Natural Health Products (NHPs) and Health Claims
The previous background article on this subject looked in general at NHPs, at the regulatory approach for NHPs, and at Health Canada’s NHP Directorate. The article proposed that Health Canada has attempted to establish a thoughtful regulatory framework in response to perceived public demand for the legitimization of NHPs in Canada.
That framework is a compromise between those who want few, if any, regulations and those who see the need for rigorous safety and efficacy standards. The process of establishing the framework, however, has fallen victim to a few unintended consequences. For example, with the influx of complementary and alternative medicine (CAM) practitioners to advise on NHPs, Health Canada runs the risk of having their traditional medical professionals being displaced and their regulatory decision-making apparatus being taken over. Also, highly questionable NHPs (e.g., homeopathic products) are acquiring tacit legitimacy through association with valid NHPs (e.g., vitamins) and endorsement by Health Canada.
The focus of this article is NHP Health Claims. If there is anything that is sure to energize skeptics about NHPs, it is the topic of efficacy. How is it that the NHP industry can get away with making Health Claims for their products and seemingly not be held accountable for proving them?
When skeptics look at NHPs, they see a broad spectrum of products ranging from those proven effective under certain circumstances (vitamins) to those with possible pharmacological properties yet unproven (naturopathy) to those which are the very essence of quackery (homeopathy). Skeptics see efficacy regulations as necessary to prevent wasting healthcare spending on nonsense and to protect the public from fraud and the dangerous distraction of ineffective treatments.
When CAM advocates look at NHPs, they see a rich pharmacopoeia of natural remedies whose curative powers, tapped through ancient wisdom, can be experienced firsthand without the need for scientific sanction, the dangers of “allopathic” medicine or the enrichment of “Big Pharma.” NHP supporters see efficacy regulations as unethical restriction and unnecessary expense.
These are the extreme public positions between which Health Canada has to choose a regulatory compromise. In the end, Health Canada has elected to allow both CAM-based claims (see Traditional Use Claims and Homeopathic Claims) and science-based claims (see Non-traditional Use Claims) with the claim wording being very carefully chosen so as to seem inclusive without being speculative or literally wrong. However, the subtlety of their semantics turns out, in the end, to be misleading.
Therapeutic products (i.e., drugs, NHPs and medical devices), whether imported or domestic, must undergo a regulatory process in order to be sold in Canada. The process, which ensures the safety, quality and efficacy of the products, consists of a sequence of pre-market to post-market activities, generally in the phases shown below. For NHPs, which fall under the jurisdiction of Health Canada’s NHP Directorate, the activities tend to be less rigorous than for drugs because of the lower safety risk:
Pre-clinical / Clinical Trials. Pre-clinical trials (i.e., in-vitro and in-vivo testing) and clinical trials (i.e., human testing) are not common for NHPs, although Health Canada encourages their conduct in order to:
- discover or verify the NHP’s clinical, pharmacological or pharmacodynamic effects;
- identify any adverse events that are related to the NHP’s use;
- study the NHP’s absorption, distribution, metabolism and excretion; and/or
- ascertain the NHP’s safety or efficacy.
Instead, existing human-use evidence is typically cited to demonstrate safety and support effectiveness for the limited Health Claims being made for NHPs.
Product License Application (PLA). The PLA for an NHP is based on the product’s Recommended Conditions of Use (see the Monograph section below), which is the information that describes the NHP’s identity, method of use, risk information and, most importantly, recommended use/purpose. This last data element is the Health Claim. In reviewing the PLA, Health Canada evaluates the safety, quality and efficacy data submitted for accuracy and risk. The Health Claim made in the application must be supported by sufficient evidence.
Market Authorization. Upon PLA approval by Health Canada, the NHP is licensed and assigned a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). (Since when did homeopathic products become medicine?) These eight-digit numbers, like Drug Identification Numbers (DINs) for drugs, are intended to facilitate the identification, monitoring, inspection and recall of NHPs marketed in Canada.
Public Access. With the licensed NHP on the market, information about it is made available to consumers for their safety and informed choice. The information is required to be displayed through product inserts and labelling and may be conveyed by advertising. The only Health Claim that can appear in inserts, on labels and in advertising is the one approved as worded in the PLA.
Surveillance, Inspection and Investigation. NHP manufacturers are responsible for monitoring the safety of their products and for promptly reporting adverse reaction and safety incidents. Health Canada maintains the MedEffect alert notification program for consumers and carries out inspections and investigations in response to complaints about therapeutic products concerning such issues as:
- labelling and advertising violations;
- product contamination;
- tampering allegations;
- product sales without authorization; and
- counterfeit drugs or fraudulent products.
Health Canada currently only investigates product ineffectiveness complaints for drugs and medical devices and product failure complaints for medical devices.
Therapeutic Claims. How an NHP can be used to mitigate or prevent “a disease, disorder or abnormal physical state, or its symptoms in humans.”
Risk Reduction Claims. How an NHP can “reduc[e] the risk of developing a specific disease or abnormal physiological state” by ” significantly altering a major risk factor or factors recognized to be involved in [its] development.”
Structure-Function Claims. How an NHP affects “a structure or physiological function in the human body” or how it supports “an anatomical, physiological, or mental function.” (e.g., “maintains healthy gums,” “reduces blood cholesterol”)
Non-specific Claims. Although Health Canada prefers the use of specific Health Claims, sadly they “will also consider certain non-specific claims …, but only in cases where there is adequate evidence to demonstrate safety.” This appears to be a major concession to the CAM community. Example claims provided in the guidelines include such terms as “tonic” in the context of a Traditional Chinese Medicine claim and “adaptogen” in the context of a Naturopathic claim, to get the flavour of this type of claims.
Traditional Use Claims
Traditional use claims are made in the context of the traditions of a particular culture or system of medicine, such as in the claim “Traditionally used in Chinese Medicine to …” Health Canada defines “traditional medicine” as:
“the sum total of knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.”
Traditional use claims must conform to the dosage and method of preparation used traditionally and cited as evidence. Such methods include extracts, infusions, salves, ointments or the use of all or part of an organism in a fresh, dried, freeze-dried or preserved form.
Wording of the Claim. As stated in the guidelines:
“Claims for traditional use must be prefaced with qualifiers such as ‘traditionally used…’. If the claim uses terminology specific to a particular culture or system of medicine, that culture or healing paradigm of medicine should be specified in the claim (e.g.: ‘In Traditional Chinese Medicine used to replenish Qi…’, ‘traditionally used in Ayurvedic medicine to treat over-active agni’).”
Who knew that Qis need to be replenished or that agnis could become over-active.
“If traditional and scientific evidence are available to support a proposed claim, the applicant may choose whether to use the wording ‘traditionally used…’. If a Health Claim is solely supported by scientific evidence, it must not include the words ‘traditionally used…’ “
So, therein lies the subtlety, two words – “traditionally used” – are the discriminator between a Health Claim that is proven and one that is just believed. And the amazing power of these two words is that they can change a claim from arguably false to literally true. For example, note the change of plausibility from “prevents the onset of a cold” to “traditionally used to prevent the onset of a cold.”
Evidence. Evidence for these claims must indicate “a history of at least 50 consecutive years of traditional use of a medicinal ingredient within a cultural belief system or healing paradigm,” which is intended to represent at least two generations of use. For evidence, reference must be made to at least one accepted pharmacopoeia (e.g., Pharmacopoeia of the People’s Republic of China, Ayurvedic Pharmacopoeia of India) or, failing that, an accepted combination of reputable written references and expert opinion (e.g., ethnographic authority, indigenous elders) sufficient to prove the use of the treatment within the specified cultural context for at least 50 consecutive years.
Non-traditional Use Claims
Non-traditional use claims could better be called scientific claims or evidence-based claims. These claims:
“are more rigorous than what is required to support a traditional use claim. Non-traditional claims must be supported by scientific evidence (e.g. clinical trials), which may be supplemented by other forms of evidence.”
Evidence. The guidelines acknowledge that there are many different types of evidence and discuss what constitutes acceptable, credible, high quality evidence. In fact, the guidelines do such a good job of explaining the tenets of good scientific evidence that it makes Health Canada’s acceptance of some of the flaky NHP claims all the more perplexing.
Strength of Evidence. Not all evidence, even scientific studies, is the same. The guidelines establish the following scale of Levels of Evidence:
|I||Well-designed systematic reviews and meta-analyses of randomized controlled trials or other clinical trials, or at least one well-designed randomized controlled trial (preferably multi-centred)|
|II||Well-designed clinical trials without randomization and/or control groups|
|III||Well-designed descriptive and observational studies, such as correlational studies, cohort studies and case-control studies|
|IV||Peer-reviewed published articles, conclusions of other reputable regulatory agencies, previous marketing experience, expert opinion reports or textbooks|
|V||References to traditional use|
Credibility of Evidence. The guidelines offer the following list of questions to demonstrate how Health Canada determines evidence credibility:
|Is the reference generally available?
Is it widely recognized and widely used?
Are the authors knowledgeable in their field?
Do the authors cite their sources?
Has the reference been peer reviewed?
|Is it used in other jurisdictions?
Does it present balanced data?
Is it based on the totality of existing evidence?
Has it been commercially published?
Is it the most current information or edition available?
Quality of Evidence. The guidelines similarly offer the following list of questions to demonstrate how Health Canada determines evidence quality:
|Were the objectives of the study defined?
Were the methods and outcomes clearly defined?
Was there a clear description of the inclusion and exclusion criteria?
Were the methods of statistical analysis adequate and well-described?
Was there at least one control group?
Was the study randomized?
|Was the study double-blinded?
Was any risk information described?
Was the medicinal ingredient in the study adequately identified and characterized?
Were potential sources of bias adequately addressed?
Was the study published in a well-recognized, reputable source?
Was the study peer-reviewed?
Did the authors cite their sources?
Adequacy of Evidence. There is no precise or prescribed rule for adequacy of evidence. Health Canada reviews all evidence submitted and determines its adequacy based on the evidence’s own strength, credibility and quality, as well as on the type of claim, the severity of the symptoms and condition, and the risks involved. The evidence for a Non-traditional Use Claim is deemed adequate if it specifically supports the claim, reflects the totality of evidence, and is from reputable, well-recognized, high quality sources at the appropriate levels.
A “homeopathic medicine” is defined by Health Canada as a product referenced and prepared in accordance with one of the five accepted homeopathic pharmacopoeias (i.e., Homeopathic Pharmacopeia of the United States, German Homeopathic Pharmacopoeia, French Pharmacopoeia, European Pharmacopoeia, and Encyclopedia of Homeopathic Pharmacopoeia).
Types of Homeopathic Claims
- Non-specific Use Claim. Homeopathic products that do not make a claim for a specific recommended use/purpose are not permitted to make a Health Claim. In place of the claim, the term “Homeopathic Medicine,” “Homeopathic Preparation,” “Homeopathic Drug” or “Homeopathic Remedy” must appear on the label, and a risk statement to the effect of: “Consult a health care practitioner if symptoms persist or worsen” must be included.
- Specific Use Claim. A specific use claim is not quite the same as a specific Health Claim. The “out” for homeopathic products seems to be that the claims do not state what they can do but what they are intended to address. So instead of saying “Helps relieve symptoms associated with sore throat,” a homeopathic claim might state “Intended for relief of symptoms associated with sore throat.” Again, there is subtlety and literal truth in the claim, but what is gained by it? For evidence, although Health Canada is always eager for Level I-III scientific studies in support of claims, “[h]omeopathic materia medica and homeopathic provings are the most commonly available evidence, and are accepted as Level IV evidence.” Self-referential evidence – a homeopathic product works because homeopathic practitioners say it does.
See the Post-script at the end of the article for a list of humorous regulatory statements concerning homeopathy.
NHP manufacturers should not be required to prove over and over again the same Health Claims for the same, common medicinal ingredients if the claims have already been accepted. Instead, many of these approved Health Claims are captured in the form of monographs and maintained by Health Canada. NHPs seeking license with the same Recommended Conditions of Use and same Health Claims as in an accepted monograph can just cite the monograph as evidence for the claim instead of submitting all of the primary evidence from scratch.
Monographs typically comprise the following information:
- Proper/Common names
- Source materials
- Routes of administration
- Dosage forms
- Uses or Purposes – General, Specific, Dose-specific
- Doses – Directions for use, Duration of use
- Recommended Daily Allowance (if applicable)
- Risk information – Cautions and warnings, Contraindications, Known adverse reactions
- Non-medicinal ingredients
Example Use/Purpose Statements (i.e., Health Claims):
Vitamin C: Oral
- A factor in the maintenance of good health (IOM 2006; IOM 2000).
- Helps the body to metabolize fats (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 2000).
- Helps the body to metabolize proteins (Shils et al. 2006; Groff and Gropper 2000; IOM 2000).
- Helps in the development and maintenance of bones, cartilage, teeth and gums (Shils et al. 2006; Groff and Gropper 2000; IOM 2000).
- Helps in connective tissue formation (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 2000).
- Helps in wound healing (MacKay and Miller 2003; Groff and Gropper 2000; IOM 2000).
- An antioxidant (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 2000) for the maintenance of good health.
- Helps to prevent vitamin C deficiency (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 2000). [Note: Vitamin C deficiency is rare in North America (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 2000).]
Aloe vera: Topical – Leaf gel
- Traditionally used to treat minor burns and cuts, and sunburns (Williamson 2003; Barnes et al. 2002; Willard 1991).
- Traditionally used to assist in wound healing (Boon and Smith 2004; Williamson 2003; Foster and Tyler 1999; Atherton 1997).
- Helps to promote healing of minor wounds such as cuts and burns, and minor skin irritations (Boon and Smith 2004; WHO 1999; Fulton 1990).
- Traditionally used to fight off colds, flus and infections (Barnes et al. 2002; Bradley 1992).
- Acts as supportive therapy in the treatment of colds, flus, upper respiratory infections and urinary infections (Blumenthal et al. 2000; Bruneton 1995; Melchart et al. 1994; Bisset and Wichtl 2001; Iwu 1993; Bauer 1991; Bradley 1992; Schöneberger 1992; Awang 1991).
- Traditionally used for the relief of sore throat due to colds (TPD Labelling Standard, Blumenthal et al. 2000)
- Used in Traditional Chinese Medicine (TCM) to tonify the spleen and augment the Qi (vital energy): for spleen deficiency presenting with a lack of appetite, fatigue, and diarrhoea (PPRC 2000; Benksy and Gamble 1986).
- Used in TCM to tonify the lungs and for frequent colds (PRC 1998; Benksy and Gamble 1986).
- Used in TCM to augment the protective Qi and stabilize the exterior: for deficiency with spontaneous sweating (PPRC 2000; Benksy and Gamble 1986).
- Traditionally used in Ayurveda as Rasayana (rejuvenative tonic) (Sukh Dev 2006; API 2001; Upton 2000).
- Traditionally used in Ayurveda to relieve general debility, especially during convalescence or old age (API 2001; Kapoor 2001).
- Traditionally used in Ayurveda as a sleep aid (Khare 2004; Upton 2000).
- Traditionally used in Ayurveda to balance aggravated Vata (nervine tonic, sedative) (Kapoor 2001; Khory and Katrak 1999; Nadkarni 1954).
- Traditionally used in Ayurveda for memory enhancement (Sukh Dev 2006; Upton 2000; Nadkarni 1954).
What probably started as Health Canada’s well-intentioned attempt to include NHPs in the regulatory framework without resorting to falsehood, yielding to credulity or endorsing pseudoscience has turned out badly. Health Canada has again fallen victim to unintended consequences. Health Claims are worded so subtly now as to make speculation indistinguishable from fact.
Take the Health Claim for Echinacea that states that it is “traditionally used to fight off colds.” Are consumers going to read this and think that Echinacea has not been proven to fight off colds but is used in the hope or belief that it will, or are they more willing to think that Health Canada endorses Echinacea as a cold cure? And what does the wording “acts as supportive therapy in the treatment of colds” really mean? It sounds Monty Pythonesque – “acts to help to support the assistance of a therapy that aids in the facilitation of …”
If Health Canada had intended a guarded acknowledgement of other traditions and systems of medicine in order to ensure a safe supply of NHPs for consumers, the gesture now looks like a full embrace of CAM. Canadian tax dollars are now being spent to pay regulators to ensure that packages of Astralagus include the warning:
“According to TCM, do not use in cases of exterior excess, Qi stagnation, damp obstruction, food stagnation, Yin deficiency with heat signs, or skin lesions in their early stages or where there is a heat toxin.”
What is the consequence of error for that job? Could someone with exterior excess who ended up with diminished Qi sue a regulator who overlooked the warning? Restricting NHPs to making only well supported Health Claims seemed like a good idea, but look where it has led.
The next NHP article will look at the specifics of Bill C-51 and the changes it proposes for the NHP regulatory framework discussed in these last two articles.
Post-script: Humorous Homeopathic Regulatory Statements
- “The term ‘quantity’, as it appears on the PLA form, refers to the amount of medicinal ingredient per dosage unit. A statement of quantity is required for all medicinal ingredients. Enter the homeopathic potency (e.g. 12 CH) in the column entitled ‘quantity’ on the PLA form.” – Note: 12 CH is a dilution ratio of 1:10^24, which is a dilution that is chemically unlikely to contain any molecules of original material. Wouldn’t the correct quantity of medicinal ingredient per dosage unit in this case be zero?
- “The medicinal ingredients in some homeopathic medicines are potentially toxic at material doses. The serial dilutions involved in the manufacture of a homeopathic medicine are a factor which mitigates the risk of toxicity from these medicinal ingredients. Minimum homeopathic potencies have been established in some jurisdictions to ensure that such medicinal ingredients do not exceed a safe dose.” – Note: The use of the word “toxic” here seems like a politically correct way of indicating that lesser dilutions might have a real effect.
- “The duration of use should take into consideration the following: … The persistence and/or worsening of symptoms associated with some conditions will warrant consultation with a health care practitioner.” – Note: Having symptoms probably warranted seeing a real medical professional in the first place.
- “All non-medicinal ingredients that appear in a homeopathic medicine must be listed on the PLA form” – Note: If the non-medicinal ingredients were not listed, then would the form be blank?
- “Indicate how often the product should be taken. … Applicants are not permitted to include the term ‘or as needed’ (e.g. four times per day or as needed) as part of the dose frequency” – Note: the brutal honesty of admitting that a homeopathic product is never needed.