Week of October 6 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• NATO executive director discusses the state of vapor and nicotine pouches in convenience stores - CSP

David Spross: It’s been a major push amongst the trade associations for a couple of years now and really based on the feedback from our members over concerns of the lack of transparency coming out of the FDA. It’s been a frustrating process. If you look at the premarket tobacco product application (PMTA) process, there is a lack of information coming out of where applications stand, and coupled with that is the lack of product authorizations. We were just talking earlier today about the 30-some odd vapor products that have been approved or authorized. If you look at a lot of those 30 products, they’re not commercially viable. I think the ask of the FDA was a couple of things. Because of the lack of product approvals, it’s created this huge environment for the illicit vapor disposables to influx the market. What we wanted was increased enforcement from the FDA, more transparency from CTP on what they’re doing for enforcement and as it relates to the PMTA process. The FDA has acknowledged the relative risk of whether it be vapor products or nicotine pouches compared to combustible cigarettes, so hopefully we will see more action in that regard.

In the vapor space, same opportunity. The Juul authorization in July I thought was a watershed moment for the vapor segment. Juul came under a lot of public scrutiny through the years, but I think certainly at the end of the day the FDA recognized the relative risk of that product and authorized it. That’s a great sign to me. I think we’ll probably see other authorizations within the vapor space.

• Farrelly Returns as Director of OS at CTP - Nicotine Insider

The Center for Tobacco Products’ (CTP) Office of Science (OS) will have a returning director, according to the CTP website. Matthew Farrelly, who first joined the CTP as director of the OS in 2023 and was then reassigned in early 2025 to another role within the Department of Health and Human Services (HHS) due to a restructuring, is returning to lead the OS once again.

Farrelly’s name is listed as director of the OS on the U.S. Food and Drug Administration’s CTP’s leadership list on the agency’s website; however, it’s unclear if his name was ever removed in the first place, as no formal position at HHS was ever publicly announced. Farrelly also never changed his LinkedIn page from serving as the “present” OS director.