By Rick Kingston, President, Regulatory and Scientific Affairs
In recent years, the FDA has increased inspections of dietary supplement companies regarding good manufacturing practices (GMPs), which include the processes, procedures and documentation that ensure the product is indeed what appears on the label. During the inspection process, the company’s adverse event documentation and serious adverse event reporting systems (SAERs), or lack thereof, are thoroughly scrutinized by the FDA.
For almost 10 years, mandatory adverse event (AE) reporting has been in effect, but many dietary supplement companies still struggle with meeting the requirements of the FDA regulations. As many have learned, there are a variety of things that can go wrong when products hit the shelf and are in the hands of consumers. Adverse event management services, including a robust AE monitoring system, will ensure that risk managers can identify and mitigate issues before they can put the company, its brand, and its customers at risk.
An AE is defined by law as “any health-related event associated with the use of a dietary supplement that is adverse.” The manufacturer or distributor whose name is on the bottle is the responsible party, but that responsibility can be delegated to others in the supply chain, such as contract manufacturers, through a written agreement. The essence of the law is that the responsible party must document and evaluate all allegations of AEs independent of whether or not the manufacturer believes the alleged AE was caused by the product. Each reported event must also be evaluated to determine if it meets FDA’s criteria for serious adverse events (SARs). Those that do must be reported to FDA within 15 business days.
Compliance with the regulations is required and the FDA expects manufacturers to hire or assign qualified, medically trained personnel to manage and monitor all allegations of AEs. The AE information needs to be documented within an FDA compliant database and all AEs, serious and non-serious, must be archived for a period of six years.
The FDA recognizes that many supplement manufacturers may not have the necessary internal expertise to meet the requirements, so encourages the use of third party medical experts. This is where SafetyCall comes in. If your company needs assistance, contact SafetyCall today. Keep in mind that Natural Products Association members receive a special first-time-customer discount.