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.

Nutravigilance Verified by Supplement Safety Solutions

Nutravigilance® is a registered trademark of Supplement Safety Solutions LLC.

Adverse Event Monitoring & Analysis

Adverse or unexpected health-related events associated with the use of your supplement are reviewed by a Supplement Safety Solutions physician. While most events are non-serious (>95%) and require no follow-up, the identification of cases that require additional review and analysis is critical to maintaining regulatory compliance. 

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).

FDA Interaction

A Supplement Safety Solutions physician serves as your Responsible Person to the US Food and Drug Association, reporting all Serious Adverse Events to the FDA on MedWatch Form 3500A or electronically via the Safety Reporting Portal (SRP).

We will interact with the FDA on your behalf as needed and prepare your staff when an audit is mandated.

Risk Analysis

We’ll perform a comprehensive Risk Assessment of your product portfolio, analyzing the potential for problems based on supplement components. We’ll review the design and implementation of Phase I protocols or Phase I safety results and review product labeling for adherence to FDA Guidance.

Procedural Training

We make that you are at the center of your products’ safety and customer satisfaction by training your staff in Good Clinical Practices (GCP), Good Manufacturing Practices (GMP) and US Pharmacopoia (USP).

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.

Support Services

We use our technical expertise and supplement safety experience to write product education and labeling materials. We perform monthly literature searches for Adverse Event reports and other competitive information.

We provide Annual Reports to the US Food and Drug Association.

Supplement Safety Solutions

Bringing supplements to market is your business.

Keeping them safe is ours.