Myblu Is First Major Brand Pod Device Rejected by FDA

The FDA has 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.

Read full article here.

Jim McDonald – Vaping360 – 2022-04-08.