By Timothy S. Donahue

Top Takeaways:

• FDA framework has sound bones, implementation remains inconsistent and politicized, and authorizations of reduced-risk products are too slow.
• States are reshaping outcomes through taxes, flavor bans, and registries that often blur into federal territory and become a barrier to the shelf.
• Confusing risk communication leaves consumers and even clinicians unsure about relative risk, and panelists urged plain-language messaging and interactive reviews.

During the Global Tobacco and Nicotine Forum 2025 (GTNF) in Brussels, held from October 6 to 8, an audience comprising nicotine industry regulators, manufacturers, researchers, and policy observers listened closely as five experienced industry and legal experts analyzed the current state of U.S. tobacco and nicotine regulation.

The panel, U.S. Regulatory Landscape, was moderated by Paige Magness, Senior Vice President of Regulatory Affairs at Altria Client Services. Magness opened the session with a clear statement of purpose. “We have a marketplace kind of run amok,” she said. “We have dysfunctional product pathways, and a regulatory system falling far short of what was intended when it was established.”

The goal, she explained, was to examine what has gone wrong in the United States, what changes may be coming under a new administration, and how the system might return to its original legislative intent.

Laura Leigh Oyler, Vice President of Regulatory Affairs at Haypp Group, started the discussion by highlighting the patchwork of state-level regulations. Representing a company that runs the online nicotine pouch retailers Northerner and Nicokick in the U.S. market, she noted that the country’s regulatory system is not uniform. “There are 50 different states, and those states have the power to regulate tobacco, in addition to what the federal government does,” she said.

The Family Smoking Prevention and Tobacco Control Act delegated the U.S Food and Drug Administration authority over product standards, premarket review, manufacturing practices, and labeling, while granting states control over sales, advertising, promotion, and taxes. In reality, those boundaries often become unclear.

Oyler used menthol regulation as a clear example. “Menthol is an ingredient, and therefore any attempts to regulate it should be treated as a product standard,” she said. “Even with something like a product standard, it has been ruled to be a marketing issue instead.” That confusion has allowed states to implement flavor bans, often through marketing-related interpretations, resulting in a patchwork of overlapping rules.

Oyler warned that flavor restrictions are also gaining momentum. “We can confidently forecast that the two states that have flavor bans today will more likely become more like 10 or 12 by the time we’re through with the next legislative cycle,” she said, noting that this comes “despite evidence that flavors are not just important but maybe even necessary to help smokers transition to lower-risk products.”

Registry bills aimed at illicit vape sales are also increasing, and once those bills appear, “they can take on a life of their own,” sometimes expanding to include pouches and other legal products.

Beth Oliva, Partner at Fox Rothschild, expanded on Oyler’s remarks by describing how state and federal regulations are clashing. Using California as an example, she pointed out that the state now has a full flavor ban and a new product registry requiring manufacturers to submit detailed information about their FDA filings to stay on the unflavored product list. “The FDA is the barrier to entry, the states are the barrier to the shelf,” she said. “The two are combining in ways that they were never meant to.”

Oliva pointed out a growing trend of state attorneys general communicating directly with the FDA, blurring jurisdictional boundaries and creating a new kind of enforcement uncertainty. On the federal level, she said the FDA’s approach is caught between reform rhetoric and institutional inertia.

She projected a slide that summarized the current moment with single words—expedited pathways, transparency, common sense, gold standard science, enforcement discretion, illicit market—and said these reflect both optimism and disarray. “Disruption was needed,” she said. “Whether this is the right disruption, only time will tell.”

Oliva questioned how the agency interprets its guiding standard, “appropriate for the protection of public health.” Originally intended to balance adult access and youth prevention, she said it now shifts with politics. “Whose discretion, whose priority, and what is enforcement today,” she asked, “when the illicit market is thriving in plain sight?”

The focus then shifted to the consumer through the perspective of Dr. Jessica Zdinak, Founder and Chief Research Officer at Applied Research and Analysis Company (ARAC). “They are not us,” she told the room, referring to the population of American smokers and nicotine users. Her firm conducts product perception and behavioral studies that contribute to regulatory submissions, and the findings are often stark. Many smokers, she said, have limited incomes, lower educational levels, and live with layered economic stress.

Their understanding of risk remains flawed. Zdinak shared quotes from participants who misunderstood product warnings. One asked how to place a nicotine pouch in the mouth if the label warns not to touch it with skin. Another said, “Zero tobacco nicotine means no nicotine.” These comments reveal a common confusion among consumers that Zdinak says regulators often overlook.

Equally concerning is the decline of trust. “They do not trust industry,” she said. “They actually don’t trust the federal government, but they trust their nurse and their physician.” Yet many doctors keep confusing nicotine with smoking, telling patients that vaping or pouch use is just as harmful. The result is a halt in progress. “Until we correct that,” Zdinak said, “there is little hope for more global change and U.S. change.”

Zdinak also warned that the FDA’s expedited pouch pilot could create “another Wild West” if standards are unclear or enforcement is inconsistent. Using national data from the U.S. Centers for Disease Control, she noted that adult use of nicotine pouches remains modest, youth use is low, and cigarette rates are decreasing. The main public health opportunity is in helping adult smokers switch through clear product communication and available flavors.

Valerie Briggs Solomon, Vice President of Scientific Affairs and Public Health Affairs at Reynolds American, offered a perspective shaped by three years abroad with British American Tobacco. Returning to the United States, she said, was sobering. “Some things have changed quite a bit,” she noted. “A lot has not changed, unfortunately, or certainly not for the better.”

Solomon said she was pleased to see recent marketing granted orders and FDA statements acknowledging the harm-reduction potential of nicotine pouches. However, the narrative remains inconsistent. “Even the bright spots are being muddied by statements that hyperinflate youth vaping or call things an epidemic that are not,” she said.

The agency, she argued, should focus less on eliminating combustibles through rules like very low nicotine content and more on clearly defining pathways for new products. A formal definition of “appropriate for the protection of the public health,” she added, would help stabilize expectations.

She also emphasized that the FDA needs to improve its communication of risk. She mentioned that misperceptions among adults are worsened by a fear-based message aimed at teens.

“Reading the quotes you provided from your surveys,” she told Zdinak, “It’s very clear that they don’t get it.” Reynolds’ own research across 15 countries indicates that while over half of healthcare providers discuss harm reduction with patients who smoke, only 20 percent feel sufficiently informed to do it effectively. “It’s a massive missed opportunity,” Soloman said.

The discussion shifted back to the FDA’s new expedited pathway for nicotine pouches. Oliva welcomed the idea of “interactive” review meetings after years of FDA staff being mostly silent during applicant sessions.

Zdinak expressed doubt about focusing solely on pouches, saying the move seems like an “easy win” for leadership that wants to show progress without reopening the politically sensitive debate on electronic nicotine delivery systems (ENDS). Solomon agreed, calling the pathway “an easier early win” for an agency still recovering from years of anti-vaping rhetoric that defied the science behind vaping.

From the floor, an attendee asked whether FDA reviewers genuinely balance youth protection with adult access. The panel agreed that the reviewer pool is diverse, with many scientists who understand harm reduction, but politicization skews the institution toward caution. Oyler reminded everyone that the best way to help youth is to support their parents in quitting, since parental smoking is the strongest predictor of youth initiation.

When asked whether the U.S. authorization model could serve as an example for global regulators, Oyler and Oliva said the framework Congress created is fundamentally sound, but its implementation has become unpredictable.

Decisions often depend on shifting leadership priorities rather than consistent scientific criteria. Even when authorizations happen, consumers rarely understand what they mean. “The average consumer does not know what is ‘appropriate for the protection of public health’,” Oyler said. “Hell, I barely understand it.”