New regulations could mean the end of the natural health product industry, says lawyer

A non-profit organization that works protect access to natural health products (NRPs) warns that provisions in the 2023 federal budget that affect these products will be the industry’s “death knell” unless some portions are repealed.

Bill C-47the Law on the implementation of the budget, which was royally approved on June 22, “amends the Food and Commodities Act to extend measures related to therapeutic products to natural health products”- such as vitamins, herbal remedies and homeopathic and traditional medicine – something the action previously explicitly excluded.

While the bill says the amendment, whose effective date has yet to be determined, is intended to strengthen safety oversight, the Association for the Protection of Natural Health Products (NHPPA) has a very different opinion.

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

The paper explains some of the ways the changes will affect the industry, which are part of the “over-the-counter” framework being implemented by Health Canada.

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

The paper says more changes to the self-care framework will be implemented soon. Traditional evidence of use will no longer be sufficient to support efficacy and safety claims, and clinical studies will be required. The ability to put ingredients together in one package is also at risk.

And the changes would limit NHP health claims to minor conditions, where a person would not need to seek advice from a licensed healthcare professional, such as a naturopathic physician or nutritionist, further reducing the number of products available.

The budget proposes amending the Food and Drug Act to extend regulatory powers to NRPs 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 more forceful action when health or safety concerns are identified with natural health products on the market,” the budget states.

Fight with the industry

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

“What is happening Health Canada tries to over-regulate natural products to take them away, and then citizens revolt and have to back down. And then Health Canada waits for that to subside and then they try again. And we’re only at the third major now [attempt] in my career,” he said.

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

Regulations due to come into effect in 1998 led to a legal challenge and public uprising that led to the then Liberal government’s withdrawal. After consultation, the Regulations for natural health products entered into force in 2004.

In 2008, then-Conservative Health Minister Tony Clement introduced Bill C-51 to unify drug and NHP regulations in a scheme similar to the one currently proposed. However, public backlash again caused the government to back down. The powers proposed in 2008 appeared in 2013 under Account C-17or Vanessa’s Law, which alone applied to “medicines and medical devices, other than natural health products.”

In 2016, then-Liberal Health Minister Jane Philipott reaffirmed her support for expanding the self-care framework to NHPs, and Health Canada instructed her Natural and Over-the-Counter Health Products Directorate to implement the policy.

‘Mom and pop industry’

Buckley, who previously did legal work for Health Canada, said the agency’s model appears to be one where it “gets us all funneled into the chemical drug model.”

He believes that an expensive and rigorous burden of proof is appropriate for future drugs, but neither necessity nor economics make it appropriate for NHPs.

“Drug companies pay for site licenses, fees and product placement, annual fees for the rights to sell their products, and the natural health product industry has never been subject to that,” he said.

“It’s more of a mom and pop industry. It’s a mid-sized manufacturer, they produce and 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 rules they just created.

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

The NHPPAs Discussion paper calls the regulations the “death knell” of the industry, noting that if the changes are implemented, it will be “functionally illegal to treat anything but the smallest ailments with natural products.”

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

Health Canada: ‘modernized approach’

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

“While natural health products (NRPs) are considered lower-risk health products, this does not mean they are risk-free,” the department said. “Health Canada has seen evidence of industry non-compliance with the Natural Health Products Regulations, resulting in health and safety risks for Canadians. Examples include product contamination due to non-compliance with Good Manufacturing Practices and the presence of ingredients that are not listed on the labels.”

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

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

Push back

The NHPPA previously ran a postcard campaign calling on MPs to amend the Budget Implementation Act to exclude regulatory changes from the NRP. That has now changed to call for the repeal of the articles in question. The organization also wants the self-care framework to be discontinued and a charter of health freedom introduced for Canadians.

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

“They have 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 through August 10 proposed fees to cover some of the costs of its activities to regulate NHPs, similar to those for medicines and medical devices. The rates will take effect on April 1, 2025.