Supplement Safety Solutions Launches Nutravigilance Program

BEDFORD, Mass.Supplement Safety Solutions debuted Nutravigilance, a new safety and adverse event surveillance, monitoring and reporting program.

Nutravigilance is a comprehensive approach to product safety derived from defined principles commonly used in the pharmaceutical industry.

According to the programs co-founders, Dr. Hector L. Lopez Jr. and Dr. Stephen Schmitz, Nutravigilance marks the beginning of a new era of adverse event reporting (AER) in which supplement manufacturers are taking the lead in demonstrating their products safety. The program was recently published in the International Journal of Food Sciences and Nutrition, and co-authored by Drs. Stephen Schmitz, Hector L. Lopez, Jr. from Supplement Safety Solutions and The Center for Applied Health Sciences, and Duffy MacKay of the Council for Responsible Nutrition (CRN).

The supplement, natural product, and functional food industries can benefit from increased efforts to demonstrate to their consumers and to regulatory agencies like the FDA that they take their safety responsibilities very seriously,"  Lopez said. Instead of waiting for and reacting to product safety issues, the industry must embrace proactive best practices from other industries and adapt them."

Supplement Safety Solutions has also launched a Nutravigilance verified seal. Companies in the dietary supplement, natural products and medical foods industry can license the trademarked seal after meeting specific requirements as defined by the Nutravigilance program for display on product labels, TV, radio, print and online marketing materials. The seal demonstrates that a company has made a strong commitment to product and consumer safety that exceeds current regulatory standards.

Companies following the Nutravigilance program verify that they train their employees to recognize adverse events, maintain detailed standard operating procedures for processing and reporting adverse events and product quality complaints. Companies are also responsible for identifying an appropriately trained Responsible Person" to interface with regulatory agencies, perform signal detection activities to assess ongoing product safety regularly, and assess relevant scientific and medical literature for safety-related reports.

If you are not taking proactive steps to protect product safety, then youre not doing enough," Schmitz said. That makes you vulnerable to regulatory liability and safety issues, and it decreases the essential dialogue between the consumer and the dietary supplement manufacturer or brand."

Nutravigilance-verified companies create high-quality adverse event narratives and reports, regularly search the literature for safety reports related to ingredients found in their product formulation, perform periodic safety signal detection exercises, and summarize the totality of data in annual safety reports."