In its efforts to streamline the adverse events reporting of dietary supplements, the Food and Drug Administration (FDA) announced today that is now accepting online submission of voluntary and mandatory dietary supplement adverse event reports. As of December 22, 2007, manufacturers, packers, and distributors of dietary supplements in the United States have been required to submit reports of serious adverse events associated with the use of supplements to FDA. This requirement was mandated under the Dietary Supplement and Non-prescription Drug Consumer Protection Act of 2006 ("Act"). Companies may also voluntarily submit reports of non-serious "adverse events". The Federal Food, Drug, and Cosmetic Act provides that safety reports of either type do not constitute admissions of fault or responsibility.
Under the Act, a "responsible person" must report any serious adverse event associated with the use of dietary supplements. A serious adverse event is defined as an adverse event that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect or reasonably requires a medical or surgical intervention to prevent such a result. These reports must be submitted to FDA no later than 15 business days after receiving sufficient information to identify a "serious adverse event."
As the FDA is more aggressively exercising its control over the dietary supplements industry, companies must ensure that their manufacturing practices and processes allow them reliably to capture information from the field regarding adverse events, evaluate it and then identify and report serious adverse events in timely manner. Non-compliant companies are more likely to fall under FDA's continual scrutiny.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
