FDA Modernization Act (FDAMA) Claims

Guidance

• Guidance for Industry Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. June 11, 1998.

Electronic Submissions

• Electronic Submission of Health Claim Petitions and Notifications April 14, 2004

Specific Claims

• Choline
  • Nutrient Content Claims Notification for Choline Containing Foods August 30, 2001
• Fluoride and the Risk of Dental Caries
  • Health Claim Notification for Fluoridated Water October 14, 2006
• Potassium and the Risk of High Blood Pressure and Stroke
  • Health Claim Notification for Potassium Containing Foods October 31, 2000
• Saturated Fat, Cholesterol, and Trans Fat, and the Risk of Heart Disease
  • Health Claim Notification for Saturated Fat, Cholesterol, and Trans Fat and Reduced Risk of Heart Disease November 15, 2006
• Substitution of Saturated Fat with Unsaturated Fatty Acids and Risk of Heart Disease
  • Health Claim Notification for the Substitution of Saturated Fat in the Diet with Unsaturated Fatty Acids and Reduced Reduced Risk of Heart Disease May 25, 2007
• Whole Grain Foods and the Risk of Heart Disease and Certain Cancers
  • Health Claim Notification for Whole Grain Foods with Moderate Fat Content December 9, 2003
  • Health Claim Notification for Whole Grain Foods July 8, 1999
    • For additional information concerning single ingredient whole grain foods, see Docket ID FDA-2008-Q-0270 (May 6, 2008)