Safety, Evidence, and Natural Health Product Regulations

Do you watch CBC marketplace? I don’t. But enough of my social media is wrapped up health and wellness that I saw a lot about last Friday's episode on the natural health product regulations. Although the episode sensationalized their results (It’s television, what were you expecting) as a whole, it raised a single important question; how much evidence do we need for a natural health product to be available on our pharmacy and health food store shelves? 

In Canada, natural health products (NHPs) have their own set of regulations under our Food and Drug Act. If you are a policy nerd like me, you might like to read the full text of the regulations here The regulations outline what information is needed to receive a license for a natural health care product. It’s a fairly straightforward list with things like the product’s name, ingredients, conditions used for, as well as “information that supports the safety and efficacy of the natural health product when it is used in accordance with the recommended conditions of use.” 

Most people are happy with the fact that there are regulations in place that govern what health products can be sold in Canada. I know I find it reassuring. So what’s all the fuss? CBC marketplace, and others critical of natural health product regulation in Canada, feel that the standards are not high enough. On CBC marketplace, their made-up homeopathic fever remedy is backed only by photocopied pages from a Materia Medica, a type homeopathic textbook that summarizes homeopathic evidence. The episode claims that this is insufficient; they even interview a medical doctor who explains that natural health product regulations fall short of what we expect for prescription medications. 

But is that a surprise? Getting a new pharmaceutical approved is a big production. Is the CBC truly positing that consumers need the same level of evidence for chamomile tea that is required for Dulcolax? Chamomile has been used medicinally since the 1st century AD ( Dolcolax’s active ingredient, Bisacodyl, was synthesized in 1953 ( I point this out not to mock pharmaceutical development, or the rigorous process that puts new, safe and effective pharmaceuticals on our shelves, but from a place of opening up our conversation about evidence. A two thousand year history of safe and effective use is nothing to ignore, whether or not the remedy has been able to scare up some funding for randomized controlled trial. 

Our natural health products, and their regulations, don’t look a lot like our pharmaceutical regulations, and there is a reason for that. As I mentioned above, NHPs are regulated under the Food and Drug Act. They are treated differently than pharmaceuticals because they are different, with a different history. NHPs live in the grey area between food and drugs, and are regulated appropriately. Are these regulations perfect? No, I don’t think any regulations are. But to say that a Materia Medica is not a good source of information on homeopathy is simply not true. To say that natural products require pharmaceutical level evidence to be proven safe and effective ignores the base of our (recently developed) evidence pyramid. 

In the case of natural health products, or any products for that matter, I think we can agree that more evidence is better. In our drive to use the best possible evidence, lets not ignore the information we already have on our traditional medicines. Let’s strive to be open-minded in our conversations about evidence. Let’s look at the body of evidence as a whole and avoid skimming off the top. Ask yourself again; how much evidence do we need for a natural health product to be available on our pharmacy and health food store shelves?