Court Grants Triton a Rehearing on the Company’s Original MDO Appeal Ruling

Triton Distribution, a vape manufacturer, is the protagonist of a case with a charming appeal to those of us in the vape industry. The reason is that the company was originally given a marketing denial order (MDO) by the FDA. This MDO was issued for Triton and for its vape juice sister company, Vapetasia.

For a while now, vape distribution and manufacturing companies have been required by the FDA to apply for a premarket tobacco application (PMTA) in order to keep doing their business. A PMTA is an application that must be reviewed and approved by the FDA before said company can continue to sell its products, and this has to be done for all new tobacco and vape products. At a certain point in time, synthetic nicotine products eluded PMTAs, but this is no longer the case since the last time the law changed.

PMTAs have posed an incredibly difficult challenge for smaller companies because the cost of it ranges from $117,000 to $400,000 per product. An amount that is unbelievably difficult to cover, especially for up-and-coming brands and entrepreneurs.

Once the PMTA is submitted, companies have to then receive a written marketing order from the FDA, which can take some time to make, if they make it at all since the FDA regulates tobacco products based on a public health standard that can be motivated by incredibly biased forces, as we briefly mentioned in our latest blog post on vape regulations.

On top of that:

If the company or product is denied its PMTA, the FDA will then issue an MDO. In other words, they will receive the opposite of what they invested, applied, and waited for. Which is where Triton Distribution comes in.

The Triton Case

After receiving its MDO, Triton placed an appeal on the decision, which was originally denied by a three-judge panel, but the company was subsequently granted a rehearing of the appeal on the FDA’s issued MDO.

This decision means that the original decision against Vapetasia and Triton is vacated and a panel of all active Fifth Circuit judges will make a new decision. But why is this newsworthy? Well, getting another run at an appeal on a panel decision is incredibly rare. It’s safe to say that not many cases are resolved this way.

All Triton briefs must be presented to the court by February 22nd this year and the FDA’s response must be submitted by March 24th, while the oral argument is scheduled for May 15th. Throughout this series of dates, Triton will be able to provide information that was not available to the court in the first panel, including the fact that before the July rule against Triton in 2022, another three-judge panel of the same court had unanimously stayed Triton’s MDO back in 2021. This was a decision that was expected to rattle the FDA’s PMTA review process but didn’t seem to have the impact it was expected to have. Especially because at that moment the MDO issued to Triton was called “capricious and arbitrary”.

So, what does this mean in simple terms?

It means that 9 of the 16 active judges voted to grant Triton its rehearing and that at least 4 judges are likely to vote in favor of Triton (3 that stayed the MDO and 1 that dissented in the last vote).

In other words:

The future seems bright for Triton and the brands included in its original MDO-Suicide Bunny, Boiler Maker, Vape Hooligan, Chewy Clouds, and Teleos.