OTTAWA, Canada—Following industry and consumer pressure since the mid-1990s, Health Canada has revamped its antiquated natural health products regulations. Beginning this month, Canadian companies have a two-year transition period to register and label their products with approved health claims and establish GMPs for manufacturing facilities.
"We're hoping this initiative will be recognised as an appropriate approach to product health claims and improved access to products that are useful to consumers," said Philip Waddington, N.D., directorate general of Health Canada's Office of Natural Health Products (ONHP).
In the past, Canadian natural products with health claims were regulated as drugs; otherwise they fell under food regulations. The ONHP's 30-member staff consulted with industry experts to develop a front-end approach that ensures scientific evidence exists to support a product's health claim. ONHP has developed monographs on vitamins, minerals, botanicals and other supplements that will be expanded as research supports new health claims. The level of evidence will be proportionate to the level of the claim, meaning more scientific evidence will be required for a product that attempts to treat a disease than for a product that helps prevent or assists in disease prevention.
"We looked at the US under its Dietary Supplements Health and Education Act (DSHEA), but its claims are not adequately supported by evidence," said Waddington.
Still, the US market obviously weighed on the government's decision to liberalise its markets. An estimated 40 per cent of the products sold in the US have not been allowed in Canada.
Although much of the feedback on the new rules is positive, Waddington noted concerns about what constitutes an appropriate good manufacturing practise (GMP) as well as appropriate standard of evidence for scientific research.
"The world is watching Canada," says Kelley Fitzpatrick, president of Saskatchewan Nutraceutical Network. "We're trying to avoid the US mistakes regarding quality issues, consumer education and media misinterpretation."
Institut Rosell-Lallemand of Montreal, a supplier and manufacturer of probiotics, has hundreds of products for which to obtain product licensure, GMPs, site licensure, new labelling and packaging. Lallemand's regulatory affairs coordinator, Donna Clements, while optimistic about the domestic market, expressed concern about overseas export markets where probiotics are regulated more stringently as a drug.
The proposed regulations can be found at Health Canada's Web site, www.hc-sc.gc.ca.