Hands OFF My NHPs!
Health Canada is determined to impose new regulations on natural health products (NHPs).
This is bad news for consumers.
Currently, all natural health products (NHPs) sold in Canada are subject to the Natural Health Products Regulations, which came into being on January 1, 2004. Since then, NHP regulations have been overseen by the Natural Health Products Directorate (NHPD), a division of Health Canada.
Recently, the NHPD became the Natural and Non-prescription Health Products Directorate (NNHPD) in preparation for its recently-expanded mandate to add non-prescription and disinfectant drugs to its oversight. Hence, the regulatory harmonization of NHPs and Over the Counter Drugs (OTCs).
To summarize, proposed Health Canada NHP regulations will alter the current regulatory process as follows:
- Current NHP regulations will be phased out and replaced.
- NHPs will be regulated under the same requirements as OTCs.
- Allowable manufacturer claims will be reduced. Evidence-based claims that NHPs can positively impact chronic and serious disease will not be allowed.
- Health Canada will have the ability to refuse or cancel a product license at the discretion of a Health Canada employee.
- Manufacturers may be subject to monetary administrative penalties. They may also be subject to licensing fees.
- Practitioners’ ability to prepare (compound) natural remedies may be reduced; Health Canada has been unclear on this point.
Proposed Regulations Impacts
Proposed NHP regulations could adversely affect Canadians in the following ways.
1. If traditional claims are no longer allowed to support safety and efficacy of supplements, many will no longer be available to consumers.
- This applies to the majority of herbal ingredients approved by Health Canada, including, but not limited to: Aloe vera, Arnica, Ashwagandha, Black cohosh, Chamomille, Chaste tree, Devil’s Claw, Dong quai, Eleuthero, Garlic, Ginseng, Hawthorn, Lemon balm, Licorice, Milk thistle, Peppermint, Saw palmetto, Senna, St. John’s Wort, and Valerian.This also applies to, and threatens the future of, Traditional Chinese Medicine (TCM) in Canada.
- Homeopathic remedies may become unavailable if manufacturers lose the ability to make claims based on traditional references.
Proposed NHP regulations do not respect the traditional health practices of a multi-cultural Canada.
2. Consumers will pay more for supplements. New regulations will significantly increase the costs associated with the production and licensing of natural health products. These costs will be transferred to customers. There will be direct adverse health impacts for people who rely on, but cannot access, their supplements. Resulting increasing acute and chronic disease will burden provincial medical systems.
3. Consumer choice will decrease. Proposed regulations will result in the disappearance of some companies from the marketplace, especially smaller companies that tend to be the most innovative and values-based.
The Canadian supplement industry, well-respected around the world, will suffer irreparably if proposed regulations are implemented. This clean, industry, full of potential as a global leader, should be supported and encouraged by the federal government.
Arguments Against Proposed NHP Regulations
- Current NHP regulations, implemented only 15 years ago, are not only adequate; they are globally respected.
- Proposed NHP regulations are unnecessary, are not based on a specific concern or incident(s) and contravene Canadians’ right to their own health choices.
- Proposed NHP regulations will result in reduced allowable manufacturer claims.
- Evidence-based claims that NHPs can positively impact chronic and serious disease will not be allowed.
- Proposed NHP regulations have not clearly indicated whether practitioners will be allowed to prepare (compound) natural remedies according to individual needs.
- Proposed NHP regulations will stifle product innovation due to claims restrictions.
- Proposed NHP regulations will give Health Canada the ability to refuse or cancel a product license at the discretion of a Health Canada employee.
- Proposed NHP regulations will subject natural health companies to potential administrative monetary penalties.
- Health Canada’s indication that they’d like to implement a “more consistent” fee approach may mean that NHP companies will have to pay for licensing.
- All of the above will adversely impact manufacturers, retailers, and ultimately, consumers.