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Federal Agencies 101 - Cannabis: Federal Regulation Basics


Join INCBA as we provide an overview of the main US Federal agencies companies in the Cannabis industry should be aware of and discuss how these regulatory regimes interact. How is Cannabis regulated at the federal level and how did we get here? What lessons have we learned from the regulation of hemp?

Matt Zorn, Attorney, Yetter Coleman LLP

 

Matt focuses on complex commercial litigation, representing clients in IP, contract, and regulatory litigation in federal and state court. He has significant expertise in federal jurisdiction and procedure. Matt is at home digging out case-changing evidence, crafting legal strategies under arcane statutes and procedures, eliciting critical deposition or trial testimony, and arguing on his feet to courts and arbitrators, all to help his clients win needed relief. Matt was honored as a 2020 Pegasus Scholar by American Inns of Court. In one of his favorite areas of complex litigation, Best Lawyers in America named Matt "One to Watch," and Thomson Reuters' Super Lawyers recognized him as a "Texas Rising Star" in IP Litigation. Based on recent pro bono work, Matt also is recognized as an authority in the byzantine federal regulatory scheme relating to cannabis research, even being named to the Law360 2020 Cannabis Editorial Advisory Board. Before joining the firm, Matt was a judicial clerk to the Hon. Rodney Gilstrap, U.S. District Judge for the Eastern District of Texas, spending hundreds of hours in court helping manage one of the busiest trial dockets in the country. Before then he was a litigator with Paul, Weiss in New York City.

Shane Pennington, Partner, Porter Wright Morris & Arthur LLP

Shane is a partner in the Litigation Department where he counsels clients on federal regulatory issues involving a number of industries, including energy, pharmaceuticals, controlled substances, aviation and agriculture. A former law clerk to federal judges on the D.C. Circuit, the Fifth Circuit and the D.C. District Court, Shane brings unique insight and strategic thinking to assist clients facing complex regulatory issues.

Rated “One to Watch” and a “Rising Star” in appellate law by The Best Lawyers in America and Super Lawyers, respectively, Shane has argued cases in the U.S. Courts of Appeals for the First, Ninth and D.C. Circuits, securing landmark results for clients. In a series of cases on behalf of veterans and scientists, for example, Shane raised a novel claim under the Freedom of Information Act to uncover a secret 2018 Opinion of the Office of Legal Counsel that revealed the unlawfulness of a longstanding agency policy that had obstructed cannabis research for over half a century. Shane regularly litigates cases concerning federal and state agencies that involve the Administrative Procedure Act, the Controlled Substances Act, and Federal Food, Drug and Cosmetic Act.

Clients turn to Shane to advance their strategic goals within existing regulatory and legal frameworks, but also to develop creative strategies to reimagine those frameworks amidst rapidly changing industries. To that end, Shane often advocates for clients at the administrative level, working with state and federal regulators to devise novel solutions to seemingly intractable problems. He has represented companies, scientists and industry coalitions before the Drug Enforcement Administration, the Department of Health and Human Services, the Food and Drug Administration, the Department of Justice, and the Securities and Exchange Commission.

Shane has published extensively on topics related to administrative law and drug policy, including the private nondelegation doctrine, the Single Convention on Narcotic Drugs of 1961, judicial deference to administrative agencies, and bureaucratic management and the limits of presidential power. Shane often provides commentary on administrative law issues to the Yale Journal on Regulation Notice & Comment blog and is a regular contributor to the “News From the Circuits” column published in the American Bar Association’s Administrative and Regulatory Law News.

Marisa Malek, Attorney, King & Spalding LLP

A partner in our FDA and Life Sciences practice, Marisa Maleck focuses on litigation, regulatory matters and public policy, with a focus on consumer products and services. As a former senior counsel at an FDA-regulated company and in private practice, Marisa has substantial experience with and is skilled in providing creative solutions in the face of uncertainty. 

Marisa represents clients in a variety of matters with a focus on FDA-regulated products and life-science services like food, beverages, pharmaceuticals, medical devices, wellness products, cosmetics, telehealth, tobacco and cannabis. As a former senior counsel at an FDA-regulated vaping company and as a former partner in King & Spalding’s Litigation and Global Disputes practice group, she handled hundreds of suits in a multi-district litigation, multiple agency inquiries, an FTC lawsuit and 10+ state Attorney Generals actions. With a special focus on consumer fraud, social-media marketing and personal injury/wrongful death lawsuits, Marisa has successfully drafted and/or argued appellate briefs and critical motions in numerous cases—including class actions and complex litigation—before the U.S. Supreme Court, federal and state courts of appeals, and federal and state trial courts. She has also advocated tirelessly for her clients through engagement with agencies, policy-makers, and legislators. She also represents her clients in investigations, enforcement actions, private litigation and private-equity investments. 

Marisa also advocates for her clients’ interests in the court of public opinion. She is often solicited for her balanced legal analysis by members of the media. Marisa has appeared on (tv/radio) MSNBC, MSN, CNBC and NPR, and in (print) Newsweek, the National Law Journal, The Wall Street Journal, The Washington Post and Politico.

In addition, Marisa has an active pro-bono practice representing indigent defendants through federal appellate appointments as part of the Criminal Justice Act program, through active partnership with public-interest groups, and as a screener for the Mid-Atlantic Innocence Project.

Previously, Marisa served as a law clerk for Associate Justice Clarence Thomas of the Supreme Court of the United States and for Chief Judge William H. Pryor, Jr. of the United States Court of Appeals for the Eleventh Circuit.


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