The natural health product industry is in crisis.  New natural health product regulations set by Health Canada are driving smaller manufacturers out of business and driving up the cost of safe and effective natural health products.  Thousands of quality products are now illegal as a result of the regulation process, and innovation is grinding to a halt.

I strongly advise all consumers whose health depends upon specific natural health products (NHPs) to purchase a lifetime supply as soon as possible.  There's no way to predict when Health Canada will target your favourite product and remove it from the shelf.

Health Canada's assault on the industry does not make sense-the NHP industry is incredibly safe.  To my knowledge, there has never been a death in Canada caused by any NHP.  Meanwhile, Statistics Canada reports that hundreds of us die each year from nutritional deficits.  Really, Health Canada should be promoting the NHP industry rather than smothering it.  So why are we in the situation of losing access to valuable products? Part of the answer, I believe, is that Health Canada is stuck in a drug paradigm and inappropriately applying it to NHPs.

NHP regulations dangerous
Health Canada has had some dramatic failures in the chemical drug approval process.  The most notable was the thalidomide approval, which led to serious birth defects.  Such failures caused Health Canada to adopt the mind-set that all drugs are dangerous until they have been proven to be safe.  In the case of chemical pharmaceutical drugs, I think that this is a necessary and appropriate attitude for Health Canada to take.  This attitude becomes dangerous, however, when applied to nutrients that have naturally been in our food chain for thousands of years.

NHPs are categorized as drugs under our Food and Drugs Act.  Health Canada doesn't have to apply its "dangerous until proven safe" approach to NHPs, but it does, failing to understand that its approach is dangerous and causing harm to Canadians.  Many NHPs have tremendous health benefits.  I came to understand this when I was preparing for a trial.

Strauss Heart Drops on trial
My client was an herbalist charged with practising medicine because he claimed he could cure heart disease with Strauss Heart Drops.  There was no question that he made this claim, so I planned to defend him by claiming that the Act, which says only doctors could make such claims, violated our right to free speech.  To show the court that my client was telling the truth, I had to provide evidence that the product worked.  I asked my client if he had any evidence the Strauss Heart Drops worked and he gave me boxes and boxes of letters that people had written telling him how he had helped them.  I interviewed scores of people and selected five to be witnesses.  All had the following in common: (1) they had serious heart disease; (2) they had undergone at least one by-pass surgery; (3) after the surgery their health had deteriorated again and needed another by-pass surgery; (4) they were either unwilling to go through another surgery or the medical profession would not give them another as they were not good candidates to survive; and (5) all then started using the Strauss Heart Drops and returned to health.  When I say these witnesses "returned to health," I mean they went on to lead normal healthy lives.  The only side-effect was that all were upset that they had not learned about the natural remedy before their surgery.

Through this trial preparation, I realized that some NHPs have real and powerful health benefits.  In the case of my five witnesses and the thousands of other people who had written my client thank you letters, access to the Strauss Heart Drops was a matter of life and death.  And yet, Health Canada later charged the Strauss Herb Company for selling the remedy in an effort to take the remedy off the market.  Strauss was, fortunately, found not guilty at the trial.

Guilty of not fitting in
Assuming that Health Canada exists to protect Canadians, why did they attempt to take the Strauss Heart Drops off the market, when doing so would have caused tremendous suffering to thousands of Canadians who relied upon them? There were no consumer complaints about the product, and Health Canada's own lab analysis found nothing unsafe about the product.

From Health Canada's illogical perspective, the remedy posed a safety issue because Strauss had not proved to Health Canada that the Heart Drops were safe. The way to do this, from Health Canada's perspective, was to apply for the costly processing of receiving a drug identification number (DIN).  However, it was impossible for Strauss to get a DIN for their remedy because the DIN process was designed for single compound synthetic drugs.  A product like the Strauss Heart Drops is made from several plants and does not qualify for a DIN.  That is why Strauss Heart Drops were attacked.  They, along with 90 percent of the NHPs on the market at the time, did not have a DIN.  Since almost all NHPs could not get DINs, Health Canada was free to attack them in the name of "safety." Unfortunately, as demonstrated in the case of the Strauss Heart Drops, it was Health Canada's inappropriate regulations and attack that creates a health risk to Canadians.

Regulations new, uproar old
Health Canada's risky assault on the NHP industry is not new.  In fact, the new NHP regulations were born in reaction to Canadians rallying against Health Canada attacks on NHPs.  The clear message from consumers, motivated by groups such as HANS, was that they wanted their access to NHPs protected.

The political uproar forced the government to refer the matter to a Standing Committee on Health.  The Committee came up with 53 recommendations directed to protecting consumer access.  Health Canada then went to work drafting new regulations.  The natural products industry and consumers were expecting NHPs to be given their own category under the Food and Drugs Act, so that they would not be treated as drugs.  Instead, Health Canada, armed with the belief all things are dangerous until proven safe, came up with drug-style regulations.

The new NHP regulations are being used by Health Canada to continue their risky assault on the NHP industry.  Instead of legalizing the industry as was hoped, over half of licence applications have been refused and there's little hope for new products.

Time to speak up (again)
It's bad enough that Health Canada is assuming that NHPs are dangerous unless proven safe and enforces regulations that are impossible to follow, but they fail to understand that removing NHPs from the market pose a tremendous health risk to Canadians.  Many NHPs have tremendous health benefits.  Many are quickly disappearing.

Once again, consumers are going to have to take action to protect their health.  We simply cannot sit back and allow Health Canada to remove effective NHPs from the market because of a "presumption" of danger.  The real danger is being created by Health Canada.

Shawn Buckley is a lawyer who specializes in assisting manufacturers of NHPs navigate the Food and Drugs Act and Regulations.

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