July 23, 2012
Is seaweed with medicinal qualities considered a food or drug in Canada? The Canadian regulated class of Natural Health Products" (NHPs) covers many new and popular consumer substances that many would argue do not easily fit into either of these categories. Under Canadas regulatory scheme, the Food and Drugs Act, we look to the Natural Health Product Regulations for the rules that apply to NHPs.
The regulations define NHPs in Canada. The definition has two parts. First, NHPs include plants or plant materials, alga, bacterium, fungus, non-human animal material, extracts of these substances, specific vitamins, amino acids, fatty acids, minerals and probiotics. As a result, products can range from traditional Chinese medicines (TCMs) to omega-3 supplements. Certain substances may also take the form of synthetic duplicates. In a general sense, NHPs are the rough equivalent of biologically based products" within the category of Complementary and Alternative Medicine (CAM) in the United States.
The second part of the definition describes what these products are used for. An NHP makes some sort of health claim, meaning that it is manufactured or sold for the diagnosis, treatment, mitigation or prevention of a disease; restoring or correcting organic functions in humans; or modifying organic functions in humans.
As the demand for natural ingredients has grown in Canada, the range of products classified as NHPs has continued to expand, and now also includes certain non-prescription toothpastes, antiperspirants, shampoos and other personal hygiene products.
The Licensing Process
The NHP regulations were introduced on Jan. 1, 2004, following seven years of public consultations with industry, practitioners, stakeholders, academics and consumers. They were designed to strike a balance between providing consumers with a range of choices and keeping products available that were being sold in Canada prior to implementation of the NHP regs, while at the same time ensuring safety and effectiveness.
The regulations are administered by the Natural Health Products Directorate and cover six broad areas: (1) initial product licensing, (2) package labeling, (3) manufacturing site licensing, (4) manufacturing practice, (5) adverse reaction reporting and (6) conduct of human clinical trials. The Directorates stated goal was to make a decision on an application within 60 days. However, due to a backlog of applications, products that are not evaluated in that time frame may be eligible for unlicensed sale. When a NPH does receive standard approval, it will receive a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) that must be displayed on the packaging.
Unprocessed Product License Applications
At the time of the introduction of the regulations in 2004, so many products were already on the market that an immediate and significant backlog of applications resulted. In the hopes of not hampering the market, the Directorate implemented the Natural Health Products (Unprocessed Product License Applications) Regulations. These additional regulations allow for the sale of certain classes of products after the license application has been received, but before Health Canadas full evaluation has been completed. Approved products are given an Exemption Number (EN) within 180 days of the initial license application. The EN is to be made visible on the product packaging within a reasonable amount of time. Certain products are not eligible for an EN number, for example, those that pose a specific risk to the pregnant population. These unprocessed product regulations are currently scheduled to be repealed on Feb. 4, 2013, as the backlog is expected to be cleared by that date.
Claims About Preventing/Treating Diseases
In Canada, products aimed at the general public must make reasonable claims regarding treatment, prevention or curing of diseases. The Food and Drug Act provides that products cannot be marketed or represented as treating or curing certain diseases and conditions, such as cancer or depression. However, the regulations provide that NPHs are exempt from this provision to the extent that they may claim to prevent such diseases.
Manufacturing in and Exporting to Canada
All manufacturers in Canada require site licenses, which require that Canadian standards for GMPs (good manufacturing practices) be met. These standards touch on all aspects of the manufacture, storage, handling, and distribution of NHPs. These standards also apply to importers, who must meet the same requirements, even if they do not store or manufacture the products.
The vibrant and growing consumer market for NHPs in Canada means manufacturers and distributors that navigate cost-effectively through the regulatory framework will be rewarded for their efforts.
Steven F. Rosenhek ([email protected]) is a partner in the Toronto office of Fasken Martineau DuMoulin LLP, a full-service law firm with Canadian offices in Vancouver, Calgary, Toronto, Ottawa, Montreal and Quebec City, and international offices in London, Paris and Johannesburg. The firm has considerable expertise in the licensing and regulation of NHPs in Canada and the EU, as well as all aspects of bringing such products to market.
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