Workshop A — Working Group on Compliant Commercialization of Hemp-Derived CBD Dietary Supplements: Understanding the Current Domestic and International Legal Status and How to Manage Legal Risks for Distributing Hemp-Derived CBD Products

Jun 25, 2020 9:00am – 12:30pm

Shawn Hauser
Partner
Vicente Sederberg LLP (Boulder, CO)

Patricia Kim
Legal Counsel
Papa & Barkley LLC (Pasadena, CA)

Douglas “Duffy” MacKay, N.D.
Senior Vice President Scientific & Regulatory Affairs
CV Sciences, Inc.
(San Diego, CA)

(Registration Opens at 8:00 am)

As consumer demand for supplements containing hemp-derived CBD grows stronger, dietary supplement manufacturers need to be aware of applicable laws and regulations, as well as risks associated with successful product launches and viable and compliant commercialization. Legitimate supplement makers seeking to launch CBD products must continue to play by the dietary supplement rulebook, as they always have, and develop appropriate systems to ensure product safety and quality, in the absence of clear FDA guidance and a legal path for CBD in supplements. This workshop will provide an A to Z guide for getting your product on market and avoiding scrutiny through playing by the rules.

Topics of discussion include:

Legal, Regulatory and the Industry Standards

  • Understanding current FDA position regarding the use of CBD in dietary supplements and foods
    • Lessons learned from recent FDA warning letters • Examining the DEA’s perspective on hemp and its removal from the Controlled Substances Act
  • Understating the effect of the 2018 Farm Bill nearly two years after its passage
  • Comparing and contrasting federal and state laws on CBD use
  • Assessing how industry best practices for other botanical and similar ingredients may help CBD companies develop safe and effective products
  • Recognizing gaps where current standards do not address challenges with manufacturing CBD
  • Understanding what industry stakeholders can glean from the FDA’s approval of the drug Epidolex

Developing Strategies for Successful Market Entry

  • Understanding the steps needed to place your product on the market from start to finish
  • Examining current consumer perceptions about CBD • Outlining the risks and liabilities associated with using CBD in dietary supplements
  • Devising effective strategies for developing claims substantiation and labeling that helps reduce legal risks
  • Avoiding disease claim and other prohibited claims

International Perspectives

  • Surveying international rules and regulation for hemp-derived CBD
    • Comparing and contrasting the various rules and regulations of hemp-derived CBD in dietary supplements in Europe vs.
      Asia vs. Latin America
  • Examining the European Food Safety Authority (EFSA)’s position on CBD