Week of June 2 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• Will the FDA “Save” Vaping or Bury It? Questions Swirl Around New Leadership - Vaping Post

The recent appointment of Dr. Martin Makary as Commissioner of the U.S. Food and Drug Administration (FDA) has stirred alarm within the tobacco harm reduction (THR) community, following comments that many view as deeply misleading and potentially damaging to public health policy. During a May 22nd Senate Appropriations Subcommittee hearing, Dr. Makary painted an alarmist picture of adolescent vaping… while there is widespread agreement that unauthorized and illicit vaping products should be eliminated from the market, THR proponents argue this can only happen efficiently if the FDA focuses on expanding the authorization of legitimate, lower-risk products… Meanwhile, Dr. Makary’s comments signal a troubling direction for FDA leadership. His portrayal of a teen vaping “epidemic” disconnected from reality may pave the way for policies that ignore the needs of adult smokers. By repeating debunked claims and relying on anecdotes rather than evidence, the FDA risks undermining not only its own legitimacy but also the broader goal of reducing smoking-related disease and death.

• FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People - FDA  

The U.S. Food and Drug Administration (FDA) today launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people.

Built within a high-security GovCloud environment, Elsa offers a secure platform for FDA employees to access internal documents while ensuring all information remains within the agency. The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff.

Elsa is a large language model–powered AI tool designed to assist with reading, writing, and summarizing. It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications. These are just a few examples of how Elsa will be used across the enterprise to improve operational efficiency.

• Ingredient up to 13,000 times sweeter than sugar lurks in vapes popular with teens, study shows - Stat News

The study, published Monday in JAMA, found neotame in all 11 of the popular disposable vape brands it tested, including Elf Bar, Breeze, and Mr. Fog. Neotame was also detected in vapes marketed as “zero-nicotine” or that used nicotine analogs. All of these vapes are technically illegal in the U.S., but remain widely available at many gas stations and convenience stores as well as online. The study did not find neotame in the four e-cigarettes it tested that are authorized for sale by the Food and Drug Administration, nor in Juul, which has an application pending with the FDA.