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