Dietary Supplements

Guidance Documents

Guidance documents contain nonbinding recommendations

Table of Contents

• Current Good Manufacturing Practice (CGMP)
• Labeling and Regulation
• Health Claims
• Qualified Health Claims
• Adverse Events Reporting

Current Good Manufacturing Practice (CGMP)

• Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements December 2010
• Final Rule: Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements
  • Fact Sheet: Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts June 22, 2007
  • Consumer Update: Final Rule Promotes Safe Use of Dietary Supplements June 22, 2007
  • FDA Press Release: FDA Issues Dietary Supplements Final Rule June 22, 2007
• Proposed Rule: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements
  • Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking October 21, 2002
• Advance Notice of Proposed Rule: Current Good Manufacturing Practice in Manufacturing, Packaging and Holding of Dietary Supplements Federal Register, February 6, 1997
• New Dietary Ingredients
  • Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues July 2011
  • Final Rule:  Premarket Notification for a New Dietary Ingredient Federal Register, September 23, 1997
  • New Dietary Ingredients in Dietary Supplements (Explanation including: definition, notification process, and table of notifications received) February 2001
• Special Issues
  • BSE ("Mad Cow Disease")
    • FDA: Bovine spongiform encephalopathy (BSE) (background, industry and consumer information, recent actions, etc.)
  • Ephedrine Alkaloids
    • See Special Issues web page.
• Warnings and Safety Information
  • Dietary Supplement Alerts and Safety Information (consumer advisories on specific supplements including kava, PC SPES, St. John's Wort, etc.; how to report problems; and other safety information )

Labeling and Regulation

• New Dietary Ingredients (NDI): New Dietary Ingredient Notifications and Related Issues July 2011
• Liquid Dietary Supplements: FDA Letter to Industry Concerning Liquid Vitamin D Dietary Supplements June 2010
• Liquid Dietary Supplements: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods December 2009
• Labeling: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act December 2007; Revised December 2008 and September 2009
• 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