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Why are regulations needed for natural health products?
Before January 1st, 2004, natural health products (NHPs) were sold as either drugs or food under the Food and Drugs Act and Regulations because there was no other category under which to classify them.
If classified as a drug, natural health products must follow the drug review process (including proving safety and efficacy through clinical trials) and have 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 have to provide much safety information on their labels.
As more and more Canadians began to use NHPs, it became obvious that neither classification (as either a drug or food) was appropriate, and that a new policy which would directly address the unique nature of NHPs was needed. The Natural Health Products Regulations were developed to address this need.
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2. Natural health products are regulated as a subset of drugs under the Food and Drugs Act. Why doesn’t Health Canada regulate NHPs as a distinct category separate from both food and drugs?
Under the Food and Drugs Act, NHPs must be classified as either a food or a drug since there is no other category in which to classify them. Because NHPs are taken for therapeutic reasons and not for caloric purposes or to address hunger, they are more similar to drugs than food.
Under the current Food and Drug Regulations, foods can make only limited diet-related or nutritional content claims (and not treatment claims, for example). Also, the current regulations do not include a complete good manufacturing practices framework which is needed to ensure the quality and safety of NHPs. Finally, foods are generally not subject to pre-market review and assessment by Health Canada before they can be sold.
During consultations on NHPs, Canadians consistently asked for controls to make sure what is on the label is in the bottle and ensure a pre-market assessment of health claims. While creating another category distinct from both food and drugs was considered, an amendment at the level of the Act would have been necessary. Because the timelines and legislative process needed for a change of this magnitude would be long, it was decided that natural health products would be considered drugs under the Act, but with a set of regulations specific to NHPs.
Health Canada is currently conducting a comprehensive review of its health protection legislation to replace outdated statutes with a new health protection legislative regime. The objectives of the legislative review are to strengthen and modernize the legislation, and to provide policy direction in the area of health protection. The creation of additional categories for certain classes of health or therapeutic products may be considered as a part of this process.
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Chondroitin sulfate is a chemical found in human and animal cartilage. It is commonly used by mouth with glucosamine or other ingredients for osteoarthritis.
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