The FDA's Currently Required Statement on Nutrients and Nutritional Supplements
DSHEA: Dietary Supplement Health Education Act of 1994
Quote from the FDA website:
Why do some supplements have wording (a disclaimer) that says, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.
Reference: https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements
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