Dietary Supplements Regulations and Guidance
Background Information

• Guidance Documents
  • November 2004 Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act (Federal Register Notice of Availability November 9, 2004)
    • Fact Sheet on FDA's Draft Guidance for Industry: Substantiation for Dietary Supplement Claims November 4, 2004
    • Questions and Answers: Draft Guidance for Industry Substantiation for Dietary Supplement Claims November 4, 2004
  • Current Information on Guidance
• Structure Function Claims
  • April 24, 1998 FDA Proposes Rules to Make Claims for Dietary Supplements More Informative, Reliable and Uniform (press release)
    • FDA's Response to the Report of the Commission on Dietary Supplement Labels - Fact Sheet (April 27, 1998) and Federal Register notice (April 29, 1998)
    • FDA's Dietary Supplement Proposal - Fact Sheet (April 27, 1998) and Federal Register proposed rule (April 29, 1998)
  • Current Information on Proposed and Final Regulations
• Dietary Supplement Labeling
  • January 2, 1996 Dietary Supplement Rules Proposed, Talk Paper
  • Current Information on Proposed and Final Regulations