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The Vaping Industry Appeal for PMTA denied

The Vaping Industry Appeal for PMTA denied

The 4th Circuit Court of Appeals, governed by a three-judge panel has unanimously rejected appeals from the vaping industry, the U.S. Food & Drug Administration (FDA), and the cigar industry in a call of a 2019 decision that canceled the August 2021 deadline for submitting Premarket Tobacco Product Application (PMTA).

Therefore, the coalition appeal from various vaping groups challenging the September 9 deadline for many e-cigarettes, cigars, and other deemed tobacco products has been denied. 

The implication of this is that the September 9, 2020, deadline for PMTA is still fixed for deemed “new tobacco products” that have been in the market on August 8, 2016.

The FDA initially announced in 2017 that it would delay the deadlines for PMTA and substantial equivalence that were set for August 2018 to last for three years. But a year later, a group of anti-tobacco groups and Maryland-based pediatricians filed suit in federal court, claiming that the FDA had no authority to delay the deadline for PMTA for three years from 2017.

However, many of the plaintiffs that sued the FDA had made attempts previously to intervene in the main lawsuit of the cigar industry in Washington, D.C., but they could not gain standing.

But the district court in AAP, in May 2019, gave judgments in favor of the public health groups, plaintiffs, and physicians who rose against FDA’s request for an extension of the deadline of PMTA for deemed “new tobacco products” that were on the U.S market on August 8, 2016, being the effective date of the deeming regulation.

Judge Paul W. Grimm, gave rulings, which affects all deemed tobacco products, but made no mention of cigars. He focused exclusively on vaping products and e-cigarettes and asked both the plaintiffs and FDA to make recommendations about an alternative deadline.

After much deliberations and considerations, the district court, in July 2019, had to make adjustments to the August 2021 deadline for submission of PMTA and moved it to May 2020.

The district court in October 2019, issued an order:

  • Permitting the vapor industry trade associations to make interventions for appeal
  • Denying the motion of the vapor associations’ to stay pending appeal
  • Denying the cigar association’s motion to intervene for the purpose of appeal

Subsequently, a number of parties appealed to Grimm’s decisions. The vapor association appealed to a different federal court but lost. The cigar industry called Amit P. Mehta, a U.S. District Court Judge who has overseen the primary cigar industry- FDA lawsuit but lost still. 

 Pending the appeal, On January 2, 2020, the FDA made conclusions on its new compliance policy guidance, leaving out that of August 2017, that had been the basis of the AAP case.

The appeal was later taken to the U.S Court of Appeals for the Fourth Circuit in Richmond, Va. But the appellate judges held that the January 2020 guidance issued by the FDA moots the vape group’s appeal. This is based on the fact that the guidance supersedes the directives from August 2017. This guidance reshuffled FDA enforcement priorities. Hence, there is “no possible meaningful relief” that can be granted by the court. 

“Any ruling by this court to reconsider the August 2017 guidance would amount to nothing but an advisory opinion,” the court said. 

Hence, The Fourth Circuits decision on May 4, 2020, held that:

  • Based on the replacement of the August 2017 guidance, the vapor associations’ appeal is now moot. This leaves no possible relief from the capacity of the court.
  • The district court was not at fault when it denied the motion of the cigar associations’ to partake in the appeal.
  • The FDA’s appeal is dismissed.

The Cigar industry groups that jointly appealed argued that the district court’s order on deadline posed a significant challenge to cigar and tobacco manufacturers as well.

But the court said that the cigar industry acted rather late. It should have worked earlier in the Maryland case, but it stayed out until after Grimm ruled against FDA. This made it unfair to permit the cigar industry to appeal the case so late in the process.

Moving on, Federal district court judge, Paul Grimm imposed a May 12, 2020 deadline for PMTA submission. But due to the logistical problems caused by the global coronavirus pandemic, the district court modified its remedy order and granted the FDA request for the deadline to be moved to September 9, 2020. 

Besides, the vape groups argued that the May Deadline is not giving enough room for manufacturers to file complete applications.

This is against the motion of public health groups who previously pushed to accelerate the FDA’s regulation on vape products under the Tobacco Control Act, citing vaping-related illnesses that left nearly 70 dead in 2019. 

However, the FDA stated that most research organizations and laboratories in charge of the clinical trials for the regulatory applications have halted in-person testing and shut down due to the COVID-19 pandemic.

Applications are, therefore, expected to be submitted on or before September 9, 2020, for cigars, e-cigarettes, and many deemed tobacco products.  

But several vaping groups are appealing for the PMTA deadline to be reconsidered to prevent many small vaping shops and stores from going out of the industry.

But the FDA, along with various anti-vaping and health groups, had countered that the appeal was based on 2017 guidance from the FDA, a formal roadmap to enforce regulations. However, the newly introduced guidance for tobacco regulations introduced on January 2, 2020, almost centered on vaping and e-cigarette products and made the 2017 advice moot.

Hence, the vaping industry does not have any valid basis for appealing—the January guidance restricting the sale of flavored, vaping products rendered moot the appeal. 

 The agency had previously said, “The district court’s order does not influence the enforcement timetable in the January 2020 guidance, and any order by the court to reverse the guidance would have no effect on the statute and regulations laid against e-cigarette manufacturers.”

Still, the vape group disagreed, expressing their concerns that the January guidance was passed without proper notice and procedures.  

But the court stressed the fact that it cannot offer the vape groups the relief they are demanding. The panel also mentioned that the Maryland district court’s action in denying the motion of the cigar industry groups’ to intervene is justifiable, saying those groups occurred rather late.

Both the counsel for the vape groups and cigar and a representative of the FDA did not come together in time to respond to the requests for comment Monday. 

Notwithstanding, the panel made it clear in a footnote that the groups can take a separate action in the appropriate district court to challenge the January 2020 guidance.

The appellants, comprising of a group of vapor industry associations, were represented by Eric Gotting of Washington, D.C- based law firm Keller and Heckman. Azim Chowdhury, one of the Keller attorney, announced the intention of the industry groups’ to appeal the PMTA decision last August.

Now, it is still unknown if the vaping coalition will attempt to appeal or file a new lawsuit in district court. But if the vaping industry wins in a new trial, the FDA might be forced to replace its informal guidance with rules made through proper Administrative Act procedures, making provisions for a mandatory public comment period.

 

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