Overview
Late last year, USDA issued its Interim Final Rule (IFR) that establishes and administers a program for domestic hemp production and testing, including oversight of state and tribal plans for hemp regulation. The USDA is accepting comments on the IFR through January 29, 2020, which will influence the final rule. Meanwhile, the framework described in the IFR is currently in effect and the agency has begun approving state and tribal plans. This webinar will discuss how the IFR oversees hemp production and testing, issues the IFR leaves unresolved, themes that have emerged from the comments USDA has received thus far, and USDA’s next steps.
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Speakers
Mai T. Dinh, Assistant General Counsel, Marketing, Regulatory, and Food Safety Programs, Division Office of the General Counsel, USDA
Kelly Fair, Director of Legal, USA, Canopy Growth Corporation
Evelina Norwinski, Partner, Arnold & Porter LLP
Moderated by Frederick (Rick) R. Ball, Partner, Duane Morris LLP and Treasurer, FDLI Board of Directors
KELLY FAIR is Canopy Growth’s US General Counsel, serving as an officer of the California courts since 2006. In her role, Kelly manages all day-to-day US federal and state legal engagements for Canopy Growth. Prior to joining Canopy, Kelly was a Partner at Dentons US LLP, San Francisco office, where she led the Dentons US Cannabis Group since 2014, advising domestic and international cannabis and hemp industry clients in a broad range of state and federal regulatory risk assessments, and corporate and transactional matters, including investment transactions and financings, strategic mergers and acquisitions, joint ventures, and commercial agreements.
EVELINA NORWINSKI is a partner at Arnold & Porter LLP where her practice focuses on white collar defense and compliance issues. She has conducted internal investigations for a variety of domestic and multinational companies in industries such as consumer products, pharmaceutical, government contractors, financial services, and agricultural products. She also regularly counsels clients on corporate compliance programs, regulatory compliance, legislation, and ethics. She has particular experience assisting clients in developing and implementing strategies to address product distribution issues, including federal and state compliance, strategies to address counterfeit or contraband versions of a client’s products in the distribution chain, collaborative engagement with law enforcement agencies, litigation strategies, and longer-term legislative strategies. Ms. Norwinski also maintains an active pro bono practice, representing individuals in criminal matters in federal courts. Before joining the firm, Ms. Norwinski served as an Assistant Federal Public Defender in Washington, DC, where she briefed and argued more than 20 federal criminal appeals in the US Courts of Appeal and lectured on criminal law issues. Ms. Norwinski clerked for the Honorable Donald S. Russell of the US Court of Appeals for the Fourth Circuit.
FREDERICK (RICK) R. BALL is located in the Boston office of Duane Morris LLP. Mr. Ball focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. He serves as a team lead for the Duane Morris Life Sciences/Biotech industry group. Mr. Ball helps pharmaceutical companies, biologics manufacturers, medical device manufacturers, contract service providers, food companies (including supplement manufacturers), pharmacies, long term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements. Mr. Ball assists companies bring product to market through patent analysis, identifying marketing and approval pathways, and, when necessary litigation. Mr. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal.Virtual Learning FAQ
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