‘War on Natural Health’: Product Regulations Favour Pharmaceuticals, Say Industry Insiders

The regulations will cost businesses so much that Canadians will see far fewer natural health products on the shelves, they say.

A customer looks at vitamins at Green Street Natural Foods in Melrose, Mass., on July 10, 2001. Darren McCollester/Getty Images

Health Canada has for years made periodic attempts to bring natural health products under greater government control, but it’s never come this far before.

While the department says its latest regulations are in response to safety concerns, critics say such concerns are unfounded and the government is favouring the pharmaceutical industry.

“This is really a war on natural health … on access to natural health products that stand in the way of the pharmaceutical industry having a complete monopoly,” David Stephan of Hartleyville, Alberta, told The Epoch Times.

Mr. Stephan works for TrueHope, the natural health product (NHP) business his father founded in the 1990s, and he has long stood in opposition to Health Canada’s attempts to increase regulation.

The latest regulations announced in June 2023 are similar to those Health Canada tried to establish in the past. Previous attempts have met with much protest, but this time “they slipped it under the radar,” Mr. Stephan said.

The federal government reclassified NHPs as “therapeutic products” with legislation included in Bill C-47, the omnibus budget bill passed last year.

NHPs are now treated more like drugs and medical devices in some ways. This allows Health Canada to engage in stronger surveillance of the industry, impose fines of up to $5 million daily for products deemed unsafe, recall products, require labelling changes, and more. Health Canada will also start charging NHP companies to cover the government’s costs for regulating the industry.

Mr. Stephan and others say this will make business costs so burdensome that Canadians will see far fewer NHPs on the shelves. Such products include vitamins and minerals, probiotics, amino acids, herbal remedies, homeopathic medicines, toothpastes and shampoos, and others.

The costs of complying with new regulations are yet to be determined, but Mr. Stephan estimates it could drive up product costs some 25 percent, despite promises from Health Canada to give some fee discounts to small businesses. He said a few of TrueHope’s products will no longer be viable for sale in Canada under such conditions.

He also noted that big pharmaceutical companies can easily pay the fines for non-compliance whereas small NHP companies could be shuttered by a single fine.

Safety Debate

NHPs were already regulated in Canada before the recent Bill C-47.

Since 2004, Health Canada has required NHPs to receive government approval and licensing before going to market. The department issues eight-digit natural health product numbers, displayed on packaging, for approved products. Companies must also ensure each product is manufactured in a facility with a site licence issued by Health Canada. The product and site licensing undergoes periodic renewal.

A 2021 auditor general’s report, however, said Health Canada’s enforcement and oversight were inadequate. Health Canada’s responses within the report promise the measures now being put in place.

The report indicates some companies did not comply with all regulations, but it is unclear how grievous the infractions were. For example, more than half the companies audited had “misleading label information,” the report says, including the wrong dosage of medicinal ingredients or an incomplete list of risks and ingredients. But it’s not clear how far off the dosages were or how serious or rare were the risks.

The report gives as an example of “misleading information” product claims about relieving fatigue, enhancing endurance, or burning fat, that haven’t been verified by Health Canada.

The auditor general highlighted a case in which a serious risk was flagged. In 2017, an importer was found to have sold a product containing a pharmaceutical ingredient that could cause miscarriage and birth defects.

One person was hospitalized, and subsequent testing of the product found the ingredient. Health Canada cancelled the product licence, but it was still marketed online as of 2020.

When Health Canada visited the company site, some quantities of the product had been removed, the report says. The importer admitted it was possible the product had been contaminated with the pharmaceutical ingredient. It is unclear if the problems pertained only to a particular batch of the product.

Health Canada did not reply by press time to Epoch Times inquiries about NHPs.

The department has been tracking complaints of serious adverse reactions related to NHPs. Between 2017 and 2019, it recorded 40 complaints, according to the auditor general’s report. Health Canada successfully removed 36 of the products in question from the market, but could not confirm whether the other four were removed.

The new regulations stipulate that hospitals must report adverse NHP effects, whereas previously the reporting was voluntary.

Retired clinical herbalist Robert Rogers of Alberta says the risks posed by NHPs are negligible.

“All products, including the food we eat, have a risk and benefit,” he told The Epoch Times. “But when it comes to natural health products, the risks are so low.”

He said people who use natural products to keep themselves healthy are less likely to need pharmaceuticals. “So there’s a profit agenda from [pharmaceutical companies],” he said, arguing that pharmaceutical lobbying is at play. The Council of Canadians reported in February 2023 a quadrupling of pharmaceutical lobbying in Ottawa since early 2022.

Mr. Stephan says NHP companies are restrained from wrongdoing not only by moral concerns, but also fear of litigation. They don’t want to be sued if people experience adverse effects. He noted not a single death has been reported in Canada from NHPs, and that adverse effects are rare.

Mr. Stephan’s trust in NHPs over pharmaceuticals has deeply personal roots, as does his battle against regulations he feels will impact Canadians’ ability to choose NHPs.

A Personal History

In 1996, Mr. Stephan’s mother committed suicide—only a few weeks after she began taking Prozac for her bipolar disorder. Suicidal ideation was later revealed to be a side effect of Prozac. U.S. officials raised the alarm in 2005 that Prozac maker Eli Lilly may have known about this as early as 1988, though the company has denied it.

Mr. Stephan’s father spent years thereafter formulating a vitamin and mineral treatment for the disorder, looking to help two of Mr. Stephan’s nine siblings who were also bipolar. The supplement, now called EMPowerplus, seemed to instantly alleviate symptoms in the siblings, and now thousands of people use it to treat bipolar disorder and depression.

The extent of its efficacy and how much people rely on it was examined in court in 2006, during one of the many battles TrueHope has fought with Health Canada. At the time, Health Canada insisted EMPowerplus go through the same licensing requirements as those for a drug, but TrueHope said that was impossible.

It is hard, for various reasons, for a nutrition-based treatment that involves many active ingredients to meet the proof of efficacy required of a pharmaceutical drug. Such testing usually focuses on one ingredient and extends for years at great expense.

Alberta judge G.M. Meagher saw merit in testimony from many experts concerning the efficacy of EMPowerplus, including from Harvard University psychiatrist Dr. Charles Popper, who said symptoms of depression and bipolar disorder would immediately return if patients were denied access to the supplement. Dr. Popper saw hundreds of patients experience better results with EMPowerplus than with pharmaceuticals.

Given his family’s dedication to NHPs and its contentious relationship with Health Canada over the years, Mr. Stephan said he was “disgusted” to see Health Canada Chief Medical Advisor Supriya Sharma use the 2012 death of Mr. Stephan’s son as justification for the new NHP regulations.

Dr. Sharma told a House committee during a Sept. 27 briefing that NHPs “are generally low risk.” "But we had a tragic 19-month-old in Alberta that died because of using natural health products instead of treatment for meningitis.”

That 19-month-old was Ezekiel Stephan, Mr. Stephan’s son. Some MPs objected to Dr. Sharma’s use of the example because natural remedies did not cause the infant’s death. Mr. Stephan says the cause of death was examined in detail through court hearings and the case had many nuances.

David Stephan carries his son, Ezekiel Stephan, on his back. Courtesy of David Stephan

A recent photo of David Stephan and his family. Courtesy of David Stephan

Dr. Sharma did not reply to an Epoch Times request for further comment. She also cited the example of an epilepsy patient in Toronto who switched from pharmaceutical medications to natural remedies and died from a series of continuous seizures.

Mr. Stephan says Health Canada is denying Canadians the right to choose their method of health care, making the choice of natural remedies too expensive due to rising costs.

Starting in the 1990s

In the 1990s, proposals to treat NHPs like drugs met with protest in Canada and the United States, where actor Mel Gibson famously took part in an ad showing a swat team raiding his house for his vitamin C tablets (the U.S. authorities did actually raid some health stores at the time, though less dramatically).

The United States is currently much more relaxed in its NHP regulation than Canada, Mr. Stephan said. TrueHope’s U.S. website still shows the company’s claims regarding treatment of bipolar disorder and 35 scientific studies related to those claims, whereas that information has been censored from its Canadian website.

TrueHope's Canadian website illustrates information Health Canada has prohibited it to display regarding scientific studies related to its products. Screenshot

In 2004, Health Canada began requiring companies to get products approved and receive the natural product numbers, but Mr. Stephan says enforcement was weak and only really began several years later. Even then, it came in spurts.

In 2008, Bill C-51 related to consumer protections again attempted more stringent NHP regulations, but met with protest and failed. Mr. Stephan says the current Bill C-47 is very similar. Although it has passed, multiple MPs have reported receiving overwhelming complaints from constituents over it. A few MPs have tabled petitions against it, and MP Blaine Calkins has tabled Bill C-368 attempting to reverse the new regulations.

Mr. Stephan believes that, met with great protest for its outright attempts to strongly regulate in the 1990s, Health Canada has instead opted for a “slow boiling of the frog.”

“Over the last about 14 years, we’ve seen a constant diminishment of the amount of natural health products available in the Canadian market,” he said. “And it’s just taking place at a slow enough rate that the average person wouldn’t catch it.”