The federal government is hoping to strengthen its regulatory power over natural health products, such as vitamins and homeopathic medicines, according to a measure in Tuesday’s 2023 budget.
The budget proposes amending the Food and Drugs Act to extend powers by the Protecting Canadians from Unsafe Drugs Act (also known as Vanessa’s Law) to natural health products.
“These changes would protect the health of Canadians by enabling regulators to take stronger action when health or safety issues are identified with natural health products on the market,” the budget states.
Vanessa’s Law is a piece of 2014 legislation that requires the reporting of serious adverse effects for medications used within the Canadian health-care system, explained Barry Power, editor and chief of the Canadian Pharmacists Association.
The law applies to an array of products including prescription and over-the-counter drugs, vaccines, gene therapies, tissues and organs, and medical devices. It does not cover natural health products.
“With natural health products, there is no requirement for health-care professionals or consumers to report side effects that come with it,” Power said.
In Canada, natural health products are currently regulated separately from pharmaceutical drugs, and include vitamins, minerals, herbal remedies and homeopathic medicines, and “must be safe for use as over-the-counter products,” according to Health Canada.
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All natural health products sold in the country are subject to the Natural Health Products Regulations, which came into force in 2004, Health Canada states.
Some commonly used natural products usually contain echinacea, gingko or glucosamine.
But many of these products have not been proven to benefit from what is advertised.
For example, according to the NIH, several studies of the herb echinacea did not find evidence of benefit against the common cold. And studies of ginkgo, including a large study that enrolled more than 3,000 older adults, found that ginkgo supplements don’t help prevent or slow dementia or cognitive decline.
'Deadly consequences'
Steve Flindall, an emergency room physician in the Greater Toronto Area, applauded the government’s proposal to extend Vanessa’s Law to natural health products, saying a lot of people who take them do not know what they are ingesting.
“We’ve known for a long time that a lot of these products are not regulated,” he explained, adding that some studies have shown that the amount of the so-called active ingredient in some of these products can be much more than claimed or can, in fact, be nonexistent.
Power agreed with Flindall and added that not only are side effects not well documented for natural health products, but another danger is for people taking it in combination with other medications.
If Vanessa’s Law makes natural health product manufacturers report serious adverse effects, it will “help to build a database that will better inform health care professionals and consumers about some of the potential downsides of using the medications,” he explained.
Whether the natural product is zinc, probiotics or omega-3 fatty acids, Flindall argued there should be regulation on what the product can be used for.
He explained he had a patient who had “well-controlled seizures” and was on a “well-studied antiepileptic drug.”
But a “naturopath told them to stop this toxic drug and to start taking zinc as a replacement. And unfortunately, the young man went into status epilepticus and eventually ended up dying,” he said.
“People are being treated with supplements to treat chronic, dangerous heart conditions, epilepsy conditions like this, where claims made by some so-called practitioners are not supported by the evidence and can lead to deadly consequences,” he said.
The Canadian Pharmacists Association has been advocating to extend Vanessa’s Law to natural health products since it was first drafted in 2013, according to Power.
The federal proposal is a “needed step” to improve the safety of natural products in Canada, Power said, but added there are still some lingering questions: “Who will be required to report the side effects and what side effects will be required to be reported?”
In an email to Global News, a spokesperson from the department of finance said, “this legislative change will ensure that all natural health products available for sale in Canada are subject to the same monitoring and enforcement activities as drugs and medical devices.”
“Additional details will be made available in due course,” the spokesperson added.
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