title: Regulation of natural health products in Canada.
abstract: In Canada, all natural health products (NHPs) are regulated by Health Canada (HC) under the Food and Drugs Act and the Natural Health Product Regulations. All authorized products undergo pre-market assessment for safety, efficacy and quality and the degree of pre-market oversight varies depending on the risk of the product.
  
  
  BACKGROUND
  In Canada, over 70,000 products have been authorized for sale and over 2000 sites have been licensed to produce NHPs. In the management of NHPs on the Canadian market, HC employs a number of active and collaborative methods to address the most common issues such as contamination, adulteration and deceptive or misleading advertising practices. HC is currently evolving its approaches to NHPs to recognize them as part of the larger group of health products available without a prescription. As such, the regulatory responsibility for all over-the-counter (OTC) drugs, including non-prescription drugs and NHPs, has been transferred to a single federal division.
  
  
  CONCLUSIONS
  As a result of this transition a number of benefits are being realized with respect to government efficiency, clarity for industry, support for new innovations and consolidated government interactions with the Canadian market.
authors: Natural Health Products Directorate, Health Products Food Branch, Health Canada, 2936 Baseline Road, Postal Locator 3301A, Ontario, Ottawa, Canada(1).
authors: Alysyn
authors: A
authors: Smith
authors: Natural Health Products Directorate, Health Products Food Branch, Health Canada, 2936 Baseline Road, Postal Locator 3301A, Ontario, Ottawa, Canada(1). Electronic address: Sumedha.jogalekar@hc-sc.gc.ca.
authors: Sumedha
authors: S
authors: Jogalekar
authors: Natural Health Products Directorate, Health Products Food Branch, Health Canada, 2936 Baseline Road, Postal Locator 3301A, Ontario, Ottawa, Canada(1).
authors: Adam
authors: A
authors: Gibson
mesh_terms: D000329:Advertising / Q000331:legislation & jurisprudence; D001688:Biological Products / Q000009:adverse effects / Q000592:standards*; D002170:Canada; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004340:Drug Contamination / Q000331:legislation & jurisprudence / Q000517:prevention & control; D006801:Humans; D007880:Legislation, Drug; D004366:Nonprescription Drugs / Q000592:standards
chemical_list: D001688:Biological Products; D004366:Nonprescription Drugs
keywords: Canada; Herbal medicine; Monograph; Natural health products; Regulation