‘Death Knell’: New Regulations Could Spell End of Natural Health Products Industry, Advocate Says

Natural health products at a pharmacy in Toronto in a file photo. (Angelo Cordeschi/Shutterstock)

A non-profit that works to protect access to natural health products (NHPs) is warning that provisions in the 2023 federal budget affecting these products will be the “death knell” of the industry unless some portions are repealed.

Bill C-47, the Budget Implementation Act, which received royal assent June 22, “amends the Food and Drugs Act to extend measures regarding therapeutic products to natural health products”—such as vitamins, herbal remedies, and homeopathic and traditional medicine—something the act previously explicitly excluded.

While the bill says the amendment, whose effective date is yet to be determined, is to strengthen safety oversight, the Natural Health Products Protection Association (NHPPA) takes a vastly different view.

“All the things that we didn’t want to have happen to the natural health product industry are now happening—all at once,” the NHPPA says in a “discussion paper on 2023 Health Canada initiatives.”

The paper explains some ways in which the changes will impact the industry, which are part of the framework for “self-care products” being implemented by Health Canada.

It says significant new fees and regulations will drive many NHP businesses and practitioners out of business, prices will increase, “censorship” of NHP health information will occur, and Health Canada will have “dramatic” new powers over the industry including the ability to impose hefty fines.

The paper says more self-care framework changes will soon be implemented. Traditional use evidence will no longer be adequate to support efficacy and safety claims, and clinical studies will be required. The ability to compound ingredients in a single package is also in jeopardy.

And the changes would restrict NHP health claims to minor conditions, where someone wouldn’t need to seek advice from a licensed health-care practitioner, such as a naturopathic doctor or nutritionist, thus further reducing the number of products available.

The budget proposes amending the Food and Drug Act to extend regulatory powers to NHPs under the Protecting Canadians from Unsafe Drugs Act, also known as Vanessa’s Law.

“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.

Battle With Industry

In an interview with The Epoch Times, NHPPA president Shawn Buckley said the NHP industry has been in a continual battle with the government for decades.

“What happens is Health Canada tries to over-regulate natural products to take them away, and then citizens rebel and they have to back off. And then Health Canada waits until that simmers down and then they try again. And we’re just now on the third major [attempt] in my career,” he said.

A separate NHPPA report outlines how the self-care products framework came about.

Regulations set to come into effect in 1998 prompted a legal challenge and public revolt that led to the then-Liberal government backing off. Following a consultation, the Natural Health Product Regulations came into force in 2004.

In 2008, then-Conservative health minister Tony Clement introduced Bill C-51 to unite drug and NHP regulations under a scheme similar to the one currently proposed. However, public backlash again made the government back off. The powers proposed in 2008 reappeared in 2013 under Bill C-17, or Vanessa’s Law, which only applied to “drugs and medical devices, other than natural health products.”

In 2016, then-Liberal health minister Jane Philipott confirmed her support for extending the self-care framework to NHPs, and Health Canada instructed its Natural and Non-Prescription Health Products Directorate to implement the policy.

‘Mom and Pop Industry’

Buckley, who formerly did legal work for Health Canada, said the agency’s model appears to be one where it ensures "we’re all funnelled into the chemical drug model.”

He believes an expensive and rigorous burden of proof is appropriate for prospective drugs, but neither the need nor the economics makes it appropriate for NHPs.

“Drug companies pay for site licensing, fees and product placement, yearly fees for the rights to sell their products, and the natural health product industry has never been subjected to those,” he said.

“It’s more of a mom and pop industry. A medium-sized manufacturer, they manufacture and they package and label and distribute, and now you’re asking them to pay $60,000 a year for that privilege that they never paid before.”

Buckley says those fees will simply go into Health Canada’s pocket as “cost recovery” for the “enforcement arm” of the strict regulations they’ve just created.

“Most of the natural products industry is still relatively small and they just simply won’t survive. And then [the government] is going to limit the types of uses to literally over-the-counter uses,” he says.

The NHPPA’s discussion paper calls the regulations the “death knell” of the industry, noting that if the amendments are implemented, it will be “functionally illegal to treat anything but the most minor of conditions with natural products.”

“Many Canadians are only alive because of natural health products. Many more solve or manage serious health conditions with them. We cannot pretend that taking away treatments people rely upon for their lives and/or well-being will not lead to death or suffering,” it states.

Health Canada: ‘Modernized Approach’

In response to a query from The Epoch Times, Health Canada said by email that it is “modernizing its oversight” of the NHP industry.

“While natural health products (NHPs) are considered lower-risk health products, it does not mean they are without risk,” the department said. “Health Canada has seen evidence of industry non-compliance with the Natural Health Products Regulations, resulting in health and safety risks to Canadians. Examples include product contamination due to non-adherence with Good Manufacturing Practices and the presence of ingredients not listed on labels.”

The department said its efforts align with recommendations made in an audit of the NHP program in April 2021 by the Commissioner of the Environment and Sustainable Development, “highlighting the need for a modernized approach.”

“The audit made a number of recommendations, including the need to strengthen the post-market oversight of NHPs,” Health Canada said. “These legislative amendments provide the Department with stronger tools to manage serious health and safety risks when products present a serious or imminent risk of injury to health, in line with the recommendations of the audit.”

Pushback

The NHPPA previously held a postcard campaign to call on MPs to amend the Budget Implementation Act to exclude the NHPs regulatory changes. That has now changed to calling for the concerning sections to be repealed. The organization also wants the self-care framework stopped and a charter of health freedom enacted for Canadians.

Lana Van Dijk, owner of Body Fuel Organics in Regina, told The Epoch Times she is deeply concerned about the impact the regulations will have on the NHP industry. She said her industry was not consulted, and some in it remain unaware of the threat the changes represent.

“They’ve now revised the definition of ‘therapeutic products’ to include natural health supplements. There was no debate; there was no option for debate,” she said.

“It has blindsided the industry.”

Health Canada is holding consultations until Aug. 10 on proposed fees to cover part of the costs of its activities to regulate NHPs, similar to those for drugs and medical devices. The fees are slated to come into effect April 1, 2025.