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NPN’s are NOT Drugs
When you walk into your local CHFA Member health food store, you can find all kinds of safe, effective and high-quality natural health products (NHPs) that you and 77 per cent of Canadians use for the maintenance of good health.
These NHPs could include vitamin C to reduce the duration and severity of the common cold. Or a probiotic to keep your immune system primed and ready to combat those winter bugs. Or vitamin D, since there are few natural dietary sources and because supplementing with vitamin D is almost universally recommended, particularly for those in greatest need like infants and the elderly.
Whatever NHPs you choose, it is important to know Canada is a global leader in the regulation of these products, which can include vitamins, minerals, probiotics, herbal products, homeopathic remedies and traditional medicines.
You can be confident that the Canadian regulations that already exist for these products are among the best in the world. These regulations are based on 53 recommendations made by the Standing Committee on Health (SCOH) in 1998. The SCOH met with hundreds of witnesses, including consumer groups, Health Canada, the Canadian Food Inspection Agency, International regulators, and received numerous submissions over a half a year of consultation.
Based on the robust consultation process, an appropriate framework was created for the regulations of NHPs. This work resulted in the passage of the Natural Health Products Regulations (NHP Regulations), which came into effect in 2004. Along with the regulation came the establishment of the then Natural Health Products Directorate (NHPD), now the Natural and Non-prescription Health Products Directorate (NNHPD), a branch of Health Canada dedicated to the review and oversight of NHPs.
The Canadian approach to regulation is often referred to as a “pre-approval” system, which means that all NHPs must be licensed by Health Canada before they are allowed to be legally sold to Canadians. Other countries have alternative methods for regulating products similar to NHPs. For example, the United States calls these products Dietary Supplements and they are regulated as food products, where oversight is done through “post-market reporting.” This means that Dietary Supplements can be marketed and sold in the U.S. without pre-approval and manufacturers are expected to report any adverse effects.
Currently, when you buy an NHP at your local CHFA Member health food store, you can feel confident knowing that the company selling that product has provided evidence to support any health claims made.
The level of evidence that is required to be submitted for NHPs seeking approval in Canada depends on the claim being made and the overall risk of the product, and the condition it is being used for. A product such as a multivitamin that makes a claim, “helps with the maintenance of good health,” will have to provide different evidence than an omega-3 that makes the claim, “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.
No NHP can be licensed for sale in Canada without providing evidence to support the claims being made. 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, which provides details including what is in the product, and what claims have been approved based on the evidence submitted and reviewed by Health Canada.
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 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 that you have access to NHPs that are safe, effective and of high quality, while respecting 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 store shelves. Providing the evidence required for drugs is vastly expensive, which is why the prices for drugs are significantly higher compared to NHPs. Requiring the same level of evidence as a drug, will result in price increases and loss of product from the retail level. 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 these ones 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.
To help ensure you continue to have access to the NHPs you know and love, we need your help. Please visit chfa.ca right now to send a message to your Member of Parliament, letting them know these proposed changes are not acceptable. It will only take you one minute and will make a big difference in helping us ensure you continue to have access to your favourite safe and effective natural health products.
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