Significant Cases

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In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA) marketing denial order (MDO) of petitioner’s premarket tobacco applications (PMTAs) violated the Administrative Procedure Act (APA).

The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and retailers.  The agency has been criticized for not doing enough to fight the sale of unauthorized vapor products, but these actions should at least remind manufacturers and retailers that the agency’s warning letters are not empty threats.

Over the last decade, hundreds of localities have passed ordinances restricting or prohibiting the sale of some or all types of tobacco products. Some of these ordinances have been challenged in court, but, in most cases, the localities have prevailed. In this case, a group of retailers (the Retailers), sued Multnomah County, Oregon (the County) in January 2023 alleging that the County’s flavored tobacco product ban was unlawful. Earlier this month, consistent with the overall trend, the court ruled against the Retailers and upheld the County’s flavor ban.

Last summer, we wrote about the Iowa Attorney General’s $133 million suit against the tobacco manufacturers that are signatories to the Master Settlement Agreement (MSA).  Brought in Iowa state court, this suit alleged that those manufacturers (commonly referred to as “Participating Manufacturers”) acted in bad faith by disputing (and delaying the ultimate payment of) the amounts they owe to the state under the MSA. On August 22, 2023, Iowa compromised its past and future claims under the lawsuit and joined 37 other states that have settled similar disputes. Iowa Attorney General Brenna Bird announced that the state reached a settlement with the Participating Manufacturers that will result in the state receiving payments of more than $171 million over the next six years.  

Yesterday, August 9, 2023, Judge Amit P. Mehta of the US District Court for the District of Columbia issued his decision vacating the decision of the Food and Drug Administration (“FDA”) to “deem” premium cigars covered by FDA’s 2016 rule that swept all tobacco products under the same set of regulations.  In previous decisions, the District Court already had vacated the portions of the Deeming Rule that required premium cigars to display health warnings on packaging and advertising and to engage in the burdensome premarket authorization process. 

Published in Law360 on June 27, 2023. © Copyright 2023, Portfolio Media, Inc., publisher of Law360. Reprinted here with permission.

On May 11, R.J. Reynolds Tobacco Co. Inc. went on the offensive to keep its new line of nonmenthol cigarettes marketed with language like “crisp,” “smooth” and “mellow” on store shelves in California.[1]

This suit, R.J. Reynolds Tobacco Co. v. Bonta, seeks declaratory relief in the Superior Court of California, County of Fresno, that California’s attorney general misinterpreted and misapplied the state’s ban on flavored tobacco products, and incorrectly concluded that R.J. Reynolds’ new products violate this ban.

On May 11, RJ Reynolds Tobacco Company, along with two convenience stores and the American Petroleum and Convenience Store Association, sued the California attorney general and district attorney for Fresno County in their official capacities, seeking declaratory relief that these California officials misinterpreted and misapplied California’s ban on flavored tobacco products and incorrectly concluded that RJ Reynolds’ new products violate this ban.

California voters have approved Senate Bill 793, which prohibits tobacco retailers from selling flavored tobacco products or tobacco product flavor enhancers. A lawsuit has been filed in federal court claiming that it is unconstitutional.

On November 8, 2022, California voters said “yes” to Proposition 31, a referendum on a 2020 law that would prohibit the retail sale of certain flavored tobacco products. The constitutionality of the referenced law, Senate Bill 793 (“SB793”), is at issue in a case filed the next day in the U.S. District Court for the Southern District of California, R.J. Reynolds Tobacco Co., et al. v. Bonta, et al., No. 3:22-cv-01755 (S.D. Cal.); however, the plaintiffs’ success in that case will likely depend on the development of favorable precedents in other cases pending before appellate courts.

On November 3, Judge Gary L. Sharpe of the U.S. District Court for the Northern District of New York issued a preliminary injunction, blocking cannabis regulators from issuing marijuana retail licenses for five geographic regions across the state, while a constitutional challenge to the program proceeds.