Dietary Supplements - Webinar CD/Transcript

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Dietary Supplements: How to Deal with New Criminal, Civil Enforcement Realities

This is no longer your father’s dietary supplement landscape — criminal, civil and individual liability have all increased over the past several years for both dietary supplement companies and suppliers.

Now, with the U.S. Department of Justice's “Yates Memo” in full force, individual liability concerns are in play and no one is immune from criminal or civil lawsuits, especially suppliers, and especially with new GMP requirements and fraud scrutiny.

Scott Bass, head of Sidley Austin’s Global Life Sciences team, discusses the areas in which dietary supplement stakeholders face increasingly liability, how to prevent and mitigate that liability, and what to do if enforcement actions are initiated against your company.

You’ll hear expert analysis of the most recent and impactful enforcement actions, settlements and litigation that could directly affect your company or organization.

Specifically you will learn:

  • How to change practices that expose your company to new criminal enforcement
  • How to mitigate CEO and senior officer liability
  • How to alert executives to new enforcement trends
  • How to update GMP awareness
  • Dietary supplement and OTC companies

Scott Bass heads the Sidley Austin’s global life sciences team, coordinating pharmaceutical, medical device, food and dietary supplement matters in the United States, Europe and Asia. He is ranked internationally among the top authorities on FDA-related enforcement and regulatory issues, especially in the area of dietary supplements, and has led audits and investigations involving off-label promotion, pharmacovigilance, PDMA, GMP, and fraud and abuse issues, as well as DEA and FTC matters. Scott has also acted as an advisor on an FDA dietary supplement website. Scott has represented such companies as Bayer, Genentech, Colgate Palmolive, Allergan, Novartis, Cargill, Herbalife and Roche in a number of regulatory or enforcement matters. His experience includes leading dietary supplement and functional food analyses for top multinational companies. He is recognized as one of The Best Lawyers in America in FDA Law (2013–2016 editions) and is regarded as one of the pre-eminent authorities on FDA enforcement by Who’s Who Legal.