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 Q:  How do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA?


 A:

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 at: http://www.fda.gov/medwatch/report/hcp.htm. 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 at: http://www.fda.gov/medwatch/report/consumer/consumer.htm. 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.

For a general, not serious, complaint or concern about food products, including dietary supplements, you may contact the consumer complaint coordinator at the local FDA District Office nearest you. See the following Web address for the telephone number: http://www.fda.gov/opacom/backgrounders/complain.html.

 

Source: Excerpted from Overview of Dietary Supplements January 2001

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