Consumers who depend upon Natural Health Products (NHPs) have not figured it out yet, but they have been duped by the new Natural Health Product Regulations that many believe were implemented to protect their access to NHPs in the first place.
Consumers can be forgiven for their naiveté; in the late ‘90s, Health Canada began taking action against NHPs by classifying them as “drugs” and requiring manufacturers to obtain Drug Identification Numbers for their products. The minister of health also sought to implement fees that would raise their price. Alarmed that both the availability and affordability of NHPs were under attack, consumers took action to protect their access, including initiating a national petition to stop treating NHPs as drugs. A parliamentary assistant told me that it was either the largest or second largest petition drive in Canadian history. In addition to the petition, there were rallies, letter writing campaigns, and a law suit to strike down the proposed fee regulations. On the eve of the law suit, former Health Minister Allan Rock agreed to drop the fee regulations. He referred the issue to the Standing Committee on Health, which subsequently held the most comprehensive hearings in its history.
The committee included input from consumers, consumer groups, manufacturers, distributors and retailers. In conclusion, the Standing Committee made 53 recommendations, hearing the message loud and clear from consumers and manufacturers alike: Canadians wanted their access to NHPs protected.
Almost everyone involved in this process believed they were on their way to protecting access to NHPs. The problem, however, was that Health Canada had been squeezing the industry by imposing a chemical, pharmaceutical drug model upon NHPs. I would estimate that more than 90 percent of NHPs could not comply with this model, meaning that almost the entire NHP industry was unlicensed and illegal – not because manufacturers did not want to comply with the drug regulations, but because they could not. This left companies and their products in the position of sitting ducks should Health Canada decide to take action against them.
The purpose of the consumer movement and the 53 recommendations was to convince Health Canada to stop treating NHPs like chemical drugs, in order to ensure their availability to the public. After a long delay, the new NHP regulations, which can only be described as drug-style regulations, were introduced. NHPs are still classed as drugs; the regulations themselves mirror the chemical drug regulations.
While it is true that many NHPs will be able to comply with the new regulations, and hence in theory be “legal,” consumers do not understand that many, if not most, of the NHPs on the market before the regulations will not be able to comply because the compliance process is either too onerous or too costly. I am a lawyer who specializes in assisting natural health product manufacturers with the Food and Drug Act and regulations. I am acutely aware of what manufacturers are facing. I know of several manufacturers who have dropped much of their product line because it will bankrupt them to comply with the new regulations.
The only products they are trying to obtain licences for are their top sellers. Other products that consumers have depended on for decades are being dropped because the cost of obtaining licences is too high. Some manufacturers have stopped making NHPs altogether. Further complicating the access problem, several US manufacturers have stopped shipping into Canada because they do not comply with the new regulations.
The removal of NHPs that have been available to the Canadian public for years is set to accelerate this year. Unless consumers wake up and take action, products and manufacturers that they have relied upon for their health will be forever lost, due to regulations that ironically are supposed to protect access to NHPs.
The new NHP regulations also squash innovation. To obtain a licence, a manufacturer must show that the NHP is effective. In some cases, Health Canada is asking for a clinical trial. Most people would consider this reasonable as it is dangerous to allow a health product on the market without a clinical trial proving its safety. The problem with this is twofold. First, because there are no intellectual property rights with NHPs, the few manufacturers that could actually afford them are not willing to pay for them. If the trial is successful, any other manufacturer can copy the product and sell it at such a low price that the cost of the trial cannot be recovered.
The reality is that this requirement is grinding innovation to a halt.
The second problem with the requirement of clinical trials is that it ignores the actual risk profile of NHPs. When the NHP regulations came into effect, Health Canada estimated there were between 40,000 to 50,000 NHPs on the market. Despite this staggering number of products, I don’t believe that there has ever been a single death in Canada attributed to a NHP. This is not to say that NHPs carry no risk, but risk is relative. For example, we have documented deaths in Canada every year from both peanuts and shellfish. There are also numerous documented hospitalizations caused by these foods. To put it into context, the entire NHP industry, with up to 50,000 different products, is dramatically safer than the common peanut or a scallop.
We do not require clinical trials for peanut butter manufacturers who add a new ingredient to peanut butter. Yet if a NHP manufacturer adds garlic to an herbal heart remedy that has been on the market for decades, a clinical trial may be needed because, with the addition of garlic, it is now a “new” product, and, as such, its safety and efficacy must be proven under the new regulations.
As a taxpayer, I am appalled that the government is spending hundreds of millions of dollars to regulate an industry that is exceedingly safer than peanut butter and shellfish. If the government were to implement an expensive peanut butter directorate, taxpayers would be enraged. At the same time, we tolerate the NHP Directorate’s management of NHPs, which are far safer. We also sit by while the cost of NHPs is being driven up as manufacturers begin to pass on to consumers the high cost of complying with the new regulations.
The rising cost of NHPs should be a concern to all Canadians. Although many of us may be able to pay the higher prices, those on fixed incomes cannot. I have already heard of retailers passing on concerns to manufacturers that seniors on fixed incomes are not able to pay for the products they rely upon for their health. This is extremely troubling.
I am also troubled by a complete lack of awareness about the cost to people’s health from removing effective NHPs from the market. The new regulations, with their drug-style model, are premised on the belief that all drugs – remember; NHPs are drugs – are presumed dangerous until they are proven to be safe. I agree with this premise when dealing with chemical pharmaceutical drugs. Non-natural chemicals are dangerous to introduce without proof of safety. However, applying this philosophy to NHPs, which contain natural plants and/or animal ingredients already in the food chain, is problematic. It leads to the absurd result that ingredients we commonly eat cannot be sold for “health” purposes as NHPs because they are presumed to be dangerous.
There is a tremendous health cost to removing NHPs from the market. I, personally, rely upon NHPs for two different health concerns. For one, I tried all the treatments recommended by doctors and specialists without success. I then found a NHP that solved my problem. Unfortunately, the manufacturer has advised it is no longer making the product because of the new regulations. I don’t know what I will do when I run out. For my other health issue, the medical solution is periodic, minor surgery which promises to be invasive and painful, offering only a temporary fix. I found a NHP from the US which completely solves the problem and is only needed occasionally. I can still get the US product as that manufacturer has not yet experienced enough problems at the border to stop shipping to Canada. While my health problems are minor, many Canadians rely on NHPs for serious and life-threatening conditions. If and when they are removed from the market, there will be serious consequences.
The consumer-driven movement that led to the new regulations was aimed at protecting access to NHPs because people depended upon them for health reasons. It is ironic that the new regulations consumers believed would protect their health could actually be a threat. To make matters worse, I believe that the new regulations are illegal. Under our Constitution, Parliament and the provinces are each given separate areas of jurisdiction. The provinces have jurisdiction over health matters, which is why the provinces run hospitals, determine what is covered in the provincial health plan and regulate the medical professions.
The new regulations are based on Parliament’s jurisdiction over criminal law. Most of us do not think of health regulations as a criminal law issue, but the idea is that if a substance is harmful enough, then it is a criminal law issue. So, for example, Parliament has made heroin and cocaine illegal because they are harmful. Where this gets tricky is when Parliament tries to use the criminal law power for substances that are not harmful.
One of the leading cases is referred to as the Margarine Reference. The Dairy Industry Act banned the sale of margarine. This was a criminal law, the preamble of which explained a ban was necessary because margarine was “injurious to health.” The Supreme Court of Canada disagreed. They reasoned that for Parliament to prohibit a substance using its criminal law power, the substance had to carry a substantial risk. Otherwise, Parliament could regulate any area of provincial jurisdiction using the criminal law power by simply arguing “harm.” Although it could be argued that margarine is harmful, it was simply not harmful enough to be deemed criminal.
A more recent Supreme Court of Canada decision employing this principle is the case of R. v. Malmo-Lavine (2003). In this case, it was argued that Parliament did not have the jurisdiction to criminalize the simple possession of marijuana. The court disagreed because it found that the harm to vulnerable groups, such as youth and pregnant women, may be serious and substantial. As a result, the law was a valid exercise of the criminal law power.
So are NHPs harmful enough to be considered criminal? Under the NHP regulations, a product cannot be licensed for sale until Health Canada is satisfied that the product is safe for over-the-counter use (i.e. consumers can simply purchase it off of the shelf without any advice or restrictions). Can it be said that products safe enough to be placed on any store shelf are harmful enough to be considered criminal? If this were the case, Parliament could declare that anything in a grocery store is criminal. For example, Parliament could declare that peanut butter and scallops are illegal, criminal substances. I think that most of us would consider this ludicrous. Although peanut butter and shellfish are more harmful than the entire NHP industry, we do not think of peanut butter or scallops as criminal substances. Similarly, NHPs safe enough to be licensed are not harmful enough to be considered criminal. As soon as Health Canada issues a product licence for an NHP, it is confirming that it does not have jurisdiction to regulate that NHP.
NHPs that Canadians rely upon for their health are being driven from the market by regulations that I consider illegal. Unless consumers wake up and take notice, it will be too late for them to protect the NHPs they rely on.
Shawn Buckley is a constitutional lawyer who specializes in the Food and Drug Act and Regulations. He acts primarily on behalf of manufacturers of natural health products.