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

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

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.”
Continue Reading Nebraska case: Are Certain Cigars Cigarettes?

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 October 16, the Montgomery County Council publicly authorized its lawsuit filed in federal court on October 11, against Juul Labs and Altria Group for alleged violations of Maryland and federal law based on claims of aggressive marketing of e-cigarette products to minors.

Council President Nancy Navarro remarked, “The Council authorizes taking legal action against Juul Labs and Altria Group. This lawsuit supports our ongoing efforts to protect our community members from the public health impacts associated with e-cigarette products and vaping.
Continue Reading Montgomery County, Maryland Takes Judicial and Regulatory Action Against E-Cigarette Manufacturers and Distributors

On October 21, 2019, the Massachusetts Superior Court for Suffolk County preliminarily enjoined the State – from and after October 28, 2019 – from implementing and enforcing the ban as to “nicotine-vaping products” unless and until the executive branch promulgated the regulation in accordance with Massachusetts due process requirements.  The court allowed the ban to continue with respect to “products containing tetrahydrocannabinol (THC) and any other cannabinoid or to black market products.” 
Continue Reading Massachusetts Trial Court Temporarily Enjoins State Ban on Vapor Products Pending Further Rulemaking

Flavored vapor product bans in two States were temporarily stayed this week.  On Tuesday, October 15, 2019, a Michigan state judge temporarily blocked the State’s emergency ban on flavored vapor products, which went into effect earlier this month.  The plaintiffs were two vapor product retailers and an individual owner.  In addition to presenting evidence that the ban had significantly hurt their businesses (resulting in the complete shutdown of one of the companies’ business), the plaintiffs also presented several witnesses whose testimony showed that the ban presented a harm to the public, challenged the efficacy of certain surveys presented by the State and challenged the supposed correlation between youth consumption of burning tobacco and e-cigarettes. 
Continue Reading Michigan and Oregon Courts Block Vapor Bans Pending Further Review

The City of New York filed on October 9, 2019, a lawsuit in federal district court against 22 national online e-cigarette retailers for allegedly selling their products to underage New Yorkers. The complaint alleges the online retailers do not have age verification systems in place and engage in marketing directed toward minors in violation of city law. 
Continue Reading Online Retailers Sued by City of New York

On the heels of a Maryland federal judge’s order advancing to May 2020 the deadline for premarket review submissions (discussed here), a group of public health advocates (led by Iowa Attorney General Tom Miller) has petitioned the Secretary of Health and Human Services to appeal the court’s decision and to revamp the premarket review process for electronic nicotine delivery systems (ENDS).
Continue Reading Public Health Advocates Urge FDA to Revamp ENDS Premarket Review Process and Appeal Maryland Ruling