March 8, 2022 Dr. Robert Califf, FDA Commissioner Re: Six Months Since PMTA Deadline CC: Mitch Zeller, Director, FDA Center for Tobacco Products
CC: Xavier Becerra, Secretary, Department of Health and Human Services
Submitted by e-mail Dear Commissioner Califf, What’s taking so long? It has been six months since the court-ordered deadline of September 9, 2021 for the Food and Drug Administration to act on all Premarket Tobacco Applications (PMTA) for electronic cigarettes. While we appreciate that FDA has reviewed and denied the majority of applications for flavored products, we are deeply concerned that the market leaders--including JUUL, Suorin, SMOK, and NJOY--are still under review and remain on the market without full regulation. They are easily accessible to the millions of kids whose lives have been upended by the ongoing youth vaping crisis. Many of these young people are severely addicted to nicotine, causing elevated anxiety and depression, and further substance use. Others suffer from a variety of serious health issues including asthma, seizures, and lung injury. Millions of parents across the country have waited far too long for the FDA to protect our kids from these dangerous products and predatory tobacco companies including those, like Puff Bar, that used the delay to make unsubstantiated claims of synthetic nicotine use, allowing them to avoid any regulation at all. We urge you to deny all pending and any subsequent applications for ALL flavored e-cigarettes including menthol, one of the most popular flavors among youth. If you don’t act now, you are allowing an entire generation of young people to become Big Tobacco’s next lifetime customers. Sincerely, | 
