The natural health products industry seems to be under fire from several groups; Health Canada - who are becoming ever increasingly more stringent, the pharmaceutical industry - for obvious reasons and health care professionals - who generally think natural medicine is “mumbo jumbo”.
Regulatory Double Standards?
A recent editorial published in the Canadian Medical Association Journal, alleges that natural health products are not scrutinized enough by the Natural Health Product Directorate (NHPD) and that they should undergo the same assessment as pharmaceuticals. What this editorial does not take into account are the requirements and stipulations upon the natural health product industry that have to be met for every product on the market for consumer safety and efficacy of the claim.
In essence, natural health products must be as safe to use as over-the-counter products and not need a prescription to be sold. Products that require a prescription are regulated by Health Canada under the Food and Drugs Act. The NHPD assess all natural health products for sale in Canada, and all manufacturing, packaging, labelling, importing and distributing must be in accordance with the Good Manufacturing Practices set out in the Natural Health Products Regulations. In addition, post-marketing surveillance is conducted under the Canada Vigilance Program where adverse reactions to health products, natural or pharmaceutical can be reported by consumers, patients and health professionals.
Are Energy Drinks a Natural Health Product?
The examples used in the editorial are slimming aids and energy drinks. In general people who use natural health products follow a holistic lifestyle, exercise, have a diet rich in whole and super foods, and do not feel the need for slimming aids and energy drinks. What about other natural health products like oil of oregano, black walnut, manuka honey, dandelion root, and fennel seeds (just to name a few). Should these be in the same category as energy drinks and slimming products? Many would say “no”.
Standards of Evidence
It is suggested that manufacturers of natural health products have found a “loophole” and products are being sold in Canada without providing adequate proof of their health benefits. It is however not as easy to get approval as suggested.
Evidence for Traditional Herbal Remedies
The definition of traditional medicine used by the NHPD comes from the World Health Organization (WHO):
The most popular form of traditional medicine is of course herbal remedies which have made their way out of the indigenous culture, and into the marketplace. However, evidence of traditional use for at least 50 consecutive years within a cultural belief system or healing paradigm is required from multiple sources for each traditional remedy. Additionally, the dose, claim and methods of preparation must be the same as those traditionally used.
Non-Traditional Herbal Remedies.
Claims for non-traditional remedies are harder to substantiate. The preference is for clinical studies that show safety and efficacy of use in humans at the dose, route of administration, and duration for the claim that is being made. Going back to the editorial, the author points out that before marketing a pharmaceutical substance Phase III randomized controlled trials are carried out providing extensive evidence that the product makes a quantifiable difference. These trials are extremely costly; however the pharmaceutical industry has one of the highest profit margins in comparison to other industries and can therefore afford numerous trials and studies.
Unlike those carried out by pharmaceutical companies, studies available to the natural health product industry are those that are peer reviewed and publicly available. These include human use data, animal models and in vitro studies, usually submitted in combination to prove that the product of interest is safe for human use and its claim is accurate. Finding enough scientific evidence to substantiate a claim is no easy task and the data that is submitted must be concrete and inconclusively show that the benefits outweigh the risks.
Schedule A Diseases
Pharmaceutical drugs have the monopoly on what Health Canada call ‘Schedule A’ diseases, these are conditions like depression, asthma, cancer, diabetes, acute alcoholism, hypertension, obesity and hepatitis. Although there is some very unarguable data on the use of natural sources and their derivatives; if aimed at the general public, these products cannot claim treatment, prevention or cure for ‘Schedule A’ diseases. While prevention claims can be made, the standards of evidence are as rigorous as a treatment or curative claim.
Active Ingredients
In agreement with the authors of the editorial, natural health products would not be efficacious in the absence of an active constituent that is responsible for the products beneficial outcome. There appears to be an increasing amount of research on these active ingredients than on the whole extract, and constituent comparisons are then required by Health Canada. There is however another school of thought when considering herbal remedies, like a drug, an extract can be a complex mixture and the activity of its key component may be modified by the other constituents that could be important to its overall action. Taking out one active ingredient is not necessarily the best course of action.
Protecting Consumers
The NHPD was formed to ensure that Canadians have access to safe and effective natural health products at the same time taking into consideration freedom of choice and philosophical and cultural diversity. The majority of the industry feels that although natural health products are not pharmaceutical products they are being increasingly expected to provide similar evidence. The fact of the matter is that if evidence that is deemed sufficient by Health Canada cannot be provided, some popular natural health products may disappear from the shelves; examples include oil of oregano, certain brands of probiotics, digestive enzymes and black walnut. The next course of action for these products may be clinical trials; however what must be considered is who will ultimately pay the price. If the cost of clinical studies is reflected in the final manufacturing cost of the natural health product, wouldn’t consumers be footing the bill?
