Is It Really FDA Approved?
FDA does not approve structure-function claims on dietary supplements and other foods.
Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body. One example is "calcium builds strong bones."
Dietary supplement firms that make structure-function claims on labels or in labeling must submit a notification to FDA. This notification must be submitted no later than 30 days after marketing the dietary supplement with the structure/function claim. Additionally, the notification must include the text of the claim, as well as other information, such as the name and address of the notifier. FDA does not require conventional food manufacturers to notify FDA about their structure-function claims.
Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been reviewed by FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease. Conventional foods are not required to carry such a disclaimer.
Misuse of FDA's logo may violate federal law.
FDA's logo should not be used to misrepresent the agency nor to suggest that FDA endorses any private organization, product, or service.
For more information about topics for your health, visit the FDA Consumer Information Center (www.fda.gov/consumer).
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