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Agustin is sought after by clients for his strategic counsel on their most challenging competitive and regulatory compliance issues, including tobacco Master Settlement Agreement issues, federal and state enforcement investigations, licensing and excise tax issues, developing compliance programs, and evaluating advertising and marketing practices. A partner in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group as well as its Tobacco and Cannabis law practices, he represents manufacturers, distributors, retailers, and suppliers in all aspects of their businesses, including regulatory compliance, FDA requirements, administrative disputes involving federal or state governmental entities, mergers and acquisitions, commercial agreements, and taxation matters.

In this post, we take a closer look at state tobacco and nicotine product licensing considerations. When approaching state licensing issues, it may be helpful to establish a checklist to help manufacturers, importers, distributors, and retailers determine the impact of these laws on their products and distribution models. State licensing requirements can be complicated but, with a basic understanding of the key issues described below and good practices, manufacturers, importers, distributors, and retailers can ensure they remain compliant.  Continue Reading State Licensing Considerations for Tobacco and Nicotine Product Manufacturers, Importers, Distributors, and Retailers

In the first half of 2024, the U.S. Food and Drug Administration (FDA) continued ramping 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. Continue Reading FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

Agustin Rodriguez and Cole White of the Troutman Pepper Cannabis Team will be attending the 2024 CANNRA External Stakeholders Meeting. This in-person event will be held in Minneapolis, MN from June 3-6, 2024, and presents a great opportunity for government and industry members to share perspectives on issues related to regulatory compliance and policy.

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The landscape of tobacco product and cannabis flavor bans or restrictions varies significantly across the country. In both industries, some states restrict all or some flavors in all types of products, while other states restrict all or some flavors in some, but not all, products. Below, we provide a high-level overview of the flavor ban and restriction landscape in both industries. As we will discuss, there is a wide disparity between cannabis and tobacco product flavor bans or restrictions and, where they exist, there appears to be more flexibility among cannabis flavor restrictions than for tobacco product flavor bans or restrictions.Continue Reading The Varied Landscape of Tobacco and Cannabis Flavor Bans or Restrictions

The Food and Drug Law Institute’s 2024 Annual Conference is happening May 15-16, 2024! Agustin Rodriguez of the Troutman Pepper Tobacco + Nicotine team will be participating in a panel discussion on “State Regulation of Nicotine Products: Evaluating Flavor Bans and Registration Lists.” Agustin’s panel will discuss actions being taken at the state and local

In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and Cosmetic Act (FDCA), known as the “Deeming Rule.” This decision exempted premium cigars from FDA’s tobacco product authorities. In September 2023, however, FDA appealed, and the U.S. Circuit Court of Appeals for the D.C. Circuit is currently weighing the matter. So, what would it take for FDA to succeed on appeal, and what is at stake for the premium cigar industry?Continue Reading What’s at Stake for the Premium Cigar Industry as DC Circuit Considers FDA Appeal?

Mark your calendars for the TMA 2024 Annual Meeting and Conference! The Troutman Pepper Tobacco + Nicotine team will be in attendance, with our very own Bryan Haynes participating in a panel discussion, “Taking Stock: Discussions on Legal Challenges and What Comes Next.” Bryan will discuss court actions challenging the Center for Tobacco Products’ decisions

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.Continue Reading Advocacy Organizations Sue FDA Over Delay in Menthol Cigarette Ban

The Prevent All Cigarette Trafficking (PACT) Act, 15 U.S.C. § 375 et seq., is a federal law with two primary objectives: (1) to prevent federal and state tax evasion on tobacco products, and (2) to prevent sales of tobacco products to minors. Government agencies, increasingly concerned about cheap, untaxed products getting into the hands of underage consumers, are using the PACT Act’s enforcement tools to crack down on noncompliant companies.

If you are involved in the online sale and/or shipping of tobacco products, here are five things you need to know about the PACT Act.Continue Reading PACT Act Basics: Five Things Tobacco Sellers and Shippers Should Know