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The Regulation of Natural Health Products

How The Process Affects The Canadian Marketplace

Over the past 20 years the use of natural products has increased dramatically. This caught the attention of government, pushing them to pass laws governing natural products. The Canadian government has been regulating all Natural Health Products, also known as NHPs (vitamins, minerals, herbals, probiotics, etc.) since 2004. They do this because their responsibility (as written in law) is to ensure that all NHPs are “safe and effective”. To this, the government is supposed to license all aspects of NHPs. This includes raw materials, manufacturing, testing, packaging, labeling, distribution and selling.

The majority of the NHP industry wanted regulation; the controversy has been in just how the regulations would look and how they would be enforced. The challenge has been, and will continue to be the interpretation of the regulations. Industry often takes one view while Health Canada often takes an opposing view.

The whole process begins with how products are manufactured. Every importer and manufacturer needs to be licensed (called a site license). This is to ensure that the premises, manufacturing equipment and storage conditions don’t harm finished products. The database of all licenses is publicly accessible so you can check that the products you use are manufactured under a license. (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/sl-list-le-eng.php)

The next step is product licensing. Each company must submit its formula, and rationale for that formula (including therapeutic claim(s)). As part of the product license process, manufacturers need to test the product for purity and contamination. Each licensed product carries a unique registration number known as an NPN (Natural Product Number) which appears on the package. The database of all NPNs is publically accessible so you can check that the products are licensed. (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php).

With all manufacturers licensed and all products licensed, where do the difficulties come from?  In a perfect world, every company that applied for a manufacturing license would get one and every company that applied for a product license would get one. That however is not the case. Literally thousands of manufacturing licence applications have been refused and the number of product license refusals has been staggering.

Most site license applications are eventually granted with the applicant company modifying procedures or paperwork to ultimately comply. In the case of product licenses, the situation is entirely different. This is where most of the “friction” exists.

When a company applies for a product license, it does so believing the product is safe and effective (and will ultimately be profitable). The company fills in all the paperwork (and there is a fair bit), includes supporting evidence for safety and efficacy and then waits. The wait can be anywhere from 30 days to almost a year, depending on the complexity of the formula. For the lucky ones (and usually simplest formulas) the wait is short and the license is granted. For the less lucky the wait is long and the license is granted. Often Health Canada will send an IRN (Information Request Notice) where they will ask questions and give you a time limit to respond. If they are happy with your response the process continues. If they feel you did not answer correctly to their satisfaction, the license is denied.

For the unlucky ones, be it a long time frame or a short time frame, the license is refused. Often the refusal is because the applicant company is unable to locate credible (in Health Canada’s opinion) sources to back up the formula’s safety and efficacy. This rubs many the wrong way as they will bring up that these products are inherently low risk and have been used for centuries without significant harm.

I understand and can sympathize with both sides of this issue. On the one hand Health Canada is giving manufacturers a “seal of approval” when it grants a license to manufacturers to sell a product and consumers should feel a degree of assurance with that seal. I see also that the overwhelming majority of products are safe (even when taken without regard for the dose listed on the package).

BUT there are some “natural” products that have been rightfully refused licenses because they are not safe, and should rightfully not be sold. An example is the “ECA stack”. These were products containing Ephedrine, Caffeine and Aspirin. They were sold as weight loss products and were very popular in the late 90’s. They were popular because they worked. Unfortunately they were incredibly hard on users’ hearts, causing heart attacks and in some cases death.

Where do I stand on the issue? I believe that Health Canada has improved the process greatly over the past few years but can do much more to lighten both their load (reducing costs) and improve the ability of companies to get licensed, enabling consumers to see more of the product they want on store shelves. At the same time I think companies need to be realistic and apply for products with ample safety and efficacy documentation, making it easier for Health Canada to say, APPROVED!

One issue that has yet to be addressed is the regulation’s inherent stifling of innovation. Because all formulas become public knowledge in order to get a license, it is out there for everyone including your competition to see. This has a chilling effect on many companies. This pushes everyone to create “me too” products rather than investing time and money into creating something truly unique. The ultimate loser in this (existing) scenario is the Canadian public. I challenge Health Canada to work with the industry to solve this problem together.