Complaints & Recalls - FAQs:

(NIH The FDA published a final rule on April 12, 2004, banning the sale of dietary supplements containing ephedrine alkaloids. After a careful review of the available evidence about the risks and benefits of ephedra in supplements, the FDA found that these supplements present an unreasonable risk of illness or injury to consumers. The data showed little evidence of ephedra's effectiveness, except for short-term weight loss, while confirming that the substance raises blood pressure and stresses the heart. The increased risk of heart problems and strokes negates any benefits of weight loss.

There is strong evidence that ephedra is associated with an increased risk of side effects, possibly even fatal ones. There is no evidence that ephedra products enhance athletic performance. There is little evidence of any benefit except for short-term weight loss. Taken together, the FDA recommends that consumers immediately stop using dietary supplements containing ephedra or ephedrine alkaloids.

Learn More:

Dietary Supplement Fact Sheet: Ephedra and Ephedrine Alkaloids for Weight Loss and Athletic Performance (NIH)

How do I, my health care provider, or any informed individual report a problem or illness caused by drugs and other medical products regulated by the HHS Food and Drug Administration (FDA)?

If you think you have suffered a serious harmful effect or illness from a product FDA regulates, such as drugs, medical devices, medical foods and dietary supplements, the first thing you should do is contact or see your health care 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/how.htm.

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 by reporting on-line at: http://www.fda.gov/medwatch/how.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.

For a general, not serious, complaint or concern, you may contact the consumer complaint coordinator at the local FDA District Office nearest you. See the following Web address for the telephone number in your region: http://www.fda.gov/opacom/backgrounders/complain.html. The identity of the reporter and/or patient is kept confidential.

What does the HHS Food Drug and Administration (FDA) do with defective products?

Products found to be unfit for consumers are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. These products usually are destroyed, or in some cases, they are reconditioned to be in compliance with FDA regulations.