Qualified Health Claims

General Information on Qualified Health Claims

• FDA's Implementation of "Qualified Health Claims": Questions and Answers August 27, 2003 (Includes: Timelines, Submitting a Petition)
  
• Consumer Health Information for Better Nutrition Initiative Task Force Final Report July 10, 2003
  • Press Release: FDA to Encourage Science-Based Labeling and Competition for Healthier Dietary Choices July 10, 2003
  • Backgrounder: FDA Implements Enhanced Regulatory Process to Encourage Science-based Labeling and Competition for Healthier Dietary Choices July 10, 2003
• Summary of Qualified Health Claims Permitted, September 2003
• Electronic Submission of Health Claim Petitions and Notifications April 14, 2004

Guidance Documents for Qualified Health Claims

• Guidance for Industry and FDA: Interim Procedures for Qualified Health Claims in the Labling of Conventional Human Food and Human Dietary Supplements July 10, 2003 (Includes: criteria for exercise of enforcement discretion, procedures, and content of petitions)
• Guidance for Industry and FDA: Interim Evidence-based Ranking System for Scientific Data July 10, 2003

Petitions for Comment, Comments Received, and Submitting Comments

• All Petitions Received
• Qualified Health Claim Petitions Open for Comment

Qualified Health Claims: Letters of Enforcement Discretion or Denial

• Summary of Qualified Health Claims Permitted, September 2003
  
  
  
• Cancer
  • Selenium and Certain Cancers, April 28, 2003
  • Letter Regarding Dietary Supplement Health Claim for Selenium and Certain Cancers February 21, 2003
  • Letter Regarding Dietary Supplement Health Claim for Antioxidant Vitamins and Risk of Certain Cancers April 1, 2003
  • Revocation: Food Labeling: Health Claims and Labeling Statements; Dietary Fiber and Cancer; Antioxidant Vitamins and Cancer; Omega-3 Fatty Acids and Coronary Heart Disease; Folate and Neural Tube Defects Federal Register, October 3, 2000
  
  
  
• Cardiovascular Disease
  • Omega-3 Fatty Acids
    • Letter Responding to Health Claim Petition dated November 3, 2003 (Martek Petition): Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease September 8, 2004
    • Letter Responding to Health Claim Petition dated June 23, 2003 (Wellness Petition): Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease September 8, 2004
    • Letter Responding to a Request to Reconsider the Qualified Claim for a Dietary Supplement Health Claim for Omega-3 Fatty Acids and Coronary Heart Disease February 8, 2002
    • Letter Regarding Dietary Supplement Health Claim for Omega-3 Fatty Acids and Coronary Heart Disease (Docket No. 91N-0103) October 31, 2000
  • Discretion: Walnuts and Coronary Heart Disease March 9, 2004
  • Discretion: Nuts and Coronary Heart Disease July 14, 2003
  • Denial: Letter Regarding Dietary Supplement Health Claim for Vitamin E and Heart Disease February 9, 2001
  • Settlement Reached for Health Claim Relating B Vitamins and Vascular Disease May 15, 2001
  • Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B₆ , and Vitamin B₁₂ and Vascular Disease November 28, 2000
  
  
  
• Cognitive Function
  • Phosphatidylserine and Cognitive Dysfuntion and Dementia, May 13, 2003
  • Letter Regarding Dietary Supplement Health Claim for Phosphatidylserine and Cognitive Dysfunction and Dementia February 24, 2003
  
  
  
• Neural Tube Defects
  • Letter Regarding a Health Claim for Folic Acid And Neural Tube Defects April 3, 2001
  • Letter Regarding Dietary Supplement Health Claim for Folic Acid with Respect to Neural Tube Defects October 10, 2000