Natural Health Product (NHP) Regulation in Canada
The recent controversy concerning Bill C-51 has drawn people’s attention to the concept of regulating NHPs. Given the amount of commotion, you would think that NHP regulation is something new to Canada or that the government is acting suddenly and arbitrarily. Neither is the case. In response to
a mandate from the recommendations* of the House of Commons Standing Committee on Health, Health Canada has been evolving and implementing an NHP regulatory framework for the past decade. This is not even the first time that the Food and Drugs Act has been amended for NHPs. Bill C-51 is just the next step in this ongoing regulatory development process.
[* Correction (7 May 08): Poor wording on my part. A House Committee cannot give a mandate to a Department. In this case, the Minister of Health at the time, Allan Rock, decided to adopt the recommendations in the Committee’s report.]
To put Bill C-51 into context, it is useful to look at NHP regulation in Canada over the last decade. This article will attempt to provide this high-level overview. Future articles will look more closely at the regulations related to NHP treatment claims – the point of contention for skeptics – and at the details of Bill C-51 itself.
The Food and Drugs Act
For much of its history, an important objective of the Food and Drugs Act has been the limiting of product claims for the treatment of certain specified ailments, typically listed in Schedule A of the Act. Section 6A of the 1934 version of the Act reads (see Section II of the Regulatory Impact Analysis Statement for SOR/2007-288):
No person shall import, offer for sale or sell any remedy represented by label or by advertisement to the general public as a treatment for any of the diseases, disorders or abnormal physical states named or included in Schedule A to this Act or in any amendment to such Schedule. [emphasis added]
In 1946, the word “remedy” was replaced by “food or drug,” and in 1953, the product class was expanded to “food, drug, cosmetic or device,” and the concept of “selling” was expanded to include “advertising.”
Over time, Schedule A has been amended both to insert and remove ailments and to update their terms. The latest amendment to Schedule A used the following as its criteria for revision (see Section III of the Regulatory Impact Analysis Statement for SOR/2007-288):
- The condition or disease results in serious risks to individuals and generally requires diagnosis, treatment, and management by a health professional.
- The disease is likely to be spread within the population and may be a risk to public health without appropriate treatment.
- There is an emergency situation where self-care is inappropriate or not possible.
- The severity of the disease limits the person’s ability to make health decisions.
- The disease state has only recently been recognized by medical science and it is unclear whether or not self-treatment is appropriate.
- The disease or condition is one which renders individuals especially vulnerable to harm (e.g. pregnancy).
Based on these criteria, the updated list of Schedule A diseases includes:
|Acute anxiety state||Glaucoma|
|Acute infectious respiratory syndromes||Haematologic bleeding disorders|
|Acute psychotic conditions||Hepatitis|
|Acute, inflammatory and debilitating arthritis||Hypotension|
|Addiction, except nicotine addiction||Nausea and vomiting of pregnancy|
|Cancer||Sexually transmitted diseases|
|Congestive heart failure||Strangulated hernia|
|Convulsions||Thrombotic and Embolic disorders|
|Depression||Ulcer of the gastro-intestinal tract|
Keep in mind that this list concerns the making of treatment claims in the sales or advertising of food and drugs. Other Acts, such as the Tobacco Act and the Controlled Drugs and Substances Act, impose other regulations with respect to products.
The Push for an NHP Strategy
By the mid 1990s, NHPs had become popular and were becoming widely available. People demanded access to them, and in meeting that demand, the NHP industry was not shy about making treatment claims. But were NHPs drugs or food? If the industry insisted on making treatment claims, then NHPs should be treated as drugs, which meant extensive trials, costly licensing and restricted access. However, public pressure grew on a broad front to limit regulations.
The NHP industry wanted to produce, import and market NHPs freely without the costs and limitations that come with regulations. Some social liberals demanded cheap and easy access to NHPs because they had developed a belief in the efficacy of holistic medicine, they wanted freedom of choice in health care, they had become dubious of the traditional medical establishment, they were suspicious of the corporate interests of the pharmaceutical industry, and they supported the rights of cultures that practised traditional medicine. At the same time, some libertarians and social conservatives endorsed the free-market interests of the NHP producers, expressed their desire to limit government bureaucracy and spending, and supported the basic tenet of freedom of personal choice.
This growing public pressure challenged Health Canada’s ability to enforce the Food and Drug Act. How far could the government pursue legal action against the numerous NHP producers that were making unsupported treatment claims and claims contrary to the Act knowing that the unpopularity of the enforcement effort could prove to be political suicide? On the other hand, the government could not abrogate its responsibility to protect the health and safety of Canadians or to defend them against quacks and swindlers. There were, also, a good number of NHP users, producers, distributors and practitioners who supported regulations in order to ensure the safety and quality of their products and to legitimize NHPs in the public policy arena.
In 1997, the government established an Advisory Council on Herbal Remedies and then followed up with a series of hearings with the Standing Committee on Health. The final report, Natural Health Products: A New Vision, which was delivered in November 1998, made 53 recommendations that have established the approach for regulating NHPs in Canada. This approach, intended to be a compromise between the pro- and anti-regulatory camps, is summed up by the mission statement of the subsequently established NHP Directorate (NHPD):
[To] ensure that all Canadians have ready access to [NHPs] that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity.
For readers skeptical of NHPs, this mission statement seems more of a surrender than a compromise, but there is a lot of depth in the word “effective.” This principle of efficacy ensures that the NHP industry is not let off the hook concerning the making of treatment claims. Partly in adherence to this principle, an attempt by NHP advocates in 2005 to deregulate NHPs through Bill C-420 was rejected.
Another way to sum up the adopted regulatory approach is by considering the Guiding Principles of the Natural Health Products: A New Vision report, paraphrased here:
- Distinctive nature of NHPs
- Safety of NHPs (identified as the primary concern)
- Quality of NHPs
- Consumer access
- Informed choice for consumers
- Cost of regulations minimized for industry, consumers and government
- Informed regulatory decision-making
- Availability of appeal
- Transparency for stakeholders
- Respect for cultural diversity
Here, the concept of efficacy is not as explicity stated, but it is included in the principle of Informed Choice. Subsequent to this report, specific reference to efficacy becomes more prevalent in the regulatory development process.
What is an NHP?
A point that usually comes up in discussions about NHPs is the difficulty of distinguishing between a food, a drug and an NHP. For example, a piece of fruit (food) can undergo a traditional preparation to treat an ailment (NHP) or can be chemically refined into a pharmacological compound (drug) for a similar purpose, with the boundaries between these categories being fuzzy and sometimes overlapping. However, in the public policy arena, fuzziness is not an option. Categories had to be determined. (see Schedule 1 of SOR/2003-196)
Included. In Canada, the following are examples of products included in the NHP category:
- a plant, plant material, alga, bacterium, fungus or non-human animal material
- an extract or isolate of an above substance, the primary molecular structure of which is identical to that which it had prior to extraction or isolation
- vitamins A, B6, B12, C, D, E, biotin, folate, niacin, pantothenic acid, riboflavin and thiamine
- an amino acid
- an essential fatty acid
- a synthetic duplicate of an above substance
- a mineral
- a probiotic
Excluded. In Canada, the following are examples of products excluded from the NHP category:
- biologics, except a drug that is prepared from an alga, bacterium or fungus, or a homeopathic preparation involving a biologic substance
- a substance regulated under the Tobacco Act
- a substance regulated under the Controlled Drugs and Substances Act
- a substance that is administered by puncturing the dermis
- an antibiotic (or synthetic duplicate) prepared from an alga, bacterium or fungus
Much has been made of the prevalence of NHP use in Canada. Health Canada quotes an Ipsos-Reid survey that indicates 71% of Canadians have used NHPs and 38% use them daily. The problem with these statistics is that the numbers are skewed by vitamins. Note the breakdown of NHP use by type:
|don’t know/not sure||4%|
Clearly, vitamin usage is in a class by itself. This is not to say that vitamins are not NHPs, but it is a concern that questionable products, like homeopathic preparations, have inherented a sense of respectability by association with them. The survey implies that there is a seemingly large demand for all NHPs in Canada when, in reality, the demand is somewhat limited aside from vitamins.
In line with the approach initiated by Natural Health Products: A New Vision, regulations have been developed and implemented over the past decade. Natural Health Products Regulations (SOR/2003-196) came into effect in June 2003, and Regulations Amending Certain Regulations Made under the Food and Drugs Act (SOR/2007-288 and SOR/2007-289) in December 2007. These statutory instruments put in place regulations for:
- Product licensing
- Site licensing (manufacturers, packagers, importers and distributors)
- Good manufacturing practices
- Clinical trials
- Adverse reaction reporting
Of these, the regulations related to efficacy are product licensing, labelling and advertising. How these regulations relate to treatment claims will be the subject of the next article on NHPs.
The NHPD, whose mission statement was presented earlier, is the Canadian regulating authority for NHPs. Part of the Health Products and Food Branch of Health Canada, it implements existing NHP regulations and advises on new ones being considered. Unfortunately, with the NHPD being such an obvious sub-group of Health Canada, any actions they take are seen to be done under the auspices of Health Canada. As a result, when the NHPD makes controversial decisions, such as approving COLD-fx’s questionable treatment claim, the action is attributed to Health Canada and not to a group known to have a CAM bias. In the US, NHPD’s peer organization, the National Center for CAM (NCCAM), is part of the National Institutes of Health (NIH) but has the optics of seeming to be an independent centre. Rightly or wrongly, NIH’s reputation will be relatively unaffected by questionable actions taken by NCCAM, and similarly, NCCAM’s decisions will not be seen to carry the weight of the NIH.
The NHPD runs an NHP Research Program (NHPRP), which researches and disseminates information on NHPs in the following areas:
- Biomedical research
- Product quality
- Clinical research
- Health systems and health services research
- Societal, cultural, environmental influences on health and the health of populations
- Issues related to NHP regulations
- Information and knowledge transfer
The NHPD is supported by an Expert Advisory Committee (EAC), which is responsible for providing expert advice on issues related to the “safety, quality, efficacy, claims, use, and regulation of NHPs.” The 10 to 14 members of the EAC are “selected for their knowledge and expertise in NHPs, relevant medical sciences, and the practice of healthcare” and intended “to reflect an appropriate blend of gender, regional, ethnic and language representation for Canada.” The professional make-up of the currently listed EAC is:
- Professor of Biology specializing in Phytochemistry
- Vice President of R&D for a commercial firm specializing in marine-derived supplements
- MD who is a Director in US NIH’s Office of Dietary Supplements with a background in Pharmacognosy
- Assistant Professor of Pharmacy
- Professor of Pharmacognosy
- Professor of Biological Sciences specializing in Toxicology, Pharmacology and Traditional Chinese Medicine
- Herbalist, Homeopath and Nutritionist
- Professor of Kinesiology specializing in Nutritional Science and Dietary Studies
- Professor of Pediatrics
- CAM Advocate and Social Activist
- Professor of Biochemistry specializing in Nutraceutical Science and Technology
Although the EAC is staffed by a wide range of professionals who are accomplished and even, for a few, distinguished in their fields, it is unfortunate that all of them have backgrounds in CAM to some degree. Of course, for an advisory group on NHPs, this should not be too surprising, but where is the balance? Where is the counterpoint? How does the EAC ensure that it will not fall victim to groupthink?
The Compromise Approach
Hopefully, this overview shows that there has been some thought and effort put into developing a regulatory framework for NHPs, even if the result has required settling for a compromise. Health Canada was probably entirely staffed by traditional medical professionals a decade ago when given the mandate to adopt NHPs. Thankfully, they did not completely roll over, such as could have happened in 2005 with Bill C-420. However, it is worrisome that, as time goes by, more and more CAM practitioners are likely joining the ranks of Health Canada, especially the NHPD, in order to provide NHP expertise. I fear that pretty soon the inmates will be in charge of the institution, if it has not already happened. In the future, will Health Canada be trusted to make scientific, evidence-based decisions concerning NHPs and Canadians’ health? One indicator is how NHPs are held to account for making treatment claims, which is the subject of the next article.