The appeal by Gripum, an e-liquid manufacturer based in Illinois, was rejected by the United States Court of Appeals for the 7th Circuit.
This marks one of the many appeals from vape manufacturers in response to recent marketing denial orders (MDO) issued by the Food & Drug Administration (FDA) as a result of the premarket tobacco application process (PMTA).
However, this latest turn of events resulted in all three of Gripum’s appeals being rejected. The court deemed that the reasoning given by the FDA for the denial was fair and just. This reasoning was considered against the Tobacco Control Act, which the FDA must comply with.
Gripum LLC received a temporary stay on November 4, 2021. However, this rejection of their appeal means that their MDO will need to be adhered to, and their denied products must be removed from the market immediately.
Many of the companies receiving court rulings were granted temporary stays in 2021. However, it appears that this period of respite is over as both stays and rejections are being ruled in court.
The last option for Gripum is to request an en banc in an attempt to sway the judges with a new argument against the FDA. However, it is very unlikely that this request will be accepted.
Other MDO Appeal Rejections
The list of appeals by vape companies represents, at best, a mixed bag of results. There have been both stays and rejections for only a few companies, while many still have a ruling pending.
It has appeared that certain legal circuits are cracking down harder than others. Both the 5th Circuit Court of Appeals and D.C. Circuit Court of Appeals have ruled exclusively in favor of the FDA’s marketing orders, rejecting appeals from vaping companies.
Triton Distribution and Vapetasia both submitted appeals to the Federal Court of Appeals for the 5th Circuit Court of Appeals. However, these were both rejected.
The reasoning for these rejections could certainly be considered unjust, and even biased.
Judge Catharine Haynes concluded that in the case of Triton’s appeal “where the parties disagree on the science, we owe deference to the FDA.”
In the D.C. Circuit Court of Appeals, four companies also received rejections. The appeals from Prohibition Juice Co., Cool Breeze Vapor, Ecig Charleston, and Jay Shore Liquids were essentially rejected due to technicalities in their arguments.
These companies cited that the FDA had blatantly ignored their marketing strategies. However, the judges agreed that this was simply a “harmless error.”
In the case of other successful appeals, these are the very same grounds that allowed for the court to issue stays.
Small Wins for Some Vape Companies
Those who have found success are in the minority, but there have been signs of hope coming from the Court of Appeals for the 11th Circuit specifically. This court has granted a total of six stays as of now.
Bidi Vapor, Diamond Vapor, Johnny Copper, Pop Vapor Co., Union Street Brands, and Vapor Unlimited have all been successful in this district.
The main justification for the ruling is that the court found evidence that the FDA had ignored these companies’ marketing strategies, something that was outlined as a consideration that will be made for marketing orders.
Gripum LLC joins the ranks of several companies whose MDO appeals have been rejected by various Federal Court of Appeals. Despite being issued a temporary stay of their MDOs last year, their individual fights against the FDA’s marketing orders appear to be coming to their conclusions.
There is the option to request a rehearing with the courts. However, these can be considered a hail mary at best. Time will tell if Gripum does go this route but it is likely that they will continue to fight.
Conversely, a handful of companies in other circuits managed to win their appeal cases, particularly in the 11th Circuit. At best, this offers a glimpse of hope for the countless companies still waiting for their rulings. At worst, it demonstrates the inherent biases against vaping in certain regions.