... There are many links available regarding nutritional supplements and FDA approval.....they are not required of nutritional supplements.
BMart:
Simply because dietary supplements do not require FDA approval does not mean they have license to promote themselves by making unwarranted health claims about specific diseases. The following excerpt from an FDA web site concerning the Dietary Supplement Health and Education Act of 1994 (DSHEA) may be of interest:
NUTRITIONAL SUPPORT STATEMENTS
The DSHEA provides for the use of various types of statements on the label of dietary supplements, although claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease (unless approved under the new drug provisions of the FD&C Act). For example, a product may not carry the claim "cures cancer" or "treats arthritis." Appropriate health claims authorized by FDA--such as the claim linking folic acid and reduce risk of neural tube birth defects and the claim that calcium may reduce the risk of osteoporosis--may be made in supplement labeling if the product qualifies to bear the claim. Under DSHEA, firms can make statements about classical nutrient deficiency diseases--as long as these statements disclose the prevalence of the disease in the United States. In addition, manufacturers may describe the supplement's effects on "structure or function" of the body or the "well-being" achieved by consuming the dietary ingredient. To use these claims, manufacturers must have substantiation that the statements are truthful and not misleading and the product label must bear the statement "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." Unlike health claims, nutritional support statements need not be approved by FDA before manufacturers market products bearing the statements, however, the agency must be notified no later than 30 days after a product that bears the claim is first marketed.
vm.cfsan.fda.gov
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