Dietary Supplements

Guidance Documents

Guidance documents contain nonbinding recommendations

Labeling and Regulation

• A Dietary Supplement Labeling Guide (April 2005)
• Ephedrine Alkaloids: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (July 17, 2008)
• Label Warning Statements: Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 17, 2003)
• Labeling: Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide (January 1999)
• Nutrient Content Claims: Food Labeling; Nutrient Content Claims; Definition for "High Potency" and Definition for "Antioxidant" for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods Small Entity Compliance Guide (July 2008)
• Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002)
• Substantiation for Claims: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act (November 2004)

Health Claims

• Evidence-Based Review System for the Scientific Evaluation of Health Claims (January 2009)
• Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999)
• Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (June 1998)

Qualified Health Claims

• Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (July 10, 2003)

Adverse Events Reporting

• Adverse Event Reporting and Recordkeeping: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (June 2009)
• Labeling: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (December 2008)
• Adverse Event Reporting and Recordkeeping: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act - Draft Guidance (October 2007)