May 6 update
Fontem filed a petition for review today in the U.S. Circuit Court of Appeals for the District of Columbia. The company joins about 40 other vaping manufacturers challenging MDOs in federal courts around the country.
The FDA today issued a Marketing Denial Order (MDO) to Fontem US for its myblu pod vape device and multiple flavors of refill pods. The rejection of the myblu Premarket Tobacco Application (PMTA) is the first announced MDO issued for a pod-based vape product made by a major tobacco company.
Myblu is a Blu product, made and sold by Fontem US, the vape product arm of Imperial Brands (formerly known as Imperial Tobacco)—a major international tobacco company valued at more than $20 billion.
The denial is significant because the FDA is still reviewing PMTAs submitted by other large companies for pod-based devices—including Juul Labs’ JUUL device and pods, British American Tobacco’s Vuse Alto, and NJOY’s Ace device. Those devices (and their refill pods) make up a majority of the convenience store/gas station segment of the vaping market.
The myblu denials could indicate that the FDA will reject those other pod-based products too, perhaps because their nicotine delivery is more effective than the older-generation Vuse Solo and the two Logic products that have received marketing authorization.
The rationale for the denials, the FDA said in a press release, included Fontem’s myblu applications lacking “sufficient evidence regarding design features, manufacturing, and stability.” No one can be certain what that means without seeing the actual denial orders, but it could involve almost anything related to the performance or physical structure of the device, pods or e-liquid.
“Additionally,” said the FDA, “the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth.” That refers to the authorization standard announced by the FDA in August 2021—almost a year after the September 2020 PMTA submission deadline.
These are the myblu products receiving publicly announced MDOs:
The FDA has also issued MDOs for some myblu pods not currently being marketed, and therefore not named on the FDA’s publicly available list of PMTA submissions. Fontem has not announced which additional flavors were included in its April 2020 myblu PMTAs, but said at the time it had submitted “a wide range.”
Other Blu products, including Blu’s disposable cigalikes and rechargeable PLUS+ cigalikes, are still under review by the FDA. Oddly, two menthol myblu pods also remain under review, although they would be entirely useless without the already-denied device required to vape them.
Fontem must stop selling the products immediately or face possible enforcement action. The company now has 30 days to file a legal challenge to the myblu MDOs. More than 30 small, independent vaping companies have challenged their MDOs in federal court, and others have filed administrative appeals with the FDA (which is also an option for Fontem). Some manufacturers have received stays of their denial orders, and the FDA has been forced to rescind some others.