Week of June 23 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• FDA says Elsa can’t hallucinate, unlikely to ever be connected to the Internet - Regulatory Focus

FDA Chief AI Officer Jeremy Walsh said that the agency is quickly updating Elsa and plans to add capabilities within the next 30 days. Beyond that, the agency is also working to add new features.

 Walsh emphasized that FDA has taken measures to prevent Elsa from hallucinating. “It caElsa currently does not have direct access to the Internet, and allowing it to have access could pose security challenges, according to Walsh. He described scenarios where the system could accidentally share proprietary information after being connected to the Internet and given sensitive agency documents.

 "I don't know if Elsa will ever be able to have real-time access to the internet,” said Walsh. “None of our models, especially Elsa, are being exposed or open to the Internet. That’s a big security risk.”

 Ultimately, Walsh said that FDA’s aim is to move toward a real-time regulatory environment. He said that could mean receiving, reviewing, and approving applications in real time. He also added that it could mean conducting inspections, surveillance, and ensuring compliance in real time.

 "Our goal is to look at the way that we are doing these functions and to figure out how we move it toward real time," said Walsh. "I think the AI tool we recently released, Elsa, is a great example of that.”

 As an example of how AI tools could be used to regulate in real time, Walsh said that the fastest way they've been able to output studies from FDA's Sentinel Initiative, which tracks safety reports for regulated products, is 3-4 weeks. Using AI tools, he said, they can potentially develop those reports in real time, improving postmarket and premarket surveillance.n't hallucinate, it's not allowed to come up with figments of its imagination,” he said.

• The Right Stuff: Glas Focuses on its PMTAs - Nicotine Insider

Since submitting its first PMTA in mid-2021, Glas has built what Greenbaum describes as the most comprehensive FDA submission of any flavored vaping product now awaiting authorization—a package that includes proprietary age-restriction technology, rigorous scientific studies, compelling smoking cessation data, and fully U.S.-based e-liquid manufacturing. While federal regulators have struggled to keep pace with PMTA reviews, Glas’s product remains stuck in regulatory limbo, its ability to compete hampered by the very rules it has spent years trying to follow.

• Michael Bloomberg announces new $20M fund for tobacco control - Devex

Bloomberg Philanthropies is injecting new funding to further help countries implement tobacco control measures.

Billionaire philanthropist Michael Bloomberg announced a new $20 million Accelerator Fund on Monday at the World Conference on Tobacco Control in Dublin, Ireland. He hopes it will help more countries implement proven tobacco control measures, which include advertising bans on tobacco, raising taxes on cigarettes, and passing legislation banning smoking in public places.

Publications

• Elevated Toxic Element Emissions from Popular Disposable E-Cigarettes: Sources, Life Cycle, and Health Risks Mark R. Salazar, Lalima Saini, Tran B. Nguyen, Kent E. Pinkerton, Amy K. Madl, Austin M. Cole, and Brett A. Poulin ACS Central Science Article ASAP DOI: 10.1021/acscentsci.5c00641

Abstract

The rapidly evolving market of disposable e-cigarettes poses unknown health risks to adolescents and young adults. We report excessive emissions of toxic metallic elements in aerosols from flavored and “clear” versions of three popular products (Esco Bar, Flum Pebble, and ELF Bar), orders of magnitude higher in concentration than traditional cigarettes and other e-cigarettes. Heating coil elements (chromium (Cr), nickel (Ni)) likely leached into e-liquids and aerosols from coil degradation during use, increasing up to 1000-fold in concentration over the device life. In Esco Bar devices, high concentrations of lead (Pb, ≤175 ppm), Ni (≤38 ppm), copper (Cu, ≤546 ppm), and zinc (Zn, ≤462 ppm) were observed in both e-liquids and aerosols. We identified the illicit use of leaded bronze in nonheating device components in contact with e-liquid as the source of Pb. Elevated antimony (Sb) in Flum Pebble and Esco Bar samples had unknown origins. Analyses showed Cr was present as nontoxic Cr(III), while Sb was a mixture of nontoxic Sb(V) and carcinogenic Sb(III). Risk assessments revealed cancer risks from Ni and Sb(III) and noncancer toxicity risks from Pb and Ni exceeded safety thresholds. These findings highlight critical gaps in e-cigarette regulation, characterization, and enforcement, with implications for public health.