Proposed new legislation designed to overhaul the 50-year-old Food and Drugs Act is causing widespread concern in Canada's natural health industry.
Currently being debated in the House, Bill C-51 aims to protect consumers from unsafe food and health products and improve access to information about product safety.
Changes to the Act include a general prohibition against the manufacture, importation, advertisement or sale of products that endanger health or safety and new powers for the government to recall unsafe products.
Fines for violations will increase dramatically. A first offence for a summary conviction jumps from $500 to $250,000, and an indictable offence from $5,000 to $5 million.
While most agree that changes to the Food and Drugs Act are long overdue, the natural health industry fears that Bill C-51 pushes Natural Health Products (NHPs) further into the same category of laws that govern prescription drugs.
Under the bill, both drugs and NHPs are classed as "therapeutic products." NHPs include herbal remedies, vitamins, minerals, homeopathic medicines, sports nutrition products, and organic foods.
According to Health Canada, "therapeutic product" covers all products which are used for therapeutic purposes, such as medical devices, drugs, cells, tissues, organs, vaccines and veterinary drugs, as well as NHPs.
Donna Herringer, director of sales and marketing with Naturally Nova Scotia, says that grouping NHPs together with drugs under therapeutic products came as a surprise to her.
As a past president of the Canadian Health Food Association (CHFA), Herringer says CHFA and other groups lobbied for years to have NHPs classed as its own distinctive category, separate from drugs.
"The Natural Health Products industry fought very hard for 25 years to distinct NHPs from drugs because they are inherently safe. You don't hear of people dying from vitamins or minerals, yet every day there are deaths that occur from prescription as well as over the counter drugs."
But Health Canada spokesperson Paul Duchesne says the use of the term "therapeutic product" does not indicate a move toward a more drug-like regulation for NHPs.
"This definition allows for greater regulatory flexibility and does not change the current definition of a drug or natural health product, as defined in the current Natural Health Product Regulations. The definition of a natural health product remains within the Natural Health Products Regulations."
Duchesne adds that "there are benefits, such as facilitating international trade," that come from NHPs being considered under legislation as a subset of drugs.
Another worrisome aspect of the bill is that it will broaden current laws that allow for the seizure of NHPs without a warrant or a judge's approval, something Herringer calls "a grave concern."
"That's a very uncomfortable part of it. It's a very strong enforcement act that really empowers the inspectorate, the people who enforce the regulations."
The power to seize and detain a product already exists under the current Food and Drugs Act, something Brad Stephan, operations manager with the Alberta-based Truehope Nutritional Support Ltd., is well aware of.
In July 2003, 17 police and Health Canada officials stormed Truehope's office in Raymond, near Calgary, downloaded information from computers and confiscated stacks of documents.
Truehope was marketing Empowerplus, a combination of 36 vitamins, minerals and anti-oxidants designed to treat bi-polar and other mood disorders. Under the law, making health claims classifies a supplement as a drug. Health Canada seized personal shipments of Empowerplus and ordered Truehope to stop selling the supplement in Canada.
"The part that did the damage was when [Health Canada] stopped the product at the border," says Stephan. "We had suicides. We lost contact with 300 clients."
When Truehope continued to sell the supplement, Health Canada took them to court. However, in 2006 Truehope was found not guilty. The judge ruled that the company was "overwhelmingly compelled to disobey…in order to protect the health, safety and well-being of the users of the supplement."
Although Empowerplus had been undergoing a double-blind study at the University of Calgary, the study didn't meet the requirements of Health Canada and was shut down.
"Health Canada said the double-blind study couldn't go ahead as it was, it had to be done drug-style," says Stephan.
And this, say critics, is another problem with Bill C-51 because if Health Canada reviewers look at NHPs the same ways as drugs, they're going to want to see very high standards such as double-blind studies.
While most pharmaceutical drugs contain only one active ingredient, NHPs usually have multiple ingredients, each of which would need to be studied, costing hundreds of millions of dollars.
"The only people who can afford double-blind studies are the pharmaceutical companies because they can make billions and billions of dollars," says Herringer.
This is one of the reasons why, says Stephan, natural products with a long history of use should be assumed safe unless otherwise proven or demonstrated to cause harm.
Natural health products continue to grow in popularity. An Ipsos-Reid survey found that over 75 per cent of Canadians purchased NHPs in 2005. According to CHFA, the NHP industry is currently worth $2.5 billion in Canada.
Bill C-52 takes a "life cycle" approach, meaning that products which initially seem fine but have problems surface later on can be withdrawn from the market, something that historically was left up to the manufacturer.
This is one of the bill's strong points, says Shawn O'Reilly, executive director of the Canadian Naturopathic Association, because it will provide more "regulatory oversight" over drugs.
However, the definition of "practitioner" under the bill will exclude naturopathic doctors from access to natural substances that may, at Health Canada's discretion, be designated as prescription therapeutic products, says O'Reilly.
"Naturopathic doctors currently do not have prescribing rights and yet they are the experts in natural substances, so we have a concern there. Also some of the definitions seem to be contradictory to definitions that exist in provincial legislation which again would impact a naturopathic doctor's practice."
O'Reilly questions whether those who decide if a natural substance will be considered a therapeutic product or a prescription product "have the training, education and expertise to be making that decision."
Herringer says she feels that while crafting Bill C-51, the government focused only on getting something done quickly about unsafe products coming into the country while possibly limiting freedom of choice for Canadians in the process.
"They're acting fast but they're not acting thorough because on the one hand they will be protecting Canadian citizens but on the other hand they may deny them the freedoms of natural health products."
Meanwhile, a protest against Bill C-51 will take place outside the Calgary Federal Court on May 9. At the same time inside the courthouse, Truehope will be seeking a permanent injunction against Health Canada to prevent it from ever again seizing Empowerplus from Truehope's clients.
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