By Abigail Popple, Local Journalism Initiative Reporter, RMG
Michele Dallaire, owner of local health food store Infinity, says that recent and forthcoming federal legislation is contributing to skyrocketing prices for her business and customers.
In an interview with The Goat, Dallaire and longtime Infinity customer Ann McKirdy-Carson laid out their concerns with amendments to the Food and Drugs Act which were passed last June.
Under the amended Act, natural health products are subject to the same labelling regulations and federal oversight that applies to pharmaceutical products.
The amendments were folded into the Budget Implementation Act 2023, also known as Bill C-47.
Dallaire and McKirdy-Carson believe that this move prevented businesses and consumers from having the opportunity to provide feedback, and was unnecessarily opaque.
“Why would Health Canada impose [a new set of food and drug regulations] and pass it with a budget?” Dallaire asked.
In a statement emailed to The Goat, Health Canada said that all amendments – including those passed within budget implementation acts – are subject to rigorous debate and consultation with stakeholders.
While these amendments were folded into the Budget Implementation Act 2023, there was no money earmarked for changes to the Food and Drugs Act.
When asked why this was the case, Health Canada only aid that the federal government had decided not to give funding to these amendments.
“The tools enabled through Bill C-47 complement existing compliance and enforcement tools. It is the Government’s decision on how funding is allocated to support its mandate, and no additional funds were allocated for [changes to the Food and Drugs Act],” the agency said.
The Goat also reached out to the Department of Finance, who sent an email statement but asked not to be directly quoted. However, the Department’s statement was nearly identical to that of Health Canada: budget acts are subject to rigorous debate and stakeholder engagement, just like other legislation, they said.
What’s in a label?
The new regulations include a requirement to label natural health products according to the Protecting Canadians from Unsafe Drugs Act, also known as Vanessa’s Law.
Natural health products are now subject to Plain Language Labelling standards, which requires manufacturers to submit mock-ups of their labels for review by Health Canada before products are put on the market. Labels must also include a product facts table with ingredient information, health warnings, and directions for safe use of a product.
Additionally, manufacturers may be compelled to re-label their products to more clearly reflect health risk information and ensure that their ingredients list is accurate.
According to Health Canada, these changes were prompted by findings of non-compliance among natural health product retailers and manufacturers.
“A pilot inspection program conducted between March 2021 and March 2022 to assess whether [natural health product] manufacturers and importers were following regulatory requirements for good manufacturing practices found that all of the sites had compliance issues, ranging in severity,” the agency told The Goat.
Additionally, a 2021 audit by the Commissioner of the Environment and Sustainable Development found gaps in the regulatory oversight of natural health products, including instances of misleading labels in 56 per cent of sampled products. The changes in Bill C-47 allow Health Canada to order recalls, compel label changes or impose higher fines on rule breaking companies, the agency continued.
Dallaire said that these fines and new labelling requirements are putting a logistical and financial burden on natural health product retailers. This is causing prices to rise, she said.
“My main concern is the customer. We’re seeing prices go up on a continuous basis, and for those that want to choose alternative healthcare, or supplements or herbs, I feel like this is taking away that choice.”
McKirdy-Carson agreed that rising costs are making alternative healthcare inaccessible. She worries that if users of natural health products can no longer access them, they will enter an already-strained health care system en masse.
“Everybody loses in this game, as I perceive it,” she said. “We don’t take from the health care system, we pay for our own [alternative] health care. And if all of us were to land on the health care system with all of our aches and pains, it would hurt everybody.”
Bill C-47 isn’t solely responsible for rising costs, said Joel Thuna, general manager of natural health products retailer Pure-LÄ” Canada. It is, however, part of a patchwork of legislation that he says poses an existential threat to the industry.
Companies may need to purchase new containers for their products to accommodate the larger, more information-dense labels, said Thuna. He is also concerned that the stricter labelling requirements introduced by Bill C-47 will lead to manufacturing delays alongside the cost of designing and creating new labels.
“It’s also going to increase because, for example, our company is certified kosher and certified organic […] So every time we design a label, we have to get it pre-approved by the organic and kosher agencies because there’s requirements for both of their regulations. And that just increases time delays and costs,” he said.
Threat to the industry
On top of the costs associated with new labels, Thuna said that a new fee proposed by Health Canada last May will decimate the natural health industry if it goes forward as planned. He pointed to an economic impact analysis of the proposed fees commissioned by the Canadian Health Food Association, which found that 83 per cent of health product manufacturers and retailers have a low or very low capacity for absorbing the proposed fees should they go into effect.
“I know companies ten times our size that said the fee structure would wipe them out entirely,” Thuna told The Goat. “About 80 per cent of the companies in the industry wouldn’t survive the first year, and for every product and company that did survive, the minimum costs would double.”
According to the Health Canada proposal, the fees would cover the cost that the agency incurs annually for regulating natural health products. The proposal introduces right to sell fees, which would cover the cost of surveilling products already on the market, as well as site licence fees to cover the cost of assessing facilities where products are manufactured. It also introduces pre-market evaluation fees to assess and licence new products entering the market.
In an email to The Goat, Health Canada said that consultation on cost recovery fees and other natural health product regulations has been ongoing since 2016.
“The department published the Proposed fees for natural health products as part of its transparent public consultation process encompassing all stakeholders, which ran for 90 days from May 12th to August 10th, 2023 and received close to 5000 comments,” the agency wrote to The Goat.
“Since that time, Health Canada has completed the review of the comments received and is revising the initial proposal and will be engaging stakeholders later this month in another open and transparent process.”
Thuna says that his company has participated in consultation with Health Canada before, but feels that the agency has been unreceptive.
“Their idea of consultation and our idea of consultation are two very different things,” he said. “Natural health product regulations were created by industry, consumers, academics and the government working together through a series of consultations […] Health Canada has moved away from that model, to ‘This is our idea. We’ll now listen to you complain about it.'”
Dallaire agreed that Health Canada has not conducted sufficient consultation with businesses. She has contacted MP Bob Zimmer in the hopes of raising awareness about the issue, she said, but has not heard back from him.
Swatting a fly with a sledgehammer
Aside from new fees, Thuna said that the regulations included in Vanessa’s Law are redundant to already-existing natural health product regulations, which he believes were sufficient on their own. Natural health products were already subject to adverse event reporting, just like drugs and medical devices: if a consumer experienced adverse side effects, or a health professional witnessed adverse side effects in a patient, they could voluntarily send testimony to Health Canada.
Now, health professionals are mandated to report adverse events related to natural health products to Health Canada within 30 days of their occurrence. The agency is then able to issue a product recall or compel a label change on the product in question, Health Canada said in its email to The Goat.
Thuna feels that this change will burden retailers with managing the fallout from adverse events. Retailers will have to justify that their product is safe to use any time Health Canada receives an adverse event report, he said.
“What Vanessa’s Law does is basically forces us to do another level of reporting even though the first level worked,” he said. “It’s akin to if all of a sudden, you were driving a Toyota Corolla and ended up rear-ending someone and every automobile manufacturer in Canada had to justify why their car should stay on the road.”
Thuna said that the previous model of voluntary adverse event reporting was sufficient. He added that companies have to routinely conduct mock product recalls in order to remain licensed, and they have to meet stringent manufacturing standards to retain their Good Manufacturing Practices license.
“It seems like you’re using a sledgehammer to swat a fly that isn’t even there anymore,” he said of the Vanessa’s law regulations.
Additionally, Thuna is concerned that a dwindling number of Canadian natural health retailers would lead to foreign companies marketing sub-par, unregulated products to Canadians. While Canadian producers must be licensed by Health Canada, he worries that foreign producers would not be held to the same standards.
However, Health Canada told The Goat that non-Canadian producers would be subject to the same set of regulations as Canadian ones.
“All domestic or international companies that sell natural health products directly to Canadians – whether online or at retail outlets in Canada – must comply with Canadian regulations,” the agency said. “As such, they are subject to legislation and regulations, including the proposed fees associated with these regulatory activities.”
Canadians travelling abroad may purchase small quantities of natural health products. However, Health Canada encourages Canadians to only consume products that have been authorized by the agency, as foreign-sourced products may not have been developed under the safety and quality standards required in Canada.
For Dallaire’s part, she has been distributing information from the Natural Health Products Protection Association in Infinity as well as other businesses in Valemount. She hopes to raise awareness of the campaign against Bill C-47 being led by the Natural Health Products Protection Association. The Association recently launched a Private Member’s Bill, C-368, that would repeal the divisions of C-47 related to natural health products if passed.
“It’s really about writing letters to our MP’s, to our politicians,” Dallaire said. “It’s about communicating that this issue is really important, and we want our government to take specific steps to protect our access to natural health products.”
