Are There FDA Approved Supplements?
The Federal Drug Administration (FDA) is charged with approving the efficacy and safety of new drugs before they are available to the general public to ensure that they do not have any life-threatening side-effects. Unlike these drugs, dietary supplements are not reviewed or approved by the FDA to determine their effectiveness or safety and thus there are no FDA approved supplements.
The FDA consider dietary supplements in only a limited set of circumstances where the supplement to be introduced contains a new dietary ingredient that has not previously been sold in the United States. In these cases, and unless a formal exception is sought by the manufacturer, they require a notification to be sent to the FDA no sooner than 75 days before they commence selling the product. This notification must provide information that supports the manufacturer’s basis for concluding that the supplement is reasonable expected to be safe to use.