The Natural Health Products Regulations that came into effect in January 2004 are intended to raise standards within the industry. In particular, they require better labelling, better manufacturing practices and better-supported claims regarding benefits to health. These claims may be backed by scientific studies, references to traditional use or by pharmacopeias. Implementation will be phased in over six years, but several hundred products have already been approved. Under these regulations, all natural health products must undergo evaluation before a marketing license can be issued.
The regulations define the following as natural health products:
- vitamins and minerals
- remedies derived from medicinal plants
- homeopathic remedies
- traditional remedies, such as traditional Chinese remedies
- probiotics
- other products, such as amino acids and essential fatty acids
The new regulations require:
- that products be manufactured under appropriate sanitary conditions (effective for all manufacturers as of 2006)
- that private individuals (excluding retailers) who wish to sell a natural health product obtain a marketing license (already in effect)
- that packers, importers, manufacturers and labellers obtain a site exploitation license (already in effect)
- that all claims be supported by adequate, sufficient evidence (2008)
- that all products carry clear labels showing the following: detailed composition, source, potency of active ingredients, dosage and contraindications (2008)
- that an eight-digit identification number be affixed to each product, preceded by an NPN (natural product number) (2008) or by NPN-HM in the case of a homeopathic product (2010)
This does not mean that everything is now regulated. Precautions, for example, need only include drug interactions observed repeatedly in humans. For more information, visit the Natural Health Products Directorate website at: www.healthcanada.gc.ca/dpsn
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