Late yesterday, April 22, 2020, the U.S. District Court for the District of Maryland issued its long-awaited Order formally extending the May 12, 2020 deadline for submitting marketing applications for those deemed “new tobacco products” that were on the U.S. market on August 8, 2016.  That deadline is now September 9, 2020.

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In early April, Virginia Governor Ralph Northam signed Senate Bill 918, approving industrial hemp extract, such as cannabidiol (“CBD”), as a food, subjecting it to applicable laws and regulations.  The bill defines “food” as “any article that is intended for human consumption. . . [and] does not mean drugs as defined in [Va. Code] § 54.1-3401.” The bill establishes requirements for the production and manufacture of hemp extracts and authorizes the Virginia Board of Agriculture and Services to adopt regulations regarding contaminant tolerances, labeling, and batch testing.
Continue Reading Virginia becomes the most recent state to regulate hemp extracts as food

On April 3, 2020, several tobacco companies, including R.J. Reynolds, Imperial and Liggett, filed suit in a Texas federal court challenging the U.S. Food and Drug Administration’s (“FDA”) March 2020 rule requiring the placement of graphic warnings on cigarette packaging and advertising (“the Rule”).
Continue Reading Tobacco Companies Challenge FDA’s Rule Requiring Cigarette Graphic Warnings

Will the May 12 deadline for premarket tobacco applications and substantial equivalence reports remain in place?  The FDA has decisively moved in that direction, but the final answer will depend upon further proceedings

There was a significant development on April 3, 2020, when Judge Paul W. Grimm of the U.S. District Court for the District of Maryland issued an indicative ruling in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.), on appeal, Nos. 19-2130, -2132, -2198, -2242 (4th Cir.).  Judge Grimm indicated that, “if the case were remanded for that purpose,” he would grant the FDA’s motion to extend the deadline to September 9 “in light of the global outbreak of respiratory illness caused by a new coronavirus.”  The case is pending with the U.S. Court of Appeals for the Fourth Circuit, which would have to order a limited remand prior to Judge Grimm’s issuing any actual ruling on the extension.
Continue Reading FDA and Federal Court Move Toward Extension of May 12 Deadline for Premarket Review Applications

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