VV EXCLUSIVE: Lawsuit could extend PMTA deadline beyond May 12, 2020


September 17, 2019

The deadline isn’t set in stone. The court-ordered deadline for vapor companies to submit premarket tobacco applications (PMTA) to the US Food and Drug Administration (FDA) could be extended beyond the current May 12, 2020, deadline if a Motions to Intervene and Stay the court order succeeds while an appeal to the ruling makes its way through the courts.

Lawyers with the law office of Keller and Heckman (KH), a
Washington DC law firm that represents the vapor industry, filed Motions to Intervene
and Stay with the U.S. District Court for the District of Maryland pending
appeal of the July 12, 2019 Memorandum Opinion and Order (Remedies Order) on
behalf of several vapor trade associations. The trade associations represent
small U.S. businesses that manufacture, distribute and sell vapor products to
adults. A Stay will temporarily suspend the District Court’s initial ruling
which started the 10-month PMTA clock.

KH also filed a Notice of Appeal with the United States
Court of Appeals for the Fourth Circuit on July 30, informing the appellate
court of its intent to appeal the District Court’s order denying the trade
associations initial attempt to intervene in the case on the remedies issue.

In its Motion to Stay, KH attorney Eric P. Gotting argued,
among other things, that “the remedies issue – and in particular whether the
Court properly set a PMTA deadline instead of remanding back to FDA for further
consideration – turns on the appropriate application of the D.C. Circuit’s ‘extraordinary
circumstances’ exception.” KH stated that it was “not aware of any case in
which the Fourth Circuit has applied that principle” previously.

On July 11, Judge Paul Grimm of the U.S. District Court for
Maryland ruled in a lawsuit filed by anti-tobacco groups that the regulatory
agency had exceeded its authority in allowing electronic nicotine delivery
systems (ENDS) to remain on the market until 2022 before companies applied for
regulatory approval. The order was filed on July 12.

“Given the uncertainty in the efficacy of e-cigarettes as
smoking cessation devices, the overstated effects that a shorter deadline may
have on manufacturers, the Industry’s recalcitrance, the continued availability
of e-cigarettes and their acknowledged appeal to youth, and the clear public
health emergency, I find that a deadline is necessary,” Grimm wrote. “I will
impose a ten-month deadline for submissions and a one-year deadline for
approval, as the FDA suggested.”

Attorneys for the plaintiffs asked the court to rule that
applications for marketing orders be filed within 120 days of issuance of the
“Court’s order and products for which applications have not been filed within
this period shall be subject to FDA enforcement actions.” The Plaintiffs also
asked that “products for which applications have been timely filed may remain
on the market without being subject to FDA enforcement actions for a period not
to exceed one year from the date of application while FDA considers the

The FDA has until tomorrow, Sept. 18, to respond to the Motion
to Stay.

Category: Breaking News

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Source: VaporVoice