By working together with anyone who shares the common goal of improving public health in the US, we can find new solutions only made possible through collaboration.
4. Better Understanding: An unwavering commitment to THR requires leveraging sound science to inform adult smokers on potentially reduced risk alternatives.

These four pillars enable us to pursue our most important goal – finding a Better Way to A Better Tomorrow^TM.

In the coming weeks, we’ll dive more deeply into each of these important pillars and work to provide you with a better understanding of Tobacco Harm Reduction and why it is so important.

To learn more about Tobacco Harm Reduction, and Reynolds’ commitment to creating A Better Tomorrow by Building a Smokeless World, visit the Reducing Harm page on ReynoldsAmerican.com.

At °µÍř˝űÇř, underage access prevention (UAP) is more than a policy; it is a core principle that drives every facet of our business. We are resolute in our commitment to ensuring that our products are not accessible to individuals under 21. This steadfast dedication influences our practices, technology, and collaborations with stakeholders across the board.

Our aim is unambiguous: We do not want our products in the hands of underage individuals. Period. This conviction propels us to operate with the highest level of responsibility, forging strong partnerships with regulators, policymakers, and retail partners. Our aim extends beyond simply complying with industry standards—we strive to set them.

In our pursuit of excellence, we leverage cutting-edge technology, trusted data, and robust marketing controls to enhance our underage protection measures. By integrating the latest scientific advancements and technological innovations, we are able to address emerging challenges and continually refine our strategies to safeguard youth.

Our vision for “A Better Tomorrow” is not just about transitioning adult smokers to potentially reduced-risk alternatives; it’s also about establishing the highest industry standards for preventing underage access. We are heartened by the significant decline in underage smoking and vaping rates, which is a testament to the collective effectiveness of our initiatives to keep these products out of the hands of youth.

A cornerstone of our strategy involves stringent contractual agreements with retailers. We require them to enforce strict age restrictions on the sale of tobacco and nicotine products, including rigorous age verification at the point of sale. This approach has achieved an impressive 99.9% compliance rate, reflecting our commitment to preventing the sale and distribution of tobacco products to minors.

Our dedication to underage access prevention is further reinforced through ongoing training and responsible marketing practices. We take a proactive approach to restrict our advertising to media where at least 85% of the audience is over 21, as verified by independent third parties. Employees of the °µÍř˝űÇř organization are continually engaged in training programs focused on Retailer Compliance, Responsible Marketing, and Underage Access Prevention. Additionally, we support TruAge, a digital solution that enhances the security and reliability of age verification processes for adult tobacco consumers. We have also been an active supporter of the We Card program since its inception in 1995. This program provides retailers with essential materials and training to help prevent the sale of tobacco and nicotine products to minors.

We are vigilant in ensuring that our marketing and advertising content does not portray underage activities or imply that using our products is crucial for social status or success, and our advertising practices strictly avoid the use of celebrities or individuals who might appeal to youth.

At °µÍř˝űÇř, our commitment to underage access prevention is always ongoing. We are dedicated to continually working with regulators, policymakers, and retail partners to enhance our strategies and maintain the highest standards of integrity and responsibility. For more information about our unwavering dedication to underage access prevention, visit our dedicated page at ReynoldsAmerican.com. Together, we are committed upholding the highest standards of responsibility and protect the well-being of our youth.