Natural health products are not drugs

Changing the way NHPs are regulated will have an impact on the products you will find on your store shelves. Providing the evidence required for drugs is vastly expensive, which is why the price for drugs is significantly higher compared to NHPs.

Tell Health Canada to leave our NHPs alone

 

by Helen Long

Health Canada has recently launched the Consulting Canadians on the Regulation of Self-Care Products in Canada document. Previously referred to as the Consumer Health Product Framework, this document has changed dramatically since its original inception, and proposes that, in the future, many natural health products (NHPs) be regulated using the same rules as drugs. We want to make one thing clear: natural health products are not drugs. Health Canada is proposing changes that could:

  • Cause many of the supplements that you use to disappear forever.
  • Increase the cost of the products that are left.
  • Reduce the amount of information available to you about the natural health products you rely on.

Help us stop this by sending a message to your Member of Parliament, letting him or her know this is not OK. You can do this in less than a minute. Send a letter to your MP today stating you want to be able to continue to access natural health products. Visit www.chfa.ca and on the homepage click on Save our Supplements.

When you walk into your local Canadian Health Food Association (CHFA) member health food store, you can find all kinds of safe, effective and high-quality natural health products (NHPs) that 77 percent of Canadians use for the maintenance of good health.

Whether you choose a vitamin, mineral, probiotic or herbal product, you can be confident the Canadian regulations that already exist for these products are among the best in the world.

The Canadian approach to regulation is often referred to as a “pre-approval” system, which means that all natural health products (NHPs) must be licensed by Health Canada before they are legally allowed to be sold to Canadians.

No NHP can be licensed for sale in Canada without providing evidence to support the claims being made. The level of evidence required for NHPs seeking approval in Canada depends on the claim being made, the overall risk of the product, and the condition it is being used for.

A product such as a multivitamin that makes a claim, for instance, that it “helps with the maintenance of good health” will have to provide different evidence than an omega-3 that makes the claim that it “helps to reduce serum triglycerides and support brain function.” This evidence could include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources.

Each product that is licensed receives a Natural Product Number or NPN, which is printed on the front of the package. You can look up this NPN in Health Canada’s online database (visit www.hc-sc.gc.ca and search for NHP numbers database), which provides details including what is in the product and which claims have been approved based on the evidence submitted and reviewed by Health Canada.

When you buy an NHP at your local CHFA Member health food store, you can feel confident knowing the company selling that product has provided evidence to support any health claims made.

Health Canada is now proposing a framework that could significantly alter the way that NHPs are currently regulated under the existing NHP Regulations, and instead wants to regulate some NHPs using the same rules as drugs, based, it appears, on a single consumer survey and six weeks of consultation.

This proposal is trying to fix a system that is not broken and it will be a step backward instead of forward. Our current regulations take into account the unique properties and low-risk nature of these products, ensuring you have access to NHPs that are safe, effective and of high quality, while respecting consumers’ freedom of choice and the philosophical and cultural diversity of our country.

Changing the way NHPs are regulated will have an impact on the products you will find on your store shelves. Providing the evidence required for drugs is vastly expensive, which is why the price for drugs is significantly higher compared to NHPs. Requiring the same level of evidence as a drug will result in price increases and loss of product from shelves. Currently, all NHPs on store shelves are reviewed, licensed and receive an NPN.

This proposal suggests that Health Canada will no longer review some of the products and those products not reviewed will be required to have a disclaimer in line with “Health Canada has not reviewed…” Additionally, claims based on previously accepted evidence may no longer be allowed and would be removed from the label. This will limit the amount of information the consumer receives about the product.

Help us ensure you continue to have access to the NHPs you know and love. Visit chfa.ca right now to send a message to your Member of Parliament, letting them know these changes are not acceptable. It will only take a minute and it will make a big difference in ensuring you continue to have access to your favourite natural health products. j

Helen Long is the president of the Canadian Health Food Association (CHFA). The CHFA is the voice of the natural health industry in Canada, and Canada’s largest trade association dedicated to natural health and organic products. Its members include manufacturers, retailers, wholesalers, distributors and importers of natural and organic products. These can include foods, vitamin and mineral supplements, herbal products, homeopathics, sports nutrition products, health and beauty aids and more. www.chfa.ca


 

Industry feedback

Health Canada has suddenly decided to blow up the Natural Health Product regulations – regulations that, finally, in the last few years are starting to function properly.

Health Canada is proposing to cancel 100,000 licenses that our industry and government spent millions of dollars and countless hours developing. Canada is now the gold standard around the world for the regulation of this sector and Health Canada wants to abolish that.

Health Canada must be stopped and Canadians’ right to purchase safe, effective supplements with health claims must be preserved. Please write your MP; go to www.chfa.ca and click on Save our Supplements on the homepage to send your letter.

In 1999, the Parliamentary Standing Committee on Health extensively studied the issue and consulted Canadians from coast to coast for almost a full year. The Committee made 53 recommendations on how to regulate supplements in Canada, including:

“NHPs should be allowed to make health claims, including structure-function claims, risk-reduction claims and treatment claims” and “The evidence [for NHPs should] not be limited to double blind clinical trials, but also include other types of evidence such as generally accepted and traditional references, professional consensus, other types of clinical trials and other clinical or scientific evidence.”

Based on this feedback, in 2004, Health Canada introduced the Natural Health Product Regulations, and over the past 12 years, industry and government have worked together to regulate an industry that supplies safe and effective natural health products to Canadians.

Blowing up the regulations will have a devastating impact on the natural health industry in Canada and cost us thousands of jobs. It will also severely limit Canadians’ access to these products.

Health Canada is proposing that, going forward, supplements will not be allowed to make health claims unless they undergo pharmaceutical style double-blind placebo clinical trials. Since such trials typically cost $20 million each, Health Canada knows this is impossible. They also know this directly contravenes the will of Parliament.

Reading through the text of the Health Canada proposal, they keep referring to themselves as an “evidence based institution,” yet they provide no evidence there is anything wrong with the current NHP regulatory model. When it comes to scientific studies of NHPs, the medical literature is immense; there are tens of thousands of studies from major research institutions supporting the safety and efficacy of vitamins and herbs.

It is truly disturbing that after 12 years of developing these regulations based on the Committee’s recommendations, Health Canada has come out with this proposal to blow up the regulations and take us back 20 years to a pharma paradigm, which does not allow for traditional Chinese medicine, Ayurveda and traditional herbalism – not to mention vitamins and minerals – to make health claims. It’s crazy. They did not consult the CHFA at all and they gave only a 45-day notice period for consultation!

To be honest, I don’t think this was part of the plan of the new government. I think Health Canada is pulling a fast one on a new government that is not educated on this issue. But the new government, so far, is allowing this to happen.

Our industry wants and welcomes regulatory oversight. We want Health Canada to review products before they come to market to ensure Canadians are buying safe effective NHPs. What we can’t support is a pharmaceutical review process for products that are not pharmaceuticals. Again, please write to your MP and tell them you don’t want Health Canada to stop regulation of the industry.

– Matthew Breech

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