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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 late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be revived under a future administration, the withdrawal ends both of the current rulemaking processes. The move also strongly indicates shifting FDA priorities under the second Trump administration. Amid these changes, industry may find the agency more receptive to its arguments — particularly those submitted in comments to proposed rulemaking.

Hearings on the merits of the Drug Enforcement Agency’s (DEA) proposed cannabis rescheduling, initially set to begin this month, have been cancelled. The preliminary hearing period has been littered with accusations that the DEA improperly excluded certain parties from participating, that the DEA itself does not adequately support rescheduling, and that the DEA engaged in improper ex parte communications with anti-rescheduling parties.

Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of which are unauthorized — there is little evidence that these enforcement efforts have reduced illicit sales. Indeed, some observers estimate that flavored ENDS account for more than 80% of all ENDS sales. With a new administration on the horizon, our team highlights two opportunities for FDA to step up its enforcement efforts: (1) focusing enforcement on imports and (2) authorizing premarket tobacco product applications (PMTAs) for flavored products.

With power changing hands in Washington, D.C., what can marijuana industry members expect from the 119th Congress? Two GOP proposals from the 118th Congress may foreshadow the likely path for federal marijuana legalization. These bills — the “States Reform Act of 2023” and the “Strengthening the Tenth Amendment Through Entrusting States (STATES) 2.0 Act” —would explicitly support states’ legal marijuana regimes, while leaving states with the ultimate decision of whether to establish such regimes.

In October, the Oregon Court of Appeals ruled that a law restricting the packaging of e-cigarettes violates the state constitution’s free speech protections. The decision illustrates the utility of free speech arguments against packaging requirements and the importance of state constitutions in regulatory challenges generally.

In September, the U.S. Food and Drug Administration (FDA) announced that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025, in an enforcement policy outlined in a short guidance document. Although a federal district court previously found the rule unconstitutional, an appeals court reversed that decision, and the final rule is now in effect. According to the guidance, FDA will not begin enforcement until December 2025 at the earliest, but we believe it likely that the rule might yet again be postponed or vacated, as it remains the subject of ongoing litigation.

In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN) to U.S. Customs and Border Protection (CBP) for imports of such products. This rule could result in the denial of entry for ENDS imports for which the manufacturer has not submitted a premarket tobacco product application (PMTA) to FDA.

When Minnesota legislators passed House File 4065 in 2022 — legalizing the sale of certain hemp-derived THC edibles and beverages — few could have predicted that a multimillion-dollar THC-infused beverage market would result. Today, Minnesota consumers enjoy access to THC beverages in many places traditionally reserved for alcohol — liquor stores, breweries, bars, and restaurants.