The Dietary Supplement Health and Education Act of 1994 (DSHEA) authorizes statements of nutritional support. A statement for a dietary supplement may be made if:
- The statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, or
- The statement describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient.
To make these statements, the manufacturer of the dietary supplement must have substantiation that the statement is truthful and not misleading. The statement also must contain, prominently displayed and in boldface type, the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
These statements may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. For these purposes, FDA defines a disease as “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension).” However, the definition excludes diseases resulting from essential nutrient deficiencies, such as scurvy and pellagra.
If a manufacturer of a dietary supplement proposes to make a statement described above in the labeling of the dietary supplement, the manufacturer shall notify FDA no later than 30 days after the first marketing of the dietary supplement.
Per FDA regulations, the notification must include:
- The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement on its label or in its labeling.
- The text of the statement that is being made.
- The name of the dietary ingredient or supplement that is the subject of the statement.
- The name (including brand name) of the dietary supplement that bears the statement.
- The signature of a responsible individual or other person who can certify the accuracy of the information in the notification. The person who signs the notification must certify that the information in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.
Sources
1. Section 403(r)(6) (21 U.S.C. 343(r)(6)) of the Federal Food, Drug, and Cosmetic Act
2. 21 CFR § 101.93
3. “Notifications for structure/function and related claims in dietary supplement labeling.”
4. “Small entity compliance guide on structure/function claims”
5. “Regulations on statements made for dietary supplements concerning the effect on the structure or function of the body.”
