Last Friday afternoon, July 12, 2019, a federal court decision established deadlines for e-cigarette manufacturers and makers of candy-flavored cigars to submit their products for FDA review. The Court took this action after medical and public health groups sued the Food and Drug Administration for the agency’s failure to appropriately regulate e-cigarettes and cigars in a timely and effective manner.
Under the court order, e-cigarette manufacturers have until May 12, 2020 to submit their products for review by the FDA. The FDA will then have an additional 12 months to review and decide on the product applications. This process also applies to a new generation of candy-flavored cigars that recently entered the U.S market. Any manufacturer that fails to meet the product application deadline will be subject to removal from the market by the FDA.
Judge Paul Grimm noted in his decision, “…the record before me shows a purposeful avoidance by the industry of complying with the pre-market requirements despite entreaties from the FDA that it can do so, and it establishes a shockingly low rate of filings. And, it is far from clear how an impending deadline would force some of the more successful companies to withdraw from the market entirely, when they have large purses and the resources to complete promptly the applications that they have had before them for years. Thus, the record offers little assurance that, in the absence of a deadline for filing, the Industry will do anything other than raise every roadblock it can and take every available dilatory measure to keep its products on the market without approval.”
The ATS submitted an amicus brief to the court documenting the recent surge in youth e-cigarette use and how the lax regulatory deadlines established by the FDA were contributing to the problem and forcing the court to establish aggressive, but effective deadlines for accelerating the FDA e-cigarette and cigar product review process.
“As chair of the ATS Tobacco Action Committee, this court decision brings mixed emotions,” said Michelle Eakin, PhD. “I am proud of the role the ATS played in urging the court to take swift action to enforce regulation of these new tobacco products and I am pleased the court responded in a way that reflects the urgency of the situation. But I am also frustrated that it took court action to force the FDA to take even the most basic regulatory measures to respond to the rapidly growing youth e-cigarette epidemic. I hope this court case marks a turning point in a more responsive FDA to the epidemic of youth e-cigarette use.”