Dietary Supplements - Adverse Event Reporting
To report an illness or injury associated with a Dietary Supplement
FDA can be contacted to report general complaints or concerns about food products, including dietary supplements. You may telephone or write to report general complaints or concerns to FDA.
If you think you have suffered a serious harmful effect or illness from a dietary supplement, your health care provider can report this by calling FDA's MedWatch hotline at 1-800-FDA-1088 or report online. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.
Consumers may also report an adverse event or illness they believe to be related to the use of a dietary supplement by calling FDA at 1-800-FDA-1088 or online. FDA would like to know when a product causes a problem even if you are unsure the product caused the problem or even if you do not visit a doctor or clinic.
To submit a serious adverse event report to the FDA
- For Industry: Dietary Supplements - Reporting an Adverse Event At A Glance
- Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act October 2007
- Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1 December 2008
- FDA Form 3500A