June 28, 2016 - 9:15 AM - 10:15 AM ET

"Roundup on FDA Rulemaking and Guidances Impacting the Dietary Supplement Industry" at ACI's 4th Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements

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The Andaz Wall Street
75 Wall Street
New York, NY 10005

NDI Guidance

  • Assessing whether the creation of the new ODSP may herald the release of the NDI guidance
  • Anticipating the contents of a revised NDI guidance in light of industry contentions from the prior draft NDI release
  • Predicting whether the industry’s dissatisfaction with current FDA review and classification procedures for NDIs may be resolved by the revised guidance

'Natural' definition

  • Understanding the significance of FDA seeking to define the term natural for the dietary supplements industry
  • Review of industry comments
  • Anticipating possible next steps by Agency

Proposed Rule on Food Labeling-Revision of the Nutrition and Supplement Facts Label

  • Update on status of FDA’s proposed Rule on changes to the Supplement Facts label
    • proposed changes vs. present label status
    • relationship to proposed changes to the Nutrition Facts label

Claudia A. Lewis, Partner, Venable LLP

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