Health Canada is planning to completely overhaul their regulations on natural health products, otherwise known as homeopathic remedies, which they say can be misleading, unproven and may often have false claims on their labels.
Natural health products are currently regulated similarly to drugs, but with lower requirements for scientific evidence of their effectiveness. Drug manufacturers wanting to sell their products in Canada must go through an application process for Health Canada’s approval. Manufacturers of natural health products do not have to provide evidence of their products’ effectiveness during the approval process.
Health Canada’s new system would bring natural health products, over the counter drugs, and cosmetics under a single, unified system aimed at regulating the potential risks they may pose to consumers.
Natural health products would no longer be licensed by Health Canada and will therefore not be able to make claims about disease treatment or prevention without proof or the inclusion of a disclaimer stating they have not been verified by Health Canada.
“Health Canada, as a science-based regulator, wants to make sure that Canadians can trust that a standard has been met when we authorize a claim,” the department said in the consultation document.
Consumers will be given all the information necessary to make an informed purchase, and will be further protected from potentially false or misleading advertising.
“If someone is marketing something, they’re going to have to back that up with evidence,” said Timothy Caulfield, a Canada research chair in health law and policy at the University of Alberta.
Caulfield predicts Health Canada will face significant backlash from natural health product manufacturers.
The debate in Canada over natural health products came to a head in 2012, after the death of a toddler from rural Alberta who was treated exclusively with natural medicine and supplements.
Ezekiel Stephan was 19 months old when he contracted meningitis. His parents, believing him to have the flu, spent the following two-and-a-half weeks treating him with natural remedies including hot peppers, horseradish, onions, and garlic.
Ezekiel stopped breathing, prompting the parents to bring him to a doctor. By then, the infection had caused severe neurological dysfunction, leaving him brain dead.
His parents were convicted this year of “failing to provide the necessaries of life” to their child.
Ezekiel’s parents, David and Collet Stephan, were sentenced to four months in prison and three months of house arrest respectively. The conviction carries maximum sentence of five years in prison.
Health Canada is also looking into user fees for the manufacturers of natural health products, in concurrence with regulations for manufacturers of nonprescription drugs.