The FDA’s premarket tobacco application (PMTA) process has left a wake of disgruntled vaping companies since its submission deadline on September 9, 2020.
The FDA has issued countless marketing denial orders (MDOs) that would have vape and e-cigarette manufacturers pull their products from the shelves within the United States.
Most of these companies accepted their MDOs, whilst others have sought legal action to intervene in the orders received and allow for continued business operations.
The chronological list below consists of the most notable legal challenges against the agency.
- February 1, 2021 – Diamond Vapor, Johnny Copper, and Bidi Vapor issued stays of their MDO from the United States Court of Appeals for the 11th Circuit, pending resolution of their petition for reviews.
- November 4, 2021 – Gripum issued a stay of their MDO from the United States Court of Appeals 11th Circuit pending resolution of their petition for review.
- September 8, 2021 – The FDA subjects the MDO issued to My Vape Order Inc. to a review process.
- September 10, 2021 – FDA partially rescinds MDO to ECS Global for some of their products.
- October 7, 2021 – FDA fully rescinds MDO to TPB International LLC.
- October 22, 2021 – FDA rescinds their MDO to Fumizer LLC for certain products.
- October 26, 2021 – Triton receives a stay of their MDO from the United States Court of Appeals for the 5th Circuit pending petition for review.
- October 26, 2021 – Vapetasia issued a stay of their MDO from the United States Court of Appeals for the 5th Circuit pending petition for review.
- November 1, 2021 – FDA puts Avail Vapor LLC under review. A stay is issued pending the review.
- November 2, 2021 – FDA fully rescinds Humble Juice Co. LLC.
- November 3, 2021 – FDA issues a stay for the MDO issued to Al Khalifa Group LLC pending its review.
- November 23, 2021 – FDA partially rescinds Pop Vapor Co LLC’s MDO for certain products.
- January 19, 2022 – FDA partially rescinds marketing orders to My Vape Order Inc. for certain products.
- February 1, 2022 – Vapor Unlimited receives a stay of their MDO from the United States Court of Appeals for the 11th Circuit pending its review.
- June 24, 2022 – Juul was granted a stay of the MDO by a United States Court of Appeals pending review.
The companies above prove to be the most noteworthy to have challenged the FDA’s initial marketing denial orders (MDO).
However, this list is not comprehensive as there are other companies that did not publicly challenge the orders issued by the FDA. According to The National Law Review, roughly 45 different lawsuits were filed against the FDA by the end of 2021.
The outcomes listed were noted in by the FDA in the most updated list of MDOS issued.
Interestingly, there are several examples of the FDA fully rescinding or at the very least partially rescinding their MDO pending another administrative review period for a company.
In some of these instances, it is unclear whether if there was any intervention by a federal Court of Appeals or rather the FDA simply changed its view on a company’s application purely from said company filing a petition for review.
A Continuous Lack of Competence
The stays issued by the federal courts do not promise any company permanent staying power on the market, only temporary respite while the FDA reviews their application again.
Thankfully for many of these companies, the FDA has proven they are exceptionally unable to cope with the sheer volume of applications brought in since the 2020 deadline. This allows companies to hold onto their court-ordered stay for a decent amount of time.
These court-ordered stays are based on the merit of the company in question. While the court cannot grant a permanent stay, these are only issued if a vape company can prove that its application has the potential to meet the FDA’s PMTA process standards.
In saying that, it is worth noting that many companies have expressed unhappiness with the constantly changing standards laid out by the FDA.
If anything, this demonstrates a number of flaws in the decision-making structure within the agency.
Groups like American Vapor Manufacturers have expressed significant disapproval of the practices the FDA has shown since the PMTA process.
External Pressure on the FDA
There have been a number of federal courts applying external pressures on the FDA through issuing stays, to the much more direct court order by Judge Paul Grimm.
“I will impose a ten-month deadline for submissions and a one-year deadline for approval, as the FDA suggested,” said Judge Grimm in his court order.
Judge Grimm’s order came as a result of the FDA being incredibly far behind in the review process for a huge amount of companies.
Another obvious pressure comes from the numerous companies that have been seemingly wronged by the unjust PMTA process, some even with backing from big tobacco companies like Altria Group.
Is the FDA Fit for Duty?
The Food and Drug Administration is a federal agency that has the power and responsibility to administer a huge array of products in regard to the health of the population.
In theory, they should be the leading voice in spearheading healthy practices and proper regulation for both food and drugs, without providing excess fault in their methodology. This is true not only of the US but within the global community.
And yet, even federal courts have deemed it necessary to intervene in their flagrantly incorrect decisions.
These courts do not have the same level of expertise as the FDA is supposed to have. Judges are not trawling through huge databases of research and studies like the FDA should be in their review processes. And yet, they are able to see the merit in PMTAs from vape companies and errors in the agency’s methodology.
The FDA continues to change decisions, proving they are in no position to make many of these decisions in the first place.
A number of federal courts have given stays to the vape companies that were issued MDOs by the FDA. Out of the countless number of MDOs issued since the PMTA deadline, over 45 lawsuits have been filed against the agency.
The FDA’s methodology has been under scrutiny for a considerable period of time now, and these issues continue to perpetuate a lack of trust in them, particularly by the vaping and tobacco community.