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Zie Alere

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Zie is an associate in the firm’s Regulatory Investigations, Strategy + Enforcement Practice Group. He assists in developing effective strategies to help deter or mitigate the risk of enforcement actions and litigation. As a summer associate, Zie drafted compliance guidelines, worked on pro bono matters, and created analytical memoranda.

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration (FDA) from requiring graphic warnings on cigarette packs. As we noted in prior coverage, the March 2020 FDA rule at issue would require new textual health warning statements alongside color, photorealistic images displayed on the top 50% of the front and rear panels of cigarette packs and the top 20% of cigarette advertisements.

In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River) from the state tobacco directory based on Grand River’s alleged violations of the Federal Food, Drug, and Cosmetics Act (FDCA). The FDCA preempts state law actions based solely on FDCA violations if the U.S. Food and Drug Administration (FDA) has not already found that such violations exist, the court explained.

In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened enforcement against sellers of unauthorized ENDS in 2023 and predicted that this pattern of enforcement would continue. A year-to-date review of 2024 shows that FDA is placing a high priority on action against unauthorized ENDS.

Across states, lawmakers often embrace “medical” marijuana as a precursor to establishing a “recreational” marijuana market. Although marijuana remains illegal at the federal level — and would remain illegal even under the proposed rescheduling — federal regulators also recognize the therapeutic potential of certain marijuana-adjacent substances. At the federal level, the U.S. Food and Drug Administration (FDA) has approved one drug product derived from the cannabis sativa L. plant and three synthetic cannabis-related drug products. At the same time, 38 states and Washington, D.C., have established legal frameworks for access to medical marijuana. Comparing these frameworks to FDA’s drug approval process reveals fundamental differences between state and federal approaches to determining whether cannabis is “therapeutic.”

A recent lawsuit in Alabama, challenging the award of medical cannabis licenses by regulators, underscores the potential pitfalls in licensing regimes where applicants are selected based on specific enumerated factors. Below, we examine the Alabama lawsuit in greater detail and consider the alternative policy of utilizing a lottery system to award licenses.

On April 2, three advocacy organizations filed a complaint in the U.S. District Court for the Northern District of California seeking an order directing the U.S. Food and Drug Administration (FDA) to promulgate its already-proposed rule banning menthol as a characterizing flavor in combustible cigarettes. The case comes as FDA has missed several internal deadlines for promulgating a final rule on the topic.

We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar bills have been introduced in Arizona, Hawaii, Iowa, Nebraska, New York, South Carolina, South Dakota, Vermont, Washington, and West Virginia. Additionally, a bill in Oklahoma would update the state’s existing directory framework to be consistent with the proposals of these recent bills. The directories would allow states to prohibit the sale of vapor products that are not authorized by the U.S. Food & Drug Administration (FDA) or subject to a pending premarket application. Like the proposals discussed in our previous coverage, these bills are intended to reduce the proliferation of illicit vapor products.

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).

In an era where privacy, security, and artificial intelligence are at the forefront of many business operations, staying informed about the latest developments is crucial. Our 2023 Privacy Year in Review is an in-depth analysis of the past year’s significant advancements and challenges in these areas.