The following summarizes the MedWatch program. Realistically, the only way the FDA can establish that a dietary supplement is unsafe is through adverse event reporting by responsible consumers, physicians and other healthcare workers. To carry out its responsibilities, the FDA needs to be informed whenever an adverse event or product problem occurs. Only if FDA is provided with such information, can it be able to evaluate the risk, if any, associated with a product. Once a risk is assessed, the FDA can then take whatever action is necessary to reduce or eliminate the public's exposure to the risk.
Regulatory actions range from labeling changes to product withdrawal.
To ensure the marketing of safe and effective products, certain adverse events must be reported. Two very similar forms are used to implement reporting of adverse events and product problems. Individual health professionals are not required by law or regulation to submit voluntary adverse event or product problem reports to the agency or the manufacturer. There is one exception. Hospitals are not required by Federal law or regulation to submit adverse event reports on medications.