FDA Says One MDO Appeal Won't Be Resolved Till 2025

Five vaping manufacturers got bad news in court last week, but another received welcome confirmation that the FDA will kick the can on its review far down the road. In fact, the FDA says My Vape Order’s internal agency appeal will likely take until January 2025 to resolve.

About 40 vaping manufacturers are currently challenging FDA marketing denial orders (MDOs) in court, or pursuing MDO appeals through the FDA’s own internal appeals process.

On July 26, a three-judge panel of the District of Columbia Circuit Court of Appeals unanimously denied MDO appeals by four small e-liquid manufacturers whose cases had been consolidated. The companies are:

• Prohibition Juice Co.
• Cool Breeze Vapor
• Ecig Charleston
• Jay Shore Liquids

The four companies had all received MDOs in 2021 for premarket tobacco applications (PMTAs) submitted a year earlier for flavored vaping products. None of the companies received a stay of enforcement. Oral arguments in the case were heard in April.

The judges agreed with the Fifth Circuit majority in the recent Triton decision that held the FDA did not mislead manufacturers as to what evidence would be required to prove flavored vaping products could be “appropriate for the protection of public health” (the standard for product authorization under the Tobacco Control Act). They also agreed that the FDA’s decision to not review the companies’ marketing plans was a “harmless error” because the manufacturers “failed to identify how individualized review of the plans they submitted could have made any difference.”

The decision, written by Judge Cornelia T.L. Pillard, contains passages that could have been copied from a Campaign for Tobacco-Free Kids brochure.

“Flavored tobacco products lie at the heart of the problem,” Judge Pillard wrote. “A vast body of scientific evidence shows that flavors encourage youth to try e-cigarettes and, together with the nicotine, keep them coming back.” There is, in fact, no evidence that flavors encourage youth use, other than the fact that youth use them. Adults also overwhelmingly prefer vaping products with non-tobacco flavors.

There are also no factual bases for Judge Pillard’s claims that “e-cigarettes can permanently damage developing adolescent brains” or “cause chronic lung diseases.” These are deceptive words appropriated from anti-vaping activists, not the considered observations of an objective jurist.

Judge Pillard was appointed to the circuit court by President Barack Obama. The judges who concurred in the decision—Gregory Katsas and Karen LeCraft Henderson—were appointed by Presidents Donald Trump and George H.W. Bush, respectively.

It isn’t known if the four vape manufacturers will seek an en banc review of the case (a re-hearing by the full D.C. Circuit). Triton and Vapetasia are pursuing that option in the Fifth Circuit.

Earlier last week, the same circuit court ruled against Fontem US on its emergency motion for a stay of the MDO issued April 8 for its myblu device and refill pods. The April 8 MDO was the first issued to a device made by a major tobacco company. Fontem is a subsidiary of Imperial Brands (the former Imperial Tobacco).

Fontem had originally said it would pursue a reversal of the MDO through the FDA’s administrative appeal process, then decided to also file a petition for review in the D.C. Circuit in early May. However, the company waited an additional two months, until July 12, to file an emergency motion for a stay of the MDO. That was too long for the court.

“Fontem has demonstrated that the marketing denial order is causing it harm, but by waiting more than two months after the marketing denial order’s issuance to seek emergency relief, Fontem weakened its claim of irreparable harm,” the court wrote, according to Vapor Voice. “That delay also suggests it may have been practicable to seek a stay from the agency.”

The court also said that Fontem, in its petition for review, “has not made a strong showing” that its appeal is likely to succeed on its merits. The D.C. Circuit granted a stay to Juul Labs in June, but has not issued stays to any other vaping manufacturer seeking relief.

Despite the denial of its motion for a stay, Fontem’s appeal will be expedited. The court has ordered the first brief from the company to be submitted by Aug. 10, with all briefs and responses to be complete by Oct. 14. After that the court will hear oral arguments

Fontem is also continuing to pursue its administrative appeal with the FDA. According to Tobacco Reporter, the company will continue to sell myblu, even without protection from FDA enforcement. The FDA has still made no decisions on PMTAs submitted for Fontem’s disposable blu e-cigarettes, which make up half of the brand’s U.S. sales.

The final news comes not from a court decision, but a court filing. The FDA and California e-liquid manufacturer My Vape Order (MVO) filed a joint status report with the Ninth Circuit Court of Appeals, asking that MVO’s petition for review be held in abeyance (put on hold) while the FDA’s internal appeal of the company’s MDOs continues.

The FDA issued denials to MVO for 52 flavored products (most, if not all, sold under the Air Factory brand) on Sept. 8, 2021, claiming the company’s applications “lack sufficient evidence demonstrating that your flavored ENDS will provide a benefit to adult users that would be adequate to outweigh the risks to youth.” It was the same rationale used to deny PMTAs for millions of products sold by hundreds of small companies.

MVO filed a petition for review in the Ninth Circuit on Sept. 30, but before the court could take any action, the FDA issued its own stay of the MDO on Oct. 18, 2021, pausing any enforcement against the company while the agency’s internal appeal process plays out. (Later, in January 2022, the FDA partially rescinded the MDO, putting some of the products back into PMTA review.) The court agreed on Jan. 5 to hold MVO’s petition in abeyance, and asked for occasional status reports.

Incredibly, in the status report filed with the court on July 19, the FDA says its review of My Vape Order’s MDOs could take until January 2025.

“As the parties have previously informed the Court, FDA will complete its re-review of Petitioner’s application after it completes further review of the applications of one or more of My Vape Order’s collaborators,” says the joint status report. (We are not certain who MVO’s collaborators are, or why their applications must be assessed first.)

“Due to the volume of pending applications and according to FDA’s current prioritization of applications,” the report continues, “the agency estimates that it will complete rereview of petitioner’s collaborators’ applications in or about January 2024, and that it will complete re-review of petitioner’s application in or about January 2025.”

That gives MVO about two-and-a-half years to sell products without concern about FDA enforcement. The court accepted the status report, and ordered a follow-up report by Jan. 31, 2024.

Whatever FDA foul-up forced the agency to push MVO’s appeal to the back of the PMTA queue must have been monumental indeed. If it was a strategy on the company’s part that caused the agency to jump away from its PMTA as though it were a scorpion, perhaps MVO should bottle that and sell it.