Health Claims Meeting Significant Scientific Agreement (SSA)

Guidance

Electronic Submissions

Approved Health Claims 

Denied Health Claims

Guidance

• Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims January 2009
• Guidance for Industry: A Food Labeling Guide April 2008

Electronic Submissions

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

Approved Health Claims

• Calcium, Vitamin D, and Osteoporosis
  • 21 CFR 101.72 Health claims: calcium and osteoporosis
  • Final Rule: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
• Dietary Lipids (Fat) and Cancer
  • 21 CFR 101.73 Health claims: dietary lipids and cancer
• Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease
  • 21 CFR 101.75 Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease
• Dietary Non-cariogenic Carbohydrate Sweeteners and Dental Caries
  • 21 CFR 101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries
  • Final Rule: Food Labeling: Health Claims; Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries May 27, 2008
    • Interim final rule: Food Labeling: Health Claims; Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries September 17, 2007
  • Final Rule: Health Claims; D-tagatose and Dental Caries July 3, 2003
    • Interim Final Rule: Health Claims; D-tagatose and Dental Caries December 2, 2002
  • Final Rule: Food Labeling: Health Claims; Dietary Sugar Alcohols and Dental Caries December 2, 1997
  • Final Rule: Food Labeling: Health Claims; Sugar Alcohols and Dental Caries August 23, 1996
• Fiber-containing Grain Products, Fruits and Vegetables and Cancer
  • 21 CFR 101.76 Health claims: fiber-containing grain products, fruits, and vegetables and cancer
• Folic Acid and Neural Tube Defects
  • 21 CFR 101.79 Health claims: Folate and neural tube defects
  • Final Rule: Food Labeling: Health Claims; Folate and Neural Tube Defects March 5, 1996
  • Final Rule: Revoking January 4, 1994 Regulation That Became Final By Operation of Law September 24, 1996
• Fruits and Vegetables and Cancer
  • 21 CFR 101.78 Health claims: fruits and vegetables and cancer
• Fruits, Vegetables and Grain Products that contain Fiber, particularly Soluble fiber, and Risk of Coronary Heart Disease
  • 21 CFR 101.77 Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease
• Sodium and Hypertension
  • 21 CFR 101.74 Health claims: sodium and hypertension
• Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease
  • 21 CFR 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD)
  • Final Rule: Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (Barley Betafiber) August 15, 2008
    • Interim Final Rule: Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (Barley Betafiber) February 25, 2008
  • Final Rule: Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease May 1, 2008
  • Final Rule: Health Claims; Soluble Dietary Fiber from Certain Foods and Coronary Heart Disease (CHD) (Barley) May 22, 2006
    • Interim final rule: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease (CHD) (Barley) December 23, 2005
  • Final Rule: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease (Oatrim) July 28, 2003
    • Interim Final Rule: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease (Oatrim) October 2, 2002
  • Final rule; correction: Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Coronary Heart Disease; Correction (Psyllium husk) April 9, 1998.
    • Final Rule: Food Labeling; Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (Psyllium husk) February 18, 1998.
  • Final Rule: Food Labeling: Health Claims; Soluble Fiber From Whole Oats and Risk of Coronary Heart Disease Amended. March 31, 1997.
  • Final Rule: Food Labeling: Health Claims; Oats and Coronary Heart Disease January 23, 1997.
  • FDA Allows Whole Oat Foods to Make Health Claim on Reducing the Risk of Heart Disease January 21, 1997
• Soy Protein and Risk of Coronary Heart Disease
  • 21 CFR 101.82 Health claims: Soy protein and risk of coronary heart disease (CHD)
  • Final Rule: Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease October 26, 1999
• Stanols/Sterols and Risk of Coronary Heart Disease
  • Proposed Rule: Food Labeling: Health Claim; Phytosterols and Risk of Coronary Heart Disease December 8, 2010 NEW
  • FDA Letter Regarding Enforcement Discretion With Respect to Expanded Use of an Interim Health Claim Rule About Plant Sterol/Stanol Esters and Reduced Risk of Coronary Heart Disease February 14, 2003
  • 21 CFR 101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD)
  • FDA Authorizes New Coronary Heart Disease Claim for Plant Sterol and Plant Stanol Esters September 5, 2000
    • Interim Final Rule: Food Labeling: Health Claims; Plant Sterol/Stanol Esters and Coronary Heart Disease September 8, 2000

Denied Health Claims

• Alkaline and Earth Alkaline Citrates and Risk of Osteoporosis October 30, 2007