Marvin JS Ferrer
A previous article authored by Marvin JS Ferrer noted that Health Canada is currently reviewing its regulations regarding natural health products in Canada.
What is the current regulatory framework?
Natural health products (NHPs), along with cosmetics and non-prescription drugs, are the three product types that fall under the broad category of “self-care products” as defined by Health Canada.
Cosmetic products can only make claims about appearance. NHPs have only natural ingredients, non-prescription drugs have artificial ingredients, and both types can make claims about health.
Non-prescription drugs can only make claims supported by scientific evidence, such as randomized controlled double-blinded clinical trials.
NHPs are: 1) specifically listed by Health Canada, 2) a traditional medicine, or 3) a homeopathic medicine. Many health claims made by many natural health products, such as those for vitamins and minerals, can be supported by scientific evidence, the same standard as claims by non-prescription drugs.
Health Canada also recognizes traditional medicines based on knowledge, skills, and practices reflecting different philosophical backgrounds and cultural origins that improve or maintain physical or mental health. Traditional medicines can make health claims after demonstrating two generations of use, or by meeting European or Australian standards which are accepted by Health Canada.
Homeopathic NHPs can make health claims by relying on references like homeopathic materia medica or pharmacopoeia, which are lists of products and their intended use compiled and published by various homeopathic “expert” authors or editors. For example, to support claims that a natural health product treats nausea, Health Canada accepts photocopies from reference texts with relevant parts underlined (highlighting is discouraged).
Why are changes being proposed?
For this article, Health Canada was asked about proposed changes and the rationale behind them. Health Canada spokesperson Gary Holub said that although self-care products pose a lower risk to Canadians than other products like prescription drugs, “low risk does not mean no risk.”
In practice, there can be little difference in the mechanism of action between types of self-care products despite the different regulations they face. For example, toothpaste can be a cosmetic, non-prescription drug, or NHP depending on the claims it makes on its packaging and its ingredients. Toothpaste treated as a non-prescription drug receives a much higher degree of regulatory scrutiny, similar to those for prescription drugs, while another product claiming to treat a specific condition might not receive as much scrutiny if regulated as an NHP.
“The goal is to align the level of health and safety scrutiny with for each product with its potential risk to consumers,” Holub said.
Health Canada’s public consultation document also emphasizes that it is a “science-based regulator.” The document states that Health Canada wants to ensure “a standard has been met when we authorize a claim.” By accepting different kinds of evidence (traditional, homeopathic, and scientific) for self-care products, consumers may think a homeopathic, traditional and non-prescription drug product are equally effective, when that may not be the case.
Health Canada’s power to regulate after a self-care product enters the market also differs among product types. Health Canada can order a recall of non-prescription drugs, but not NHPs. Maximum fines for manufacturers or retailers of NHPs who break laws are 0.1% of the value of the maximum fine for of non-prescription drugs.
The new proposed frameworks build on consultations conducted in 2014. However, those consultations yielded only 31 respondents; three-quarters were from industry and only three respondents were consumers. Health Canada followed with public opinion polling of 2,500 respondents in 2016 to gauge consumer use and knowledge of self-care products.
What are the proposed changes?
Health Canada proposes to bring cosmetics, NHPs, and non-prescription drugs under the same regulatory framework. The proposed framework uses a risk-based approach to determine the level of regulatory review appropriate for a product.
Risk is defined as certainty around safety in established conditions, as well as the level of safety concern to a user in case of “failed efficacy” of a product (if it fails to do what it claims to do).
Health claims are redefined to those which state that products treat, diagnose, prevent, cure, or mitigate a disease or condition. Examples of health claims include: “relieves pain,” “relieves nausea,” or “treats cold, flu, and cough symptoms.”
Lower risk products would not receive pre-market review by Health Canada. They would not be able to make health claims. Some ingredients would be prohibited from lower risk products. To bring products to market, manufacturers would need only to notify Health Canada, and meet quality standards.
Holub said there would be an easier path to market in the proposed framework for “self-care products that are recognized as lower risk, including many natural health products.”
Moderate risk products would receive some pre-market review. Manufacturers must be licensed and meet safety, quality, and efficacy standards. These products can make health claims if the claims are supported by scientific evidence; Health Canada would review the claims and evidence.
Higher risk products would receive a full Health Canada review. Manufacturers must be licensed and provide evidence of safety, quality, and efficacy; like moderate risk products, higher risk products can make health claims supported by science.
Any product would be permitted to make general claims related to its function or ingredients. Examples of general claims include: “cleans teeth,” “moisturizes skin,” and “source of vitamin C.” The claims must be truthful and evidence must be held to support them. Disclaimers may be required to clarify that the claim was not reviewed by Health Canada.
What are possible challenges?
Health Canada was also asked about the possibility that professionals may continue to make health claims about self-care products that products themselves are not approved to make.
“Health Canada does not regulate the conduct of any health profession or practice,” Holub said. Therefore, the proposed framework would “only apply to the product themselves.”
“Health Canada will be consulting with provinces and territories and taking their views into consideration as we develop the framework,” he added. “You may wish to contact your provincial government.”
“We are unable to respond to your questions,” said Carol Lammers from the Ontario Naturopathic College when asked for comment regarding the potential regulatory impact of Health Canada’s proposed framework, and the Ontario Homeopathic College did not respond to requests for comment.
Similar challenges exist regarding other products that Health Canada regulates. Physicians often propose the use of medications for patients in conditions other than those for which the medication was licensed by Health Canada; this is called “off-label” use of a medication. Health Canada also does not regulate off-label use of medications by physicians, as it falls under provincial regulatory jurisdiction. However, the advertisement or promotion of off-label use of a medication is prohibited.
The Senate Standing Committee on Social Affairs, Science and Technology released a report in 2014 on off-label drug use in Canada, and found it occurs in specific contexts. Rare diseases for which there is no standard treatment are often treated with medications off-label given that few drugs are developed to treat these diseases. In addition, scientific clinical trials are rarely performed on some subgroups of the population, such as children, older Canadians, and pregnant women. Therefore, they are also often treated with off-label medications; up to 75 per cent of pediatric prescriptions are described as off-label.
In contrast, proposed “off-label” use of NHPs would likely occur in contexts where established evidence-based alternatives are available, which was explored in a previous article.
Holub gave no expected timeline for a resolution to consultations and final decisions regarding Health Canada’s proposed framework. Although public consultations by Health Canada ended in October 2016, consultations with stakeholders are ongoing. Holub said Health Canada continues to reach out to health practitioners, manufacturers of NHPs, retailers, academics, and others, to “refine the proposed approach.”
Marvin is a member of the Master of Public Policy Class of 2018 at the University of Toronto. He previously completed his master’s and doctoral degree in the cell biology of reproduction and fertility at Queen’s University, where he helped many Canadians start new families. His policy interests include science and research policy, industry-government relations, and health policy. As a politically-minded scientist, he would like to advance the use of the scientific method to improve evidence-based decision making.