Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard
Authorized health claims in food labeling are claims that have been reviewed by FDA and are allowed on food products or dietary supplements to show that a food or food component may reduce the risk of a disease or a health-related condition. Such claims are supported by scientific evidence and may be used on conventional foods and on dietary supplements to characterize a relationship between a substance (a specific food component or a specific food) and a disease or health-related condition (e.g., high blood pressure). The Nutrition Labeling and Education Act of 1990 (NLEA) directed FDA to issue regulations providing for the use of health claims. All health claims must undergo review by the FDA through a petition process.
To be approved by the FDA as an authorized health claim, there must be significant scientific agreement (SSA) among qualified experts that the claim is supported by the totality of publicly available scientific evidence for a substance/disease relationship. The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship.
To learn more about authorized health claims and qualified health claims, visit Questions and Answers: Authorized and Qualified Health Claims in Food Labeling.
More information on Qualified 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
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 September 2008
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
- Interim Final Rule: Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease December 2016
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 2008
- Final Rule: Food Labeling: Health Claims; D-tagatose and Dental Caries July 2003
- Final Rule: Food Labeling: Health Claims; Dietary Sugar Alcohols and Dental Caries December 1997
- Final Rule: Food Labeling: Health Claims; Sugar Alcohols and Dental Caries August 1996
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 1996
- Final Rule: Revoking January 4, 1994 Regulation That Became Final By Operation of Law September 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
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 2008
- Final Rule: Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease May 2008
- Final Rule: Health Claims; Soluble Dietary Fiber from Certain Foods and Coronary Heart Disease (CHD) (Barley) May 2006
- Final Rule: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease (Oatrim) July 2003
- Final rule: correction: Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Coronary Heart Disease; Correction (Psyllium husk) April 1998
- Final Rule: Food Labeling; Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (Psyllium husk) February 1998
- Final Rule: Food Labeling: Health Claims; Soluble Fiber From Whole Oats and Risk of Coronary Heart Disease Amended March 1997
- Final Rule: Food Labeling: Health Claims; Oats and Coronary Heart Disease January 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 1999
Stanols/Sterols and Risk of Coronary Heart Disease
- Proposed Rule: Food Labeling: Health Claim; Phytosterols and Risk of Coronary Heart Disease December 2010
- 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)