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In case you missed it: VTA sues FDA for ‘moving the goalposts’ of PMTA

The Vapor Technology Association (VTA) in coordination with Vapor Stockroom (VSR) filed a lawsuit in federal court last week against the U.S. Food and Drug Administration (FDA and the Department of Health and Human Services.   The lawsuit accuses the federal agencies of imposing an “unreasonable and arbitrary” deadline of May 11, 2019 on the Pre-Market Tobacco Applications (PMTA) process as originally identified in the revised deeming regulations of 2016.

The main point of contention, according to a VTA press release,  is that this deadline keeps moving. The latest variation was only recently announced in mid-July and fast-forwards the compliance requirements by over a year. 

“Since 2016, FDA has provided five different PMTA submission deadlines: August 8, 2018; November 8, 2018; August 8, 2022; August 8, 2021; and now May 12, 2020. The most recent deadline was only just established on July 12, 2019 – leaving a scant ten months for vapor industry manufacturers to attempt to comply, which is now 27 months earlier than previously set by FDA.”

Thanks to a prior court ruling against the public health agency earlier this summer, the vaping industry now has less than 10-months to submit applications for each and every product or be forced to pull their stock from store shelves. In the former case filed by The American Academy of Pediatrics, U.S. district court Judge Paul W. Grimm ruled that the FDA acted illegally when it moved forward the August 8, 2018 PMTA deadline by four years to August 8, 2022. 

Related Article: Judge makes it official: Vape retailers have 10-months to submit PMTAs…or else

The FDA could have contested the new time limit with Judge Grimm, but it refused to do so.  Meanwhile, the vaping community is now at risk of losing over three million vapor products if the new VTA lawsuit fails in court.  The plaintiffs maintain that vapor manufacturers cannot possibly “conduct the many complex and time-consuming tests and studies currently being required” in just a few short months. 

Furthermore, the FDA has yet to fully clarify the necessary guidelines and requirements for the supporting scientific documentation which must accompany each application per the FDA deeming regulations.  VTA Executive Director Tony Abboud is seemingly growing increasingly frustrated by the non-stop confusion surrounding the PMTA and its potentially devastating effects on thousands of small and mid-sized vape shops around the country.

“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful. The Agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act. Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime…”
 
“It is time for FDA to stop moving the goalposts and changing the rules in the middle of the game to the detriment of our manufacturers and small businesses.” 


Last week’s VTA lawsuit is essentially seeking “preliminary and permanent injunctive relief” from the court which would create a sort of legal domino effect resulting in the following.

      • The FDA would be forced to issue new and fully complete rules governing the PMTA process, including the specifications required for the supporting testing and scientific data.
      • The FDA would be required to establish yet another PMTA deadline that is “reasonable” and based on the fully clarified rules and guidelines.
      • The FDA would be prohibited from taking law enforcement actions on any vapor product until after the new and revised PMTA deadline occurs.
      • The prior court ruling of Judge Grimm and its related 10-month PMTA deadline would become void, pending the new and improved PMTA rules and guidelines.   

The VTA lawsuit filed last week in the U.S. Fourth Circuit Court of Appeals now awaits a judge’s decision to either allow or deny the case to move forward.  If the judge issues the requested federal injunction, then the VTA will have forty days to file its initial legal brief.  From there, the final ruling could be held up in court for several months or perhaps just a few days. 

Related Article:  In case you missed it: FDA recalls 44 vapor products from four companies

(Image courtesy of Shutterstock)

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