New regulations for natural health products will mandate reporting of adverse side effects, changes to product labelling and more.
Since he moved to Alberta from Montreal in 1986, Jean Dansereau has been helping his regular clients as well as their children — and now grandchildren — use natural health products (NHP) to remedy fatigue, pain, digestive issues, sleeplessness and more.
A player in the natural health industry since the 1970s, Dansereau opened Healthy Solutions health store on Perron Street in St. Albert 21 years ago to cater to customers curious about using non-pharmaceutical alternatives to treat their ailments, and to offer clients health consultations.
“It’s kind of a Ma and Pa store in some ways,” Dansereau said. “For me these clients are like my extended family. I take care of them as best I can, advise them as best I can, make sure they’re doing well in their lives.”
But new rules introduced in the Liberal government’s omnibus budget bill passed June 22, as well as incoming rules about product packaging and proposed regulatory fees, will soon change how NHPs are regulated in Canada.
Dansereau fears he will have to close his store when the regulations come into full force.
The legislation passed in June will bring natural health products such as vitamins, minerals and probiotics; homeopathic medicines; traditional medicines; and non-traditional products for managing weight or aiding sleep under the Protecting Canadians from Unsafe Drugs Act, also known as Vanessa’s Law.
Introduced in 2014 to more closely monitor the effects of prescription and over-the-counter drugs as well as vaccines, Vanessa’s Law mandates health care institutions report adverse drug reactions to Health Canada.
Under the new rules, Health Canada will also be able to order recalls and label changes of NHPs that pose a serious risk to human health, impose higher fines for non-compliance and “order a person to provide information to determine if a product presents a serious risk of injury to human health,” according to Health Canada’s website.
Last year Health Canada ordered new labelling requirements for NHPs, and the agency has proposed charging fees to the industry for evaluating, licensing and monitoring its products.
Dansereau said although he believes ensuring product safety is important, he thinks of NHPs as food like parsley or garlic, not drugs that need a higher level of scrutiny from health regulators.
He’s also concerned the NHP industry will bear the financial costs of additional regulations, increasing prices for customers.
“Availability of products will diminish dramatically and whatever is available will be so costly that it will be prohibitive to a lot of people,” he said. “The cost of living for everyone right now is pretty bad.”
Many Conservative MPs have spoken out against the rule changes, including MP for St. Albert-Edmonton Michael Cooper, who met with Dansereau earlier this month to discuss the concerns.
Cooper said in a tweet on X, the platform formerly known as Twitter: “Canadians are at risk of losing access to health products (because) of Trudeau’s red-tape, unnecessary fees & bureaucratic gatekeeping.”
A balancing act
University of Calgary law professor Lorian Hardcastle, who specializes in health law, said although the legislation may have caught the natural health industry off guard, the situation is probably not as dire as they claim.
“The expensive part of getting a pharmaceutical product on the shelf isn’t reporting to Health Canada or having to change a label — it’s the millions of dollars they have to invest in clinical trials,” she said. “That part isn’t going to apply to natural health products.”
According to Hardcastle, more stringent regulations for natural health products have been on the agenda for a long time.
An auditor’s general report published in 2021 found Health Canada “did little to prevent poor information from being given to consumers about licensed natural health products” and that, of a sample of 75 licensed NHPs, 88 per cent were advertised with misleading product information and 56 per cent had misleading label information.
More consultation with industry groups and customers before announcing the legislation could have helped to dispel fears or work through solutions, Hardcastle said.
She said that although NHPs on the market are relatively safe, there are cases of interactions with medications and that regulating any industry involves trade-offs.
“The regulations are always a balance between trying to improve safety but not overregulate to the point that we’re driving industries out of business.”