Why are Regulations required for natural health products?
Prior to January 1st, 2004, natural health products (NHPs) were sold as either drugs or foods under the Food and Drugs Act and Regulations because there is no other category under which to classify them. If classified as a drug, natural health products must adhere to the drug review process, including proof of safety and efficacy through clinical trials, and receive a Drug Identification Number (DIN) to be sold. If classified as a food, natural health products can make only very limited health claims and do not provide adequate safety information on their labels. As more and more Canadians began to use NHPs, it became apparent that neither treatment (as either a drug or food) would be appropriate, and that a new policy which would directly address the unique nature of NHPs was required. The Natural Health Products Regulations have been developed in order to address this policy requirement.
