UPDATE (July 11, 2022)
On July 5, 2022, the FDA administratively stayed the marketing denial order.
The FDA said that this stay temporarily suspends the marketing denial order while it conducts further review, but does not rescind it.
The FDA said it has determined “there are scientific issues unique to the Juul application that warrant additional review.”
The FDA has also stated that stay and review do not “consitute authorization to market, sell or ship Juul products.”
After nearly two years, the FDA has finally issued marketing denial orders (MDO) to Juul. The news was released by the agency on June 23, 2022.
The MDO issued means Juul was forced to cease all sales of their products and remove them from shelves within the United States. This is inclusive of every vape and e-cigarette product from Juul, both flavored and unflavored.
After the long-awaited marketing order was issued, Juul was quick to respond to the less-than-satisfying news, sparking a legal back and forth between the company and the FDA.
Timeline of Events
June 25 – Juul Files Appeal to Federal Appeals Court
Juul’s response to the marketing order issued saw the company filing an emergency motion to a federal appeals court. This motion pleaded with the court to intervene in the agency’s decision.
This was filed by Juul on Friday, June 25, only a day after the news was released by the FDA.
July 7 – FDA’s Response to Temporary Pause
The appeal was successful after a three-judge panel granted a temporary pause on the ban issued by the FDA. The temporary pause will be in place until July 7, by which the FDA will have to have submitted a response to Juul’s motion.
July 12 – Juul’s Response
Juul will thereafter have until July 12 to respond.
The best possible outcome for Juul is to receive authorization for their tobacco-flavored products, similar to the other manufacturers that have already received such authorization.
However, given Juul’s past infamy, it is rather unlikely that they will be successful in deterring the seemingly deliberate example the FDA is hoping to make out of them.
More Information About the Decision
While the FDA has authorized the marketing of a number of products recently, most likely as a result of increased pressure to do so from the Federal Court, such a stern MDO seems somewhat out of left field.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf in the news release posted on June 23.
Manufacturers like NJOY, Vuse, and Logic all received authorization to market their tobacco-flavored products — Juul was not given such preferential treatment, though. All of the products under Juul’s lineup have been issued to be removed from the market.
This did not go unnoticed by the manufacturer, highlighting it in their appeal and claiming to be judged to a different standard than the likes of other companies.
The decision was made as Juul’s premarket tobacco product application (PMTA) “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of these products would be appropriate for the proportion of the public health.”
This statement has been rightly met with confusion and anger in the pro-vaping community, particularly amongst those that remember that the FDA authorized products like IQOS and traditional cigarettes despite having significantly worse toxicological properties than Juul’s products.
The FDA’s manufactured reasons for denying the PMTAs are complete nonsense. They authorized IQOS and VLNCs, both of which obviously have worse tox profiles than a Juul.
FDA is also ordering immediate removal of the products. My initial thought is Juul needs to file suit today. https://t.co/iLuLx5x62w
— Gregory Conley (@GregTHR) June 23, 2022
It is highly likely that Juul could have been used by the FDA to help bolster its agenda through the PMTA process. Juul has been targeted by many anti-vaping groups as a result of their products amongst the youth population, sparking the public to believe that they had a significant role in the increased popularity of underage vaping.
The FDA’s decision regarding Juul will likely have dashed the hopes of smaller manufacturers hoping the string of positive marketing orders from the agency was a sign of better prospects in the near future. It has also reduced confidence in the agency’s claimed dedication to true tobacco harm reduction.
In the motion filed by Juul, the company claimed that “more than two million adult smokers have switched completely from cigarette smoking because of Juul products.” With Juul having such a high market share, this figure seems highly plausible.
Who is Juul?
Juul has been one of the most prominent names in e-cigarettes and vaping in recent years. They are based in San Francisco and came onto the market in 2015. Since then, they have been incredibly popular, leading to success for multiple years. The company managed to hold approximately 75% of the US e-cigarette market by 2018.
A huge concern amongst pro-vaping groups is that a hugely significant portion of the market will be tempted to return to much more harmful traditional cigarettes should the ban become permanent.
Juul is no stranger to legal issues, being the target of the majority of the anti-vaping campaigns that have plagued the landscape for years.
The concerns around underage vaping resulted in Juul being singled out as one of, if not the, worst offenders. This led to the company being demonized in the public eye.
Juul has since managed to recover from what seemed to be endless waves of legal actions.
The company enjoyed somewhat of a two-year respite from the hostilities since it submitted its nearly 125,000-page PMTA in 2019. However, their legal issues and checkered past have risen once again.
The FDA has issued marketing denial orders to Juul, one of the most popular e-cigarette brands in the United States. The e-cigarette manufacturer quickly countered the news via the submission of an emergency motion to a federal appeals court, resulting in a temporary stay on the market ban ordered by the FDA.
A legal back and forth has been set by the federal court between the FDA and Juul. While it is likely to go on for longer, the court set the final response for July 12, wherein the court will make a ruling.