Health Canada expands power with the Wookey decision

The Ontario Court of Appeal found that a drug is any substance that modifies an organic function. That definition would lnclude water.

The noose tightens

by Shawn Buckley

The Ontario Court of Appeal found that a drug is any substance that modifies an organic function. That definition would lnclude water.

Many of the broad powers that created concern years ago with Bill C-51 are now law in the Food and Drugs Act. The only saving grace is they do not yet apply to natural health products because of the public backlash that readers like you created during the Bill C-51 fight. Eventually, I predict the broad powers we were all concerned about will apply to natural products. A story, or stories, about harm caused by natural products will circulate in the media, and calls for imposing the broad powers on natural products will be made. Armed with the public cry for protection, the government will dutifully comply and expand the powers to cover natural health products. At that point, anyone involved in natural health could be completely and totally destroyed financially and jailed for long periods for not complying with Health Canada demands, regardless of how unfounded they may be and regardless of whether complying will cause harm or death to others.

Less noticed is the expansion of Health Canada’s powers by Court decisions. What occurs is after decades of Health Canada interpreting the Food and Drugs Act in one way, it changes its interpretation to expand its powers. Eventually, someone challenges them in Court to say the “new interpretation” is wrong. When this happens, the Court is faced with having to choose which Health Canada interpretation to accept: the original one often followed for many decades or the new one. Unfortunately, in a couple of key decisions, the Court has sided with Health Canada’s new interpretations.

The first Court decision, which I have written about before, is Strauss Enterprises Ltd. v. Canada. This is a 2008 decision of the Federal Court. At the time, the list of drugs available by prescription was set out in a Regulation called Schedule F. Anything on the prescription drug list was subject to restrictive regulations aimed at ensuring that prescription drugs were only available through doctors and pharmacists. This was necessary as many of the prescription drugs were extremely dangerous, even with doctor and pharmacist supervision. The prescription drug list was, and is, primarily a list of chemical substances. It did, however, also include some specific plants and plant extracts that were deemed to require the direct management of doctors and pharmacists. Anyone familiar with the Natural Health Product Regulations understands that anything on the prescription drug list cannot be in a natural health product.

Everything with the prescription drug list was fine for decades. The list made it abundantly clear as to what was a prescription drug and what was not a prescription drug. If a chemical or a plant was on the list, it was a prescription drug. If a chemical or a plant was not on the list, it was not a prescription drug. This was Health Canada’s interpretation of the law until roughly 2007. Then Health Canada changed its interpretation so that anything was a prescription drug if a prescription drug could be extracted from it.

The problem with this approach is that prescription drugs can be extracted from many common food and natural product ingredients. For example, common things like chocolate, tea, coffee, eggs and broccoli all contain prescription drugs, in that with enough lab work, you can extract a substance on the prescription drug list from them. It is likely that most multi-ingredient natural health products, and many single ingredient ones, could be deemed to be prescription drugs if enough lab work was done by Health Canada. Strauss Enterprises challenged this new interpretation and lost.

The effect of the Strauss decision is that now it can no longer be said with any certainty what a prescription drug is. Before the decision, anyone could look at the very clear list and know if a product was or was not a prescription drug. Now if a client asked me in my law practice, for many products the answer would be, “It depends on whether Health Canada decides to target you for attack.” In short, for a large number of multi-ingredient products, if Health Canada decides they want to remove the product from the market, they can with this new interpretation.

The significant problem with this is that the rule of law depends on certainty. Whereas, before there was certainty, now there is complete uncertainty. Now Health Canada has complete discretion as to whether or not to target a product, which to the rest of the rational universe is not a prescription drug. This creates tyranny, which simply is the unfettered exercise of discretion. The unfortunate side effect of the Court siding with Health Canada on this issue is that it undermines confidence in the law. When there is no certainty, and when the state can arbitrarily decide whom to attack, confidence in the system is lost.

The decision of R. v. Wookey, which came out in August, makes this uncertainty even worse. In Wookey, a company was selling a chemical called BZP. BZP can act like an amphetamine, but it was not listed as a controlled drug in the Controlled Drugs and Substances Act at the time. I say “at the time” as shortly after BZP was listed as a controlled drug, which made it clear to all that it could not be sold. Health Canada could have accepted there was a gap in the law that was quickly fixed. Rather, the State decided it was necessary to charge Mr. Wookey with something, despite his reasonable reliance on the apparent law at the time. The State used the Food and Drugs Act to charge Mr. Wookey, alleging that the definition of “drug” in that Act included substances sold for recreational purposes.

Up until the Wookey decision, the definition of “drug” was not concise, but there was a longstanding consensus and understanding that it covered substances that were being made, sold or advertised for a therapeutic or medicinal purpose. Food, which is clearly necessary for health, and which affects all of our cells, let alone all of our biological functions, was not a “drug” unless being made, sold or advertised for a medicinal purpose. For example, parsley that you buy in the vegetable section of your grocery store was not a drug when you bought it as a food. However, when it was sold for a medicinal purpose it was a drug and subject to the drug regulations. This is why some parsley is sold as a natural health product with a Health Canada licence as a drug (natural health products are a category of drug).

The definition of “drug” includes the words: “drug includes any substance or mixture of substances… for use in modifying organic functions in human beings.” Prior to Wookey, it was clear that these words, in the context of the entire definition, were restricted to changes for a medicinal or therapeutic purpose. However, the Ontario Court of Appeal in Wookey found that they apply generally to any substance that modifies an organic function in human beings regardless of the purpose or intent. I cannot think of a single food that does not modify an organic function. For example, water clearly does, especially when a person is dehydrated. If anyone had approached my law office asking for something like BZP to be licensed as a drug when the purpose of them selling it was to create euphoria, we would have advised them it could not be licensed as a drug, as euphoria as recreation is not a medicinal or therapeutic purpose. If pleasure now makes a product a drug, cheesecake advertised as delicious is a drug. Cheesecake certainly modifies the organic function of your taste buds, and then a series of biological process along the way to excretion. If Wookey is correct, how can alcohol and cigarettes be left on the market without drug approval?

The effect of the Wookey decision is twofold. First, it creates confusion and uncertainty for anyone selling substances that are ingested or might moisturize the skin. Second, it gives Health Canada almost unfettered discretion to destroy anyone who would have previously been legally selling a food or item fully believing they were in compliance with the law.

People who act as NHP consultants are still going to have to pretend that, under the Act, there are four distinct categories into which to slot a product: foods, drugs, cosmetics, or devices. No one is going to try to license Bud-Light as a drug anytime soon. Persons selling literally anything ingested, or something that affects the skin, will need to be advised, however, that at any time Health Canada could arbitrarily decide to attack their product as a drug. I have witnessed Health Canada attacks that destroyed small and medium sized businesses so they are not to be taken lightly.

Rather than accept there had been a gap in the law concerning BZP that had been fixed, the Ontario Court of Appeal made a decision that creates uncertainty and which leaves persons at risk of attack solely at Health Canada’s discretion. As with the Strauss decision, the Wookey decision will lead to a loss of confidence in the law…

The United States, which has a common law tradition, regulates natural products under the Dietary Health and Education Act, 1984. Under that Act, there is wide freedom to access any natural product. To remove a product, the State has to have evidence of risk. It is common knowledge that the US has the largest number of available products than likely any other country. I personally order products from the US that I cannot get in Canada. Contrast the US with Germany, a civil law country. The only natural products available are a small number on a specific list the German government allows.

In Canada, I have been witnessing a steady progression, supported by the Courts, away from our liberal common law heritage to a restrictive civil law model. This move to make illegal anything not specifically approved of by the government is not restricted to food and drugs. It covers all areas of our lives, even speech. Indeed, so much of our regular activities have become criminalized, that if anyone asked me, as a lawyer, to give them a summary of what is illegal I would say, “Living is illegal.”

Perversely, with things like the undermining of our food safety regulations, the privileging of chemical drugs, the allowance of chemicals and genetically modified organisms in our food, to short list a few, it is clear the government is trying to stop our ‘illegal’ behaviour as quickly as it can.

Excerpted from the original article posted at (September 6, 2016). Shawn Buckley (LLB) is president of the Natural Health Products Protection Association (NHPPA). His expertise combines detailed knowledge of our Constitution and the Food and Drug Act, with 15 years experience successfully defending natural health stakeholders from prosecution by Health Canada.

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