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.”
Fontem, like all vapor companies, had to submit PMTAs for its products by September 2020, and had to prove that they would be “appropriate for the protection of public health” (APPH)—a threshold that has become understood as a given product’s likelihood to transition adult smokers to a safer alternative while not introducing a new generation to nicotine. Many assumed that a company like Fontem had the financial capabilities of funding the scientific studies the FDA seems to require to meet that barrier.
Additional Blu products, which include some outdated cigalikes, remain under review.
Given that the FDA had yet to deny a pod-based device and its components from other large vapor companies, some speculated that this might be the start of a pattern. Juul Labs, Vuse and NJOY all still have PMTAs for pod-based vapes under consideration.
The FDA so far has authorized just a handful of products: the Vuse Solo, produced by R.J. Reynolds, along with two tobacco-flavored cartridges and a couple of tobacco-flavored e-cigarettes and heat-not-burn devices made by Logic, owned by Japan Tobacco International (JTI).
Additional Blu products, which include some outdated cigalikes, remain under review—as do the company’s menthol-flavored myblu pods. But as Vaping360 noted, these pods are essentially useless without the compatible device that was denied.
“Had Congress contemplated that the FDA would one day require products on the market for a half-decade plus to go through a ‘premarket’ review process, transparency measures would have been built in to require prompt disclosure of decision materials,” Conley said. “That is the case with modified risk tobacco product applications, but here we are left to parse words in vague statements that give no useful information to the public.”
Fontem can sue the FDA, but does not appear to be going that route.
All of this might not be the worst news for Imperial, though. One investment bank, Credit Suisse, has noted that the company actually loses money on its vapor products and will likely continue focusing on combustible cigarettes.
Fontem can also choose to sue the FDA, as a dozen of other small vapor companies have done, but does not appear to be going that route. In a press statement, Imperial Brands said that it planned “to use the [FDA’s] administrative appeal process to convince the agency that approval should be granted.”
“We are disappointed with the FDA’s decision and disagree with the scientific evaluation and conclusions they reached,” the statement read. “Based on past practice, we expect the FDA will not seek to enforce the MDOs while this appeal remains ongoing, and we therefore expect the products to remain in the market during this period,” it went on. “We do not believe that there will be any short-term impact on the business.”
Still, the myblu denials have only heightened rumors of what the vaping market might look like once the FDA has finished sorting through the avalanche of PMTAs—and how many products will actually remain.
“This is becoming like a vote for a new pope,” one vaping industry insider told Filter, who requested anonymity so as to not affect their company’s pending PMTA. “Everybody is looking at the smoke and trying to figure out what color it is and what that says about what’s been going on inside.”
The Influence Foundation, which operates Filter, has received grants and donations from the American Vaping Association. Filter’s Editorial Independence Policy applies.
Photograph by Lindsay Fox via Flickr/Creative Commons 2.0