Get Dietary Guidelines Supplement Report Of Findings - Fda

The U.S. Food and Drug Administration regulations require that dietary supplement labeling include a descriptive name of the product stating that it is a "dietary supplement"; the name and place of business of the manufacturer, packer, or distributor; a list of ingredients; and the net contents of the product.

Federal Regulation of Dietary Supplements FDA is the federal agency that oversees both supplements and medicines, but FDA regulations for dietary supplements are different from those for prescription or over-the-counter medicines. Medicines must be approved by FDA before they can be sold or marketed.

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.

If you are taking a dietary supplement and experience an adverse event, immediately stop using the product and seek medical care or advice. You should also submit a report to FDA through either: The Safety Reporting Portal at .safetyreporting.hhs.gov. An FDA Consumer Complaint Coordinator.

If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.

Online: Use the interactive form at FDA Form 3500. FDA encourages online reporting because it is the quickest and most direct route. Fax: Get the form (as above) and fax to 1-800-FDA-0178. Phone: Call 1-800-FDA-1088 Monday-Friday between 8 a.m. and 4:30 p.m. EST.

However, manufacturers and distributors of dietary supplements must record, investigate, and forward to FDA any reports they receive of serious adverse events associated with the use of their products.