Natural health products and over-the-counter drugs aren’t subject to the same scientific standards and shouldn’t be sold next to each other on pharmacy shelves, says a recent editorial in the Canadian Medical Association Journal.
Both kinds of products are approved by Health Canada, says the editorial’s author, CMAJ deputy editor Matthew Stanbrook, a physician and professor of medicine at the University of Toronto. But, they don’t have to provide the same kinds of scientific evidence to get approval.
According to Health Canada, traditional medicines can be licensed on the basis of reference to a text like the Ayurvedic Pharmacopoeia or the British Herbal Pharmacopeia – though if there is evidence of a health risk, more documentation might be required.
If the product’s claim isn’t based on traditional medicine, the manufacturer must provide scientific evidence “when necessary” to support product indications and conditions of use, said the ministry in an emailed statement.
Stanbrook believes it’s too easy for natural health products to get approved.
“If you’re an over-the-counter drug, you are regulated just the way prescription drugs are,” he said. “You have to submit evidence to Health Canada that your drug works the way you say it does and show studies that show people benefit from it. And Health Canada looks at that evidence and decides whether or not to approve you.”
It’s “very, very easy” by contrast to get a natural health product – like a herbal remedy or vitamin – approved, he said. “To get a license for a natural health product, you simply need to show some sign that someone, somewhere, sometime once used this as a therapy. And that’s really it.”
Helen Long, president of the Canadian Health Food Association, a trade association representing the natural health industry, said that Canada is considered a “global leader” in the regulation of natural health products.
“If you would like to get a license, you submit an application to Health Canada, you demonstrate the safety and efficacy of your product in relation to the claim you are making.”
The evidence submitted can be anything from showing that a given product was used in traditional Chinese medicine up to a double-blind scientific study, she said. Health Canada even provides some pre-approved information about specific ingredients on its website for use in applications to help them get licensed more quickly.
Stanbrook believes that the approval process amounts to a “rubber stamp.”
“You really just need to provide some document that shows someone’s used it. It could be a 100-year-old textbook that says it’s a traditional remedy.”
Having the two kinds of products presented together on pharmacy shelves confuses people, he said. “The average person walking in wanting something for pain or for cough or for their child’s cold sees these products and has very much difficulty in telling that one is based on rigorous science and one is based on nothing.”
Health Canada admits that the current system can be confusing. Manufacturers of natural health products follow different sets of rules for safety, efficacy and quality, said the agency in an emailed response.
“This has resulted in a system where products making very similar claims on their labels are treated very differently by Health Canada.”
“The way these products are presented or marketed in many stores, as well as the claims they make, can make it hard for some consumers to tell them apart.”
Consequences of confusion
Aside from maybe wasting your money on something that doesn’t work, said Stanbrook, there can be real consequences to treating a condition with a natural health product. If it’s ineffective, you’re essentially failing to treat your condition, which could mean it gets worse, he said. And herbal medicine can have biological effects.
“Often no one knows what the effects of these products are, and it can be found out later that they can for example cause damage to the liver, or they can be made in a way that isn’t well done and can be toxic when they shouldn’t be.”
Natural health products are generally recognized as lower-risk, said Long. “So what we’d like to see is that Canadians continue to have access to natural health products that are safe, effective, of high quality, respect their freedom of choice and lets them manage their own well-being while having the information to do so.”
While in general she believes that Canadians have enough information to tell the difference between natural health products and drugs, more information could be helpful, she said. “By including additional information on the labels we could perhaps tell Canadians more about what they’re purchasing or the product review process.”
Stanbrook believes that the only way to make it clear to consumers what they’re getting is to put all natural health products in a different section of the store.
Health Canada plans to change the current system for regulating natural health products and just completed public consultations on the issue.
“Under our proposal, companies will not be allowed to make claims that their products cure, prevent or treat an illness without credible and reliable evidence, including clinical evidence,” wrote the organization.