By Timothy S. Donahue

Top Takeaways:

• Regulatory Uncertainty Continues Amid FDA Leadership Transition: The U.S. FDA’s Center for Tobacco Products (CTP) is in flux following leadership shake-ups, with stakeholders noting a lack of clear enforcement strategy and transparency on product authorizations.
• Calls Grow for a Two-Pronged Approach: Experts say enforcement against illicit nicotine products must be coupled with an effective, fair premarket authorization pathway to support legal, reduced-risk alternatives for adult consumers.
• Industry Encouraged to Engage Directly with Administration: Panelists stressed that change is unlikely from within CTP alone and urged stakeholders to elevate concerns to the White House and HHS, where political will could redirect the agency’s approach.

During the Next Generation Nicotine 2025 panel, Navigating the Future of Next Generation Nicotine, a high-level panel of legal and policy experts painted a sobering picture of the U.S. regulatory environment for vaping products and nicotine pouches—calling it dysfunctional, politically fraught, and in urgent need of reform.

Moderated by Agustin Rodriguez, partner at Troutman Pepper Locke and co-head of the firm’s tobacco and nicotine team, the discussion focused on enforcement failures, the stalled authorization process, and potential openings for reform under the second Trump administration.

Rodriguez set the stage by noting that next-generation nicotine products—such as e-cigarettes and nicotine pouches—represent a public health opportunity that regulators have yet to harness effectively. “We’re now in a new generation with new alternatives,” he said, “products that offer a much-reduced harm profile relative to older generation products, especially combustible cigarettes.”

However, instead of a regulatory framework that supports innovation, Rodriguez said the industry is contending with “a market flooded with unauthorized products and an (U.S. Food and Drug Administration) FDA that has effectively sidelined lawful applicants.”

Leadership Shakeups and Strategic Uncertainty

Lillian Ortega, former FDA enforcement director and now chief regulatory strategist at WOW Solutions, said the new administration’s approach contrasts sharply with earlier efforts under former Commissioner Scott Gottlieb. “In 2016 and 2017, there was a plan, a comprehensive nicotine strategy, and a focus on the continuum of risk,” she recalled. “What’s different now is the disruption—most of the leadership in the Office of Science at (the FDA’s Center for Tobacco Products) CTP is gone.”

However, Ortega sees signs of renewed engagement. She called the appointment of Bret Koplow as acting CTP director a “strategic” move. “He’s not new to the agency and understands the core issues,” she said. “What’s notable is that this time, leadership is talking about bringing legally reduced-risk products to market, which is a tone shift we haven’t seen before.”

Enforcement Without Viable Pathways

Azim Chowdhury, a partner at the law firm Keller Heckman, echoed Ortega’s concerns but took a more skeptical view. “I don’t see any significant change yet,” he said. “The strategy remains enforcement, enforcement, enforcement.”

Chowdhury criticized the agency’s narrow focus on cracking down on the illicit market without addressing the core problem: the failure to approve viable alternatives. “When 99.9% of products have been refused or denied, it’s not a legitimate regulatory system,” he said. “It doesn’t incentivize compliance; it incentivizes the black market.”

He argued that the FDA’s premarket tobacco product application (PMTA) process is fundamentally broken. “The process puts the entire burden on the industry. There are no clear standards, no reliable timeline, and no transparency,” he said.

When asked whether FDA should play an active role in encouraging innovation, Chowdhury pointed to the original text of the 2009 Tobacco Control Act (TCA). “Promoting harm reduction was always a stated goal,” he said. “It’s just been completely lost in implementation.”

Political Pressure May Be the Only Path Forward

Guy Bentley, director of consumer freedom at the Reason Foundation, said the change in administration offers a “note of opportunity,” even if execution remains uncertain. “This White House is not hostile to nicotine innovation in the way the previous administration was,” Bentley said. “But as we saw with the 2017 FDA strategic plan—it’s one thing to make speeches, another to follow through.”

Bentley also questioned the feasibility of enforcement as a primary tactic. “Even in states like Massachusetts, where flavored tobacco is banned, access is everywhere,” he said. “You can’t enforce your way out of a market failure.”

Bentley and Chowdhury both argued that the most realistic path to reform lies in going over the agency’s head. “Appeals to CTP won’t work,” Bentley said. “This is a political issue, and the solution lies with the White House and Congress. They need to hear directly from the industry.”

AI Raises Hopes—and Red Flags

Panelists were divided on the recent announcement that the FDA may use artificial intelligence to assist with PMTA reviews. Chowdhury warned that AI could exacerbate existing problems if not carefully managed. “Used improperly, AI will just make it easier to issue mass denials,” he said. “The technology needs normative guidance from humans before it can be useful.”

Ortega added a note of caution, saying this is the fastest she’s ever seen the agency move to implement a new system. “I’m not convinced it’s ready,” she said. “AI must be supported by real human review to be effective—and that adds complexity and time.”

State Intervention Highlights Federal Gaps

The panel also addressed a growing trend: state-level attempts to fill the regulatory vacuum left by FDA inaction. Ortega warned that such measures, while understandable, are not legally sound. “It’s not the states’ job to authorize products. That’s clearly the FDA’s responsibility under the TCA,” she said. “But when FDA fails to act, states feel compelled to step in.”

All panelists agreed that the industry must unify and elevate its concerns beyond CTP. Ortega noted that the FDA has launched initiatives aimed at improving transparency, including roundtables and even a podcast. “There’s an open-door policy now,” she said. “Use it. Submit public comments. Request meetings. Make your voices heard.”

Chowdhury, however, argued that structural reform may be needed. “It may be too late for CTP to self-correct,” he said. “Ultimately, we need to rewrite the TCA. But even short of that, the law as written gives FDA room to regulate better than it has.”

Bentley concluded with a reminder that regulatory paralysis serves no one. “If we want a legitimate, functioning market that supports adult access to safer alternatives, the time for half-measures is over,” he said.

Stakeholders in the next-generation nicotine market face a crossroads. While the Biden-era leadership at CTP failed to modernize regulation, the new administration presents a slim but critical opening. Whether through direct engagement with federal agencies or full-scale legislative reform, the industry’s future hinges on shifting the regulatory conversation—from a politics of prohibition to a policy of innovation and harm reduction.