E-Cigarette Companies Asking for An Extension from the FDA | Clark, Perdue & List

Due to the recent coronavirus pandemic, e-cigarette makers are looking for an extension on their Food & Drug Administration (FDA) applications. A deadline of May 12, 2020 was previously set as a result of a lawsuit filed by the American Academy of Pediatrics.  The ruling from a federal district judge in Maryland ordered that all e-cigarette manufacturers submit pre-market applications to the FDA by the May deadline or remove their products from the market. Manufacturers that submit applications would be allowed to remain on the market for no more than a year while the FDA considers the application.

The FDA is looking to give a 120-day extension since many laboratories performing required studies have shut down due to the COVID-19 pandemic.

According to a recent article in the Wall Street Journal, “The FDA remains acutely aware of the recent surge in youth use of e-cigarettes and the public health imperative to ensure” that these products undergo review, Mitch Zeller, director of the FDA’s tobacco center, wrote in a court filing. “However, given the severe, unforeseen disruptions that are affecting this industry and the world, I believe it is appropriate for applicants to have an additional 120 days.”

On a previous blog, Vaping Deaths and Injuries, we covered how injuries and deaths are on the rise and a large increase of e-cigarette use has come from teenagers.  The American Academy of Pediatrics is trying to have JUUL and other e-cigarette products removed from shelves due to the increase of teenage use. E-cigarette makers must prove in their required FDA applications that their products present a benefit such as helping adult cigarette smokers switch to safer levels of nicotine instead of promoting themselves to a younger and new generation of smokers.

The FDA begin banning the use of fruit-flavored vaping cartridges in January 2020 due to their appeal to children, but the American Academy of Pediatrics says more needs to done to protect our youth.

Clark Perdue is currently investigating matters involving vaping deaths and injuries.  If you or a loved one has experienced complications from vaping, please contact us for further information.