Law360 (February 19, 2020, 8:38 PM EST) -- The e-cigarette industry faces an existential threat because the U.S. Food and Drug Administration
is about to impose regulations that violate separation of powers doctrine, a trade organization told the Fifth Circuit on Wednesday.
The brief, filed by the United States Vaping Association and Big Time Vapes Inc., a vape shop in Mississippi, marks the latest bid to delay the FDA from enforcing its new rules cracking down on electronic nicotine delivery system products that don't have premarket authorization.
The vaping parties argued in their brief that the Family Smoking Prevention and Tobacco Control Act, or TCA, of 2009 was unconstitutional because it gave regulators too much latitude to decide which products the statute should govern and that the FDA overstepped when it issued a rule in 2016 extending its scope to e-cigarettes.
"An entire industry — or at least an entire nation's worth of small businesses in the industry, including Big Time Vapes and the USVA's members — are threatened with extermination pursuant to the FDA's unilateral policy choice," the brief said.
The brief argued that the TCA remains unconstitutional under the U.S. Supreme Court
's binding 1935 decision in Panama Refining Co. v. Ryan
, which struck down a statute for delegating too much lawmaking power to the executive branch.
The vape industry parties positioned their appeal as an opportunity for the circuit court to assert a more forceful application of the nondelegation doctrine, which prevents legislators from assigning too much of their authority to other agencies, after a Mississippi federal judge tossed their suit with prejudice in December
Along those lines, the brief argued that the lower court erred when it found that Congress had included in the TCA sufficient guidance for what constituted a "tobacco product," and had, therefore, established enough of an "intelligible principle" governing how the statute should be applied, consistent with the standard set by Mistretta v. U.S.
The vaping industry parties argued that the TCA does not, in fact, contain any principle cogent enough to guide regulators' hands — not even by the standards set by court decisions that have more loosely interpreted the nondelegation doctrine in the years since Panama Refining.
"Congress left cigars, hookah, pipe tobacco, [electronic nicotine delivery system products], and all other tobacco products unregulated and punted the question whether to extend the TCA to the Secretary [of the U.S. Department of Health & Human Services], without providing any parameters or guidance whatsoever," the brief said.
The present suit was originally filed in August
but was given additional urgency after the FDA was ordered in a separate lawsuit
to impose a May 12 deadline for e-cigarette companies to submit applications to keep their products on the market.
E-cigarette companies asked the Fourth Circuit for a stay and review of that order, and the appeal remains pending. However, the FDA signaled to the appellate court in a filing
that it would abide by the May 12 deadline "independent of the district court's order in this case," and suggested that the appeal was moot.
An FDA spokesperson declined to comment on pending litigation. Counsel for Big Time Vapes and the USVA declined to comment.
Big Time Vapes and the United States Vaping Association are represented by Jerad Najvar and Austin M.B. Whatley of Najvar Law Firm PLLC
The government parties are represented by Stephen M. Pezzi of the U.S. Department of Justice
's Civil Division and Emily S. Nobile of the U.S. Attorney's Office
for the Southern District of Mississippi.
The case is Big Time Vapes Inc. et al. v. Food and Drug Administration et al., case number 19-60921
, in the U.S. Court of Appeals for the Fifth Circuit
--Editing by Jay Jackson Jr.