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Following its appeal to the U.S. Court of Appeals for the Sixth Circuit, Vapor Stockroom LLC (the “Appellant”) has filed a motion for injunction pending the decision on the merits or, alternatively, for the expedition of briefing, oral argument, and decision of its appeal.

In the Appellant’s words, “The impetus for the present motion . . . is that if this Court fails to grant injunctive relief . . . by May 12, 2020, FDA has threatened industry-wide enforcement action after that date that would require [Appellant] to shutter its business.”

The U.S. Department of Agriculture (USDA) today announced the delay of enforcement of certain requirements under the interim final rule (IFR) establishing the U.S. Domestic Hemp Production Program. Under the new guidance, USDA will delay enforcement of the requirement for labs to be registered by the Drug Enforcement Administration (DEA) and the requirement that producers use a DEA-registered reverse distributor or law enforcement to dispose of non-compliant plants under certain circumstances. While lab tests can be conducted by labs that are not yet registered with DEA, the labs must still meet all the other requirements in the IFR.

On February 15, 2020, Plaintiff Vapor Stockroom LLC filed a notice of appeal in Vapor Technology Association v. FDA, No. 5:19-cv-00330-KKC (E.D. Ky.). Vapor Stockroom is appealing the district court’s order granting the FDA’s motion to dismiss and denying their motion for preliminary injunction. The Plaintiffs alleged that, in requiring the submission of premarket tobacco applications by May 12, 2020, the FDA violated the Administrative Procedure Act, 5 U.S.C. § 500, et seq., and the Due Process Clause of the Fifth Amendment to the Constitution.  

On January 2, 2020, the FDA issued guidance concerning its enforcement priorities for electronic nicotine delivery systems (“ENDS”) and other deemed products on the market lacking premarket authorization (the “Guidance”). Just over a month later, the Comptroller of the State of Maryland has announced that the State will increase its enforcement against certain flavored ENDS products. The State purports to shore up a “loophole” in the FDA’s Guidance.

Earlier last week, a US District Court ruled that the Food and Drug Administration’s subjecting of premium cigars to warnings requirements was arbitrary and capricious in violation of the Administrative Procedure Act (“APA”), insofar as the agency failed to provide a reasoned explanation for this action. The court thus declared unlawful (and vacated) the portion of the FDA’s so-called “Deeming Rule” mandating that premium cigars display designated public health warnings on packaging and advertisements.

The question has been raised in a complaint filed on September 24, 2019, by Swisher International, Cheyanne International, and the Cigar Association of America (“Plaintiffs”) for declaratory and injunctive relief against Nebraska’s Attorney General, Department of Revenue, and Tax Commissioner (the “State”).

The case arises over a Department of Revenue notice declaring that “certain little cigars, certain filtered and non-filtered little cigars, and certain flavored little cigars may be reclassified as cigarettes effective September 1, 2019.”

On January 21, 2020, the U.S. Court of Appeals for the Fourth Circuit issued an order disposing of several motions before it in American Academy of Pediatrics, et al. v. U.S. Food & Drug Administration, et al., Nos. 19-2130, -2132, -2198, -2242. This is an appeal from the U.S. District Court for the District of Maryland, which:

  1. held that the FDA’s August 2017 guidance did not lawfully extend tobacco product compliance deadlines; and
  2. ordered new deadlines of May 12, 2020, for filing applications, and one year after application for approval.

The district court’s rulings amounted to a roughly two-year acceleration of the FDA’s deadlines.

On January 16, a federal judge in the Eastern District of Kentucky dismissed a case brought by a vapor trade organization and one of its members, leaving in place the court-mandated May 12, 2020 deadline for premarket review submissions for suppliers of “deemed” tobacco products, such as electronic nicotine delivery systems (ENDS), cigars, pipe tobacco and hookah tobacco.

As we previously blogged, FDA announced on December 26th that it is illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21.  The announcement drew much criticism because it failed to provide retailers guidance regarding whether FDA would exercise enforcement discretion, even on a shorter time frame, to allow retailers to upgrade systems, replace signage and train personnel.