Under Judge Grimm’s Revised Remedial Order, FDA must submit quarterly status reports regarding its review of pending PMTAs for certain popular vapor products.

On April 15, 2022, Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ordered  FDA to submit status reports to the Court and to the Plaintiffs in the case every ninety days, beginning on April 29th.
Continue Reading Deeming Regulations Litigation Update—Federal Court Exercises Even More Oversight over FDA’s PMTA Review

In a 2-1 decision, a panel of the U.S. Court of Appeals for the Ninth Circuit held that the Family Smoking Prevention and Tobacco Control Act neither expressly nor impliedly preempts Los Angeles County’s ban on the sale of flavored tobacco products.

In a Vapor Voice posting on April 2, 2022, the Troutman Pepper Tobacco

The U.S. District Court for the Eastern District of Pennsylvania entered a permanent injunction against Philadelphia’s enforcement of an ordinance banning the sale of certain flavored tobacco products, after the U.S. Court of Appeals for the Third Circuit upheld a preliminary injunction against the same.

Litigation over a local flavor ban came to a close on March 8, 2022, with Judge Gene E.K. Pratter of the U.S. District Court for the Eastern District of Pennsylvania entering a permanent injunction:

  • prohibiting the City of Philadelphia from enforcing City Ordinance No. 180457 (the “Ordinance”); and
  • requiring the City to void and withdraw any and all regulations regarding the Ordinance.

The case is Cigar Association of America, et al. v. City of Philadelphia, et al., No. 2:20-cv-03220 (E.D. Pa.).

Continue Reading Philadelphia Flavor Ban Case Results in Permanent Injunction Against the City

In August 2021, Swisher International Inc. filed a lawsuit against the Food and Drug Administration (FDA) seeking to have the FDA’s Deeming Rule declared invalid. Swisher followed its lawsuit with a petition for injunction to prevent FDA from taking enforcement action against Swisher while Swisher’s lawsuit against the FDA’s implementation of the Deeming Rule is under consideration and while the FDA processes Swisher’s pending 173 premarket applications. On February 3, 2022, the Eleventh Circuit Court of Appeals upheld a lower court’s denial of a motion for a preliminary injunction finding that Swisher was not likely to suffer “irreparable harm.”
Continue Reading Eleventh Circuit Denies Swisher International’s Request For An Injunction of Further Enforcement by FDA

On Wednesday, the Massachusetts Supreme Judicial Court upheld a jury’s award of $10 million in punitive damages in a wrongful-death case against Philip Morris USA Inc. (“PM USA”), rejecting the tobacco company’s argument that such relief was precluded by the 1998 master settlement agreement between the Massachusetts Attorney General, PM USA, and other attorneys general and tobacco manufacturers.[1]

Continue Reading Massachusetts Supreme Judicial Court Affirms Punitive Damages Award Against Philip Morris USA Inc. In Spite of Master Settlement Agreement Release

We previously wrote about a hemp industry case against the Texas Department of State Health Services, challenging the state legislature’s smokable hemp ban and the Department’s implementing regulations. Plaintiffs, Texas hemp producers and retailers, argued that H.B. 1325, which banned the in-state manufacture of smokable hemp, but not the possession, consumption, or importation of smokable hemp from other states, was unconstitutional because it was not rationally related to any legitimate government interest (smokable hemp could still be sold and consumed in the state, just not produced by Texas hemp businesses).

Continue Reading Hemp Industry Victory in Texas: Court Finds Smokable Hemp Ban Unconstitutional

California’s cigarette tax and escrow requirements apply to inter-tribal sales of cigarettes, held the U.S. Court of Appeals for the 9th Circuit in Big Sandy Rancheria Enterprises v. Bonta. Big Sandy Rancheria Enterprises (“BSRE”), a federally-chartered corporation wholly-owned by the Big Sandy Rancheria Band of Western Mono Indians, brought the case to challenge California’s application of its tobacco directory, licensing, and tax laws to BSRE’s sales of native-manufactured cigarettes to other Indian tribes.
Continue Reading Ninth Circuit Holds That Inter-Tribal Cigarette Sales Are Subject to State Tobacco Laws

We previously blogged about two cases challenging the constitutionality of FDA’s “Deeming Rule,” the authority by which FDA extended its regulation of tobacco products to electronic nicotine delivery systems (“ENDS”).

Both of these cases, Big Time Vapes, Inc. v. FDA and Moose Jooce v. FDA recently hit a dead end when the Supreme Court denied both plaintiffs’ petitions for review.
Continue Reading Supreme Court Won’t Hear Latest ENDS Industry Challenges to FDA Regulation

Smokable hemp is one of the fastest growing submarkets of the hemp industry, but hemp growers and manufacturers in Texas may not be able to take advantage. A pair of cases in Texas district and appellate courts are trying to make sure that’s not the case.
Continue Reading Texas Courts Hear Oral Arguments Regarding State’s Smokable Hemp Ban

Given the massive wave of medical and adult use marijuana laws being passed across the country, the average person may think there is no longer any debate as to whether marijuana has legitimate medical applications. On June 10, 2021, however the federal Court of Appeals for the Ninth Circuit heard argument on exactly that question. The case has potential to set important precedent not just for marijuana scheduling, but also other Schedule I substances being studied for their therapeutic potential.
Continue Reading 9th Circuit Hears a New Attempt at Forcing the DEA’s Hand on Marijuana Scheduling