FDA’s authorization of the marketing of four Glas Inc. e-liquid pods, 3 of which are flavored outside of tobacco, is a historic moment in the history of tobacco regulation in the U.S. Until today, FDA had long come under fire for not having authorized actual flavored ENDS products, outside of tobacco and menthol. Flavored products have been shown to contribute to smoking cessation and significant CPD reduction outcomes among adults who smoke. In our endless hours of conversation with thousands of consumers across the U.S., we also know that flavors contribute to the initiation of smokers into the ENDS category. Despite this evidence, and with good faith efforts to keep a new generation from being addicted to nicotine/tobacco, FDA had not authorized flavored ENDS other than tobacco and menthol.

Today’s announcement is a win for so many, but ultimately, it's a win for the millions of smokers in the U.S. who have sought less harmful alternatives to their cigarettes, while relying on the federal government's authorizations to help guide them in what these less harmful alternatives actually are. With a market so flooded with illicit ENDS products, we are hopeful that these MGOs will reduce the need for unauthorized vapes across the U.S.

The announcement vindicates ARAC’s thought leadership in the tobacco and nicotine space. ARAC has long advocated for the necessity of PMTA applicants to provide scientific evidence on the product use and switching behaviors associated with a candidate product, via carefully designed studies to satisfy the FDA’s APPH standard. The incorporation of device access restrictions (DAR) was also a major contributing factor to the Glas MGO, and we applaud the entire Glas team on this victory. According to Bret Koplow, acting director of the FDA’s Center for Tobacco Products, “By helping to prevent youth use, device access restrictions are a potential game changer.”

ARAC can't wait to celebrate with our colleagues, turned friends, who have worked so hard to make this happen: Kevin Higgins, Sean Greenbaum, and Stacy (Weinstein) Ehrlich. We also thank the entire Chemular Inc. team, particularly Ed Carmines, who made that faithful call to Dr. Jessica Zdinak in late October 2024. We are also so proud of our entire Applied Research and Analysis Company (ARAC) team at the time who made this 4-month endeavor possible, but particularly Elizabeth DeMartini, Tal Shahar, MBA, & Kiri Stauch, Ph.D. now stand in the mix as ARAC embraces such a huge win for science and for public health!

Read the official FDA release here.