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October 11, 2019

Courtroom Battles Ahead for Emergency Regulations Addressing Vaping-Associated Pulmonary Illnesses

In response to vaping-associated pulmonary issues emerging nationwide, states have begun restricting sales of consumer products that deliver electronically vaporized liquids (e-liquid) directly to the lungs. Affected operators and industry associations have begun addressing these measures in court, citing executive overreach. In a pair of cases in a pair of contiguous states, the Vapor Technology Association (VTA) is leading challenges to Massachusetts’ and New York State’s emergency rules for containing and combatting a growing public health crisis.

Massachusetts’ and New York’s Emergency Rules

Those rules share many similarities. Both Massachusetts and New York would restrict advertising and sales of flavored e‑liquid used in electronic cigarettes. Both states’ bans also cover individuals in addition to entities, with New York expressly including retail clerks, cashiers, employees, and other staff who interact with consumers. Both states would also impose fines on a per unit basis, with fines per violation reaching upwards of $1,000 in Massachusetts and $2,000 in New York. However, vape products approved by the Food and Drug Administration (FDA) for tobacco cessation or other medical purposes would continue to be allowed in Massachusetts and New York.

These states’ measures also bear notable differences; the Massachusetts restrictions are more expansive in two meaningful ways. First, while New York’s ban would apply to all e-liquid flavors except tobacco or menthol, Massachusetts would ban all e-liquids, regardless of flavoring.

The second difference relates to ongoing state and federal investigations that have found some correlation between illnesses and the presence of the Vitamin E acetate additive. At a point in New York’s investigation, all the patients who submitted a vape product for testing had at least one product that contained Vitamin E acetate. New York’s observations suggested those products were neither nicotine vapes nor state medical marijuana vapes, but rather were counterfeit––that is, unregulated contraband––recreational cannabis vape products. Accordingly, while there has been monitoring of regulated medical marijuana vapes, New York has not expanded the ban to cover licensed marijuana operators. Massachusetts, however, has.

MA and NY Court Cases

The gist of the VTA’s lawsuits is that nicotine vape products are highly regulated by the FDA and, accordingly, should not be treated like the largely bootleg cannabinoid vape products implicated as causing these illnesses. The VTA is seeking permanent injunctions in both cases. In New York, the VTA claims the ban is arbitrary and capricious, violates administrative procedures, and usurps a legislative function. In Massachusetts, the VTA claims the ban violates the Commerce Clause of the US Constitution, and the advertising restrictions violate the First Amendment.

So far, the results have been mixed. New York’s emergency ban was suspended recently when an appeals court granted a temporary restraining order, reversing the lower court’s denial. The Massachusetts ban, however, remains in effect absent an appeal, after the federal district court denied the VTA’s request for a temporary restraining order. The court ruled the VTA failed to show a substantial likelihood of success on the merits or that the balance of hardships favored temporary relief. The Massachusetts and New York courts are scheduled to hold injunction hearings on October 15 and 18, respectively.

It is far from certain whether the VTA will obtain either injunction or both. Even less certain is whether the likelihood of success on the merits will be altered by findings from state and federal agencies’ ongoing investigations into vaping-associated pulmonary illness. As a critical element underlying injunctive relief, nudging that likelihood in either direction could undo an injunction then in place or give grounds for a renewed request in the event an injunction is denied.

Conclusion

Amidst this uncertainty, this much is reasonably certain: The safety of cannabis patients and consumers can improve with shared knowledge, expanded research, and uniformity in regulation as the industry progresses toward federal legalization.

If you have any questions regarding the content of this alert, please contact Aleece Burgio, special counsel, at aburgio@barclaydamon.com; John Nichols, counsel, at jnichols@barclaydamon.com; Mary Volcko, project specialist, at mvolcko@barclaydamon.com, or another member of the firm’s cannabis team.

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