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RAI Services Company (“Reynolds”) submits this response to the Center for Tobacco Products’ (“CTP”) draft guidance named “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk,” 91 Fed. Reg. 11980 (Mar. 11, 2026) (“Draft Guidance”).¹

The draft guidance doubles down on a flavor-prohibitionist playbook that harms Americans by handing over the marketplace to unregulated Chinese manufacturers whose illicit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 The draft guidance gets this exactly backwards.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 �������� 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 �������� 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 �������� plays across North Carolina and Tennessee economies.

�������� 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.

Located northwest of Nashville in one of Tennessee’s fastest growing regions, Clarksville continues to attract manufacturing companies drawn to its workforce, infrastructure, and strong community ties. These role additions are part of ��������’s multiyear, forward-looking $3.2 billion investment in U.S. manufacturing operations through 2030, encompassing workforce development, technology modernization, and more than 2,000 new direct and indirect jobs.

Open positions, ranging from machine operator and maintenance technician roles to advanced manufacturing careers, will be filled on a rolling basis throughout 2026. The Clarksville site is also adopting digital and simulation-based training tools to accelerate employee development and embed new technologies across logistics, quality control, and safety operations.

“Clarksville has a strong manufacturing tradition, and we believe the future of the industry will continue to be built by skilled, engaged employees.”

��— Adriano Rusak, VP of Manufacturing, American Snuff Company

Read the full story in the Nashville Business Journal to learn more about what this investment means for Clarksville and the employees who power our operations. Learn more:

Interested candidates can view open positions at��.

Based on data from 12 million workers across 1,763 employers, the list highlights organizations where people can grow and build long-term careers.

With more than 4,300 U.S. employees across manufacturing, engineering, science, operations and corporate roles, we continue to strengthen capabilities through technology, training and workforce readiness.

Our early-career programs, including internships, apprenticeships and our immersive 18-month Global Graduate Program, give emerging talent a space to contribute, grow and lead. By growing careers today, �������� is helping to build stronger businesses, stronger communities and a stronger future.

Explore open opportunities:

As ��������’s operations continue to evolve and expand, the organization remains focused on ensuring employees have access to the skills, tools, and experiences needed to grow alongside the business. Through advanced manufacturing technologies and immersive, hands-on training, �������� is creating clear pathways for individuals to enter, advance, and thrive in high-demand manufacturing roles.

“At the heart of our transformation is a simple truth: our people power our progress.”

— Borgia Walker, SVP, Human Resources and Chief People Officer

The article also highlights ��������’s local investments in workforce development, including its partnership with Forsyth Technical Community College’s Future Ready Workforce Alliance, as well as technology-enabled learning and upskilling opportunities that support long-term career growth. By blending education, real-world experience, and modern training approaches, �������� is strengthening its talent pipeline while supporting the communities where its employees live and work.

By growing careers today, �������� is helping build a stronger workforce, stronger businesses, and a stronger future for the Triad and beyond.

Read the full article:

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 �������� 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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The Visionaries list recognizes trailblazing executives from leading consumer goods organizations who are taking measured, strategic approaches to advance transforming business operations in efficient, sustainable ways.

Since 2024, Wade has led the charge to��anticipate��our organization’s future needs, execute a three-year rolling plan, and operationalize it in ways that have yielded business results and enabled investments in��the organization’s��brands and people. Under Wade’s leadership, we have made great progress towards��the��goal��of becoming a��predominately smokeless��organization��by 2035. Specifically, through his oversight of a multi-year plan, his efforts to advance solid business strategies and increase stakeholder engagement have led to accelerated growth in smokeless categories, with our��companies’��nicotine pouch and vapor products leading market share and revenue gains.

As the organization enters��2026,��Wade��has announced plans to evolve and expand the strategy into future years, further��reinforcing��our organization’s commitment to innovation, responsibility, and transformation.

To better understand how these ambitions come to life, Wade shared insight into the organization’s vision for the future and his leadership approach in a recent Consumer Goods Technology feature. His perspective underscores why he was selected as a 2025 Visionary.

An excerpt from the feature is included below. The full article can be read on��.

Biggest Accomplishment

Huckabee led the �������� organization through a transformation during its 150th anniversary, which commemorates the founding of R.J. Reynolds Tobacco Co. in 1875. Since 2024, he has reflected on the company’s history while shaping its future strategy, emphasizing quality growth,��sustainability��and a dynamic business model. “With an ambition to become a primarily smokeless business by 2035, I’m honored to help lay the foundation that will shape the organization’s next 150 years.”

Maintaining an Innovation Mindset

Huckabee believed the most effective way he has seen organizations scale innovation is by developing direct channels that empower employees to share their ideas. “Innovation��doesn’t��come from the top down;��it’s��cultivated through a culture that values curiosity,��collaboration��and continuous improvement. By fostering open dialogue and creating space for new thinking, we unlock more efficient ways of working, drive stronger business results, and accelerate our transformation agenda.” He believes that people can be an organization’s greatest source of��innovation, and��empowering them is essential for ongoing success.

2026 Tech Priorities

����������companies��are��focusing on providing adult smokers with alternative nicotine products that carry potentially lower��risks, and��investing in its manufacturing capabilities to support the growth of smokeless products. “I believe the most impactful tech investments this year will be in ultra-high-speed manufacturing — manufacturing technologies like AI-enabled optical quality assurance and workforce upskilling.” ����������companies��created 800 new jobs in 2024 and 2025 alone and is aiming to provide innovative tools and training to future-proof its workforce as it continues to grow.

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 ��������’s journey and vision for the future:
 

The article explores how Reynolds is navigating a rapidly evolving industry landscape while remaining focused on long-term growth and environmental responsibility. It also emphasizes the company’s commitment to investing in advanced technologies and building a culture of continuous improvement.

This feature is a testament to the work being done across the organization to drive progress and lead with purpose. It offers a behind-the-scenes look at how Reynolds is shaping the future of its industry.

Employees and stakeholders are invited to read the full article and learn more about Reynolds’ vision and impact.

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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.