Legal, regulatory, and compliance forum on dietary supplements

Xin Tao will speak on a panel discussion during the Legal, regulatory & Compliance Forum on Dietary Suppements titled NAC Case Study: How to Prevent Your Supplement from Becoming the Next Target of Drug Preclusion." Topics include:

  • 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.

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