The Food and Drug Administration (FDA) asked for additional time before declaring the outcome of the final e-cigarette ruling, which ultimately determines whether or not e-cigarettes can remain on shelves in the United States. On the deadline date, the agency revealed that it had acted on 93 percent of the submitted applications. “However, there’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the danger of all tobacco products,” the regulators said in a statement.
Flavored E-Cigarettes Removed From Shelves
In total, more than 500 companies filed applications for some 6.5 million products by the September 9, 2020 deadline. The FDA’s official order is to authorize vaping products only if the manufacturing company can demonstrate the items are in the interest of public health. In other words, the FDA must compare the potential good of adult cigarette users switching to a less-dangerous option to the potential harm of young people getting addicted to nicotine.
Thus far, the FDA has ordered more than 946,000 flavored products be removed from shelves. For these vaping liquids, which include flavors like apple crumble and cinnamon toast cereal, the agency believes that manufacturers failed to provide sufficient evidence that the products benefit adult smokers enough to outweigh the potential appeal to young people.
The biggest e-cigarette manufacturer in the U.S. is JUUL. A spokesperson for the company said, “We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications. We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.”
Reshaping the Market with Final E-Cigarette Ruling
This sweeping review could reshape the e-cigarette market. If products are authorized to remain on the market, manufacturers should expect stricter controls on marketing. This sort on control has already proven beneficial: Youth vaping fell significantly last year after laws raised the legal purchase age to 21 and removed fruity-flavored e-cigarette cartridges from the market.
The agency hasn’t revealed when its review will be completed but did share that many applications are in the final stages of review.
For more information about the investigation into e-cigarettes, including JUUL products, contact us today.
Additional Reading:
FDA Removes 55,000 Flavored Vaping Products From Market
JUUL Labs Faces “Substantive Scientific Review” from the FDA
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.