By Timothy S. Donahue

Top Takeaways:

• No single rulebook: Companies face increasingly fragmented requirements across Europe, the United States and other markets, making regulatory planning part of product development.
• Science before submission: Panelists said toxicology, stability, manufacturing controls and consumer-behavior research should begin well before a regulatory filing.
• Consumer reality matters: A product can satisfy regulators on paper and still fail if adults will not use it, while products consumers want may struggle if regulators see unacceptable population-level risks.

The future of nicotine may be global, but the rulebook certainly isn’t.

That was the recurring message from an InterTabac panel examining how companies are trying to navigate increasingly diverse regulatory requirements while developing products that consumers want and regulators are willing to allow on the market.

Sarah Marking, chief strategy officer and co-founder of Sonova, moderated a discussion featuring Beth Oliva, a partner at Fox Rothschild; Elizabeth DeMartini, managing director of international and U.S. product research at Applied Research and Analysis Co. (ARAC); Victoria Taverner, a scientist at Sonova; and Liz Frank, director of business relations and operations at nicotine pouch company Ki.

The panel discussion covered the upcoming revision of Europe’s Tobacco Products Directive (TPD 3), U.S. Food and Drug Administration premarket tobacco product applications (PMTAs), consumer behavior, manufacturing controls, and the growing importance of nicotine pouches.

But beneath nearly every topic was the same problem: companies increasingly have to satisfy consumers, regulators, manufacturers, and their own business requirements at the same time. Frank described it as “a four-way tug of war” that never stops.

“Nobody’s necessarily winning the battle,” she said. “It’s just a matter of how are you all working together when nobody agrees on what success looks like.”

Consumers, Frank said, want flavor, nicotine strength and convenience. Regulators are asking different questions, including whether a product benefits adults who smoke while minimizing risks to youth and nonusers. Businesses need speed, revenue and predictability, while manufacturers seek efficiency, scale and long production runs.

“The companies that do survive this are the ones that don’t just pick one particular stakeholder and align with that stakeholder,” Frank said. “They understand what everybody needs.”

Europe stays fragmented

Taverner said Europe presents its own regulatory puzzle because requirements can vary considerably among countries, even when products fall under the EU Tobacco Products Directive.

Nicotine pouches make the problem particularly clear because they currently fall outside the scope of the TPD and are instead regulated under national frameworks. This has led to widely different approaches across Europe, including national restrictions and bans.

The European Commission is reviewing the tobacco-control legislative framework, but the specifics of any future revision remain unsettled. Separately, the Commission’s proposed Tobacco Taxation Directive would expand EU excise rules to include products such as e-cigarettes, heated tobacco and nicotine pouches.

Taverner said companies need to prepare for a regulatory environment that continues to shift beneath them. “Interesting times for the EU,” she said, “and still a lot of uncertainty around what TPD3 is going to look like.”

DeMartini said regulatory fragmentation is only half the problem. Consumer preferences also vary widely by geography. “These products are not a one-size-fits-all,” she said. Even within the United States, she said, a product that performs strongly in one region may struggle somewhere else.

That means companies should gather consumer insights early rather than build a product first and then discover whether anyone wants it.

Know the product first

Oliva said companies considering multiple markets should start with something more basic than a regulatory filing: product stewardship. “You can’t do anything without first making sure that you’re putting out the best product you can and that you know your product,” she said.

That includes understanding toxicology, stability, shelf life, ingredients, and manufacturing, regardless of whether a particular regulator explicitly requires every test.

“Knowing everything going into your product and everything coming out of your product, if you have that to begin with, no matter what your language is, you’re going to have a much easier time because you already have the answers to most of the questions you’re going to be asked,” Oliva said.

Taverner made a similar point regarding laboratory science. “Good product stewardship isn’t always just a box-ticking exercise,” she said.

A regulation may not specifically require an 18-month stability study or certain biological testing, she said, but companies can still conduct those studies to understand their products and assess potential risks.

DeMartini said that laboratory performance, however, is only one layer. “You can have a product that looks amazing on paper and it’s beautiful and all the things, but if a consumer isn’t going to use it, then we have to look at that too,” she said.

Companies also need to understand foreseeable misuse, she said, including whether product design could lead consumers to misuse a product. That becomes especially important in the United States, where FDA evaluates new tobacco products under its appropriate-for-the-protection-of-the-public-health (APPH) standard that considers risks and benefits to the population as a whole, including users and nonusers.

U.S. remains the big prize

Frank called the United States “a market that everybody wants, and nobody can afford to get wrong.” Beyond its commercial value, Frank argued that an FDA marketing authorization can confer regulatory credibility elsewhere because international policymakers pay attention to the FDA’s decisions.

But reaching the U.S. market requires a very different level of evidence than in many other jurisdictions. Frank described a PMTA, in simplified terms, as a combination of chemistry, toxicology, consumer, and manufacturing evidence.

Rather than treating that as one enormous bet, Ki has broken the process into stages, she said, using pilot testing and preliminary toxicological work to identify problems before committing to the full cost of a submission.

“If you bypass that and you go straight into your PMTA and you put your product in the application without testing it, you don’t know what’s going to come up,” Frank said. “You might have to start all over again.”

She also urged companies hoping to enter the United States to design manufacturing systems with FDA requirements in mind, even if their first commercial launch occurs elsewhere. Data generated in those earlier markets can prove useful later. “If you’re launching in the U.K., use that consumer data for your benefit,” Frank said.

Talk to FDA before spending millions

Oliva said companies entering the U.S. market should pay particular attention to the FDA’s pre-submission meeting process. FDA describes those meetings as voluntary, formal discussions between applicants and the agency about planned submissions and the design and conduct of investigations supporting those submissions.

“The agency has also, under the current administration, been much more forthcoming in meeting with applicants before they put in their applications,” Oliva said.

For companies preparing to spend hundreds of thousands or millions of dollars to generate evidence, that conversation can provide valuable guidance on whether the proposed scientific program is likely to answer the FDA’s questions. “If you are considering going into the U.S. market, it is our strong, strong recommendation you do one of those meetings,” Oliva said. “It can pay dividends.”

That observation follows significant changes at the FDA’s Center for Tobacco Products. CTP said in May that it reduced its application backlog by approximately 70% in 2025, and a new enforcement policy gives lower enforcement priority, under specified circumstances, to certain unauthorized ENDS and nicotine pouches with qualifying pending applications.

Oliva said that recent public engagement by new permanent CTP Director Bret Koplow has also provided industry with more information about where the agency is headed.

“Just last week, we had the director of the Center for Tobacco Products at the GTNF (Global Tobacco and Nicotine Forum) conference,” she said. “He actually came over to Europe to talk about the process. That’s unprecedented, really, in the history of the FDA.”

Consumers can wreck the perfect plan

DeMartini repeatedly brought the discussion back to something easily lost in a regulatory dossier: actual human beings. FDA does not simply want evidence that a lower-risk product exists, she said. It wants to understand whether people will use it, how they will use it, and whether adult smokers will actually switch.

Age-gating technology provides a particularly good example. ARAC conducted consumer research involving Glas, whose flavored ENDS products were authorized by the FDA in May and included access-restriction technology intended to limit use to verified adults.

For regulators, age-gating can address a significant concern about youth access. For consumers, it can create another obstacle. “Especially in the older adult population, it sometimes took 30 minutes, sometimes an hour, just to learn how to use that age-gating device,” DeMartini said.

“That’s all super important information,” she added. “The FDA wants to know that.”

The tension is particularly relevant in light of the FDA’s recent flavored ENDS authorizations and its increasingly explicit recognition of a continuum of risk among tobacco products. The FDA currently states that adults who smoke may reduce exposure to harmful chemicals by switching completely to authorized e-cigarettes, and that nicotine pouches can generally be a lower-risk alternative for adults who smoke, although neither category is risk-free.

One market can affect another

Frank warned that a company’s behavior outside the United States can also be relevant when seeking FDA authorization. A marketing campaign permissible in the U.K., for example, may not necessarily help a company’s case before the FDA.

“You need to figure out how much risk you’re willing to take,” Frank said.

A company might decide that aggressive marketing in another jurisdiction is worth the potential regulatory risk, she said, but the key is understanding that trade-off before making the decision.

Oliva agreed that every company needs to set its own regulatory risk tolerance. “Different companies have different tolerance for how far they’re willing to push things, depending upon whether it’s advertising, whether it’s manufacturing, whether it’s flavor or strength,” she said. “You, as a company, have to be in agreement as to what you want that risk tolerance to be.”

The American difference

The panel identified FDA’s population-level APPH standard as one of the most significant distinctions between the United States and other regulatory systems. A regulator elsewhere may primarily ask whether a product complies with defined requirements for ingredients, emissions, packaging, or notification.

FDA must additionally consider how the product could affect the population as a whole.

Oliva said she had discussed that distinction with Koplow just days earlier, including how the FDA could view a new product form if it might encourage dual use. “Dual use is going to happen anywhere,” Oliva said. But because of the U.S. population standard, she said, such behavioral questions can affect whether FDA believes a product should be authorized.

That is why consumer research is so important. DeMartini said even something seemingly obvious, such as how an oral nicotine pouch is placed in the mouth, cannot be assumed. “What we find going out in the real world, it’s not always that simple,” she said.

Companies may discover through behavioral research that instructions or labels need to be revised before submission. The APPH standard is intentionally broader than a simple product-safety test. The FDA says its decisions weigh the potential benefits to adult tobacco users against the risks to youth and non-users.

Pouches lead, but no product wins everywhere. Asked which products have the greatest potential, the panel largely favored oral nicotine, though not unanimously.

Oliva said nicotine pouches currently have considerable momentum in the United States, and new form factors, such as dissolvables and lozenges, could also emerge. Heated products may have stronger opportunities in parts of Asia, she said, while Europe’s future is likely to remain fragmented.

FDA’s recent actions support the view that pouches have become an important part of the U.S. regulatory landscape. The agency authorized higher-strength ZYN Ultra products in August and, earlier this year, granted modified-risk orders allowing 20 ZYN products to communicate specified reduced-risk information compared with cigarettes.

Taverner also favored oral nicotine because it avoids inhalation, combustion, and third-party exposure. Frank also picked nicotine pouches, arguing that consumer, regulatory, manufacturing, and commercial considerations are increasingly aligning around the category.

DeMartini said, “Not one product wins,” because she has encountered consumers who want to switch to oral nicotine but still miss the behavioral ritual of smoking or vaping. That, she said, is precisely why “the science” cannot stop at chemistry or toxicology.

A product still has to work for the person expected to use it. “As long as you have the evidence that you need for the product that you are trying to bring to market,” DeMartini said, there will continue to be room for different products.