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Bryan Haynes

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Bryan serves clients by developing and implementing creative solutions for complex issues. Focusing in tobacco industry regulatory compliance and enforcement matters, Bryan efficiently assists clients in complying with regulatory obligations and managing risk, consistent with clients' business objectives.

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In the ninth episode of our 12 Days of Regulatory Insights podcast series, Michael Jordan, a member of the firm’s Tobacco + Nicotine practice, is joined by colleagues Bryan Haynes and Agustin Rodriguez to delve into the regulatory landscape of the tobacco industry in 2024 and what to expect in 2025. Bryan, head of the firm’s Tobacco + Nicotine practice, and Agustin, also a member of the Tobacco + Nicotine practice, discuss the increased state-level actions against illicit flavored e-cigarettes due to FDA’s inaction. They highlight efforts by state AGs to combat these products, including issuing letters to retailers and establishing product registries. The conversation also touches on the anticipated regulatory changes under the new administration, the potential impact on nicotine pouches, and the implications of the Tobacco Master Settlement Agreement (MSA) and the upcoming escrow refunds for nonparticipating manufacturers. Bryan and Agustin provide insights into the evolving regulatory environment and the implications for the tobacco industry in the coming year.

Last month, California Attorney General (AG) Rob Bonta announced the awardees for the 2024-2025 Tobacco Grant Program, a program spearheaded by the California Department of Justice (DOJ) that aims to support local law enforcement agencies in their efforts to reduce illegal tobacco sales and usage, particularly among minors. Bonta also provided an update on “Operation Up in Smoke,” a comprehensive law enforcement operation targeting illegal tobacco sales. These updates illustrate that California continues to prioritize coordinated law enforcement efforts against businesses that make illegal tobacco sales, particularly to minors.

A consumer class action lawsuit has been filed in the U.S. District Court for the Southern District of New York against EVO Brands, LLC and PVG2, LLC, both doing business as Puff Bar. The lawsuit alleges that Puff Bar violated state consumer protection laws by engaging in deceptive marketing practices aimed at youth, and by misleading consumers about the legality and safety of their synthetic nicotine e-cigarettes.

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.

Earlier this month, 20 Democratic state attorneys general (AG) filed an amicus brief supporting the U.S. Food and Drug Administration’s (FDA) marketing denial orders (MDOs) of premarket tobacco applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS or e-cigarettes) currently under review by the U.S. Supreme Court. The brief not only demonstrates which side these states support, but also identifies specific enforcement priorities for these states.

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.

On August 27, the New Jersey Attorney General (AG) and the Division of Consumer Affairs announced that the state had issued notices of violation and $4,500 civil penalty demands to 19 retailers across New Jersey for allegedly selling banned flavored vapor products. This is New Jersey’s first public enforcement of the state’s 2020 flavor ban, and New Jersey joins a number of other state AGs taking similar action across the U.S.

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 June, the Bureau of Alcohol, Tobacco and Firearms (ATF) argued in federal court that the federal Prevent All Cigarette Trafficking (PACT) Act requires tribal retailers to obtain state licenses to sell cigarettes on their own reservations. If accepted, ATF’s position would greatly expand the scope of state authority over tribal tobacco sales.