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.
I was an everyday smoker since age 16. After my dad died, 4 years ago I made the change from real cigarettes to myblu gold leaf pods. I’ve had zero negative effects from this product. If myblu doesn’t win the appeal from the FDA, I’ll be pissed. This is the only product that I favor.
I totally agree with you, I smoked for almost 20 years and thanks to Myblu gold leaf pods I completely stopped smoking cigarettes and have been smoking gold leaf for about two years now and it’s definitely the only flavor I like. I really hope they win the appeal. I have no negative side effects and feel much better now that I’m not smoking cigarettes.
I smoked for 52 years. Blu gold leaf was what saved me. The FDA is a joke, nothing but drug pushers
Totally agree 100% Gold leaf got me to stop smoking cigarettes after smoking for almost 20 years. I really love the flavor! I totally agree with you about the FDA! It’s sad!
This sucks!! I’ve been a fan of Myblu gold leaf ever since I had a child and gave up cigarettes. This has been very good for me not having to smell like cigarettes and having a smooth hit without the harsh aftermath. I don’t see why now this is happening when this company has been in business so long! I can’t afford to buy the real vape pens from the vale stores. These pods come in handy plus the real vape pens are so confusing and Myblu is simple and easy to use. I really hope this gets resolved.
You might consider the NJOY Ace—a similar product that did get authorized by the FDA.
this is some straight BS, the FDA needs to work on things that really harm folks and leave us adults alone, I now smoke 10 to 12 Backwoods cigars a day now where I was only smoking maybe 3 at most because I was using the My Blu gold leaf vape, thanks FDA for causing me to smoke more….
I’ve been smoking cigarettes since I was 14 and quit tobacco 2 years ago. My doctors were thrilled. They’re still not happy about the nicotine, but they took my switch to vaping as a win. So did I. Now it seems to me that these moves by the FDA will push us back to tobacco. Our government protecting us…right. Maybe they should think less about vaping and concentrate on getting baby formula to all our babies.
I’ve smoked cigarettes for 35 yrs ,not only bad for me but for second hand smoke, been using blue gold leaf now they take it off the shelf?! Been around a very long time, what’s the reason?
Blu’s Premarket Tobacco Application (PMTS) didn’t persuade the FDA. If you’re approaching this without knowing the history of FDA’s vaping regulations, start with these:
The Deeming Rule: A Brief History of FDA Vaping Regulations
How Will the PMTA Deadline Affect Vapers and the Industry?
PMTA Decision Day: FDA Leaves Vape Industry Twisting in the Wind