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Pre-Market Approval of Dietary Supplements: The Canadian Story

98

Composition with dietary supplement capsules. Drug pills

Could the same thing happen in the US?

Analysis by guest columnist Shawn Buckley, LLB, president of Canada’s Natural Health Products Protection Association and a Canadian constitutional and criminal lawyer. He has appeared before the Senate and House Committees of the Parliament of Canada as an expert witness on constitutional and health issues.

In the 1990s there was a citizens’ rebellion in the US wanting to protect their access to dietary supplements. This led to the passage of the Dietary Supplements Health and Education Act 1994 (DSHEA). Under this Act, supplements are classed as a food and are presumed to be safe unless there is evidence to the contrary, and the FDA is not supposed to remove a supplement unless there is evidence of harm.

Soon thereafter, a citizens’ rebellion also occurred in Canada. Canadians made it clear that they were fed up with supplements being taken away, and they demanded increased access. One would have supposed that, having watched the US preserve its access to supplements, that Canada would follow suit. Instead, in 2004, Canada decided to treat supplements as a type of drug. All new supplements in Canada are presumed, to be both unsafe and ineffective (and therefore illegal); only those that can go through a pre-market approval process can remain on the market. To get approval, a supplement must be shown to be both safe and effective. This sounds reasonable on paper, but it has led to unfortunate health consequences.

If safety were a top priority, then a balanced risk assessment should be undertaken: the risk of taking a product away from people who are relying upon it to manage their health conditions, balanced with the risk of leaving the product on the market. It is dangerous and intellectually dishonest to remove a product due to a perceived “risk” without also taking into account the risk of removing the product.

Let us use nattokinase as an example. Nattokinase, an enzyme extracted from a fermented soybean product called natto, can be used as a natural blood thinner. In Canada, a decision was made that no approvals would be given for nattokinase (meaning it had to be removed from the shelves)—but the decision’s timing was telling. The New York Times, in an article called “A Promising Drug with a Flaw,” reported on a problem with Pradaxa, a blood thinning drug. Apparently people showed up at the hospital because their blood had become too thin, only to find there was no antidote for Pradaxa the way there is for other blood thinners such as warfarin (which is also used as rat poison).

However, a search of Health Canada’s adverse reaction reporting database does not reveal a single death caused by nattokinase. By banning nattokinase, Canadians whose conditions were being safely managed with nattokinase had to transition to pharmaceutical drugs that carry much more risk. You cannot move people from a low-risk product to high-risk products without health consequences. The banning of nattokinase will almost certainly cause deaths in Canada, a health consequence of “pre-approval.”

The Canadian experience shows that pre-approval also shuts down innovation. Before pre-approval became law in Canada, innovative products would disappear if they were not effective and would thrive if they were effective. Several key products that have had tremendously positive health benefits were introduced in Canada prior to the pre-approval regime. With pre-approval, the efficacy of a product must be proven to the government before it can be sold. For a new product, this means clinical trials, the cost of which has dramatically reduced innovation in Canada.

There has also been a “dumbing down” of products in Canada. Health Canada has required the amounts of therapeutic ingredients in many supplements to be reduced as a condition for approval. One manufacturer shared with me at a public forum that they decided to stop selling a key product because they knew it would not be effective at the “approved” amounts and they did not want to defraud the public. There are, of course, health consequences to rendering effective products less effective.

So what will happen if the US adopts the same paradigm as Canada? Several anti-supplement legislators have already proposed a pre-market FDA approval system for dietary supplements. Requiring supplements to be proven safe and effective to the FDA’s satisfaction before a license is granted—that is, with clinical trials costing millions or billions of dollars for each supplement—is insupportably expensive, with manufacturers unable to recoup their investment because the products are not usually patentable. This will only restrict access. And if the FDA wants to restrict access to supplements and promote access to drugs (which is demonstrably the case, considering the fact that the pharmaceutical industry funds 60% of the FDA’s drug review costs), then giving the FDA a mandate to reduce access should set off huge alarm bells. Moreover, because so many Americans rely on them to manage serious health conditions, the health consequences of such a regulatory change need to be taken into account.

The concept of pre-approval also carries an interesting philosophical change. If it is accepted that only products approved of by the government can be sold, then Americans are no longer free to decide how to manage their own health. In effect, pre-approval gives the FDA a veto over personal health decisions. Anyone supporting a pre-approval plan must understand that it will undermine the right Americans currently have to make personal health decisions.

I should disclose that I have a personal interest in the US keeping its current system. Because I live in Canada, there is a list of products I can no longer purchase in Canada due to our pre-market approval scheme. I purchase those products in the US. Indeed, when I bring this up in lectures, almost everyone indicates they do the same thing. Perhaps the most telling indictment of pre-market approval is the fact that a large number of Canadians now rely on the US marketplace to get supplements they need to stay healthy.

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