As defined by the US Food and Drug Administration (FDA), health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition.
The use - and regulation - of health claims on products varies depending on which category these fall under: medical, or non-medical. The golden rule to using claims on foods, beverages and dietary supplements is to steer clear of implying in any way that these can prevent or treat a health condition, as they would then be classified as drugs.
Foods and supplements can carry two major types of health claims: Authorized health claims or qualified health claims.
Authorized Health ClaimsNLEA Authorized Health Claims are provided for by the Nutrition Labeling and Education Act (NLEA) of 1990.
The US regulatory body - FDA - allows for the use of these claims based on a significant scientific agreement standard (click here for more information), which determines that the nutrient/disease relationship is well established.
Examples of this type of claims would include:
- Calcium and the risk of osteoporosis
- Plant sterol/stanol esters and the risk of coronary heart disease
- Folic acid and the risk of neural tube defects
Authorized health claims can also be based on an authoritative statement from a scientific body of the US government or National Academy of Sciences.
Manufacturers can use this latter type of claim on foods and beverages - but not dietary supplements - following successful notification to FDA. (Click here for FDA's guide on how to make authoritative statement-based claims.)
- Whole grain foods and risk of heart disease and certain cancers
- Potassium and the risk of high blood pressure and stroke
Qualified Health ClaimsQualified health claims are those based on emerging evidence for the relationship between a food or supplement and a reduced risk of disease.
Because the evidence is not well enough established to meet the significant scientific agreement standard, this type of claim must include qualifying language to indicate that the evidence supporting the claim is limited.
These claims are allowed by enforcement discretion letter, and can be used on both food and dietary supplement products. (Click here for more general information.) (Click here for a summary of the qualified health claims authorized by FDA.)
- Selenium and risk of certain cancers
- Walnuts and risk of coronary heart disease
Structure-Function ClaimsOther claims that can be used include structure/function claims, which describe the role of a nutrient or ingredient intended to affect normal structure or functions of the human body.
They cannot imply a link between the food and a disease or health condition, but they can characterize the means by which a nutrient maintains the body's functions. In addition, these claims can also be used to describe general well-being from consumption of a nutrient.
- Calcium builds strong bones
- Fiber maintains bowel regularity
- Antioxidants maintain cell integrity
Structure/function claims for use on dietary supplements are not pre-approved by FDA, and products that carry them must also include a disclaimer stating that the claim has not been evaluated by FDA, and that the product is not intended to prevent or treat disease.
Supplement manufacturers that use these claims need to notify FDA of this use within 30 days after marketing the dietary supplement.
Structure/function claims on foods focus on the effects derived from the nutritive value of a food. They do not require notification.
(For more information, click here.) Nutrient Content ClaimsNutrient content claims characterize the level of a nutrient in the food, either directly or by implication. They can either describe a level (e.g. low fat, high fiber), or they can compare the level of a nutrient in a food to that of another food, using terms such as 'more' or 'reduced'.
Most nutrient content claim regulations apply only to those nutrients or dietary substances that have an established daily value.
(For more information, click here.)
Click here for FDA's summary of claims that can be made for conventional foods and dietary supplements.
Click here for FDA's Food Labeling Guide, issued in April 2008.
Other articles in the series:FDA enforcement action on health claimsFTC's two-pronged approach to ensuring accurate marketingWhen FTC gets tough on misleading marketingLegal advice to avoid FDA/FTC claim clamp-down