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RAI Services Company (“Reynolds”) submits this response to the Center for Tobacco Products’ (“CTP”) draft guidance named “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk,” 91 Fed. Reg. 11980 (Mar. 11, 2026) (“Draft Guidance”).¹

The draft guidance doubles down on a flavor-prohibitionist playbook that harms Americans by handing over the marketplace to unregulated Chinese manufacturers whose illicit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 The draft guidance gets this exactly backwards.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.

WINSTON-SALEM, N.C., (March 5, 2026) — The °µÍř˝űÇř companies (°µÍř˝űÇř) announced a forward-looking commitment to invest more than $3.2 billion across its U.S. operations by 2030, reinforcing its long-term focus on value creation and American manufacturing. The investment began in 2024 and is expected to support more than 2,000 direct and indirect jobs across °µÍř˝űÇř’s operations and U.S. supply network, including roles tied to recent manufacturing expansion and innovation initiatives.

The announcement marks the launch of Growing Tomorrow; °µÍř˝űÇř’s campaign focused on driving business performance and delivering sustainable returns. The campaign reinforces °µÍř˝űÇř’s position as a leading organization with the largest multicategory nicotine product portfolio in the U.S.

“Growing Tomorrow reflects the investments we’re making today in American manufacturing and jobs,” said David Waterfield, President and CEO of °µÍř˝űÇř Inc. “By expanding manufacturing capabilities and strengthening our workforce, we’re building on more than 150 years of investment in the U.S. economy to ensure our competitiveness for the future.”

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Growing Performance

°µÍř˝űÇř’s investment supports the organization’s continued evolution toward a predominantly smokeless future, building on momentum in high-growth categories. The organization continues to expand its innovative smokeless portfolio with a multiyear investment focused on:

• Modernizing and expanding U.S. manufacturing
• Scaling innovation and production
• Strengthening domestic supply chains
• Advancing workforce capabilities and operational excellence

More than $200 million has already been invested in U.S. manufacturing over the past two years as part of this commitment.

Growing Innovation

°µÍř˝űÇř’s research and manufacturing hubs in Winston-Salem, North Carolina, and operations in Clarksville, Tennessee play a central role in the organization’s transformation, supporting a broad, science-led portfolio designed to meet the evolving preferences of adult nicotine consumers. Planned investments will further modernize facilities, expand production capabilities, and reinforce °µÍř˝űÇř’s competitive position for sustained performance.

Innovation remains foundational to that future. °µÍř˝űÇř employs hundreds of scientists in Winston-Salem, supported by approximately $100 million in annual research and development investment, with the majority focused on innovative smokeless categories.

Growing Careers & Community

Today, °µÍř˝űÇř employs more than 4,300 people across the U.S., with roles spanning advanced manufacturing, engineering, science, skilled operations, and corporate functions. Continued investment in technology, training, and workforce readiness extends the organization’s economic impact beyond its direct operations through a broad U.S. supply network.

“Investing in growth means investing in people,” said Borgia Walker, Senior Vice President and Chief People Officer at °µÍř˝űÇř Inc. “We’re focused on building capabilities, expanding opportunity, and helping our employees grow meaningful careers as we grow business performance.”

°µÍř˝űÇř’s impact extends beyond its direct business operations to agriculture and local economies nationwide. North Carolina, the nation’s leading tobacco producing state, anchors this ecosystem, with farmers and agricultural partners remaining integral to the organization’s success and domestic supply chain. In 2025, °µÍř˝űÇř was the largest purchaser of U.S. tobacco leaf from American farmers.

Together, these investments reinforce °µÍř˝űÇř’s long-term strategy focused on disciplined growth, sustained returns, and shared value creation. This approach strengthens U.S. manufacturing, supports good-paying jobs, and helps build resilient communities.

Growing Tomorrow is how °µÍř˝űÇř delivers on that commitment today and for decades to come.

About °µÍř˝űÇř Inc.Ěý°µÍř˝űÇř Inc. is a wholly owned subsidiary of the global BAT Group and the U.S. parent company of R.J. Reynolds Tobacco Company, Santa Fe Natural Tobacco Company, Inc., American Snuff Company, LLC, R.J. Reynolds Vapor Company, and Modoral Brands Inc. References to “°µÍř˝űÇř,” “the group,” “the company,” “the organization,” “we,” “us,” and “our” are simply for convenience and are not intended to imply or suggest that the subsidiaries’ businesses are operated other than as separate, distinct businesses. To learn more about °µÍř˝űÇř Inc. and its operating companies, please visitĚýwww.reynoldsamerican.com.

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Media Contact:

mediaoffice@rjrt.com

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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Winston-Salem, N.C. (December 9, 2025) – The °µÍř˝űÇř organization (Reynolds) continues to add jobs in the Winston-Salem area and beyond, with the announcement of 200 new manufacturing roles in 2026 at the expansive Reynolds Operations Center in Tobaccoville, N.C.

The newly announced positions build on two years of significant growth for the organization. Reynolds added 800 jobs from 2024 to 2025, bringing total recent role additions to over 1,000.ĚýThese new roles will accelerate the organization’s momentum by supporting the ongoing success of Velo Plus nicotine pouches and expanding their multi-category portfolio as part of its mission to Build a Smokeless World.

Reynolds recently invested approximately $200 million in its manufacturing facilities to drive growth in smokeless products and implement equipment upgrades. The workforce needed to power that equipment, and its ultra-high-speed manufacturing is increasingly high-tech. Long-time employees are embracing upskilling, and the organization is proud to hire and train even more skilled operators and technicians to grow careers at Reynolds.

“For 150 years, Reynolds has been a cornerstone of economic strength in our community, creating well-paying jobs that sustain families across generations,” says Brian Chambers, senior vice president of operations within Reynolds. “Today, we continue that legacy by embracing transformation and welcoming new team members to help grow our future.”

Hiring and training the next generation of production workers has led Reynolds to collaborate with Forsyth Technical Community College on the Future-Ready Workforce Alliance, which offers specialized training programs tailored to meet business needs.

The organization also has plans to expand its workforce in Clarksville, Tenn., with an announcement forthcoming. To apply, or find out more, visit ReynoldsAmerican.com.

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About °µÍř˝űÇř Inc.:Ěý°µÍř˝űÇř Inc. is a wholly owned subsidiary of the global BAT Group and the U.S. parent company of R.J. Reynolds Tobacco Company, Santa Fe Natural Tobacco Company, Inc., American Snuff Company, LLC, R.J. Reynolds Vapor Company, and Modoral Brands Inc. To learn more about °µÍř˝űÇř Inc. and its operating companies, please visitĚý.

Media Contact:
mediaoffice@rjrt.com

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.

By focusing on Tobacco Harm Reduction, we are able to migrate adult cigarette smokers who do not wish to quit to potentially less harmful alternatives.

We know that sustained and lasting changes to adult consumer behavior offer the greatest hope for making cigarettes obsolete and we believe that providing viable alternatives to smoking is in the public interest.

Why? Because adult smokers should be given freedom over their decision to quit smoking or switch to potentially reduced risk nicotine alternatives. ĚýAlternatives to cigarettes, and the policies that enable adult consumers to access them, must be rooted in objective science, not politics.

For Tobacco Harm Reduction to work, it should be based on a foundation of evidence-based science, smarter regulation, better enforcement, and a collective commitment to shape a sustainable future for adult nicotine consumers.

This requires constructive debate and transparency that is inclusive of all stakeholders, ensuring the public health community, regulators, legislators, scientists, and industry all have a voice.

In an effort to increase evidence-based, transparent dialogue, we are pleased to publicly make available interim data from a 24-month longitudinal study we initiated.

For the convenience of researchers and regulators, a full presentation on the study can be found at .

The above excerpt was taken from a now available on . Ěý