By Timothy s. Donahue

Top Takeaways:

• FDA engagement: Panelists said CTP has become more willing to engage with industry through meetings, conferences and direct dialogue.
• Regulatory clarity: Speakers called for more town halls, webinars and open forums to help companies better understand PMTA expectations.
• Pouch evolution: Oral nicotine manufacturers said FDA’s understanding of nicotine pouches has evolved significantly as the category has grown.

For years, one of the most common complaints among nicotine manufacturers was that they wanted more communication from the U.S. Food and Drug Administration. At the Next Generation Nicotine Delivery 2026 conference, industry experts suggested that relationship may finally be improving.

During the panel discussion Building a Strong and Effective Working Relationship with CTP, Speakers from regulatory consulting firms, scientific service providers, and nicotine manufacturers largely agreed that the FDA’s Center for Tobacco Products (CTP) has become more accessible and more willing to engage with industry than in previous years.

The panel, moderated by Melis Coraggio, a consultant with King & Spalding, included Laila Noory, senior regulatory strategist at Sonoma; Sydney Hiller, director of U.S. regulatory operations at Inter Scientific; and Samy Hamdouche, co-founder and chief operating officer of Lucy Goods, a manufacturer of oral nicotine products.

Much of the discussion centered on communication—what is working, what is improving, and where companies still want greater clarity from regulators.

Talking Before Writing

One area where panelists observed clear progress was pre-submission engagement. Noory described pre-submission meetings as among the most valuable opportunities for companies to discuss product development plans, study designs, and regulatory strategy prior to filing a PMTA.

“I do think pre-submission meetings are a great way to get in front of the agency and really tell the story of your product,” Noory said. “It allows you the opportunity to ask very targeted questions that you want to receive feedback on.”

She said the FDA has increasingly encouraged companies to seek feedback throughout product development rather than waiting until an application is complete. “What we’ve seen lately is that the agency has really come out in support of submitting a meeting request at any stage of development,” Noory said.

Hiller echoed those comments, noting that increased engagement has been especially valuable for companies developing innovative nicotine products. “I think we’ve seen recently an increase in the activity and engaging with FDA and CTP, which has been amazing and is extremely helpful for companies as they’re navigating the PMTA process, especially when it comes to study design,” Hiller said.

She added that scheduling challenges can still pose difficulties, particularly for companies based internationally that are trying to compile preliminary data before meeting with regulators.

Meanwhile, Hamdouche reflected on how dramatically the FDA’s understanding of oral nicotine products has changed over the past decade. “From the point of view of the FDA, our category didn’t really exist,” Hamdouche said. “In all our submissions and forms, the category was ‘other [tobacco products (OTP)]’ and the subcategory was also ‘other.’”

Today, he said the FDA has a far better understanding of oral nicotine products and their potential role in tobacco harm reduction. “I think in that period of time the FDA has come a long way in understanding what the category of oral nicotine is and the potential benefit to public health,” Hamdouche said.

More Questions, More Answers

If there was one message repeated throughout the panel, it was that companies want more opportunities to hear directly from the FDA.

Panelists cited recent guidance documents and enforcement announcements as examples in which additional explanation through webinars, town halls, or question-and-answer sessions could have helped stakeholders better understand the agency’s thinking.

“I think the agency providing the information in a very digestible way would be beneficial,” Noory said. “Having the ability to either have a town hall or a webinar or just a web series really explaining and outlining what it means.”

Hiller agreed, noting that many smaller companies continue to struggle to meet regulatory expectations despite the availability of written guidance.

“I do think that they’re incredibly helpful for companies that are trying to navigate this PMTA process and do so in a compliant way,” she said of FDA webinars and town halls.

Hamdouche suggested the FDA could go even further by creating forums where companies could openly discuss emerging products, scientific findings, and future innovations before those products appear in PMTA submissions.

Ultimately, the discussion returned to a familiar challenge for manufacturers throughout the nicotine industry: uncertainty. “Industry is looking for any and all ways to get more information and more clarity about the CTP’s process,” Hamdouche said.

For smaller companies in particular, he said, clearer expectations can make the difference between moving forward and staying put. “Uncertainty is important for any business, but speaking particularly as a small company, uncertainty is a killer,” Hamdouche said.

The panel concluded with praise for FDA officials who attended the conference, as speakers noted that the agency’s willingness to participate in industry events and engage directly with stakeholders is helping build a stronger working relationship between regulators and the companies they oversee.