Nutravigilance® by Supplement Safety Solutions
Nutravigilance is the science and activities that comprise the detection, assessment, understanding and prevention of adverse effects related to the use of a food, dietary supplement, or medical food.
Companies in the dietary supplement, natural products and medical foods industry may license the Nutravigilance® Verfied seal for display on product labels, online, TV, radio and print marketing materials to demonstrate that they have in place a robust, comprehensive approach to product safety, product quality and adverse event surveillance and analysis hat exceeds the current regulatory standards. Companies that follow a Nutravigilance system verify that they train their employees to recognize adverse events, have detailed standard operating procedures for processing and reporting adverse events, and have an appropriately trained Responsible Person identified to interface with the regulatory agencies.
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 an annual Nutravgiliance safety reports.
The Nutravigilance® Verified seal on product labels and marketing materials shows your customers that a qualified third-party is actively monitoring any consumer complaints or reports of potential health problems related to or associated with — but not necessarily caused by — the use of your supplement.
The seal is good steward assurance that your brand is not only meeting the minimum mandatory standards of federal and state consumer protection laws, but exceeding the requirements for both product complaint and adverse event reporting.
Adverse Event Monitoring & Analysis
Our doctors follow up on selected cases – including direct interaction with the consumer when necessary – maintain source documentation, assess every AE report (serious and non-serious) and document the assessment (e.g., non-serious or serious).
We will interact with the FDA on your behalf as needed and prepare your staff when an audit is mandated.
We’ll also work with you on the development of Standard Operating Procedures (SOPs) for clinical, manufacturing and safety-related topics and train and coach your staff on adverse event reporting and FDA audit response.
We provide Annual Reports to the US Food and Drug Association.