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April 8, 2022

Myblu Is First Major Brand Pod Device Rejected by FDA

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:

  • myblu Device Kit
  • myblu Intense Tobacco Chill 2.5% nicotine strength
  • myblu Intense Tobacco Chill 4.0%
  • myblu Intense Tobacco 2.4%
  • myblu Intense Tobacco 3.6%
  • myblu Gold Leaf 1.2%
  • myblu Gold Leaf 2.4%

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.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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25 days ago

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.

18 days ago

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.

1 month ago

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?

12 days ago

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….

4 days ago

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.

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