The United States Clarifies Claims for Dietary Supplements

~ April 2002 No.147 ~

The United States Food and Drug Administration (USFDA) recently finalized its rules for claims on dietary supplements. Although the Dietary Supplement Health and Education Act (DSHEA) has been in force since 1994, many questions have been raised about the application of the act. The rules published in the Federal Register by the USFDA are an attempt to clarify the rules for both the food manufacturer and the consumer.

At the present time there are 3 levels of claims that can be made about a food or food ingredient - a nutrient claim, a structure /function claim and a health claim.

Nutrient Claim
A nutrient claim appears on the label of foods. It states the amount of a particular nutrient contained in a defined amount of the food. Nutrient claims usually appear as a table on the product package.
Structure Function Claim
A structure /function claim describes how nutrients or dietary ingredients affect particular structures or functions in the body. Statements must be substantiated, truthful, and not misleading.
A Health Claim
A health claim states the relationship between a nutrient and a disease or health related condition. A body of evidence (usually in the form of scientific data) must support the claim.

Label claims may not use the words protects, mitigates, treats, cures or prevents as relates to a disease. Such words can only be used for drugs. Antibiotic, antiseptic and antidepressant are likewise not to be used in food health claims. However, health claims or implied health claims can be conveyed in the product name, or through pictures, vignettes or symbols that describe the product.

At the present time 11 health claims have been approved for use on food labels in the U.S. - calcium and osteoporosis; sodium and hypertension; dietary fat and cancer; dietary saturated fat and cholesterol and risk of cardiovascular disease; fiber-containing grain products, fruits, and vegetables and cancer; fruits, vegetables and grain products that contain fiber, particularly soluble fiber, and the risk of coronary heart disease, fruits, vegetables and cancer; folate and neural tube birth defects; dietary sugar alcohol and dental caries; dietary soluble fiber, such as that found in whole oats and psyllium seed husk, and coronary heart disease; soy protein and heart disease.

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