Expect Big Changes to the Regulation of Natural Health Products in Canada

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Health Canada is overhauling the way it regulates natural health products (NHP). Health Canada defines NHP’s as a substance or a combination of substances that provide pharmacological activity and reduce the risk/presence of a given disease. The problem with this definition is that the vast majority of NHP (or any supplement for that matter) do not have pharmacologic activity, nor do they reduce any disease.

An interesting case at the forefront of this conversation surrounds the efficacy of Cold-FX to accomplish the declared effects (reduce the common cold). A class action lawsuit has been filed against the makers of Cold-Fx stating that consumers were misled by the bold claims made by Cold-Fx. This lawsuit emerged from the recent discovery that the Alberta company which originally patented Cold-Fx withheld and misrepresented clinical efficacy data. These data are now available online and clearly show that in comparison to the placebo group, the group receiving Cold-Fx had the same severity and duration of the common cold.

A recent literature review discussing whether or not Cold-Fx is efficacious based on the current evidence noted peculiar inconsistencies and scientific malpractice within the Cold-Fx literature. The conclusion of the review is that these is currently no convincing scientific evidence to support the use of Cold-Fx. I would point out that this does not necessary mean Cold-Fx doesn’t work, it just means that the appropriate studies need to be performed and show an effect before Health Canada should support people spending their hard-earned money on this heavily advertised product.

Speaking of lawsuits, the current chieftain of bogus supplement claims, Dr. Oz, is being sued for his support of a compound known as Garcinia Cambogia. Dr. Oz claimed that this compound promotes weight loss, however, scientific investigations have not shown any effect of this supplement. The harm in what Dr. Oz is doing is that some of these unregulated compounds can have physiologic effects, but not the one the consumer wants. This concept is demonstrated by research investigating the effects of exercise training while supplementing with the active component in red wine known as resveratrol. Resveratrol is present in the skin of red grapes and has been suggested to play a role in the beneficial health effects associated with red wine.

In a study out of Queens University, human subjects consuming 150mg of resveratrol per day during exercise training had impaired exercise adaptations. Antioxidant (eg. Vitamin C and E) supplementation can also reduce the positive effects of exercise, and also reduce the effectiveness of some types of cancer chemotherapy. These studies highlight the importance of understanding what the supplement is and what is does, information health regulators should have in hand before allowing consumers to be bombarded with exquisitely designed marketing ploys. Indeed, the interests of consumers needs to be ahead of supplement manufacturers. Currently, this is not the case.

The good news is that under the proposed reforms, Health Canada would bring NHP, over-the-counter drugs, and cosmetics under a single set of rules and regulate them based on potential health risks. At the moment, the evidence required for Health Canada’s approval of an NHP is negligible, a point highlighted by a CBC Marketplace special in March of last year. With the new regime, any health claim would have to be supported by evidence and if not, the health claims made on product labels would have to be accompanied by a disclaimer stating the information has not been verified by Health Canada.

Canada currently has a multi-billion dollar NHP market, a number that is astronomical given the return on investment is basically non-existent. Sales of Cold-Fx alone are around $120 million annually. You could argue that by ensuring NHP claims are backed up by evidence, people wouldn’t be subject to the aggressive marketing, and our economy will be stimulated by all of the freed up cash. Furthermore, the money spent on NHP and other supplements would be better utilized to purchase fresh fruits and vegetables, and an updated bike. A healthy lifestyle has yet to be eclipsed in efficacy by any pill, especially pills not proven to work.

Healthy Living by Brennan Smith, PhD.

 

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