Robert BarnesJuul Labs Inc. is suing the Food & Drug Administration after being denied access to the documents that the agency used in issuing marketing denial orders (MDO) to the company.
The vape company filed the lawsuit on September 20, 2022. This was done in the US Court for the District of Columbia.
The basis of Juul’s lawsuit is that the FDA has violated the Freedom of Information Act on two counts after Juul requested said documents.
“We took this necessary action as we remain concerned about the inequitable treatment of our applications given the political pressure on the agency to reach a specific result,” a Juul spokesperson said in a statement.
According to Bloomberg Law, Juul is seeking the release of the currently withheld documents, along with an admission of guilt on the FDA’s part. Of course, Juul is seeking additional damages and fees from the agency as well.
This is the latest move from the vape giant since the protracted legal battle between the two groups began after the FDA issued its MDO on June 23, 2022.
This case is currently being represented by Jason M. Wilcox and various other attorneys from Kirkland & Ellis LLP.
Kirkland & Ellis have represented Juul in various cases since 2020. The most notable of these was a class action lawsuit against Juul regarding its marketing strategy allegedly targeting teens and the youth population, in which the court ruled in Juul’s favor.
Juul Vs. The FDA
It has been clear since the FDA ordered Juul’s products off the market that there would be a long battle between the two groups. This chaotic process has only been made worse by the constant indecision on the agency’s behalf.
The FDA landed the first blow when they banned Juul’s products on June 23, 2022. The agency claimed the vape company provided a lack of evidence to support the case for their products to remain on the market.
Thereafter, Juul was given a temporary stay by a federal court of appeals on the grounds that they required further time to come to a final decision on the case. Since then, the FDA itself granted their products a stay pending further review.
What’s New?
Understandably, Juul went on to request the very documents holding the reasoning for the MDO.
This was likely done to either find a solution to any of the issues highlighted by the FDA’s reasoning, or possibly to find faults in their methodology. Given the agency’s continuous blunders and poor decision-making, the vape company and its legal team were perhaps onto something substantial.
The FDA rejecting these requests only gives further indications that this may be the case. By barring access to the requested documents, it is possible that this was done as an attempt to hide the evidence of such faults.
“Withholding the disciplinary reviews that would answer these questions impedes JLI’s ability to seek appropriate relief from [the] FDA’s decision and is also completely at odds with the purpose of FOIA and the transparency Congress expects from administrative agencies,” said Juul’s statement.
The FDA rejected the request on the grounds that releasing the documents could jeopardize “the deliberative process privilege.”
If Juul is able to win this lawsuit, it can be a win not only for them, but for the countless other companies that are suspicious of the FDA’s seemingly flawed premarket tobacco application (PMTA) process.
“The public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinized decisions in recent years, especially where even FDA recognizes its order is suspect.”
The FDA has issued countless MDOs, putting many businesses out of income. If their reasoning for these decisions is discredited in this case, it could open a slew of lawsuits against the agency for the very same reason.
It is no secret that many of these smaller companies are behind Juul, hoping that their access to significant legal resources and funds can discredit the FDA.
“Sooner or later, we will learn how much corruption has directed the FDA’s decisions,” said Amanda Wheeler, the President of the American Vapor Manufacturers Association.
In Summary
The battle between Juul and the FDA has taken a further step as the once-giant in the vaping industry has filed a lawsuit against the agency. Juul took this step after the agency denied their requests to obtain the documents relevant to their marketing denial orders.
Juul is claiming this is in clear violation of the Freedom of Information Act. If this lawsuit is ruled in Juul’s favor, there may be some light shed on flaws in methodology and corrupt decision-making on the FDA’s behalf.
This may be one of the most significant turns in the legal battle between the two groups, as well as an opportunity for the tides to turn against the FDA since the PMTA process began.
Russ Ware
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