Focus on FDA

NAC Case Study: How to Prevent Your Supplement from Becoming the Next Target of Drug Preclusion

June 29, 2022 9:15am

Andrew Shao, Ph.D.
Senior Vice President, Global Scientific & Regulatory Affairs

Xin Tao
Hogan Lovells LLP (Washington, DC)

  • Examining FDA’s most recent interpretations of the scope of the 21 U.S.C. § 321(ff)(3)(B) “drug preclusion” provision
    • Findings, status, and consequences of FDA’s July 2020 warning letters and subsequent actions
  • Establishing the true intent of the of § 321” drug preclusion” clause and educating regulators as well as the industry on its meaning
  • Developing strategies to avoid drug preclusion when developing and introducing new ingredients
  • Finding ways to engage with FDA on current determinations and future ingredients of concern
  • Getting support from the scientific community for classifying your product as an old “grandfathered” ingredient versus a new dietary ingredient
    • If a new dietary ingredient, understanding the benefits of establishing stringent research and due diligence protocols for new dietary ingredient notifications that may help negate preclusion findings