Frequently Asked Questions

What is a clinical research trial?
A clinical research trial is a rigorously controlled supervised medical research study designed to evaluate the safety and or effectiveness of a drug, medical device, or medical treatment on a group of volunteers.

Who runs a clinical trial?
Medical and Healthcare professionals. The medical professional in charge of overseeing the research study is the Principal Investigator.  The study Coordinator is a healthcare professional who manages study related activities.

What is a sponsor?
The sponsor funds the clinical research study.  The sponsor may be nutraceutical company, raw material supplier, an individual drug company, government agency or private person or organization.

What is the FDA?
The Food and Drug Administration is a government agency of the United States Department of Health and Human Services.  This agency monitors, regulates and grants specific approval to products ensuring they are safe for use and consumption.  The FDA is responsible for protecting and promoting the nation’s public health.

What is the FTC?
The Federal Trade Commission is a United States government agency, which promotes free and fair competition in commerce and enforces antitrust and trade practice laws. The agency also regulates and governs laws related to advertising.  Claims on food, products, drugs, devices must be supported by scientific evidence.

What is Health Canada?
Health Canada is the Canadian Federal Department responsible for maintaining and improving Canadians’ health.  This department manages, regulates and enforces the safety standards associated with food, product, drugs, and devices in everyday use.

What is NHPD?
The Natural Health Products Directorate is the regulatory authority for natural health products for sale in Canada.  The NHPD is responsible for ensuring Canadians have ready access to natural health products which are safe, effective and of high quality.

What is GRAS?
Generally recognized as safe is a US Food and Drug Administration designation for a chemical, substance or ingredient added to food, which is considered safe by experts.  With this classification, the chemical, substance or ingredient is exempted from the usual Federal Food, Drug and Cosmetic Act (FFDCA)

What is a PLA?
A Product License Application is Health Canada’s Natural Health Products Directorate process for submitting registration of a natural health product.  This includes safety and efficacy information to support product claims.