Towards more effective supplement regulation in Canada

Unsubstantiated claims for natural health products could be a thing of the past in Canada.

I suppose I owe Health Canada some thanks. It was Health Canada’s lackadaisical  regulation of dietary supplements and natural health products that turned me from a “shruggie” pharmacist into one that started advocating, publicly, for putting consumers’ interests ahead of those of supplement manufacturers. While health regulations are seemingly created to protect consumers, Health Canada has  consistently given manufacturers the upper hand, prioritizing a company’s desire to sell a product over a consumer’s right to a properly regulated marketplace with safe, effective products. It’s now very clear that the Natural Health Products Regulations have led to an industry boom and massive sales, but also a confusing marketplace for consumers and no persuasive evidence that all those supplements have any meaningful effects on our health. Canadian drug store shelves in 2016 are packed with hundreds of products with unsubstantiated claims and untested products, and little credible information to guide selection.  Yet all of these products have been reviewed and deemed to be “safe and effective” by Health Canada.

Bogus Children’s Remedy Invented by CBC Marketplace Approved by Health Canada

Nothing is better than Nighton

Like many Canadians who saw last week’s news article “Health Canada licensing of natural remedies ‘a joke,’ doctor says” in the lead-up to Friday’s Marketplace episode on CBC, I was very interested in learning the story behind it. Unlike many Canadians, I wasn’t at all shocked or surprised by the outcome. This blog (and others) have been critical for years about the lack of oversight where the Natural Health Products Directorate (NHPD) is concerned. (The NHPD recently changed its name to the Natural and Non-prescription Health Products Directorate. (NNHPD))  See “Do the Natural Health Products Regulations Benefit Canadians?”, “Health Canada Gets Out a Big Rubber Stamp”   & “Safe and Effective? A Consumer’s Guide to Natural Health Products” for some background. For those who haven’t had a chance to view the episode, it can be viewed here:

There’s no reason to exempt Natural Health Products from Bill C-17

From Consumer Health Products Canada:

So, when is a therapeutic product not a therapeutic product? It’s a head-scratcher. Under Vanessa’s Law, disinfectant toilet bowl cleaners and hand sanitizers will be “therapeutic products,” while some cold medicines and, potentially, even low-dose statin cholesterol-reducing drugs, will not. (Health Canada has just proposed switching red yeast rice containing up to 1mg lovastatin from prescription to NHP status.) Consumer Health Products Canada believes that arming Canadians with the tools they need to take more control over their own health is vitally important to public health and to the sustainability of our health care system. Our member companies produce and sell the vast majority of the OTCs and NHPs that Canadians use in their own self-care. We embrace the provisions of Vanessa’s Law because they are entirely consistent with the law-abiding, safety-first way our members conduct business. But, if passed with the currently proposed, lop-sided definition of “therapeutic products,” we fear that Vanessa’s Law will distort the marketplace for consumer health products and could undermine consumer confidence in the roughly 50% of our member’s products that fall under the Natural Health Products Regulations.

More here.

Take action before June 10.

Natural Does Not Equal Safe: A Call to Action

One of the most pervasive yet appealing health myths is the idea that natural equals safe. It’s a statement that’s repeated constantly by manufacturers of supplements and “natural” health products. It’s been the primary argument used, with considerable success, to give these products completely different regulatory structures than exist for drug products. Weaker regulation of supplements and natural health products has been a boon to manufacturers, but the same can’t be said for consumer protection. It’s effectively a buyer-beware marketplace in most parts of the world, with little accurate information available to consumers. But supplement manufacturers aren’t content with the minimal regulation that’s currently in place – they want health “freedom”. In this case, “freedom” means the right to sell any product, while being exempted from safety and regulatory requirements. New Canadian legislation is poised to raise safety standards for drugs and enhance the ability of regulators to recall dangerous products, yet consumers of natural health products are left behind. The legislation proposes to exempt anything considered a “natural health product”. This is not only bad public policy, but it has the potential to cause avoidable harm. After all, shouldn’t users of supplements and natural health products be entitled to the same safety and quality standards as those that use prescription drugs? If the supplement industry gets its way, the answer will be “no”. (There is an opportunity until June 10 for you to provide feedback on this legislation – see below.)

Weekend Reading

Happy 2014 Everyone! It’s been a while since the last weekend reading update. Here’s some links and posts for your reading pleasure. The picture above is from the Toronto ice storm that we’re still recovering from.

Safe and Effective? A Consumer’s Guide to Natural Health Products

How far have we come from the Patent Medicine era?

The following is a summary of my Skepticamp Toronto 2010 presentation. Apologies to international readers for the Canadian-centric content.

I’ve been practicing pharmacy for over 15 years, and it didn’t take me long to realize after I started working that there was a completely different standard for safety and efficacy for herbal preparations and other supplements. That is, they were largely unregulated. Compared to Health Canada’s internationally-respected approval process for drug products, there was no process in place to regulate the supplement marketplace. To ensure consumers fully understood the potential risks of these products, I started to give two warnings to anyone that asked for my advice about these products:

Compared to drugs, there is little regulation of herbal products. Variation could exist between what it says on the label and what it actually contains.

And if they had any medical conditions, or were taking other drugs or supplements I would add:

Compared to prescription and over-the-counter drugs, the information we have on these products is limited. They could have the potential to interact with other medications and medical conditions that we are not aware of.

Until just a few years ago, Canada’s regulatory framework was not equipped to deal with non-drug supplements. Products were either drugs, and were registered as such, or they were food products, and drug regulatory requirements did not apply. A grey area existed and and all kinds of supplements appeared – with no specific regulatory oversight, no defined quality or content standards, and no objective evaluation of the efficacy claims.

Supplement Regulation – Canada versus the USA

How do Canadian regulations for natural health products compare to American regulations for dietary supplements? Which are superior, from a consumer protection perspective? Is either approach science-based? That’s the topic of my post today, over at Science-Based Medicine. Go check it out.

Unapproved Natural Health Products Banned from Ontario Pharmacies

In a stunning move, the Ontario College of Pharmacists has prohibited Ontario pharmacies from selling health products that are not approved for safety and efficacy by Health Canada. This directive, which takes effect immediately, banishes some of the most questionable “alternative” health products from pharmacy shelves. This message was sent to all pharmacies and pharmacists on January 20, 2010:

Mulberry for Weight Loss: Not just unproven, but implausible

I don’t normally read the freebie newspapers in Toronto as their content is the journalistic equivalent of the lead in the Toronto water supply: both slowly sap your intellect away.

But I ride public transit and those papers are littered everywhere, rolling around the TTC. So against my better judgment I picked up the paper on May 20,  skipped past the article from the “holistic nutritionist” (a topic for another day) and stumbled across this advertisement:

“The Man Who Made the Whole Town Lose Weight”

Impressive headline.  Reading further it turns out that “Johnny Petterson”, a local health food store owner in Alesund, Norway, had started selling mulberry leaf tablets to his customers, and they lost weight – after only 10 days.  According to the advertising copy, Johnny has helped over 1500 customers lose weight. Apparently this product is for sale at major pharmacies in Canada. So it’s time to do a bit of digging into this scientific breakthrough unearthed by a health food store owner.

Here’s excerpts from the ad (here is a similar PDF) – and my comments.