Dietary Supplements: Vitamins, Minerals and More (cont.)
In this Article
- What is a dietary supplement?
- What is a "new dietary ingredient" in a dietary supplement?
- What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
- When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?
- What information must the manufacturer disclose on the label of a dietary supplement?
- Must all ingredients be declared on the label of a dietary supplement?
- Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?
- Where can I get information about a specific dietary supplement?
- Who has the responsibility for ensuring that a dietary supplement is safe?
- Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?
- What is FDA's oversight responsibility for dietary supplements?
- Does FDA routinely analyze the content of dietary supplements?
- Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
- Who validates claims and what kinds of claims can be made on dietary supplement labels?
- 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"?
- How are advertisements for dietary supplements regulated?
- How do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA?
How do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA?
If you think you have suffered a serious harmful effect or illness from a product FDA regulates, including dietary supplements, the first thing you should do is contact or see your healthcare provider immediately. Then, you and your health care provider are encouraged to report this problem to FDA.
Your health care provider can call FDA's MedWatch hotline at 1-800-FDA-1088, submit a report by fax to 1-800-FDA-0178 or on-line. The MedWatch program provides a way for health care providers to report problems believed to be caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements.
You, or anyone, may report a serious adverse event or illness directly to FDA if you believe it is related to the use of any of the above-mentioned products, by calling FDA at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or reporting on-line. FDA would like to know when you think a product caused you a serious problem, even if you are not sure that the product was the cause, or even if you do not visit a doctor or clinic. In addition to communicating with FDA on-line or by phone, you may use the postage-paid MedWatch form available from the FDA Web site.
NOTE: The identity of the reporter and/or patient is kept confidential.
SOURCE: FDA.gov; "Overview of Dietary Supplements," May 7, 2009.
Last Editorial Review: 6/19/2009
Find out what women really need.