Would you like natural health products to be approved on the basis of whether or not they work? Instead, Health Canada is considering revising its approval process and basing it on risk.
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TRANSCRIPT:
Hey, this is Jonathan from The Body of Evidence.
Today, we need to talk about Health Canada and natural health products. As you probably know, herbal supplements, homeopathy, and these types of products are currently approved for sale by Health Canada with very little oversight. Health Canada has begun a process of consultations with the public and with interest groups because they want to modernize this regulatory pathway. I participated in the first wave of online consultations and I recently attended a public consultation in Montreal with a few familiar faces.
I first want to explain what is the current situation; how Health Canada is proposing to change things; and what arguments I’ve heard on either side, before sharing my own opinion on the topic. And, as always, I’d love to see your input in the comments below.
Right now, natural health products, like these green coffee beans here, pretty much get a free pass. They don’t need to prove that they work for Health Canada to approve them and give them an “NPN” number, as long as the claim is vague like “Weight Management”. In fact, if you read the fine print on the back, under “Recommended use or purpose”, it says, “Helps with weight management when used in conjunction with a reduced calorie-diet and exercise program”. Skeptics rightfully say that, if you lose weight using this product, it’s because you’re eating fewer calories and exercising.
Health Canada now wants to change the way in which three types of products are being approved. These products, known overall as “self-care products”, are natural health products (like these coffee beans); cosmetics (like makeup); and non-prescription drugs (like over-the-counter allergy medication and cough syrups).
The main change they are proposing-and this is, at this point, being communicated as a “proposal”-is to use *risk* to determine whether to approve a product or not. They define risk as an equation made up of two variables: how safe is the product itself plus what is the risk of harm if the product is not as effective as the manufacturer says it’s supposed to be. This would create two classes of self-care products. Class I products would be low overall risk and they would only be registered with Health Canada. Class II products would be higher risk products and would need to be actively reviewed by Health Canada. Natural health products, like green coffee beans and homeopathy, would belong to either class I or class II depending on their risk profile.
So, to summarize, so far, Health Canada wants the approval process of all self-care products to be based on risk and wants to split products into two risk classes. Class I gets a pass and only requires registration, whereas class II requires an actual review process.
With me so far? Because that next bit gets confusing and contradictory.
You can’t make any kind of health claim for a class I product. On one of their slides, Health Canada listed that class I products are intended for one of three purposes:
1) To cleanse, protect, alter the complexion/skin/hair/teeth, beautify… basically, cosmetics.
2) For general wellness, to maintain, support, manage, provide a source of, or a mechanism of action having a physiological effect… these are structure/function claims and we’ll come back to those.
And 3) To treat, prevent, mitigate certain conditions including symptoms.
But then, under class II, products are intended to likewise treat, prevent, mitigate certain conditions including symptoms. The difference? Class II must be supported by modern evidence to be reviewed by Health Canada, whereas class I can be supported by traditional use and this evidence is only needed if Health Canada requests it.
I’m going to read examples they provided of health claims that class I products…
