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  • Dietary Supplement Claims and Labeling

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Mar 14, 2013 10:00 AM
  • End Time:
  • Thursday - Mar 14, 2013 11:30 AM
  • Location:
  • Online
  • Course Description:

    This 90 minute online training will cover how dietary supplement companies should label their products for the US market in accordance with FDA requirements. It will also help in understanding the considerations to avoid claims and building regulatory compliance into company programs for development and launch of properly labeled dietary supplements.

    Course Objective:

    Dietary Supplements are one of the fastest growing food product categories in the United States, especially with a growing number of consumers taking an active role in the maintenance and promotion of health. While the product category was created and defined by Congress, the US Food & Drug Administration (FDA) has the authority to oversee claims and labeling of dietary supplements. The expansion of product offerings in this category has been met by an increase in FDA monitoring and enforcement. It is therefore important for dietary supplement companies to ensure their product labels and accompanying claims are fully compliant with applicable statutes and regulations.

    This webinar will focus on how to develop product labels and claims that comply with applicable statutory and regulatory requirements. It will cover the following areas:

    • Product classification
    o Statutory definition of Dietary Supplement
    o Compare and contrast with other FDA product classifications
    • FDA oversight of Dietary Supplements
    o Key FDA offices; senior officials and managers
    o Applicable statutes, regulations and guidances
    • Dietary Supplement labeling
    o FDA requirements for Principal Display Panel
    o FDA requirements for Supplement Facts box
    o Other statutory and regulatory labeling requirements
    • Types of dietary supplement claims
    o Unqualified health claims
    o Qualified health claims
    o Structure-Function claims
    o Nutritive value claims
    • Claim substantiation
    o Clinical and nonclinical studies
    • Truthful and non-misleading advertising
    o FDA and FTC standards
    • Enforcement trends
    • Audit readiness / documentation
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