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Agustin Rodriguez

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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.

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This is the second post in our multipart series evaluating the Food and Drug Administration’s response to the Regan-Udall Foundation report on the operations of the Center for Tobacco Products. If you missed our first post, check it out here.

There is a common refrain that appears throughout the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) — lack of transparency. The report found that stakeholders generally perceived premarket tobacco product applications (PMTAs) — required for all electronic nicotine delivery systems (ENDS) on the market — as “ineffective and problematic” due in part to a “lack of adequate guidance and transparency regarding CTP expectations,” as well as a “lack of clarity regarding review standards.”…

Continue Reading Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force

FDA’s approach to a premarket tobacco product application (PMTA) raises new questions about whether its marketing denial order was arbitrary and capricious and whether the deliberative-process exemption justifies its withholding of related records. The Agency’s approach is partially documented in a memorandum that FDA disclosed in response to a Freedom of Information Act request, and…

In this second of a two-part series, Stephen Piepgrass continues his discussion with colleagues Bryan Haynes, Agustin Rodriguez and Nick Ramos about significant developments in the tobacco industry during the past year, and their predictions on what to expect in the months ahead.

Our panel discusses tobacco excise taxes; challenges to flavor bans; FDA’s regulation…

The Virginia General Assembly recently passed — in both chambers — a bill to regulate delta-8 THC products in the commonwealth. The bill now awaits the governor’s signature. Governor Youngkin and the Republican-controlled House of Delegates have prioritized the control of these novel hemp-derived products over legislation to legalize the retail sale of adult-use marijuana…

On February 9, Attorney General William Tong sued five Connecticut retailers for violating the state’s Unfair Trade Practices Act (UTPA) by selling allegedly illegal delta-8 tetrahydrocannabinol (THC) products, many of which mimicked snack foods and candies popular among youth.

Tetrahydrocannabinol (THC) is typically associated with the high consumers feel when consuming marijuana products. Delta-8 THC…

The U.S. tobacco industry is subject to a variety of regulators at the federal and state level. In this first of a two-part series focused on significant regulatory developments in the tobacco industry, Stephen Piepgrass is joined by colleagues Bryan Haynes, Agustin Rodriguez and Nick Ramos to review what happened over the past year, and…

This article was originally published in Bloomberg Law. Reproduced with permission. Published February 2023. Copyright © 2023 The Bureau of National Affairs, Inc.

The American Veterinary Medical Association estimates that over 65% of US households own a pet. Puppies are a particularly popular choice. But sometimes, after a puppy comes home to its new…

On January 26, the Food and Drug Administration essentially threw up its hands and announced that Congress needs to create a new regulatory pathway for cannabidiol (CBD) products because the existing pathways are inadequate to mitigate possible health risks. The agency simultaneously denied three long-pending requests to allow marketing of CBD products as dietary supplements.

Published in Law360 on January 10, 2023. © Copyright 2022, Portfolio Media, Inc., publisher of Law360. Reprinted here with permission.

In late November, the New Mexico attorney general announced a lawsuit[1] in the Santa Fe County First Judicial District Court against Philip Morris USA Inc., R.J. Reynolds and other signatories to the tobacco master…

The Senate recently passed the Medical Marijuana and Cannabidiol Research Expansion Act (the Act) by a voice vote after the House of Representatives passed the bill with strong bipartisan support (325-95) last July. The Act is the first stand-alone marijuana legislation passed in decades and, according to some news sources, President Biden will likely…