The proposals are designed to provide a temporary route to market for products that have applied for – but not yet received – a product licence under Canada’s Natural Health Products Regulations (NHPR), which came into force in 2004.
“Health Canada will issue exemption numbers for products that meet the criteria of the new regulation and for which evidence of safety, quality and effectiveness has been provided,” the agency told NutraIngredients-USA.com.
“Natural Health Products (NHPs) already on store shelves and/or in queue for 180 days will be granted exemption numbers if they meet all of the criteria. New applicants that meet the criteria would be considered for exemption 180 days after application.”
Included in Canada’s definition of NHPs are certain food and beverage products claiming to benefit health (such as energy bars and juices with vitamins); supplements such as herbs, digestive enzymes, vitamins and minerals and essential fatty acids; traditional medicines (e.g. Ayurvedic, Chinese, herbal); homeopathic products and certain personal care products.
Safety criteria that would have to be met before an exemption is granted include confirming that the product is not:
- A product that contains an ingredient that is prohibited from being sold in a drug under the Food and Drug Regulations (e.g. arsenic, mercury)
- A product containing an ingredient that is likely to result in injury to the health of consumers, and whose presence in a natural health product or other drug has led to a recall or stop sale under the NHPR or the Food and Drug Regulations
- Recommended for use to treat, prevent or cure a serious disease (as listed in Schedule A of the Food and Drugs Act)
- Recommended for use in children under 12 years of age, or pregnant or breastfeeding women.
NHPs would also have to be manufactured, packaged, labelled, imported, distributed, and stored in compliance with established Good Manufacturing Practices, and manufacturers would need to report adverse events.
Easier for consumers
Along with the more than 27, 000 currently licensed NHPs on the Canadian market this proposal would bring the total number of NHPs available for legal sale in Canadian stores to approximately 39, 000, said Health Canada.
“The proposal would make it easier for consumers to know which products are exempted by requiring the name of each exempted product to be posted on Health Canada’s web site, along with the company name and exemption number.”
The natural health product regulatory proposal was published in the Canada Gazette on May 8, 2010 and can be accessed here.