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  Claims Substantiation: How to Ensure Your Dietary Supplement Product Claims are Truthful & Legal

March 3, 2006

The FDA and FTC have stepped up their enforcement activities against unlawful drug claims and unsubstantiated structure/function claims made by supplement marketers. To give you the information and tools that will set your mind at ease about your product claims, AHPA offers advice and documents from a panel of experts who are actively involved in all aspects of claims substantiation for dietary supplements. These experts address the legal standards, the necessary support evidence, and the painful consequences of noncompliance.

What you’ll learn from these experts:

  • Anthony Young, Esq, of Kleinfeld, Kaplan & Becker LLP, and AHPA’s General Counsel — explains today’s regulatory environment and the risks and liabilities marketers face if claims are not supported adequately
  • Richard Cleland, Esq, Assistant Director, US Federal Trade Commission Division of Advertising Practices — provides FTC’s perspective, recent enforcement actions, and the level of substantiation that the respondents in those actions possessed or did not possess
  • David Mark, PhD, President, DMark Consulting LLC — discusses general claim substantiation, including what kind and how much support is needed, who should review the evidence, advertising implications, and more
  • Josef A. Brinckmann, Vice-president of Research and Development, Traditional Medicinals — focuses on substantiation of traditional use claims, including guidance on what a substantiation file should contain and how it should be structured, guidance from domestic and foreign government agencies, reliable resources

Materials in this packet include:

  • AHPA resource document: Outline for Issues to Address in Creating a ‘Standard Operating Procedure’ for Making Dietary Supplement Structure Function Claims with Appropriate Substantiation Files, and an example of a Structure/Function Filing Letter
  • Bibliography of internationally recognized and respected substantiation resource documents for traditional herbal medicine as practiced in a variety of cultures
  • FTC’s Dietary Supplements: An Advertising Guide for Industry
  • FDA’s Draft Guidance for Industry: Substantiation for Dietary Supplement Claims
  • FDA’s Fact Sheet on FDA’s Draft Guidance for Industry: Substantiation for Dietary Supplement Claims
  • AHPA’s Comments on FDA’s Draft Guidance for Industry: Substantiation for Dietary Supplements
  • Course Outline, Speakers’ Presentations & Bios
  • Transcript, and answers to questions posed by attendees
  • Audio file


Member Price: $220.00

Non-Member Price: $520.00


       
 



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