Currently, dietary supplement companies are not required to submit adverse events to FDA, although companies can voluntarily do so. However, if a consumer used a product and believes something went seriously wrong, that report, if submitted to a company, should be provided to the federal agency regulating the product. Therefore, the Council for Responsible Nutrition (CRN) strongly supports the bipartisan efforts of Senators Orrin Hatch (R-UT), Tom Harkin (D-IA), Richard Durbin (D-IL), Mike Enzi (R-WY) and Ted Kennedy (D-MA) to develop legislation that would mandate the reporting to FDA of serious adverse events for dietary supplements and over-the-counter drugs (OTCs).
Consumers have a right to expect that if they report an adverse event to a dietary supplement manufacturer, FDA will know about it
- Many responsible dietary supplement manufacturers already voluntarily report any serious adverse events associated with their products to FDA. However, all companies should be required by law to report serious adverse events to FDA. Consumers should know that if they call or write to a manufacturer about a serious health event they believe is associated with their use of a dietary supplement, the company will notify FDA. It’s a positive step toward building greater consumer confidence in dietary supplements as it demonstrates a company’s confidence in the safety of its products.
AERs serve as a signal to FDA and do not prove causation between a product or ingredient and an adverse event
- In fact, dietary supplement companies receive very few serious Adverse Event Reports (AERs), which demonstrates the wide margins of safety for these products. Requiring manufacturers to report these relatively few incidents will demonstrate to FDA, the medical community and to consumers the safety of this class of FDA-regulated products. In any case, FDA treats adverse event reports as early warning signals that might suggest trends among certain products or safety concerns among the general public that may not show up in a limited clinical trial. FDA clearly advises that adverse event reports do not demonstrate causality between the FDA-regulated product and a reported adverse event.
It’s the responsible thing to do
AERs provide early warning signals to FDA of potential product problems, like product contamination or adulteration, tampering, bioterrorism and ingredient safety issues. By providing this information to a single source—FDA—manufacturers increase the likelihood that trends indicating a problem will be identified more quickly, and fewer consumers will be affected. By giving consumers more confidence in the industry, everyone benefits.
1An event that is associated with the use of a product that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity or a congenital anomaly or birth defect.