The U.S. Court of Appeals for the D.C. Circuit will hear another challenge to the FDA’s rule Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, 81 Fed. Reg. 28,973 (May 10, 2016) (the “Deeming Rule”). The challenges are based on the Constitution’s Appointments Clause and First Amendment. The cases are Moose Jooce, et al. v. FDA, et al., Nos. 20‑5048, -5049, & -5050 (D.C. Cir.).
Continue Reading D.C. Circuit to Hear Appointments Clause Challenge to Deeming Rule; Challengers Request Expedited Consideration

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.”
Continue Reading Injunction and Expedition Sought in Sixth Circuit Appeal over May 12 PMTA Deadline

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.  
Continue Reading Vapor Company Appeals Dismissal of Challenge to PMTA Deadline

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.
Continue Reading After FDA Guidance, Maryland Increases Enforcement Against Flavored Cartridge-Based and Disposable ENDS

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.
Continue Reading US District Court Grants Premium Cigars Relief on Warnings

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.
Continue Reading Fourth Circuit Expedites Appeal, but District Court’s May 12 FDA Premarket Review Deadline Remains For Now

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.
Continue Reading Federal Judge Dismisses Kentucky Case Challenging FDA’s May 2020 Deadline

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. 
Continue Reading FDA Clarifies Position on Enforcement of Tobacco 21

Earlier today, FDA issued a 52-page Industry Guidance document announcing that, effective on or around February 1, 2020 (30 days from today), it will “prioritize enforcement action” against (implicitly banning from lawful sale) all “flavored, cartridge-based” ENDS products on the market (other than tobacco- or menthol-flavored ENDS products).  The Guidance defines a cartridge-based product as a product that “consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use,” and defines a “cartridge or pod” as “any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system.” 
Continue Reading FDA issues New ENDS Guidance; Intends to Remove from the Market Flavored, Cartridge-Based ENDS Other than Tobacco – or Menthol-flavored Offerings

FDA announced yesterday via an update to its website that it is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21.  This announcement (the day after Christmas) follows the signing into law on December 20, 2019 of legislation amending the Federal Food, Drug, and Cosmetic Act to raise the federal minimum age of sale of tobacco products from 18 to 21 years.
Continue Reading FDA Alert: Tobacco Age 21 Effective Immediately Per FDA