More Vape Manufacturers Challenge PMTA Denials

At least two more vaping manufacturers have taken the FDA to court over marketing denials of their flavored vaping products since Turning Point Brands became the first to challenge the agency almost two weeks ago. Turning Point Brands has also since asked a federal court to stay enforcement of the FDA’s Marketing Denial Order (MDO) until the appeal is decided.

Several more companies are expected to file their own lawsuits soon.

On Sept. 29, Florida-based Bidi Vapor, which makes prefilled disposable vape devices, petitioned the 11th U.S. Circuit Court of Appeals to review the FDA’s MDO for 11 flavors of its BIDI Stick product. In a press release, the company says it submitted more than 285,000 pages of material supporting its Premarket Tobacco Applications (PMTAs).

Bidi Vapor is asking the court to vacate the FDA marketing denial because it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law, as well as contrary to constitutional right and in excess of statutory jurisdiction, authority, or limitations, or short of statutory right.”

Petitions for review of FDA Center for Tobacco Products marketing denials are handled by federal circuit appeals courts, as mandated by the Tobacco Control Act.

Buffalo, NY-based Magellan Technology, which sells the pod-based Juno device and also owns major vaping product distributor DemandVape, has appealed its MDO for multiple prefilled pods sold under the Juno brand. Magellan’s PMTA was handled by AVAIL Vapor subsidiary Blackbriar Regulatory Services.

Among other arguments, the Magellan petition, filed Sept. 24 in the 2nd Circuit Court of Appeals, claims the newly asserted FDA demand for a different and higher standard of evidence in PMTAs for flavored products than for tobacco- and menthol-flavored products amounts to the illegal creation of a new product standard. The FDA announced the new de facto standard on Aug. 26, along with the first MDOs issued to manufacturers of flavored vaping products.

“In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS,” wrote the FDA in August, “the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”

Many observers think an across-the-board requirement applied to a defined subset of vaping products amounts to a standard that must be formalized through processes mandated in the Administrative Procedure Act (APA). The APA creates a roadmap federal agencies must follow when creating new regulations, including issuing a notice of proposed rulemaking, accepting public comment, and responding to comments before issuing a final rule..
https://en.wikipedia.org/wiki/Administrative_Procedure_Act_(United_States)

“FDA’s adoption of a comparative efficacy standard for the granting of a marketing order for non-tobacco- and non-menthol-flavored ENDS products versus tobacco-flavored ENDS products is, in reality, a disguised tobacco product standard that has been adopted and is being applied by FDA through adjudication rather than adopted through notice-and-comment rulemaking,” says Magellan’s petition to the court.

Magellan also claims in its court petition that “FDA’s issuance of an MDO in the absence of a finalized rule setting forth the required contents of a PMTA is unlawful.”

The FDA issued its final PMTA Rule today, Oct. 4, 2021—more than five years after the Deeming Rule that mandated PMTA authorization for all new vaping products took effect. The agency issued a final rule in January, but it was withdrawn almost immediately for review by the Biden administration.

Turning Point Brands (TPB) petitioned the Sixth Circuit Court of Appeals on Sept. 23 to review the FDA’s denial of Premarket Tobacco Applications (PMTAs) for many of the company’s e-liquids. On Sept. 30, TPB asked the same court for a stay of the FDA denial order, allowing the company to continue selling the products during the court’s review.

The company’s emergency motion, which asks for expedited review even if the court is not willing to issue a stay, contains considerable information about the PMTA process. TPB in fact provides a brief history of the FDA’s actions since issuing its Deeming Rule in 2016.

The agency changed the timeline for PMTA submission several times, and waffled about the evidence that must be included in a PMTA. In fact, the FDA never offered a clear picture of what a successful PMTA for a vaping product might look like.

“FDA repeatedly instructed the industry that, to obtain marketing authorization, they did not need to produce long-term studies. Instead, FDA recommended submitting scientific-literature reviews, consumer-perception studies, or other alternatives to show that ENDS products are ‘appropriate for the protection of the public health’,” says the TPB motion.

But when TPB received its MDO, the FDA had changed its tune. “FDA reasoned that TPB failed to conduct ‘a randomized controlled trial and/or longitudinal cohort study’ or other studies performed ‘over time’ to show that TPB’s specific flavored products help adult users stop smoking more than tobacco-flavored products do,” says TPB.

“Yet FDA previously deemed these studies unnecessary,” the motion continues. “And FDA rejected TPB’s other studies as inherently unreliable, even though FDA previously encouraged these studies. The Administrative Procedure Act (APA) forbids FDA from engaging in that bait-and-switch.”

TPB also accuses the FDA of “ignoring key evidence” when justifying its claims that TPB’a PMTA evidence is insufficient, and applying a higher standard for manufacturers attempting to prove the value of their products than the FDA used to claim a high risk to youth users.

“FDA weighed the general risks that youth would use flavored ENDS products against the benefits from adult smokers transitioning to TPB’s flavored products. TPB agrees youth usage is concerning,” says the TPB motion. “But FDA concluded that the risks outweighed the benefits only by refusing to consider TPB’s specific evidence that its products do not reach or attract youth. FDA also imposed a heightened evidentiary standard for proving that TPB’s ENDS products help adults quit or reduce smoking, yet required less of itself when substantiating risks to youth.”

TPB also says the FDA “failed to consider the consequences of an across-the-board prohibition on flavored ENDS for millions of adult former smokers who will suddenly lose access to the products they have depended on to quit.”

In fact, none of the FDA’s communications since Aug. 26 have acknowledged the disaster of former smokers reverting en masse from vaping to cigarettes—a threat Center for Tobacco Products Director Mitch Zeller had himself warned Judge Paul Grimm about in the FDA’s argument against a court-imposed PMTA deadline. And the FDA has not cited the dramatic decline in youth vaping shown in last week’s preliminary 2021 CDC survey results.