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In 1999 the Office of Natural Health Products (ONHP) was created within Health Canada. This new Office will be the regulatory authority for natural health products, separate from the Therapeutic Products Programme and from the Food Directorate. The Transition Team Final Report from the ONHP is available through the ONHP site.
How are natural health products currently regulated?
Under the Food and Drugs Act, a product that is offered for sale to treat or prevent symptoms or disease must be regulated as a drug. In Canada, natural health products can be regulated either as a food or as a drug. However, if a product claims to treat or prevent illness or symptoms it must be regulated as a drug.
Why is it a problem to regulate natural health products as drugs?
Before a drug is approved for use by Health Canada it must be proven to be safe and effective. On average this takes 10 years and costs a company $10 million. To profit from drug sales a company must patent the drug. This gives the company exclusive rights to sell the drug.
The problem with Natural Health Products is that most are unable to be patented. Companies are not willing to spend the millions of dollars required to approved the product as a drug because they have no way to ensure that they will make their investment back.
In the United States, the Food and Drug Administration has approved the use of certain "structure function" health claims on foods. The Office of Natural Health Products is currently examining these claims and how to best inform the public about the health benefits of certain foods, herbals and natural-source vitamin/mineral supplements.