On April 8, the Food and Drug Administration (FDA) sent marketing denial orders (MDOs) to Fontem Ventures for some of its myblu vaping products.
It’s the first MDO issued for a pod-based vapor product made by a major tobacco company.
The denied products include Fontem’s myblu device kit, as well as its Tobacco Chill, Intense Tobacco and Gold Leaf flavored cartridges. Fontem is owned by Imperial Brands, one of the largest tobacco companies in the world.
Speculation abounded immediately, as the industry seemed somewhat shocked that the FDA had denied the premarket tobacco product applications (PMTAs) from a well-resourced manufacturer. The FDA provided little insight into its decision, stating only that those PMTAs “lacked sufficient evidence regarding design features, manufacturing and stability.”
“Without more information, it is hard to guess what exactly led to the FDA’s decisions,” Greg Conley, the president of the American Vaping Association, told Filter. “Some theories that are floating around have worse implications than others for the industry as a whole, but none give any reason to believe the FDA will ever regulate these products responsibly.”
Alex Norcia – Filter – 2022-04-12
Want More Investigative Content?
