Oral Nicotine Innovation

By Timothy S. Donahue

A standing-room crowd gathered at InterTabac in Dortmund, Germany, from Sept. 18–20, where experts delivered a data-driven outlook on the future of oral nicotine. Moderated by Dr. Nveed Chaudhary, director at NexCentra Consulting and chair of the Science & Standards Committee at the Global Institute for Novel Nicotine (GINN), the panel explored nicotine pouch regulation, toxicology, and product development from an industry-first perspective.

Chaudhary opened the discussion by linking oral nicotine to its long history and modern harm-reduction goals. “All nicotine is not new,” he noted, reminding attendees that oral consumption predates vaping and heated tobacco products. He emphasized that nicotine pouches are not just for smokers but also represent a safer alternative for existing oral tobacco users.

He explained the risk continuum widely used in tobacco control: eliminating combustion, then tobacco, then inhalation. Nicotine pouches, he argued, fall close to pharmaceutical nicotine replacement therapies (NRTs) in terms of risk. The bigger challenge is why pouches are regulated differently than medicines in many markets.

Global nicotine pouch regulations

Dr. Sydney Hiller, senior scientist at Sanova, outlined the rapidly evolving global regulatory landscape. In the U.S., pouches must go through the FDA’s premarket tobacco product application (PMTA) process. She highlighted the FDA’s new pilot program designed to speed up reviews, with decisions expected soon on filings from major manufacturers.

In Europe, products fall under the Tobacco Products Directive (TPD), though revisions are underway. Hiller pointed out differences between national rules, with France attempting a pouch ban and Sweden providing a model for “very successful regulation,” given its adult smoking rates below 5%. Elsewhere, markets like Australia and Canada are steering pouches toward medicinal pathways, a move Hiller said is not always grounded in science or harm reduction.

Chaudhary stressed the ongoing confusion between nicotine and tobacco smoke risks. Pawel Woznicki of Chemnovatic explained that nicotine itself should be evaluated separately from tobacco combustion, which drives cigarette carcinogenicity. He emphasized that pouches primarily carry cardiovascular risks linked to adrenaline and blood pressure, with impact depending on use levels.

Innovation and self-regulation in oral nicotine

Joel Rubenstein, GINN member and veteran in pharmaceutical nicotine, urged the industry to look beyond flavors as a key differentiator. “If everyone’s point of difference is flavors, that’s not sustainable,” he said. Instead, companies should focus on delivery strength, duration, and consumer safety. He warned against chasing extreme high-strength products, which could trigger regulatory backlash.

Rubenstein highlighted that pharmaceutical NRTs face strict dosage caps—typically 4 mg and in some cases 6 mg—forcing innovation in how nicotine is delivered. He challenged the industry to match the fast absorption of nicotine sprays in an oral format without negative side effects.

Consumer perception, he added, remains disconnected from science. In a Nordic study, respondents rated cigarette risk at 100%, recreational nicotine pouches at 44%, and pharmaceutical pouches at just 14%—despite near-identical product specifications. Packaging, claims, and context heavily shaped risk perceptions.

U.S. FDA regulations and PMTA challenges

Debate also centered on the FDA’s PMTA process. Rubenstein compared it to a poker game between major tobacco companies and regulators, suggesting companies are testing the FDA’s enforcement consistency. Hiller reminded the audience that under Section 910 of the Food, Drug, & Cosmetics Act, the FDA should review PMTAs within 180 days, but delays are common. If regulations remain unenforced, the U.S. market could operate more like a notification system, provided companies submit robust scientific data.

Synthetic vs. tobacco-derived nicotine

The panel also discussed the recurring debate around synthetic versus tobacco-derived nicotine. Woznicki emphasized that chemically, S-nicotine is identical regardless of source. However, he cautioned that R-nicotine and racemic mixtures complicate pharmacology. Ultimately, he said, quality and impurity control matter more than the origin of nicotine.

Investing in the nicotine pouch future

When asked how they would invest $50 million into nicotine pouch development, panelists emphasized:

• Rubenstein: Enhance NRT effectiveness with personalized quit solutions targeting multiple smoking triggers.

• Hiller: Invest in product stewardship and science to support compliance across global markets.

• Woznicki: Build a research hub to produce transparent science and consumer education.

• Chaudhary: Prioritize consumer-first harm reduction, advocating moderate strength levels around 14–16 mg/mL for heavy smokers.