A Pennsylvania Commonwealth Court judge ordered a temporary injunction last Thursday on a February recall of vape products by the state’s cannabis regulators, citing a lack of scientific evidence for the recall presented by the state. Although attorneys for the state presented no rebuttal evidence during the injunction hearing, within 24 hours of the judge’s order, state regulators submitted notice of their plan to appeal the decision.
Last February 4, regulators in the Pennsylvania Department of Health’s Office of Medical Marijuana, ordered a recall of cannabis vape products across the state, citing a state law passed in November 2021 that requires the Department of Health (DOH) to determine, “Whether the added substance is permitted by the United States Food and Drug Administration for use in food or is Generally Recognized as Safe (GRAS) under Federal guidelines.”
Determining that vaping products containing common additives like terpenes “have not been approved for inhalation by the [FDA]”, the DOH ordered a statewide vape recall impacting about 330,000 units of product valued at about $18 million.
Soon after, an injunction of the recall was requested by the Medical Marijuana Access & Patient Safety, Inc. (MMAPS), an organization purposely created for the sake of the lawsuit, according to Meredith Buettner, executive director of the Pennsylvania Cannabis Coalition, an advocacy group for cannabis operators in the state. Concerned that the plaintiffs would be charged with a lack of standing for the case, MMAPS was created to comprise only companies that were directly impacted by the state’s recall decision, said Buettner.
Curiously, attorneys for the state chose not to present any scientific evidence or witnesses during the case’s hearing, but instead argued that the petitioners have no standing, or right, to bring the action. In his decision in favor of the injunction, Judge Michael Wojcik slam dunked the state’s argument in his decision, stating that because attorneys for the state brought no witnesses to argue against the plaintiffs’ testimony, “Respondents’ argument that Petitioner’s asserted harms are speculative lacks merit and the Court finds that Petitioner has standing to bring this action.”
“The decision seems appropriate,” said Luke Schultz, a patient advocate and until recently a member of the Pennsylvania Medical Marijuana Advisory Board. “If there are real concerns with these additives and someone can show they have proof, I would not want to see those products available for patients, but we’re not seeing that at this point.”
“Just because it doesn’t say you can’t do this doesn’t mean you can. They applied a thing the legislature didn’t prescribe,” said advocate Buettner. “The state failed to provide any scientific evidence that this was unsafe. The FDA standard for inhalation has not been applied to cannabis, to apply it here with no scientific evidence makes no sense.”
Buettner says DOH has taken an aggressive stance from the very beginning. Early in the case, Judge Wojcik ordered the state and plaintiffs to enter mediation, but Buettner said, “The Department [of Health] walked in and said, ‘We’re not here to negotiate, see you in court.’”
Asked for comment on the case, a Department of Health spokesperson only replied, “On June 3, the Department of Health filed a notice of appeal to the Pennsylvania Supreme Court. This filing triggers an automatic stay on the Commonwealth Court’s June 2, 2022 order. This means that the recalled products cannot be sold until further notice.”
Indeed at least one vendor, Trulieve, got ahead of themselves on Thursday, announcing “the recalled products may now return to dispensary shelves to be sold to medical marijuana patients in Pennsylvania.” But then just hours later, after the notice of appeal was filed, rescinded their earlier press release saying, “the sale of these products and availability to the medical marijuana patients in Pennsylvania on hold again pending a second ruling from the Court.”
A hearing date for the appeal has not yet been set.