Week of October 20 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• Juul is waging a comeback with high-tech safeguards meant to keep vapes away from teens - NY Post

After being heavily implicated in the teen vaping crisis — including years of legal battles and agreeing to pay out $1.7 billion over claims of misleading advertising — many assumed Juul Labs was a relic of the past. Now, the company is trying to rise from the ashes of controversy and get back to its original mission —creating smoking cessation devices for adults trying to quit cigarettes — while keeping its product out of the hands of teenagers. “Everybody kind of thought Juul was dead and evil,” James Sagan, CEO of Architect Capital and an investor in Juul since 2023, told NYNext. “But the early investors and founders have poured a bunch of capital back into the company to save it.” Central to Juul’s comeback plan is a new vape device, Juul2, which comes equipped with biometric safeguards intended to limit access to adult smokers only. Users will have to verify their age and identity through a companion smartphone app — using their iPhone’s Face ID or other phone-based biometric logins — in order to unlock Juul’s flavored pods. All Juul2 pods will contain a hardware chip that connects to the app via bluetooth and will only unlock for a verified, authorized user who has linked their e-cigarette to their identity. “The new product is basically trying to solve [two problems simultaneously],” Sagan said. “How do you keep vapes out of the hands of people who shouldn’t be using them — kids — and how do you make it appealing to smokers?” The Juul2 also includes a larger battery, an LED display showing puff count and battery life and firmware capabilities that allow for remote updates and usage tracking. The device is currently awaiting regulatory approval in the US; it’s already for sale, without the biometric safeguards, in the UK.

• Avail Vapor co-founders launching new international e-cig company - Richmond BizSense

Several years after their multi-state vaping retail chain went up in smoke, James Xu and Donovan Phillips are getting back in the e-cigarette game and looking abroad for their market launch.

The business partners and founders of the now-defunct Richmond-based Avail Vapor recently unveiled Fav, an e-cig device company that’s rolling out its product in European countries next month.

The Fav device combines a patented coil that heats tobacco leaves paired with a liquid-nicotine delivery method. By combining vaping and heat-not-burn technology, Fav is designed to provide users an experience very similar to smoking with what’s billed as fewer health detriments.

“We decided not to introduce (Fav) in the U.S. because the regulatory environment is completely screwed up by the FDA,” Xu said in an interview last week. “We just don’t know what’s going on. We spent $10 million before (when Avail sought regulatory approval). We’re not anxious to spend another $10 million to try out.”

• Philip Morris International Reports 2025 Third-Quarter & First Nine-Months Results - StockTitan.net

Smoke-free business (SFB): Our smoke-free business accounted for 41% of total net revenues (up by 2.9pp vs. Q3 last year) and over 42% of total gross profit (up by 2.5pp vs. Q3 last year). Our smoke-free products (SFP) are now available in 100 markets, nearly half of which have at least two of our three flagship brands (IQOS, ZYN and VEEV) available for sale. Our SFB continues to deliver superior performance, with shipment volumes up by 16.6%, net revenues growing by 17.7% (13.9% organically) and gross profit increasing by 19.5% (14.8% organically).

Oral SFP shipments increased by 29.1% to 238 million cans, predominantly driven by ZYN nicotine pouches in the U.S.

Net revenues decreased by 5.0% organically, mainly reflecting an unfavorable price variance in the U.S., including the impact of special promotions to mark ZYN's return to full availability, with all promotional costs including retailer incentives taken in net revenue. This was partly offset by higher SFP volumes.