HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, February 17, 1998

• 0905

[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): I call the meeting to order. It's the eighteenth meeting of the Standing Committee on Health, and we're doing a study on the natural health products.

We have a lot of witnesses for our first hour and a half this morning. We'll be hearing from James Knights of the Traditional Chinese Medicine Association of B.C. From the Canadian AIDS Society, we will have Russell Armstrong.

Russell, are you the representative?

A voice: He's not here.

The Chair: Well, we won't be hearing from them right now anyway.

From the Fibromyalgia Society of Ontario we have Lydia Neilsen, and from the Maharishi Ayur-Veda College we have Dr. Richard Wolfson.

Dr. Wolfson, like the others, when it's your turn to speak you can introduce the people in your group.

Please try to keep your comments as short as possible. We have a lot of people and the members will have questions. We would like to have your notes. If you've already sent your notes we will have read them. Just allow them as much time as possible.

• 0910

When you're answering the questions in their five-minute slots, please keep your answers as short as possible, within reason. We'll let you go on if it's something we all need to hear.

We'll start with the Traditional Chinese Medicine Association, James Knights.

Mr. James Knights (President, Traditional Chinese Medicine Association of B.C.): Thank you, Madam Chairman.

Ladies and gentlemen and the committee, my name is James Knights and I'm the president of the Traditional Chinese Medicine Association of B.C. I practise traditional Chinese medicine, which is commonly referred to as TCM. Our membership includes doctors of TCM who have been trained in Canada and China. Some members of Chinese descent have headed departments in TCM hospitals in China.

I would like to briefly outline some points about the use of therapeutic products from a TCM perspective. In TCM hospitals and clinics, patients are diagnosed according to TCM theory. The principles used are unique to this system and the terminology used is not translatable in terms of western medicine.

A strategy of treatment is developed according to this diagnosis. A formula composed of a combination of medicinal substances is prescribed. It can be of herbal, animal, or mineral origin. This formula is often a common formula published in traditional sources. More often than not, the formula will have a centuries old clinical history of success.

This formula is then modified by the practitioner to fit the particular patient. Customizing of the formula can also involve changing the dosages of some of the ingredients, as well as removing and adding ingredients. In this way the formula becomes more effective and will eliminate adverse effects.

The formula is boiled and taken as a decoction. Sometimes the formulas are prescribed in combination with prepared medicines, which are sold in pill form. A patient will take these herbs for a certain period of time and be re-examined by the practitioner. More often than not the formula is again modified to reflect the changes that have appeared in the patient as a result of the previous formula. This process may be repeated several times during one patient's course of treatment. This is the classic form of TCM herbalogy.

Please let us be clear that a Chinese herb does not become a Chinese herb because of its name or place of origin, but by being used in strict accordance to TCM principles. As previously stated, TCM is a system of medicine based on principles not translatable into western medical terminology. This can present unique problems for those who would desire to self-medicate with therapeutic products developed from within the TCM tradition.

Self-medication is dependent upon the consumer's limited understanding of the principles of medication. Self-medication is further complicated when it is attempted cross-culturally. No amount of labelling will allow western pharmacists to fully explain the use of a TCM product to a consumer. Also, it is common practice in TCM for patients with the same western diagnosis to receive different therapy when subjected to a TCM diagnosis.

The need for re-evaluation by a trained practitioner also works against self-medication. For self-medication, regulation of Chinese formulas must be done with regard to their proper application and in accordance with TCM theory and principles; otherwise they're being abused, possibly leading to adverse effects.

The good news is that the nature of herbs in relation to the characteristics of laboratory-produced compounds is already one of relatively minimal risk, especially when they are used in balanced formulas, as are standard in TCM. The art in TCM practice is to create an effective formula, because risk is such a minimal issue.

• 0915

In past attempts at regulation, herbs were studied outside the context of their proper use in accordance with TCM principles and were then labelled as dangerous. These herbs have been used for centuries by practitioners of TCM with little or no adverse effects because they were used within the diagnostic context of the TCM system and according to TCM principles of application.

Herbs are often like small formulas in themselves. To study a combination of herbs used as medication with the exact methodology used for a single laboratory-produced compound is scientifically impossible. The best approximation for clinical study of herbal formulas and their effects is an outcome study involving a group of people with a similar complaint over a period of time. Such studies have been done for many years in TCM hospitals in China. They are usually done to show the benefit of using TCM methods in combination with western medicine. They consistently show that better results are obtained using the combined treatment, with fewer side effects. Some studies have shown better results with herbal treatment alone. All this should be taken into consideration with regard to possible regulation.

As a practitioner, I want to be confident that a product I'm prescribing contains the ingredients I assume it should contain. I do not want these products to contain substances not included in my prescription.

Food products are currently regulated in terms of ingredients, while the debate continues constantly in the media about the benefits or liabilities of particular foods. For example, peanuts are a deadly toxin to some yet need only be listed on the packaging. This same form of regulation is good enough for the vast majority of herbal products.

Given the minimal risk posed by therapeutic products of TCM origin, which is much less than that posed by tobacco, simple warnings about adverse effects brought on by abusing herbal remedies would be sufficient. Warnings such as “This product can produce adverse effects when used inappropriately” and “Consult a qualified practitioner” would be enough to alert consumers.

In TCM hospitals in China, TCM is used in combination with western medicine to minimize the side effects of western drugs. This is done with great success for heart patients, cancer patients, and any others where western drugs have an immediate benefit.

Under this system, courses of chemotherapy and radiation used in cancer treatment can be completed sooner and at lower doses, resulting in more comfort for the patient. Unfortunately this system is not presently available in Canadian hospitals. I would urge the committee to help speed the improvement of the health care system by allowing TCM therapies to flourish in Canada.

Attempting to shoehorn the therapeutic products of TCM into an outdated Food and Drugs Act will cause no end of difficulty and will provide no extra protection for the public. It will only make a medicine that is currently affordable by the working poor priced out of their reach. If products currently available become five to ten times more expensive, what benefit is this to the public? Regulate if necessary but not without cause.

I didn't realize I should supply copies of this to the members ahead of time, but I will send copies to you after I get back to B.C. Thank you for your time.

Ms. Elinor Caplan (Thornhill, Lib.): Actually if you have a copy with you and leave it with the clerk, he can arrange for it to be distributed.

Mr. James Knights: I made some changes this morning already, so I'll insert them and ship it out.

The Chair: Now we will hear from Rodney Kort from the Canadian AIDS Society.

Mr. Rodney Kort (National Programs Consultant, Canadian AIDS Society): Good morning, everyone. My apologies for my tardiness. I have a very bad flu this morning and may be able to use the help of some of the practitioners at this table after the session.

I just want to talk briefly about the role of complementary therapies and CAS's involvement in them on behalf of people living with HIV and then break down the issues into three major areas, the first being legislative, the second being internal issues with the Therapeutic Products Directorate, and the final one being comments on research on complementary therapies.

• 0920

The Canadian AIDS Society is a national coalition supporting community action on HIV-AIDS issues in Canada. It represents more than a hundred community-based AIDS organizations across the country that provide the bulk of educational support and advocacy programs and services for individuals and communities living with HIV. CAS speaks as the national voice and acts as a national forum for a community-based perspective on HIV infection and AIDS, undertakes advocacy on behalf of those people, and undertakes research and policy development as well at the national office.

Many people living with HIV disease currently use complementary therapies either as an adjunct or alternative to pharmaceutical products. A recent CAS study, in 1995, found that 78% of people living with HIV use a wide variety of complementary therapies, varying from vitamin and mineral supplements to traditional Chinese medicine and other herbal and natural product remedies. The therapies are used to treat the often debilitating side effects of pharmaceutical treatments for HIV, to facilitate immune system reconstitution, and to provide direct therapeutic benefit for HIV and HIV-related opportunistic infections.

Complementary therapies also provide an important mode of health promotion for people living with HIV. Not only are the therapies beneficial, but they enhance psychological well-being by increasing the level of control an individual has in the management of his or her health. In the traditional medical model, a lot of consumers and people living with HIV often feel they have very little control over their health management and choices in treatment.

The regulation of complementary therapies in Canada clearly has an effect on the accessibility and affordability of these treatments. There is widespread concern among people living with HIV and consumers generally that the current regulatory system limits the availability of complementary therapies. There's also concern that there may be little knowledge of the benefits and uses of alternative therapeutic approaches within the therapeutic products program of the Health Protection Branch. While the issues related to regulating complementary therapies are complex, I think it's important for the Canadian system to ensure that accessibility to potentially beneficial treatments is not hampered by an unduly formidable regulatory regime.

I now want to speak more broadly of the legislation that affects complementary therapies.

Legislation governing the regulation of therapies needs to more formally acknowledge the importance of non-allopathic therapies, the growing influence of therapies outside of brand-name and generic pharmaceutical products, and approaches outside the more traditional western medical model. Separate legislation regulating complementary therapies is required to reflect a very different therapeutic approach from allopathic medicine and to clearly distinguish complementary therapies from pharmaceutical products. In the U.S., for example, a lot of complementary therapies are regulated separately under the Nutrition Labelling and Education Act and the Dietary Supplement Health and Education Act.

I think the importance Canadians place on access to these therapies has been demonstrated by the consumer backlash against the proposed list of prohibited natural products in schedule 705 and the move on the part of the therapeutic products program to introduce establishment licensing for complementary therapies. Legislation governing the regulatory system should reflect this evolution and our understanding of health and disease management.

Due to the extremely broad definition of a drug in the Food and Drugs Act, all complementary therapies are currently evaluated as drugs, placing them in the same regulatory category as pharmaceutical products. This is despite the fact that a significant number of them have far less potential for adverse side effects than a lot of the pharmaceutical products that are currently on the market.

The definition in the Food and Drugs Act has implications for manufacturers who may wish to market their products in Canada but fear unrealistically stringent criteria will be used to judge the therapeutic benefits of their products. Manufacturers of herbal and natural products rarely have access to the multibillion-dollar research and development budgets of pharmaceutical manufacturers and are therefore hampered in their ability to meet some of the current assessment criteria—depending on the therapeutic claim being made, of course.

While the therapeutic products program does currently have somewhat different assessment criteria for complementary therapies—for example, they will accept demonstrated historical use over a lengthy period of time for safety data—the more stringent criteria required to prove a therapeutic benefit for more serious illnesses such as HIV-AIDS means that many potentially beneficial products are simply not submitted for approval.

• 0925

Mild hormone derivatives, such DHEA for example, are widely available in the U.S., where it is used to facilitate the development of lean body mass. With respect to HIV-AIDS, retention and development of lean body mass is a critical issue for people who are battling HIV-related wasting. In Canada, however, all hormone and hormone derivatives are very strictly controlled and require a physician's prescription.

Product safety should really be paramount with respect to the enabling legislation. A criterion for efficacy must be appropriate to a given therapy and requires a more holistic approach to therapeutic benefit than is currently in place, including indicators of psychological and spiritual as well as physiological benefit.

The current standards set out in the Food and Drugs Act are effective in ensuring quality control and relevant labelling standards, but the stringency of the system, unfortunately, has a detrimental effect on consumer accessibility. CAS recognizes the necessity for the therapeutic products program to protect consumers against fraud and to guarantee the safety of the product through its current inspection and compliance system. This is clearly particularly important with respect to herbal products, which may be subject to herbicides or pesticides prior to harvest and processing. Post-marketing surveillance, on the other hand, is not rigorous and is focused primarily on pharmaceutical products, and I'm speaking now of the adverse drug reaction system.

Related to consumer accessibility is the issue of cost control. Unlike the brand-name pharmaceutical sector, which is subject to price review by the Patented Medicine Prices Review Board, no mechanism currently exists to determine whether or not prices charged for complementary therapies are fair. Access is further complicated by the resistance of many provincial administrators to include them on provincial formularies. A coherent, rigorous legislative framework, coupled with increased dialogue between federal regulators and provincial administrators, would greatly increase the possibility of inclusion on provincial formularies and decrease the onerous financial burden on consumers, and I can assure you it can be considerable.

At a meeting in Vancouver recently, one of the people living with HIV there said he spent $400 a month just on complementary therapies. So the cost issue here is a significant one for people living with HIV.

The recommendations from the Canadian AIDS Society in this area are that the government consult with relevant stakeholders and experts in the field of complementary therapies and enact legislation separating the regulation of complementary therapies from pharmaceutical products. CAS also recommends that criteria for safety and efficacy be revised to focus on safety and ensure that efficacy criteria are relevant to the use of the specific therapeutic product. CAS recommends that the cost of complementary therapies should be subject to review by a regulatory agency and that the government use existing mechanisms, such as the federal, provincial, and territorial committees, to ensure a much stronger communication between federal regulators and provincial formulary administrators.

I was in a meeting at the therapeutic products program a little over a week ago and it was very clear to me that there is very little dialogue at all happening between the federal regulators and provincial administrators.

Finally, the existing adverse drug reaction system should be revised to more proactively safeguard consumers and ensure additional data collection on potential contraindications with other complementary and allopathic agents.

I want to turn my attention now more specifically to the therapeutic products program. The TPP, clearly, I think, needs to strengthen its resources in the area of complementary therapies and ensure that regulatory staff are appropriately trained and knowledgeable in this area. A comprehensive understanding of homeopathy, naturopathy, and the use of complementary therapies as a holistic alternative to traditional allopathic treatments is required to keep pace with consumer knowledge and demand.

To date, the therapeutic products program has been reactive rather than proactive in providing information on both the rather complex regulatory framework for complementary therapies and its current activities in this area. This has led to a great deal of confusion and misinformation among consumers and contributes to the perception that the regulatory framework in this area is hostile to non-allopathic therapies. I think the issue of consumer education is important here in ensuring Canadians have accurate information about the regulatory system, which I think has a profound impact on their accessibility to treatment alternatives.

• 0930

The therapeutic product directorate needs to work more closely with consumer groups, non-allopathic health care professionals, and complementary therapy manufacturers to ensure a more appropriate regulatory system and to ensure accurate information is distributed to consumers in a timely and proactive manner. There certainly has been some move on the part of the therapeutic products program to respond to this by striking the expert advisory committee on complementary therapies in November.

Currently, however, there are no consumer groups represented on that expert advisory committee, which I think is a serious drawback in ensuring that the voice of Canadian consumers is informing regulatory reform in this area.

CAS recommends that the therapeutic products directorate hire regulatory staff trained and knowledgeable in the benefits and use of complementary therapies to complement the expertise that currently exists in the department with respect to pharmaceutical products.

The Chair: Rodney, are you almost finished? You've gone well over the 10 minutes.

Mr. Rodney Kort: Okay. I have just a couple of paragraphs left.

CAS recommends that the therapeutic products directorate use existing expert committees to ensure regulatory reform is appropriate and to ensure appropriate consumer representation on these committees.

We have just a quick comment on research issues. The information from the therapeutic products directorate on herbal remedies states that manufacturers—and I quote here—“must provide scientific and clinical evidence to support specific indications to treat serious illnesses”. This criteria, I think, demonstrates a bias towards traditional models of clinical research, such as controlled, randomized, double-blinded trials, and fails to acknowledge important information that can be gleaned from alternative methods of health research, such as observational databases and other kinds of qualitative measures that approach health in a more holistic way.

There are some additional legislative issues that require some cooperation with other branches in the government. I'm speaking specifically here of the medical use of marijuana. It's very difficult indeed to do any kind of research on this substance, which is very beneficial for people living with HIV-AIDS and cancer, because of the control of it under the Controlled Drugs and Substances Act. There needs to be more cooperation with other departments to ensure that appropriate complementary therapies are available to consumers.

In the research area, again, the federal government needs to take some initiative in providing some leadership on this issue. There isn't a huge amount of money to be made in complementary therapies, as there is in allopathic remedies, and I think the federal government could facilitate more research in this area to ensure that there is more evidence to support some of the therapeutic claims.

I will close with that. Thank you.

The Chair: Thank you very much.

We'll turn to the Fibromyalgia Society and Lydia Neilsen.

Ms. Lydia Neilsen (President and Chief Executive Officer, National ME/FN Action Network): Hi. The name of the organization is the National ME/FN Action Network. We're dedicated to helping people who suffer from chronic fatigue syndrome and fibromyalgia.

I would like to introduce our vice-president, Dr. Philipa Corning, who will be speaking, along with the president of the Fibromyalgia Society of Ontario, Mr. Byron Timmermans, and his vice-president, Jana Gagnon.

Mr. Byron Timmermans (Vice-president, Fibromyalgia Society of Ontario Inc.): Thank you.

Fibromyalgia and myalgic encephalomyelitis are diseases of the central nervous system. For our purposes today I will just call myalgic encephalomyelitis “chronic fatigue syndrome”, even though it's not a good term and we're trying to have it changed.

Approximately 2.5% of the population in Canada suffers from these illnesses, about 700,000 people. There are 600,000 fibromyalgia and 100,000 ME people suffering out there. There's no cure and there's no actual treatment. They can only treat some of the symptoms. You end up with some very desperate people. You may have heard about some with chronic fatigue syndrome committing suicide with the help of the famous American, Dr. Kevorkian.

• 0935

We have a situation here where we get very little help from the doctors because they may not know that much about fibromyalgia or chronic fatigue syndrome and there's very little they can do anyway. Some doctors are not as supportive as they could be in many cases. Others are very supportive. There's very little research being done on both of these illnesses.

We have two really serious problems here. The main one is the pyramid style of marketing food supplements in a way similar to Amway. You have all heard of that one. We're facing them in a big way—not Amway. To give you an idea of how far they go, I have a book here called Reversing Fibromyalgia by Dr. Elrod, who is not a doctor but thinks he is. I don't know.

First, these food supplements, or whatever they are—they could be magnets or other things—are quite often sold through chiropractors and others who tend to give assurances that if you take their product you will get better; they will cure you. But there is no cure, and I've never heard of anybody who bought these very expensive products who was cured, other than the husband, because most people who have the disease are women. They claim they can cure it and tell how marvellously they're doing with it.

I want to give one particular example of a young girl you may have heard of who was sent to the U.S. and almost died. Her father went in front of the provincial legislature and went on a hunger strike. Eventually the government gave in and she was sent to Texas for treatment. Her body weight at the time was 60 pounds and she was dying. Now she has doubled her weight and is doing better because of what they did for her in Texas. But there was nothing they could do for her in Canada. As a result, you have a lot of very desperate people. We want to try anything that comes along.

There's another product called Intra, which has something like 22 different concoctions in it. Even though they're listed, if you put 22 different things in a bottle and a person drinks it you're just asking for trouble in a big way from the side effects, such as blood pressure and stomach problems—you name it. So we need that tested. We need to control the products they're selling.

Ms. Philipa Corning (Vice-President, Fibromyalgia Society of Ontario Inc.): Basically what Byron has been telling you is that people with these chronic illnesses are very desperate and highly emotionally charged all the time.

Many of our people have regained a portion of their normal good health by turning to complementary medicine, the use of organic foods, nutrient supplements, and herbs. This is to help their bodies repair and stimulate their immune systems. Indeed there are many reputable complementary health care professionals and companies that offer high-quality services and products respectively, but how do people tell legitimate practitioners from charlatans and good-quality products from poor ones?

• 0940

There is a bit of legislation in Canada on a provincial basis, but not that much to really help regulate complementary medicine. So there does have to be some quality control with practitioners and health care professionals in the complementary medical area, as well as in nutrient supplements.

People turn to this because it works; it really helps them get back on their feet a little bit. Basically we would like to urge the committee to recommend new regulations regarding the health care services in the field of complementary medicine, specifically in network marketing of nutrient supplements and herbs.

Essentially, we urge that the following recommendations be addressed: one, establish methods of licensing and regulating all complementary health care professionals; two, establish a board of professionals with extensive knowledge of herbs and other natural products to ensure the quality control of natural nutrient supplements and herbs; three, ensure that all products sold in health food stores or through other modes of marketing as nutrient supplements and herbs are properly tested and their package labels should include warnings of any possible side effects; four, establish a body that can regulate network marketing and address any grievances from consumers against these network marketers; finally, insist that all claims regarding cures made by health care professionals or companies selling herbs or nutrient supplements be backed up by scientific fact.

Having regulatory bodies to which unsatisfied customers can lodge complaints will go a long way to rectifying the present confusion and uncertainty in the field of complementary medicine and the marketing of natural nutrient supplements and herbs.

Thank you.

The Chair: Thank you very much.

Ms. Aileen Carroll (Barrie—Simcoe—Bradford, Lib.): Could I have a copy of that? I'm going through my material and I don't have it.

The Chair: All the groups will be asked at the end—and I ask you now—to make sure any extra material you have be sent to the clerks so we can all have a copy.

Dr. Wolfson.

Dr. Richard Wolfson (National Director, Maharishi Ayur-Veda College): Thank you. I'm Richard Wolfson, the national director of Maharishi Ayur-Veda College. With me is Wayne Foster, director of public affairs for Maharishi Ayur-Veda College, and Britt Roberts, the former director of maharishi ayurveda products in Canada.

Ayurveda is the oldest system of natural traditional medicine, originating several thousand years ago in the ancient vedic civilization of India. Ayurveda is the complete system of health care, with hundreds of text books that date back and are as comprehensive—more comprehensive than modern medicine. I brought a few of these text books with me to give you a feeling for the hundreds of texts that are available.

You also should have a packet with you containing a few things, one of which is a few of the review articles in some of the modern medical journals, such as Complementary Medicine International, and also an article from Fundamentals of Complementary and Alternative Medicine, by one of the most renowned medical publishers, with a forward by Everett Koop—Everett Koop was the surgeon general in the U.S.—and by Churchill Livingston. There's a complete amount of material and background on ayurveda in there.

You should also have some letters of support for maharishi ayurveda from some of the most eminent ayurveda representatives in India, including the president of the All India Ayurvedic Congress, which is equivalent to the president of the Canadian Medical Association, and also the presidents of the Central Council of Indian Medicine of the Government of India, and the education committee and regulation committees.

Thank you very much for allowing us to present to the health committee. Our recommendation regarding natural medicine is that the vedic system of health care, as brought to light by His Holiness Maharishi Mahesh Yogi, be incorporated in its entirety into the Canadian health care system.

The maharishi vedic approach to health includes ayurveda among 40 vedic disciplines that are vital for the prevention and treatment of disease. Natural medicine, in its supreme sense, should maintain the vitality of the inner intelligence of the body, so that the decisions of the intellect, the thoughts of the mind, and the behaviour of the senses spontaneously function in the direction of evolution. Evolution is natural to creation. Natural medicine is that which upholds life in its natural evolutionary direction and does not allow it to suffer in any way due to stagnancy of evolution. Therefore, maintaining life in accord with natural law is real natural medicine.

• 0945

So natural law has two broad categories. The first is the holistic value of natural law. The second category contains the specific values of natural law. These two values of natural law are available for their theories and practical programs in the veda and vedic literature.

I have here some of the ancient texts of the holistic approach to health. These books represent a few of the hundreds of volumes of vedic literature, which is mankind's oldest knowledge. We would like to submit these precious materials of the vedic health care system published by Maharishi Vedic University in India, including Human Physiology, Expression of Veda and the Vedic Literature by Dr. Tony Nader, MD, PhD in the west—this is his book—and Celebrating Perfection and Education, which highlights very valuable material for perfect health.

Recently the eminent physician, Tony Nader, MD PhD, has discovered that the veda and vedic literature are at the basis of the structure and function of the human physiology. The application of this in the Canadian health care system can quickly realize the creation of a disease free society in Canada. These disciplines include transcendental meditation, yoga, herbal medicines, the building of healthy homes designed in accord with natural law, and handling the influence of the counterparts of the physiology in the cosmos. Unless all these areas are taken into consideration there is no way to ensure the good health of Canadians. For example, our national Parliament buildings are not built in accord with natural law and this is detrimental to the health of parliamentarians and their decision-making ability for the health of all Canadians.

With respect to herbal medicines, ayurvedic medicine has been proven safe and effective through thousands of years of extensive practice. It is unnecessary to subject it to the same degree of testing as modern medicine, which is only a few hundred years old. We entirely support Grant Hill's bill on this. We don't need to test natural medicine because it's already been tested for thousands of years, unlike modern medicine, which has really only been around recently, and these new drugs that are just being invented everyday.

The maharishi, together with leading ayurvedic physicians and scholars, has been working to restore the complete vedic health care system. This initiative has the full support of leading ayurvedic authorities and the Government of India. You can see these accompanying letters of support.

Ayurveda and all such time-tested traditions with authentic text that have been effectively used for centuries by millions of people should be easily adopted without imposing a complex or expensive evaluation process. Having already undergone thorough clinical testing for over five thousand years, further such testing of the natural medicinal formulations from these traditions is unwarranted and redundant. Also, unlike modern medicine, which often produces hazardous side effects that need to be tested for, these time-honoured formulations are free of such toxic effects. Of course, safety testing for purity, contamination, etc., of these products is very important. Maharishi ayurveda utilizes the most advanced equipment for this, including HPTLC, high performance thin layer chromatography, and the most sensitive atomic absorption spectrometry. For property quality control, make sure there are no metals or other toxins.

Included in your materials are some review articles of recent research also showing that the maharishi vedic approach to health is both effective and cost effective. One study shows reductions in illness by up to 91%. Another example is a recent research study by Dr. Nader showing instant relief for patients suffering from such chronic conditions as paralysis, arthritis, asthma, and migraines. You should have also received an abstract of Dr. Nader's research, and you can also read about these clinical studies on the Internet on the site that's listed.

As we have stated, herbal and mineral preparations are only one component of this comprehensive system of health care. However, research shows that even one maharishi ayurveda preparation can exhibit antioxidant, cardio-protective, antineoplastic—that is, cancer-protective—immunomodular and neurophysiological effects, as well as a reduction in chemotherapy- and toluene-induced toxicities.

• 0950

This is one compound that can produce all these effects. This compound contains dozens of herbs, and it may contain thousands of chemical components.

Byron was talking about some modern herbal preparations. Intra may contain dozens of ingredients and no one knows the effects. But these ones are thousands of years old. They've been tested. They're time-honoured formulations. We know the effects. They're combined by these ancient maharishis to produce these beneficial effects.

It's beyond the scope of western expertise to evaluate these complex herbal preparations that may contain hundreds of thousands of compounds that work together synergistically to create all these effects. Our recommendation is that Health Canada needs to employ traditional ayurvedic experts. We would be pleased to help organize this.

Specifically with respect to medicinal preparations, we recommend that ayurveda, including maharishi ayurveda, be included as a newly defined traditional medicine category subject to its own good manufacturing practice, or GMP, quality control, and labelling claims, to be developed jointly by a government-industry committee of experts, at least 50% of the committee to be nominated by industry, including maharishi ayurveda representatives.

We stand fully prepared to assist in the creation of this new category and the standards by which it would operate, with the support of the leading ayurveda experts and modern scientists with expertise in natural products. We would be pleased also to assist in the incorporation of the whole of the vedic system of health as a comprehensive system that has been extensively used, and proven effective, over thousands of years.

Thank you.

The Chair: Thank you very much.

Thanks to all of you for coming today. We'll start with our questioning.

Mr. Hill.

Mr. Grant Hill (Macleod, Ref.): Thank you very much.

Thanks to the witnesses today. This is the first time we've actually heard from consumer groups talking about the vulnerability of those who are ill with a chronic illness. Rodney in fact mentioned that when it relates to HIV-AIDS, there is a vulnerability among those individuals. The Fibromyalgia Society talked about the difficulty of claims.

This is a tough area. You know that regulating practitioners is a provincial domain. It's not a federal domain. You also know there are charlatans involved in this. I struggle with this. How do you try to give the most freedom to individuals without having them, when they are vulnerable, being promised something that cannot be delivered? This is the biggest stumbling block in this area for me.

We haven't heard the vulnerability so well articulated in terms of groups that are affected. Can either one of you expand on that? What role does this committee have in suggesting that when claims are inaccurate or implausible there be action taken?

Mr. Byron Timmermans: Again, there has to be some legislation, I think national legislation, that prevents people from saying these kinds of things—that you can't cure people. I don't know how you do that, but I know one thing: this book should be taken off the market and banned because of what he's saying. He's saying something that's not true.

I think that's part of the answer. The other answer is in the actual testing of drugs that are coming out, such as Intra, to see what kind of side effects you're getting. That can be done at a federal level, I'm sure.

Mr. Grant Hill: But if there's no harm from Intra, if the claims are absolutely off the wall and there is no proven harm, side effects, or contamination, would you in fact take it off the market? If it's ground-up fish scales and it does no good but does no harm, would you take it off the market?

Mr. Byron Timmermans: If it didn't harm you, I wouldn't have any problem with that. But I don't know how you could say that, or ask that question in that particular context, due to the fact that anything we see that's coming out does harm people.

• 0955

I'll give you another example of that. Magnets are becoming more widely used in Canada, and magnets can affect pacemakers. It's big business. I've actually seen companies that sell them and have talked to them about it. If I have a magnet on right now and if Philipa has a pacemaker beside me, she's in big trouble. How do you control that?

Ms. Lydia Neilsen: What Byron is saying is there has to be accountability of the health, medicine, and alternative drugs...

I get a lot of calls from people who spend hundreds and hundreds of dollars each month listening to what non-traditional medicine is saying; for instance, one has said “reversing”. These people are desperate, because right now there is no treatment. There isn't even any test yet to diagnose it properly. So when they hear something that says, “Okay, you're going to get better”, they're going to try it. I don't know if you can say there is no harm, because each time there is something new that is brought to their attention, they try it, thinking, “Okay, this is the one”. It works for about three or four weeks. Psychologically you say, “Great, now I'm finally going to be cured.” You go that route. A month later you're looking for the next alternative, and the next, and the next. You're always on this roller coaster, up and down, trying something new. You're up again, then it goes a month down the road and you're upset. If you don't call that harm, I don't know what it is.

Mr. Byron Timmermans: In the case of the little girl I was talking about who went to Texas, I had been helping the family cope. They completely divorced themselves from medical doctors. They were using a chiropractor who brewed up a concoction that looked like dirty oil out of your car. She had been taking this for quite a long time. She went down; it's a wonder she's still alive today. There was nothing, no labels. I don't know what was in it. I don't think the mother herself knew. There is another example of quality control. A chiropractor or any other health caregiver should not be allowed to do these things.

Ms. Philipa Corning: I've given a recommendation in our brief and I'll call your attention to it.

On the national level, we could have established a board of health professionals who have extensive knowledge in nutrient supplements and herbs to regulate natural substances. You can't do it as a drug. You have to have a body that knows the nutrient supplements and the herbs. I feel that's the only way to ensure quality control. As for trying to regulate people, it's impossible.

The Chair: We'll have a short comment from Mr. Wolfson.

Dr. Richard Wolfson: In terms of protection from these herbal remedies that are being brought on the market, I think our recommendation would be to employ the expertise from the long-standing traditions. We have these traditions from India, from China, from North America, the aboriginal traditions, and we would recommend to go with that, because these traditions have been around for thousands of years.

In the west, we basically support the western system, the allopathic medicine. That's where all the funding goes. This system is producing thousands of people who actually die each year in Canada due to the side effects of modern pharmaceuticals. But these natural remedies that have been around for thousands of years have been time tested, and that's what we should be supporting.

Another point is that the Health Protection Branch a few years ago actually dissolved its natural products research division. I think the person in charge of that was Dennis Awang, and he's recognized throughout the entire world as one of the leading experts in natural medicine. Yet the Health Protection Branch dissolved that branch because of funding cuts.

We need to take our funding and, instead of entirely supporting the western method, support people like Dennis Awang. The department received letters from all over the world from leading doctors on how this department was so crucial for the world and yet it was cut.

We should be putting our money where our mouth is, so to speak. We should be supporting natural medicine, we should be supporting these long-standing traditions, and we should be supporting research departments such as Dr. Wang's, which can ensure the purity and safety of natural medicines.

• 1000

The Chair: Thank you very much.

Ms. Caplan.

Ms. Elinor Caplan: Thank you.

I thought I'd start by telling you that I had the privilege—and it was a privilege—of meeting the Maharishi Mahesh Yogi when I was in India about eight or nine years ago, and I'm aware of the network of colleges and universities across India, and their history and traditions.

Having said that, as a Canadian consumer who uses natural products, I've said repeatedly at the committee that I think consumers want to know that the products are safe, just as when they buy foods in a grocery store or when they're buying any product they're ingesting. Is there anyone who disagrees with that?

I've also said that I think Canadians expect that the product is going to be “quality”. When I say “quality”, I mean that it contains what it tells them it's going to contain. The issue for this committee, as I understand it, is the issue of claims and what consumers expect the regulator to do to ensure that when a claim is made it is proven or that evidence is provided to substantiate the claim.

That's what my question is about. You can say yes or no, and I'll phrase it this way: do you believe that if a product makes a claim there should be a requirement to substantiate the claim based on the level of harm, I guess, that might be caused by that product, or a claim based on evidence, whether it's historical or whatever? How much evidence do you think the regulator should require before we accept, on behalf of Canadian consumers, the ability of individuals to make up concoctions?

Before you answer the question, I would just like to take a minute here. Chiropractors in Ontario, and I think across the country, have colleges, and anyone who feels a chiropractor is behaving in a way that is outside the standards of practice can take their complaint to that college. College members are the ones who determine what the standards of practice are in a self-regulating profession, but they only act on a complaint or out of whatever kind of review they might do on their own. So if someone is out there doing something you're concerned about you should know you can go to the college. I just wanted to make that statement.

But on the claims, could we just go around the table? Do you think if someone makes a claim they should have to prove it?

Ms. Jana Gagnon (Chapter 16 (Windsor), Fibromyalgia Society of Ontario Inc.): You're asking about people who are affected by these products. What I've experienced in our group—and I'd like to just explain it in one incident—was really tragic. I'm also the support line for our chapter in Windsor so I get hundreds of calls. I just want to read to you about what happened on May 22, 1996.

These multilevel marketing people came into our group and told the FM-ME victims that they had something to cure them. When you've just found out that you have this disease, you become desperate for anything to get rid of it, and you're scared because you're told by your family doctor that it's permanent.

The marketing people know exactly how we feel, and they know who's new to fibromyalgia and who isn't, and who to avoid. For example, they avoid someone like me because I'll tell them to leave. But they also know we have no rules or regulations as to who can become a member and who cannot, and that's a big problem right there. But I've found a sort of solution.

• 1005

What the marketing people did on May 22 is really disgusting. They actually got up on stage and had a big set-up with a TV and a microscope—a little TV that only plays video tapes. Someone was dressed up like a nurse and they had another woman up at a podium and she was waving her hands above her head and twisting her body in all different directions. If you have fibromyalgia, that is physically impossible to do. She may as well have been doing the twist with her hands above her head. She claimed she had no problem; that she had fibro and it was cured by using Infinity products.

Then a young man between the ages of 30 and 35 came running from the middle of the group up onto the stage and said he had fibromyalgia. He looked like he'd just come back from Florida and could put Arnold Schwarzenegger to the test. He said “You can take my blood.” The woman dressed as the nurse took a syringe out of her smock pocket and actually drew blood from this man. No one saw what happened to that blood or to the needle or where it went.

I don't know what they had under the microscope and on the TV, but it certainly wasn't blood, because I know what a drop of blood looks like under a microscope. It has things in it that move, but this was not moving. The screen was being faded in and out. When you're fibromyalgia you don't realize these things.

The sad thing is that these people were being told their products would cure their fibromyalgia. The 12 brand-new people who came to that meeting for the first time after just being diagnosed with fibromyalgia within the past three to six months were desperate. They thought they had found a cure, because they were told by Infinity products they would be cured. This is the interesting part. Standing up there they were told, “We can cure your fibromyalgia for only $50. With two months' treatment, for an additional $35, we can take your blood and determine which of our products, whether it's a cookie, a candy bar, or an herb, will cure your fibromyalgia.” These 12 people couldn't wait to whip out their wallets.

Nine months to a year later I'm still receiving phone calls from these people who have cupboards full of products. They're destitute. They're on social assistance. Some of them can't get any disability. They can't get anything from workers' comp. They have these products and don't know what to do with them, because they're not helping them.

The Chair: Thank you very much.

Does anybody else want to comment on Ms. Caplan's question?

Mr. James Knights: In TCM terms, in the role of herbalogy, you'd never find a situation like that. I tried to point out in my statement that if you had three people who were diagnosed with fibromyalgia and all three went to a TCM practitioner, more than likely they would all end up with different formulas based on the TCM diagnosis.

Fibromyalgia itself would be considered a symptom in traditional Chinese medicine rather than a description of a disease. You would take into account all the other factors based on the diagnosis in order to try to rebalance the bodily functions and seek the harmonious balance the body naturally wants to achieve. So any product that was marketed in a drugstore fashion claiming to be—I'll just speak for TCM now—a TCM product for a specific disease is not really traditional Chinese medicine and couldn't be trusted as such.

• 1010

The Chair: Is there a short answer from anybody else?

Dr. Richard Wolfson: Elinor's question is very important: How do we ensure that the claims made on a product are valid? With respect to ayurvedic products, for instance, it's also very important.

I think the issue is that we don't have the expertise in Canada at the Health Protection Branch to evaluate these herbal formulations. For instance, maharishi ayurveda products—which is a separate organization—will apply for a drug identification number for a traditional ayurveda remedy. The people at the Health Protection Branch will look at that application and say the herbs in the mixture don't make sense; it's an incongruous combination of herbs. Based on the understanding of those in the Health Protection Branch...they wouldn't understand it, because the western system is based on evaluating one, two, or a few active ingredients and the combination of those. These traditional herbal remedies—and I think those from China as well—may have dozens of different herbal ingredients that work together in a synergistic way to create these effects. So what we really need is to have the expertise to evaluate it.

These claims are important. For instance, maharishi ayurveda has a whole council of these traditional ayurveda experts called vaidyas who oversee all of the formulations. What we need is for Health Canada to employ these people so that these claims can be properly evaluated. It's very important that any claims that are made are substantiated in a way that can bring these traditional experts into the system.

To tell you the truth, it's even more important to have quality control in ayurveda than it is in western medicine, because when you combine all these ingredients together there are many more different factors that have to be taken into account. Each particular herb has to be harvested at the right season, even at the right day of the lunar cycle, and often at the right time of day, because the chemical composition varies, thus affecting potency. For instance, Dennis Awang tells me there are Chinese herbal medicines that are on the market that state they are Chinese herbal medicines, but they're actually a ground-up part of the wrong part of the plant and there's no way to check it. So what's required is quality control.

What maharishi ayurveda uses is high-performance, thin-layer chromatography to ensure that all the right ingredients are in each plant in the right proportion. They take a spectral footprint of each preparation that comes out in order to ensure that it has the right components so that it's going to have the right effect. So quality control is even more important in terms of ensuring this, both through the traditional experts in these traditions as well as through the modern scientific evaluation.

The Chair: Mr. Kort, it will have to be very short, because we're way over.

Mr. Rodney Kort: The short answer is yes, absolutely, I think therapeutic claims need to be validated in some way. I think Dr. Wolfson points out the need for expertise in the Health Protection Branch to evaluate those claims. That isn't necessarily there right now.

Going back to Dr. Hill's question with respect to regulatory issues, while the regulation of health practitioners is provincial, regulation of therapies is a federal jurisdiction. There is an enforcement and compliance mechanism in place currently. First of all, it needs to be beefed up a little bit. It could also apply to complementary therapies, however, provided again that the criteria are clear, that the appropriate information is there in terms of providing that to the Health Protection Branch.

The Chair: Thank you very much.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): I thank all the presenters for coming this morning. I think you're all saying the same thing, but I want to double-check. I'll use the Advisory Panel on Natural Health Products' interim report as a basis for questioning.

Have you seen the draft regulatory framework put out by that advisory panel? If so, what do you think? If not, my sense is that what they're recommending—and what you all seem to be saying—is that there should be recognition through legislation of natural health products, herbal medicines, and alternative therapies. By implication, that means a third category in legislation. They're also recommending that there be tough regulations around labelling, around warnings and dosage issues, that there needs to be some sort of natural health products research capacity within the Health Protection Branch of Health Canada to do the quality assurance and scientific surveillance to protect consumers in the case of fraud or shysters or whatever.

• 1015

You mentioned the network marketing issues or the pyramid sales. It seems to me that's a bit beyond the scope of this committee, but is there not other legislation, provincial or federal, to apply in terms of cracking down on illegal pyramid sales and marketing schemes?

The Chair: Who wants to go first? Do you want to explain it, Mr. Kort?

Mr. Rodney Kort: I have taken a quick look at the report, and yes, I absolutely agree with every one of the recommendations you've just articulated. I do think, however, that the existing compliance and enforcement mechanism could be used to ensure that the kind of fraudulent claims that are being articulated here are dealt with in a regulatory capacity.

Mr. Byron Timmermans: May I add?

The Chair: Yes, go ahead.

Mr. Byron Timmermans: I have two quick comments, one to Ms. Caplan. We tried to go through the College of Chiropractors and we got nowhere. We were told they were very weak as far as enforcing what they were doing.

As far as the network marketing, we can't even get the health minister to write us back on a complaint, or anything at the provincial level. That's why it's so important that the federal level take charge of this kind of thing, because of the nature of the Government of Ontario.

Ms. Jana Gagnon: Perhaps I may comment.

The Chair: Just a very short comment, please.

Ms. Jana Gagnon: I have a letter back from the ministry of health in regard to being asked what was being done in fibromyalgia. This was the response. I won't go into the greeting, because it just addresses me. It says:

First of all, you should be aware that the Ministry of Health has not done a study on this condition. Diagnosis and study is carried out by physicians.

The cause of Fibromyalgia is not known and treatment is symptomatic.

Then it goes on to say that OHIP covers medical doctors and registered physicians, but nothing else.

I would like to say that down in Windsor in particular the physicians totally ignore us. It's a very grave situation. Nobody can get a doctor. When you go in to a doctor now, to get a consultation or to even get a doctor, they will first come into the room and ask you flat out if you have fibromyalgia chronic fatigue. If you say yes, they tell you on the spot, “I have the right not to accept you as a patient.” Then they leave the room, come back a couple of minutes later, and tell you to your face that they will not accept you as a patient. They tell you to go to the walk-in clinics.

The latest thing to happen was that I got a phone call from a woman who has been to three walk-in clinics in Windsor. All walk-in clinic doctors have refused her treatment because she has fibromyalgia. What are we supposed to do?

This is coming from my local MPP, Dwight Duncan. He's the Liberal Party; well, what the heck, it doesn't matter. The fact is that this is a reply from the Minister of Health, from Elizabeth Witmer.

Ms. Lydia Neilsen: I would like to point out one thing. Both the Laboratory Centre for Disease Control and Health Canada do accept chronic fatigue syndrome and fibromyalgia as illnesses. There are certain locations. There's actually a number for them to bill on OHIP or whatever for fibromyalgia. That is not yet the case for chronic fatigue syndrome; that's under a general statement. However, our organization is working very closely with the provincial organizations and with the government and the Laboratory Centre for Disease Control so we can get a clinical definition for both chronic fatigue and fibromyalgia so that all doctors will have to accept it.

The Chair: Thank you.

Dr. Wolfson.

• 1020

Dr. Richard Wolfson: Judy asked whether we supported all these recommendations. This third category is among the things that stand out. It's not obvious whether that's the way to go, a third category, or whether... I think it was Grant Hill's suggestion to change it. I think the main consideration should be that the degree of regulation should reflect the degree of risk involved. The risk for most of these natural herbal remedies is very minimal.

I'd like to point out that this committee, the natural products committee, is the third such committee, I think. The first two had very excellent recommendations and their recommendations were not implemented. I'm sure this committee will have great recommendations. Let's hope they are implemented.

I think our main suggestion is that it's important that there be regulations and that these regulations should involve a degree of risk. We think it should be set up by a joint committee that includes both government and industry. In the case of natural medicine, such as ayurvedic medicine—and we would recommend Chinese medicine—there should be expertise in the Health Protection Branch or on these joint committees, rather than being set up by people in the department who are just knowledgeable in pharmaceuticals and how to regulate them. That just doesn't work with these remedies, and it's not really fair or even cost effective.

For instance, there's no patent protection on natural remedies. This is an important point. If we impose some very expensive testing procedures, there's no way for the natural medicine industry to get the money back, whereas in the drug industry, where there is patent protection, they can recoup their costs.

Any way you look at it we need a different system, rather than just putting in, say, a third category and imposing the same kinds of regulations and rules and expensive requirements. That may not be the right way to go.

The Chair: Ms. Caplan, was your question answered?

Ms. Elinor Caplan: It actually was on the different process or alternative process as opposed to just third category under the existing regime.

Is that what you would support, an alternative process that would treat these differently and appropriately, ensuring that claims were met and that safety...?

Dr. Richard Wolfson: Yes, we need a different system. The main thing, from our point of view, is that the system should be set up by the experts in this area, not by people in the Health Protection Branch, who are only experienced in terms of pharmaceuticals, which is fine for pharmaceuticals. We need a different system set up by the experts, or in consultation with these experts in ayurveda or Chinese medicine, who are capable of evaluating these claims.

It's also important that holistically the practitioners be organized in some way. We would like to have the same body of ayurvedic practitioners somehow formally recognized in Canada, and we would also like to have some body that oversees them, just as, say, chiropractors and Chinese practitioners are starting to do, so that it could be properly overseen for safety. When someone goes to see a practitioner, they should know they're getting something that's right and that's been approved through the tradition.

Ms. Elinor Caplan: I just want to be clear. You're not asking for deregulation, such as what Dr. Hill is recommending.

Dr. Richard Wolfson: Not complete deregulation, but the idea he put forward that if something is safe—

Ms. Elinor Caplan: How do you prove it?

Ms. Carolyn Bennett (St. Paul's, Lib.): Who decides that something is safe?

A voice: How do you do that with food?

Ms. Carolyn Bennett: Then it's regulated if it's safe—

Ms. Elinor Caplan: Somebody has to say it's safe.

Dr. Richard Wolfson: Right. So there has to be some research done, some evidence that it's safe. I think even in Grant Hill's proposal it says that if there's—

Ms. Carolyn Bennett: So you don't want deregulation; you want somebody to decide that it's safe.

Dr. Richard Wolfson: Yes, we want some regulation, but I think even in Grant Hill's case, it's not complete deregulation. There's a clause in there that says if there's some evidence that this can be proven to be harmful, it shouldn't be completely deregulated. So we need to look at all the evidence. It's not completely letting things go.

The Chair: Thank you very much.

Mr. Myers, this will be the last question.

Mr. Lynn Myers (Waterloo—Wellington, Lib.): Madam Chair, I wanted to ask Mr. Kort a question with respect to HIV-AIDS. I wanted to get a sense of how therapeutic benefits are assessed now, under what criteria, how that information is disseminated to people, and how things should change according to your recommendations.

Mr. Rodney Kort: It depends very much on the particular product you're talking about. Some of it is anecdotal. Some research studies have taken place on various therapeutic products and have demonstrated some benefit. It varies very much, depending on the product you're looking at.

• 1025

What CAS is suggesting is that if a manufacturer makes therapeutic claims, those claims require some evidence, and the evidence that's required will depend on the natural product, the substance that's being evaluated. The criteria for those claims should be established by HPB in consultation with experts in the field. So that's the suggestion in terms of the regulatory system.

There has been, for example, some limited research on marijuana in the United States that indicates it is certainly beneficial in increasing appetite and controlling the nausea associated with these really toxic allopathic remedies. But it's really difficult to do research.

As I said, I was in a meeting in Vancouver a week and a half ago where Health Canada was funding some limited research into complementary therapies for HIV. I was strongly advocating that we look at marijuana as one of the substances for those research protocols, and people said it would just be too difficult to try to clear all of the regulatory hurdles to deal with the issues arising from the Controlled Drugs and Substances Act. Ultimately we didn't choose marijuana as one of the products to evaluate because of that.

Mr. Lynn Myers: Thank you.

The Chair: Mr. Myers, do you have any—

Mr. Lynn Myers: No, that's fine. Thanks.

The Chair: Do you want Mr. Knights to answer?

Mr. James Knights: On the question of safety, I think you should probably still look at it in terms of minimal risk. I used to work in the aircraft industry, and I consider flying out here safe, but there's still a degree of risk involved. That's a highly regulated and inspected industry, but having worked in the industry I'm still nervous getting on an aircraft when I can't see what the pilot's up to.

So just in terms of safety, there is no absolute safety in anything, especially in TCM terms, as I mentioned before. One formula for one person has to be mediated through a doctor of TCM to ensure minimal risk.

Ms. Elinor Caplan: Then it becomes an issue of the labelling and the warning.

Mr. James Knights: Yes.

The Chair: Lydia.

Ms. Lydia Neilsen: The thing I'd worry about is if these people are talking about non-traditional medicine, how can they be unbiased if some of them are selling those products?

The Chair: Good point.

You have to ask Mr. Myers, Ms. Bennett, if he'll give you some of his time.

Ms. Carolyn Bennett: I guess what we've been asking a number of the panellists is this. Are there things—maybe Mr. Knights would be the first—that you think should only be given by some sort of regulated practitioner, or a practitioner, rather than just be available? Are there certain products that could be harmful if just allowed on a shelf somewhere, so they should be done through a practitioner?

Mr. James Knights: Most of the formulas involved in traditional Chinese medicine should be done through a practitioner. But there are some that are standard formulas that have been used for a long period of time for things like colds, flus, that kind of thing—not more serious chronic diseases—and are proven to be perfectly safe through use in the sense that there have been no complaints related to them.

Ms. Carolyn Bennett: So even though technically harm hasn't been proven from them, still you would have a preference that there be certain products that were dealt with through a practitioner. The term “non-harmful” is not necessarily the issue; we're talking about optimal use.

Mr. James Knights: Yes, optimum effectiveness. You can get different products for a cold that are TCM products where you have to decide in TCM terms between symptoms of heat and symptoms of cold. Then you'd use a different formula. In one formula, if you use the one for heat for cold, it will maybe make the symptoms worse. It's not going to kill anybody or damage them, but they won't get the relief and their symptoms may be exacerbated.

Ms. Carolyn Bennett: Thank you.

• 1030

The Chair: Could I have a short answer, please?

Ms. Philipa Corning: That's why I think it's extremely important to have a body of individuals, professionals, who know the herbs and nutrient supplements. I think that's a critical point. If somebody's from a pharmaceutical company, they don't know.

The Chair: Our time is up now. You're losing time off your five minutes if you ask a question now.

Ms. Aileen Carroll: I'm going to ask one quick question.

The Chair: Okay.

Ms. Aileen Carroll: Mr. Knights, I'm curious, having listened to the people from the fibromyalgia association who say there is no cure. Pursuant to what you said to Carolyn, what would a practitioner of TCM say to a person suffering from fibromyalgia?

Mr. James Knights: You wouldn't talk in terms of a cure; you would talk in terms of trying to reharmonize the body. Say you were going to do TCM in a clinical setting like a hospital. Maybe you would have a hundred people with fibromyalgia come in. You would get a rate of effectiveness through an outcome study.

So it wouldn't be a matter of a cure; it would be a matter of, say, 80% of the people achieving a certain degree of effectiveness. Some people may be totally relieved of symptoms, in some there may be no effect, but you should get an outcome greater than 65% or 70%.

The Chair: Thank you very much. Thank you for coming. If you have any other comments you want us to know, just give it to us. We'll get the clerk to pass it around if you have any other information you think we need to know.

Thank you very much for coming.

We'll have a five-minute break now.

• 1032

• 1042

The Chair: We're calling this meeting back to order.

Mr. Lynn Myers: Madam Chair, just as a point of clarification, I think it was Richard Wolfson who raised Grant Hill's bill. I have not seen that bill. I've had some people contact me with respect to it. As a rookie, I find the process here a little unclear. I thought we were studying this issue as a committee, so how this got into the hopper is unclear to me—how this is proceeding and what's happening here. Is it an attempt to pre-empt what we're doing here at the committee? Is that the purpose of what's happening here?

Mr. Grant Hill: No, not at all. This particular bill has been in the making for about three and a half years. What's interesting is the time at which it was ready to be presented. I'm perfectly willing to sit down with the committee and tell members the results of these three and a half years if they're interested. I would love for this to be non-partisan. This is not designed to be partisan. It is a concept to try to move this issue forward. When it's talked about as somehow deregulating, that's just not correct, and it's a shame this has to happen in the committee.

The Chair: Grant, would you like to just give us an evening or sometime when we could come to talk to you about it? Did you want to set a time—just not right now?

Mr. Grant Hill: If the committee wants to sit down for five minutes at the start of one meeting—

The Chair: I'm not talking about the committee, just if individuals want to go.

Mr. Grant Hill: —I'd be happy to explain to you the background behind it.

The Chair: So you don't want to call a meeting so that you could brief us on it.

An hon. member: If we have five minutes at the beginning of a meeting...

Mr. Grant Hill: Or at the end of the meeting.

Mr. Lynn Myers: I'd like to see a copy of it at the very least.

The Chair: Well, you can request a copy of a private member's bill. There's no problem there.

We have two groups now. One is Sears Health Food and Fitness Shop. Who's going to be the main spokesman from that group? Donna?

Ms. Donna Herringer (Vice-President, Sales and Merchandising, Sears Health Food and Fitness Shop): Yes.

The Chair: Okay, and you're the sales and merchandising chairman or whatever.

Ms. Donna Herringer: Vice-president.

The Chair: Vice-president, that's right.

Our other group is Natraceuticals?

Mr. Lionel Pasen (Vice-President, Regulatory and Government Affairs, Natraceuticals Inc.): Yes.

The Chair: And you're Lionel Pasen, the spokesman?

Mr. Lionel Pasen: That's correct.

• 1045

The Chair: You're not together.

Mr. Lionel Pasen: No.

The Chair: Okay. We'll start with Donna. Please introduce whoever is with you.

Ms. Donna Herringer: I certainly will. Thank you, Madam Chair, and good morning, committee members.

We have put together a very large document and I think you'll find it very helpful and very interesting. I'm sure it's just what you need—one more piece of paper—but we put a lot of energy into it and I think you'll enjoy it. It's part of what we're speaking on today.

My name is Donna Herringer and I'm vice-president of sales and merchandising for the Sears Health Food and Fitness Shops. We have a chain of 40 stores across Canada and are a retail health food store within a mass market environment. I'm also the current president of the Canadian Health Food Association, and our group is in the same industry as the Canadian Health Food Association.

Stewart Brown is owner and president of Supplements Plus and a Toronto-based retailer. Lionel Pasen is vice-president, regulatory and government affairs for Natraceuticals Inc., a manufacturer and importer of supplements and sports nutrition in the Canadian marketplace.

Not presenting today but available to answer questions is David Chapman, president of Purity Life Health Products, an importer and distributor of a wide range of natural health products. David is also a member of the board of directors of the Canadian Health Food Association.

Together we are representing the views and interests of supplier and retail members of the industry of the Canadian Health Food Association.

The Canadian Health Food Association is a national trade organization representing the majority of businesses that manufacture, import, export, and retail natural health products. Our association was established in 1961 in Vancouver and now has its head office in the greater Toronto area.

Our diverse membership represents the full range of natural health products, including herbs, traditional medicines, homeopathy, vitamins, minerals, essential oils, functional foods, food supplements—the list goes on and on.

For many years our association has worked to create dialogue within the natural health products sector with government regulators. The goal has always been to arrive at a regulatory framework that is appropriate to our products and balances the need for public safety and freedom of access to our products.

On the question of why the industry requires a new regulatory framework, the CHFA supports the recommendations for a new regulatory framework that were summarized in the presentation and written submission by major industry stakeholders to the standing committee on February 3, 1998. These recommendations are listed and fully explained in appendix A in your document.

Our position is that there must be a new and separate framework for natural health products. The current system of regulation is both inadequate and inappropriate for one of the country's fastest-growing industry sectors. What began as an alternative movement in the early 1960s, characterized by a passion for natural health products, has now become a multimillion dollar industry.

Entrepreneurship has merged with the professional expertise of holistic healing and traditional medicines to serve the growing demand for natural health product remedies and therapies.

The economic impact is significant, both from the industry's standpoint and from the perspective of its positive effects on the growth in health care costs.

In reality, Canada's Food and Drugs Act and its accompanying current regulatory framework has afforded this sector a patchwork of regulations and policies, most of which are inappropriate for natural health products. Currently, natural health products arbitrarily fall into the two different regulatory categories of either food or drugs, creating conflict and confusion for the sector and leading to consumer frustration over a lack of access to products they need.

• 1050

The effort of communication has been like putting a square peg in a round hole, because for the most part natural health remedies are not foods, nor are they pharmaceutical drugs. This results in Canadian consumers personally importing products that are banned in Canada yet viewed as safe and available in many other countries throughout the world.

Our natural health product sector is losing significant sales to foreign suppliers. Canadians cannot access appropriate information on products, their benefits, and how to use them safely and effectively.

Businesses are operating in a regulatory climate that is fraught with unnecessary confusion, high costs, and limitations.

I'm going to ask my colleague Stewart Brown to give you a more in-depth analysis of the impact to retailers.

Mr. Stewart Brown (Owner/President, Supplements Plus): Retailing is hard, even at the best of times, but when you add in the issues particular to our industry, it makes it quite the challenge.

There are three particular challenges I would like to address today.

The first is that regulatory confusion is creating an unstable retail environment. Imagine trying to run a store when you're not sure which products you can legally sell and which products may not be legal tomorrow. That's the environment we have been finding ourselves in for over a decade now. Just as you, the Standing Committee on Health, have been unable to obtain from Health Canada a list of what products are legal or illegal, so have we, natural health product retailers and suppliers.

That uncertain environment is due to a regulatory process in which products have been moved arbitrarily from food to drug status, without notification to the industry. Products moved into drug status have been removed from the Canadian marketplace because regulators lacked or failed to seek reliable information on the products or their claims.

Two regulatory bodies, the Therapeutic Products Directorate and the Canadian Food Inspection Agency, are enforcing separate policies for products and food and drug classes.

As products have increasingly been moved from food to drug status, the over-the-counter status of some of the products has been threatened because they are now subject to standards more appropriate for pharmaceutical drugs. In this environment, retailers are hard pressed to do business, attract investment, and attract loans from bankers concerned about the regulatory environment for natural health products.

Natural health product retailers require clear policies and regulations that will provide permanent over-the-counter status for the products we sell.

The second issue is that the importation of U.S. products is eroding our customer base. As you know, Canadians can legally import products banned in Canada, for personal use, from the U.S.

As a retailer, I can't begin to describe to you the frustration expressed by my customers when they cannot buy in my stores products they've read about or seen advertised on American media. They're left scratching their heads as to why it's safe and legal for them to buy it in the States and consume it in Canada but they're unable to purchase it in Canada.

The result is that we now have a vast underground market in products imported from the U.S. through cross-border shopping and mail-order catalogues. As a retailer, I'm losing direct sales on those products I'm not allowed to stock legally, but more importantly, I'm losing the confidence of my customers and their loyalty.

It starts when customers turn to a U.S. source to purchase a product that is not legally available in their local health food stores. What we find is that they have to buy one product south of the border, so it's convenient for them to do all their shopping down there. The result is that the customer base of Canadian retailers from coast to coast is being eroded, not just on restricted products but legal products as well.

The third issue is that the regulations do not allow for informed choice. Current regulations severely limit what can or can't be said about a product. That makes it difficult for consumers to make informed choices about natural health products.

Contrast that to a product such as an over-the-counter headache remedy that is commonly sold in variety stores. It can be taken as part of a self-care strategy because appropriate information is provided on the label as to how to use it, as well as contraindications.

As a natural health products retailer, I'm really limited about what I can say about products. An example I'd like to use is that it's like trying to sell a dishwasher without being able to say what it actually does. I can say it looks great in the kitchen, makes a lot of noise, uses a lot of energy and water, but I can't actually say it cleans the dishes.

So it leaves people very blinded as to what to do with our products.

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In our business we must often deal with customers who have gained information through unreliable sources. As a result, some customers are misinformed about products and may be taking them for the wrong reasons, or they have used products incorrectly and have gained no benefit from them. From our perspective, this need not happen. Appropriate labelling of products will ensure that our customers can make informed, correct choices about products. Our customers are passionate and dedicated to well-being. How tragic it is that the current regulations work in such an opposing direction.

Thank you.

The Chair: We have at least the two of you here as retailers. We have already heard from the Canadian Health Food Association, and we're glad you brought their memorandum, but we'd like to hear your personal experiences in your retail business.

From Natraceuticals Inc., Lionel Pasen, could you introduce your...?

Mr. Lionel Pasen: Yes, of course. Natraceuticals is the first public company—

The Chair: Introduce the individual with you so that we know who he is, please.

Mr. Lionel Pasen: Oh, I'm sorry. Dave Chapman is a competitor and a very good friend.

Ms. Donna Herringer: I did introduce him already. He's the president of Purity Life Health Products.

The Chair: Oh, I'm sorry. I didn't have his name here.

So you have your own store, your own business?

Mr. David Chapman (President, Purity Life Health Products Limited; and Director, Canadian Health Food Association): No, I'm an importer and distributor. I bring over a hundred product lines into the country.

Mr. Stewart Brown: The two of us buy from the two of them.

Ms. Donna Herringer: We're all in the same industry. We buy products from them.

The Chair: Right. Okay.

Ms. Donna Herringer: Not just from them, but we do buy from them.

The Chair: Then we need to know what your jobs are. It's easier for the MPs here to question you. Go ahead.

Mr. Lionel Pasen: Natraceuticals is the first public company in our industry in Canada. We own a number of companies that sell vitamins, minerals, essential fatty acids, homeopathic products, herbal products—the full range of products that are used in the health food industry.

I have dealt with regulatory matters for over forty years, so I'm very well versed in the challenges of trying to deal with a bureaucratic system that basically says you're either black or white and there's no such thing as grey. Unfortunately, most of the products we carry are grey. If you try to call them black or white, invariably you're going to come up against a wall.

We have a new phenomenon called the American market, which is flooding the Canadian market with products that are quite legal within the States, but quite a few of them are illegal under the present category system here, so it is inappropriate. If I can leave you with one word with my presentation, the word is “appropriate”.

As a manufacturer, as an importer, our company wants regulation. For the Canadian product, when we sell it outside of Canada, we have absolute respect. We had the Columbia chain of hospitals approach us after they had gone to many American suppliers. They said they could not carry the American product within their hospital chain. They want supplements; they want vitamins within their new alternative section at Miami Heart, which is 20,000 square feet. They came to a Canadian manufacturer because of the regulations and the fact that they are considered drugs. That's great when it comes to exporting. It shows that we're well respected. When it's within our own country, these regulations kill us.

As an example, if you take a look at appendix C in the CHFA presentation, you'll find that one American company, Twin Laboratories, has 858 products, 42% of which cannot legally be sold in Canada. That means we as a manufacturer cannot produce them and sell them within our own country; however, any of you, or any Canadian, can import those products for personal use quite legally. Who gets hurt? The person using the product, because the product is manufactured—I'm not zeroing in on Twin Labs, because they do put out a quality product—by someone who does not have to comply with the regulatory system that we have in order to sell those products in Canada.

They can produce their product a hell of a lot cheaper. They have ten times the population. They manufacture cheaper. They advertise cheaper. They compete with us. They don't have this horrendous cost that the present regulations give to us. We just cannot compete fairly.

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With a product like melatonin...I believe you were told the Canadian Health Food Association didn't put anything in on melatonin. It was very nicely worded, so your inference was, “We have not tried.”

We have a presentation here that was given to Dann Michols and his group on melatonin. The comment made to you was, “We have not approved it because we have not received a package from the sponsor following the guidelines we have set.” That didn't mean they didn't get a presentation on the safety of melatonin. It was just that the i's weren't dotted the way they would have liked.

This has been the case for forty years of my dealing with this regulatory body. If you don't fit into its criteria, you don't fit. That's very frustrating. It has turned us into very creative thinkers in the way we present our products.

That's not what we want. We want to have laws that are appropriate and meaningful and that protect the Canadian public. Unfortunately, creativity can also create areas that are not necessarily to the benefit of the consumer. It does happen. We want a level playing field.

Again, we're talking about the regulators using inappropriate and arbitrary standards of product assessment. We do not fit into the pharmaceutical group and we don't fit into the food group. We fit into little areas, but clearly most of the products we sell are in-between. We need regulation that is clear, precise, and easy to follow. That would mean people who import would also have to comply. The Canadian public would benefit. The Canadian industry would benefit. I believe the Canadian public is number one. The industry should be considered.

Approaching that, we are saying a made-in-Canada solution would be much more appropriate. I keep saying appropriate because it is the appropriate word—appropriate to our industry.

It would give us more safety and a higher-quality product. The Canadian industry has really put a lot of money into quality. As a company we spend just under $500,000 a year on quality control. That's an expense the American companies don't have to worry about. Their products are treated as foods. They don't have to be concerned with plant inspections and annual DIN fees. It's unbelievable how much it can cost us just to operate and try to compete with companies that are ten times our size and are coming across the border in droves. We're trying to be good citizens, but by being good citizens we're losing the race.

Mail order, of course, is open to anybody and everybody. There's no way of stopping some pretty bad products coming across the border. Again, you'll find a list in our presentation today that might startle you.

Ms. Donna Herringer: We just ask that you don't order from them.

Mr. Lionel Pasen: You may have no choice but to order from them if there is something you want, such as melatonin. This gentleman to my left is legally importing melatonin for hospitals and for a variety of doctors with Health Canada's full knowledge and consent. It can only come in through the medical approach.

L-tryptophan has been on the market for years. Some bad batches came out of Japan and all of a sudden L-tryptophan became the bad guy. So did amino acids—everything around L-tryptophan. It came back on the market but as a prescription item at probably fifty times the cost. Who lost? That was a matter of poor manufacturing in Japan and had nothing to do with the product or Canadian manufacturers.

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L-tryptophan is a great ingredient in a sleep aid.

There are a number of excellent products that the regulations unfortunately wipe out because of this pharmaceuticals versus food attitude. We're not saying turn it around, wipe out the regulations or anything of the sort, but as people who have the power to adjust this, you can just adjust it to an appropriate level so that industry and the regulators can live in peace and the Canadian population can get what it wants, which is access to safe, effective, proper products.

One of the major problems we do have is that for the 40 years I've been dealing with Ottawa—and there are some very decent people there—

Voices: Oh, oh!

Mr. Lionel Pasen: There are! There are really well-meaning people who are stuck with the regulations that they're stuck with, but more importantly, they're incompetent to deal with our types of products. They're very competent to deal with pharmaceuticals or with food items, but when it comes to these, it's, “Oh, well, it's used to correct something in the body, so therefore it's a drug, period.” That's not necessarily the case.

We had a major problem with homeopathy. There was one lovely woman who was working for 11 years at Health Canada and who took homeopathy. She was a pleasure to deal with. She was able to turn some of the regulations around so that we could more easily live and deal with homeopathy. Because of the regulations, here's the situation we were in. A homeopathic supplier would say, “Here, take this product.” We would say, “What's it for?” The supplier would say, “Oh, I can't tell you. No, no, you must take it.”

As homeopathy evolved from the practitioner into the retail store, the retailer was actually breaking the law by saying, “This is for sinus.” They would infer it but the consumer might have thought it was for something else, something that just came to mind but I won't say it, something that might sound like “sinus”, and they would be using it for the wrong purpose, instead of being able to say what that product was for and retaining the use for that area.

Again, we got around that by being creative and saying hat the full directions for use have to include what it's for. In other words, if I give you this you have to say, “What's it for?” We actually stuck our necks out. We had inspectors coming in. You would have thought we were selling cocaine. They were looking in the rafters. They wanted to get these homeopathic products.

We said, “No. Your own guidelines say full directions include the purpose for which it's being used.” They were caught. They didn't quite know which side of the fence to fall on, so they backed off. As a company we have been selling—quasi-legally—this series of products for uses.

The consumer is happier and the regulatory people have backed off, because many of the regulatory people understand that the regulations aren't appropriate.

We're simply asking you to assist us, please, in turning these things into appropriate regulations. We will help.

The Chair: Thank you very much. Can I just ask you a short question, Mr. Pasen? You mentioned that there was one presentation you did on melatonin that didn't fit their criteria. Have you done other presentations on other natural products that have been accepted?

Mr. Lionel Pasen: Usually what is required—

The Chair: Have you ever had a presentation accepted?

Mr. Lionel Pasen: No—

The Chair: You've never had one accepted.

Mr. Lionel Pasen: —because Health Canada requests so much information that is inappropriate, which you cannot afford—

The Chair: But it's not just one product that hasn't been accepted.

Mr. Lionel Pasen: No.

The Chair: None of your presentations have been accepted.

Mr. Lionel Pasen: None that I can remember in 40 years.

The Chair: Thank you.

Mr. Hill, do you have a question?

Ms. Donna Herringer: We have a quick summary that I would like to do, if I may.

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This is a summary of manufacturers and retailers that we agreed to... I know you probably have personal questions for all of us, because we all have our own frustrations in terms of the business we need, but we would like to summarize by giving you our four recommendations.

First—and I'm sure you've heard this hundreds of times—we would like to confirm that we, as retailers and manufacturers of this industry, would like a separate regulatory framework, apart from those of food and drugs, to ensure, as my friend Mr. Pasen says, appropriate regulations.

Second, we would like to recommend taking a co-regulatory approach with industry that will minimize administrative costs.

Third, we want a more simplified and efficient process, which should lower costs and ensure Canadians have appropriate information from which to make informed health choices. Speaking as a retailer, I'd say that's where our biggest frustration is. We have products on the shelves, and people want to know what to use them for. It's illegal to tell them what to use them for. We cannot guide them to make their appropriate choices.

We also want to ensure the quality of our natural health products. Our recommendations call for the burden to show proof of harm be placed on our regulator, and the burden for safe manufacturing process should be with the industry.

Finally, and I think the most important thing that we all feel about our industry, which is very different as a holistic model, is that the guiding principle for change must be to create a regulatory framework dedicated to health promotion and disease prevention among the Canadian population.

The Chair: Thank you.

Mr. Hill.

Mr. Grant Hill: Thank you, and thanks for your comments.

It was to me that Dann Michols directed those comments in terms of the question on melatonin. What you're saying is that by a subtle use of language he was able to deflect my question by saying that we have not received from the industry anything on melatonin because it didn't fit our very strict criteria.

Now, Dann Michols is going to be back here. I obviously am going to reapproach that question. Melatonin is one of the products that I believe Canadians should have access to if there is no harm.

Ms. Donna Herringer: You have the document.

Mr. Grant Hill: I hope you will be able to leave that document with the committee.

Ms. Donna Herringer: Absolutely.

Mr. Grant Hill: This, to my mind, is a very subtle misuse of the authority of the department.

Mr. David Chapman: Can I speak to that?

Mr. Grant Hill: Yes, but I'm going to go one step further here.

We've heard from a number of industry people that saying things like that could result in negative repercussions, either audits or extra... What you've said is a pretty powerful statement. Do you have any fear that now, all of a sudden, you're going to get three times the inspections for making this public?

Mr. Lionel Pasen: No. When you deal with bureaucracy for 40 years, you learn how to deal with them. I have thrown out a couple of people—not physically; I've told them to leave the premises. They made some slurs against our quality control, not at his capabilities—he happens to be a PhD—but because of the fact that he is East Indian. I threw him out. I told him Health Canada was always welcome, but he was never going to step inside these premises again. I called his boss, who clearly understood that.

I just don't take it from them. That was a bad instance of a bad individual, but usually my experiences have been excellent with Health Canada. They're stuck with regulations they can't...

Many of the inspectors do manoeuvre. They have the ability to look the other way, or not find something to be as offensive. Or they will say, “Oh, maybe by the next time we come in you could correct that, or use up your labels”. Others will say, “That is not to be sold. I'm putting it under detention, and until it's corrected, you're not going to sell that product”.

That's an individual reaction. That's not necessarily Health Canada. They're stuck with regulations that are inappropriate. What do they do?

Mr. David Chapman: I have a comment.

Mr. Grant Hill: Quickly, David, if you can. I have one more important question. That's why I am trying to push forward.

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Mr. David Chapman: I wanted to quickly talk about new drug status. The new drug provision was put into the act as a result or reaction to thalidomide, and I think most of us are of the age that we can remember thalidomide. Since then, any substance that would come along that they didn't know anything about they would tend to arbitrarily shove into new drug status. Once a product has new drug status, the only way, officially, to get it out of new drug status is to do an investigational new drug submission, which can cost anywhere from half a million to $2 million, $3 million, $4 million or $5 million, which is fine if you have a single chemical entity that is patentable, but no one is going to spend that kind of money on non-patentable items.

We have approached them for years asking them to remove numerous products from new drug status, whether it be amino acids, various herbs, melatonin.

In the case of melatonin, we spent a considerable amount of money. We went to the leading experts around the world and asked for position papers. We said to Dann Michols, “Dann, no one's going to spend the money. We want to give you a submission. Would you please consider our submission?” Dr. Gillespie said, very offhandedly at a meeting, “It doesn't meet our requirements”, and that was it.

I think the situation here is that Dann Michols came into that department to attempt to clean things up. I think he's worked hard to clean it up. However, he has people working for him who I don't think are very comfortable at all with the change that's coming here. There are still people in that department who feel the Canadian public are a bunch of children and shouldn't have access to things.

Folks, there are products out there we'd love to sell. We'd love to tell people what they're for. They could tremendously help people's health, whether it's garlic for the heart or whatever.

There's a long list of products we'd love to tell people about, and there's a lot of creativity going on out there in claims that we can't make.

Are we afraid of Dann Michols being mad at us and auditing our companies because we brought it up? No. Dann's not that type of person.

I don't know how this came about.

Mr. Grant Hill: We've heard that the Canadian regulatory framework is not appropriate. Is there another country we can look at to give us some guidance? Where do you think it's at?

Ms. Donna Herringer: I think clearly the U.S. and Australia have models that we are looking at and have investigated and included. When we've talked about it as an industry for a Canadian model, I think we're looking to use the best of many countries, because there's no country that's absolutely 100% appropriate from the investigation we've done. There are some things from many countries that give more freedom to access a product than we have in Canada.

Mr. Stewart Brown: I was just going to mention that I had one incident about four or five years ago in the store where two HPB officers came in. One of them was by the book. The other one later told me that he just wanted to get on with his day. He was standing behind the first person, waving “no”. When the first one asked if we had this product in stock, he was going “no, no, no”. He later told me that he had bigger things to deal with, bigger issues. They had to reply to a complaint made by someone. They had to do that. He felt there were more important things for him, as an HPB agent, to be doing than tracking down chromium picolenate.

The Chair: Thank you very much.

Ms. Caplan.

Ms. Elinor Caplan: I really appreciate the presentation. It's nice to see you again.

I have a question on the role of regulators and perhaps a definition of “quality”, what you would include. You mentioned you have a quality assurance program, and I'd be interested in how you would define quality and whether you would include the safety aspects as part of quality or whether you'd separate that. You said safety should be the responsibility of the industry and quality the responsibility of the regulator. I'd like you to expand on that.

The Chair: Mr. Chapman, you can speak any time if you want to. You don't have to wait for him. Just go ahead and speak.

Mr. Lionel Pasen: Quality is a mindset. When you invest $5 million, $6 million, or $7 million in a manufacturing facility, you can do it right or you can do it wrong. Many of the American companies couldn't care less. They only want to put out a cheap product, make it as cheaply as possible and sell it for as much as they can. That's the way they run a business. There are many American companies that are the opposite. They want proper quality control. They put in facilities.

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There's a Canadian company that Donna used to work for, Quest. They spent a lot of money on their laboratory, on their manufacturing facility, but more important, on their paper trails. Any inspector could walk in and understand the product they buy. The raw product is tested. The product is properly dealt with all through the manufacturing process. If you have that type of facility, that should be sufficient for our level of products to not have to take it further.

Ms. Elinor Caplan: So quality requires a process?

Mr. Lionel Pasen: Yes, it requires a process.

Ms. Elinor Caplan: And safety?

Mr. Lionel Pasen: Safety requires data and experience. There's a lot of material coming out of the universities. There is traditional use.

Ms. Elinor Caplan: Safety requires information and data?

Mr. Lionel Pasen: That's correct, and proper interpretation of data. Dr. Gillespie, who is a medical doctor, is super-careful. That's sounds like, “Oh, my God, you have to have people who are super-careful in charge of that type of thing.” But a product could have been used for a hundred years—I'm not talking about five years; I'm talking about a hundred years—in traditional use throughout the world. That means millions if not billions of people over the generations have used it. And he'll say, “I found in the data one case in Borneo, and as a result of that one case, this is not going to be allowed.” That is a little extreme, because if he applied the same to the drugs on the market today, none of them would be available.

Ms. Elinor Caplan: So the next issue is risk.

Mr. Lionel Pasen: Risk and appropriate ability to discern the safety, the risk, and the traditional use.

Ms. Elinor Caplan: Or to give information on warnings, labelling, and dosages.

Mr. Lionel Pasen: Absolutely.

Ms. Elinor Caplan: That's part of being an informed consumer. So would you say that quality, safety, and level of risk are information that should be on labels?

Ms. Donna Herringer: First of all, on level of risk, if you take the whole range of products that we would carry in a retail operation, in my operation and probably in Stewart's operation also, the level of risk is very low. Other products that would be incorporated into what you would consider a natural health product—and I'm particularly talking about maybe a dozen herbs—they would have intervention by a practitioner.

But the most important thing about our products, and probably why we're sitting here, is that the level of risk is very low. That's why we feel there should be access. Safety, I believe, is what government wants and needs to have involvement in. We're looking at very few products that are above low risk.

Ms. Elinor Caplan: Would you agree that when you get out of the low or even moderate risk into high risk, that's where the assessment or the appropriate standard might be that we now consider it a drug?

Ms. Donna Herringer: No, never. I would not agree. That's my personal opinion. You're talking about our products, natural health products?

Ms. Elinor Caplan: I'm talking about high-risk products, whether they are—

Ms. Donna Herringer: Oh, the way they are today?

Ms. Elinor Caplan: I'm not saying it's necessarily a drug. If you're looking at an alternate process that includes a process for quality, safety standards, labelling on the basis of low to moderate risk, and that kind of thing, but if you have some products that are clearly hazardous, very toxic, or poisonous even, should those flip over into the procedure or the regulatory process for restricted drugs?

Ms. Donna Herringer: I think that could be managed by the professionals who would intervene. They would not be for sale on a self-serve counter. They would have professional intervention. I don't think you would still categorize that as “by prescription only” or call them a drug, because they're not. If you want to go into the description of a natural health product, it's a high-risk natural health product, not to be confused with a high-risk drug.

Mr. Lionel Pasen: But in fairness to your comment, there is the odd herb such as digitalis. We're not for one minute suggesting that we want the right to sell digitalis to a person who requires heart medication. That is clearly—although it's a natural source and although what the consumer gets is far from a natural product, it's still based in a leaf. There are some, but they're very few.

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Mr. David Chapman: The vast majority of what we sell are products that are really good for people, that don't hurt people. If you look at all the statistics in North America, the death rate is zero and the illness rate is like nearly nil for anything this industry sells, and yet we're subjected to the same criteria. In our statistics here, apparently 608 people died in Canada last year while properly using prescription drugs. I thought it was a lot higher than that.

Ms. Elinor Caplan: To this last question, just say yes or no. If anyone—a manufacturer—makes a claim, do you think they should have to provide appropriate evidence to substantiate the claim?

Mr. David Chapman: Let's discuss what appropriate evidence is and at what level.

Ms. Elinor Caplan: Okay.

Mr. David Chapman: The requirements of Dr. Gillespie seem to be back to double-blind studies that cost $500,000 or $2 million, or whatever it may cost, when we're talking new chemical entities.

I must stress that what we sell are products that, generally speaking, tend to have been around for a while. Melatonin happens to be fairly new, but it is a synthesized hormone that does exist in our bodies. But, guys, what we're selling is safe; it's effective.

I'd like to say one last thing. I'm an importer and I bring in well over 100 products lines. I import from Germany, the United States, Australia, and numerous countries of the world. It's very frustrating for me.

I want to throw at you again this mail order catalogue that has been sent to my home, which says, “Canadians, please order from us. We can give you all these products you can't have.” I can't. It's very frustrating to me.

On the issue of claims and safety, safety is very simple. What's in the bottle? If you make a claim that this is in the bottle, you should be able to prove it's in the bottle. Efficacy should be proven to our peers, which is homeopaths, naturopaths, herbalists, people who have expertise and knowledge in what we sell. The allopathic-trained people we have to deal with at Health Canada, generally speaking, don't comprehend.

We're talking holistic, which is the whole being, the whole person. I guess I could get metaphysical and esoteric, but I won't. When you're ill, folks, you're ill because of many reasons, not just the pathogen in your body. It could be emotional. There could be all sorts of issues.

We're being deluged with requests for products that we can't have that we'd love to sell.

The Chair: Thank you.

Mr. David Chapman: We're passionate.

The Chair: I'm going to add something. During the session last week I said I was feeling very ill and I went home and took two natural products. I took echinacea and zinc.

Ms. Elinor Caplan: Don't make a claim.

The Chair: Am I making any claim?

Ms. Elinor Caplan: I'm only kidding.

The Chair: Just wait and hear what I say.

I came back and didn't say what I had taken. I said I had taken two products.

I want to say this, because we're talking about whether we should know what we're taking and the effectiveness on us, and you were saying that nobody gets any effect from anything.

I had such extreme pain I was on the floor. I think I have something that affected me with those things, but the zinc was not labelled; the echinacea was labelled. I'm not asking you to solve my problem, but I'm just saying that things can happen.

Mr. David Chapman: You probably took zinc on an empty stomach.

Ms. Donna Herringer: Zinc upsets me tremendously.

The Chair: I'm just saying there was no label and it was on the market. I bought it and I had a problem. I'm saying it can happen. That's all I'm saying.

Ms. Donna Herringer: But we're not allowed to put things on the label.

The Chair: I understand that. I'm just telling you from personal experience that I'm an ordinary citizen who went out all in favour of buying natural products. I bought two. One of them obviously wasn't good to take and it effected me very badly.

Mr. Stewart Brown: We just put out a flyer that HPB came in and looked at and reviewed. All we're allowed to say is the name of the product, the quantity, and the price.

We had one product, a child's product, that said it doesn't have any artificial colour in it. We can't say that. They sent back that all you can say is price, quantity, description, and that's it.

The Chair: Could we have a copy of that?

Mr. Stewart Brown: Yes.

Mr. Lionel Pasen: As a manufacturer, we would basically say to Health Canada, take us to court and we'll discuss this before a judge, because a thing like this is a reasonable step to make an honest, true statement. The fact that the regulations and the interpretation of the regulations don't allow it is not sufficient to us, and this is the way industry reacts. We don't want to be in this situation. We want to be good citizens.

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The Chair: Judy.

Ms. Judy Wasylycia-Leis: I have three questions.

First, I know the Canadian Health Food Association is a member of the Advisory Panel on Natural Health Products, but—

Ms. Donna Herringer: They have been. I am a member of the Advisory Panel on Natural Health Products. Two of us are members.

Ms. Judy Wasylycia-Leis: Right. I don't believe retailers and manufacturers are specifically represented on this panel, so my question to you as retailers and manufacturers and importers is, what is your opinion of the interim report and the draft regulatory framework being proposed by the advisory panel?

My second question is, in terms of the obstacles you're running into in the Health Protection Branch, is it possible that some of the obstacles are a result of your threat to the pharmaceutical industry that carries over in terms of how the Health Protection Branch handles your claims and your requests?

The third question is with respect to something like melatonin. We've heard over and over again from the government that the full, proper scientific studies have not been done. Are you saying it's a proven product that doesn't need that kind of in-depth scientific research, or that the scientific research has been done and is just not recognized?

Ms. Donna Herringer: Let me address the first question with regard to the panel. I am a member of the panel and have been since the panel began. As far as the work that has been done and the document that has been put forward, please keep in mind that it's a work in progress.

There has been a lot of work, and the work was pumped up because when we were appointed as a panel we were appointed by Dann Michols; he brought the panel together. Shortly after that there was all this political activity that caused us to be reporting to the Standing Committee on Health. Because we were making our presentation—the early part that Frank Chandler made, I think, was on February 3—we had to do a lot of work fast. There was a lot of work done fast and there was a lot of Internet e-mail going back and forth for a long time.

The actual week before the presentation, from the Monday to Friday... I had just been in Ottawa during the freeze, and it was our last meeting. The following week there were actually ten drafts, and there was a lot of anxiety that the right presentation was going to be brought forward.

I was very happy with the document you got. It's not perfect, but I hope it was understood by the Standing Committee on Health that it is a work in progress.

Does that answer your question?

Ms. Judy Wasylycia-Leis: Yes.

Mr. Lionel Pasen: I would like to add to that. I sat on the original herbal and botanical committee, and we sat for ten years. I think we had four meetings. We did a lot of work. We made recommendations. The government did not really respond well because they were looking for the committee to echo what they were looking for. That was our interpretation of how we were being manipulated. We would fight. We would argue. We would say this is what we want, and we would always find that there was twisting and turning. It was not clearly what we wanted.

Hopefully, because of this, this committee—

Ms. Donna Herringer: Our mandate is different. The mandate to the advisory panel is clearly to set a new framework to be able to regulate the products we have. So the mandate is entirely different. Of course, with all the political activity coming up it really supported us in creating a paper fast.

We have our challenges. I don't want you to think that we don't have our challenges. Regulators, you know, have a different perspective from industry, and we have health professionals on our panel and they also have a different perspective. The panel has worked together extremely well, and we've met a lot, so we've become a little less than intimate. There's been a lot of work and I think it's a good work in progress.

Mr. Lionel Pasen: Addressing your second point on the pharmaceutical industry... First of all, we are very much a part of the pharmaceutical industry in Europe; $11.5 billion worth of herbs are sold in Europe, whereas we're talking maybe $150 million in North America. It's quite different. Many of the companies in North America are owned by European pharmaceutical companies.

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I don't believe there's any great conspiracy. It's dollars and cents; it's business.

The pharmaceutical industry is moving into our industry. Loblaws is now opening up health food sections, as well as Save On, Overwaitea. I could go down a whole list of mainstream people who are now going into natural sections. As it happens, I would imagine the pharmaceutical industry will probably try to force some changes that would be good for it, but not necessarily all the way, not the same attitude we have. It would be, again, on pharmaceutical standards.

As a company we can well afford all of these costs that Health Canada is now trying to put onto the industry. It would be great for us as a company; it would knock out a lot of the little guys. That would not be good for the industry; that would not be good for the Canadian people. That's why we're up here saying it's wrong. It's morally wrong to ask a simple industry to come up to that level when it's not necessary. If it were necessary, that's another story. We're talking safety; we're talking a number of things that are absolutely necessary. We don't have to go up there; we can come up here and give the same level of safety, and it would work properly. I don't think there's a conspiracy, but it's in the background.

The Chair: Thank you very much, Mr. Pasen.

Carolyn Bennett.

Ms. Carolyn Bennett: I have three questions.

First, could somebody walk me through the L-tryptophan problem? As a family doctor I found it extremely frustrating. I think that's an example of things that could happen again unless we are careful; something could be removed from the market and then put on prescription based on very poor evidence and one contaminated supply. It wasn't the amino acid that was the problem; it was the fact that there was a bad contamination from whatever it was.

So how can we prevent that kind of nonsense from happening in the future? Obviously it's still sitting there, and it's unreasonable that this would be on prescription.

A voice: And expensive.

Ms. Carolyn Bennett: And expensive—huge.

Mr. David Chapman: There's a bit of a misunderstanding here. L-tryptophan was removed from the market before this contamination problem happened. All the amino acids were yanked one day, overnight. From what we understood, it was yanked because some American couple had written a book that made outlandish and outrageous claims for amino acids. At that point, Health Canada's way of handling claims was to haul products off the market. Taheebo was hauled off the market because somebody made a cancer cure claim. Instead of going to the store that made the claim for cancer, they hauled Taheebo off the market. By the way, that is the only product we've ever had removed from new drug status, and that's because we pushed very hard.

Back to L-tryptophan. All the amino acids were removed because of the book, because they did not know how to handle it. Instead of telling the industry to be careful about what claims to make, they just put it into new drug status. Once something goes into new drug status, they really don't want to pull it out, because there are egos at stake. The contamination problem happened two or three years later—just so you have the facts clear. That contamination problem has absolutely nothing to do—

Mr. Stewart Brown: It was directed at the American market.

Mr. David Chapman: Yes.

Ms. Carolyn Bennett: Yes, we were still using it up here.

Mr. David Chapman: And you can still use it on prescription at $80 a dose as compared to $15.

Ms. Carolyn Bennett: Yes, and in terms of the kind of doses people need, it's huge.

Mr. David Chapman: We sell a lot of melatonin in our company through emergency drug release. There are many medical doctors across the country using a lot of melatonin who are extremely frustrated that the only way to get it is through emergency drug release.

Ms. Carolyn Bennett: I'm just saying that this seems like a bad system. To have them remove something this way and then stick it over here on a prescription just seems like an odd thing to do, unless you can actually prove it's dangerous.

Mr. David Chapman: The mechanisms they have been using up to this point are terrible.

Ms. Carolyn Bennett: So you think this is something we should look at.

Mr. David Chapman: Well, things have changed a little bit. There have been very few products put on new drug status over the last couple of years because things are changing. They just don't want to revisit, for whatever reason, and check things.

Ms. Donna Herringer: In 1983 I was imminently close to it because I worked for a manufacturer. A large part of our business, particularly that year, as it was being threatened to be taken away, was in amino acids.

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As David said, in 1983 Health Canada put a number of amino acids—there are still a few left—into the new drug status. The new drug status is what we in our industry call that deep, dark hole that nothing ever comes out of. It goes into it, but it never comes out of it. I'm certain that with new regulations it will be one of the first things we do.

That was the Canadian problem. The American problem was that there was a batch of L-tryptophan from a Japanese manufacturer that was contaminated.

Ms. Carolyn Bennett: That's when we lost it here.

Ms. Donna Herringer: Then it was taken off the American market. Look at when it was taken off the American market. This shows you how close we are to the American market. You, as a medical doctor, were more informed about what was going on in the U.S. than what happened several years previously in the Canadian marketplace in terms of amino acids really not being available legally.

It depended on who you were. If you were a large chain like us—we have 40 stores, Stewart has 5—there was no way you were going to have illegal product on your shelves, because you were going to be severely fined or be in severe problems. But small people can go to the U.S. market and have private access.

Ms. Carolyn Bennett: I'm just aware of the time.

The other thing I noticed in all the mail order catalogues was that a lot of the vitamins don't even have a dose. So I come back to things like vitamin B6 and things that have had some evidence of neurotoxicity or something at 200 milligrams. I'm just astounded that you can actually sell this.

Mr. Stewart Brown: Toxicity is more like two grams.

Ms. Carolyn Bennett: Two grams? But still, most of us are telling people they shouldn't take more than 200 milligrams a day.

Mr. Stewart Brown: Exactly. And these people who had the problems were taking 10 or 20 tablets a day.

Ms. Carolyn Bennett: How do they sell this stuff when you don't even know whether you're getting a 25-milligram or 50-milligram tablet?

Ms. Donna Herringer: We have to go back to the American law, and that's the frustration. As a buyer, I would much prefer to buy Canadian-made product, because we have the best GMP standards in the world. But products come over the border all the time without a dosage, without proper labelling, without all kinds of things.

Ms. Carolyn Bennett: I have a third question. You can maybe fill in the gaps. Consider the dozen or so herbs that you say you wouldn't want without the intervention of a practitioner. As for the retail part, in pharmacies, there are certain over-the-counter drugs that are behind the counter, right? You actually have to ask the pharmacist to pull it down off the shelf so he knows what you're getting.

Here's my concern. If that was part of a routine in a health food store, who would be behind the counter? My concern is about their qualifications or ability. I realize there's a certain “buyer beware”, but the actual check-out clerk shouldn't be prescribing—

Ms. Donna Herringer: I understand what you're saying, and I would share the same concerns. High-risk herbs would not be sold in a health food store; they would be prescribed by the appropriate physician, health care worker, or professional. This is especially so in Chinese medicine, because that's where you have very high toxicities. These would not be available in health food stores.

Mr. David Chapman: Things could be handled with a label warning. It could be a very simple thing saying not to take it or that you should have a discussion with a practitioner before taking this product.

Mr. Lionel Pasen: But that dozen or so would not be within our purview.

Mr. David Chapman: No, that wouldn't be for some of the things.

Mr. Stewart Brown: In here, it talks about how co-regulation can all work together with government, industry, and experts.

Ms. Carolyn Bennett: That's what the panel would sort of be able to sort out.

Mr. David Chapman: Folks, you're obviously looking for some help with putting your report together. We'd be glad to help you write your report.

The Chair: We would have a room full of people, which is very nice.

Mr. Grant Hill: The one statement you made that I found intriguing was that the regulators should be in charge when there's harm or proof of harm and the industry would be in charge when it relates to quality and making sure that what is claimed is in the bottle. Carolyn's comment about L-tryptophan dovetailed with that. Here was the regulator saying that they didn't have enough information or that they were being so super-cautious with the amino acids.

Ms. Donna Herringer: That had to do with claims for efficacy; that had nothing to do with quality in any way, shape, or form.

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What was happening was L-tryptophan for sleep—that's a claim—arginine for muscle enhancement, ornithine for weight loss, and lysine for herpes... These are claims. Claims were being made because people were accomplishing what they wanted to accomplish through the use of these products. That's efficacy, not quality.

There was never a question of quality in the Canadian marketplace of anybody who had any amino acids. It was not a quality issue; it was around claims being made about efficacy. The reason I think you can't qualify efficacy in our industry is because it's built on a holistic model, a holistic paradigm. Everybody's body works differently, everybody's needs are different, and nutrients feed the needs of the body. You cannot guarantee efficacy because what works for you, Dr. Hill, and what works for me can be entirely differently. So to make a claim around efficacy or to guarantee efficacy is not something that's possible when you're talking about a holistic paradigm.

Mr. Grant Hill: To get back to when the regulators are involved with proof of harm, what level of proof do you look for? They said, “We're unsure about L-tryptophan, we're unsure about these claims; we don't actually have proof of harm, but we're unsure. We're being so cautious.”

Ms. Donna Herringer: Once again I have to go back to claims. They're saying to us, the industry, that if these products do what everybody says they're doing, you have to prove it to us in documentation and research. It had nothing to do with quality. There was no harm. It had to do with people making claims that these products were effective, and in the eyes of Health Canada if it's effective it's a drug. These are amino acids—single amino acids—which are parts of protein.

Mr. Stewart Brown: Then it goes into the new drug category, which as David has said, it never gets out of.

Mr. Grant Hill: So a new product coming on the market, let's say the bazooga weed, which has never been heard of before—maybe I'm talking about something that already is on the market, I don't know—for which there is no evidence of harm, for which there is a claim that this gives you better night vision, let's say... Should such a product be allowed on the market if it's of good quality, pure, there's no problem, no side effects and what not, unless there is evidence of harm?

Ms. Donna Herringer: Yes, it should be on the market. If it's ginkgo biloba, say, that people are talking about for memory...as long as there is 100% ginkgo biloba in that capsule, saying in the milligrams that it says it is, and there's a full disclosure—which is what our recommendation would be for what's in the product—that to us is what's referring to safety. The customer knows exactly what they're getting, and there would probably be a suggested dosage.

Mr. Grant Hill: Regulations set up in that direction would satisfy you?

Ms. Donna Herringer: Absolutely, we want safety. Safety is important to the health of—

Mr. David Chapman: There were big battles within Health Canada as far as ginkgo was concerned. Brian Gillespie was on the record clearly and openly: he did not want it on the market because he was afraid people would use it for mental this or that. There was a big battle, and as a result the food people won the battle and were allowed to sell ginkgo without any claim at all. Now the claims are made over here somewhere.

The one thing we need to stress on claims is schedule A. Whatever its purpose when it was put into place several years ago is way past its time and way past its prime. Schedule A stops many claims and it often stops products. You're not supposed to sell hawthorn in Canada. Hawthorn is a wonderful product and used in many things, but they'll never give you a DIN for it under current policy and regulations.

You have to understand that a lot of what's going on now is the bureaucrats themselves making up policies as they go along. This is not legislation you guys ever passed. They were given carte blanche way back when the act was put into place to set policies; they went along because they're the supposed experts. Some of the policies are fine and some of the people there are fine; we just have problems with the way they've interpreted a lot of the things.

The Chair: Mr. Brown.

Mr. Stewart Brown: Taking it down to the public level, where I have customers coming into the store taking ginkgo—it's all Greek to so many people—echinacea, St. John's wort... They get it all confused. So people come in taking ginkgo for their cold and flu, and some people say it's the best thing they have ever used for it. I don't correct them.

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There are a lot of people who are just... “The lady down the street said to take this”, blah, blah, blah. They pick up the wrong product half the time, and they complain, “This stuff is useless; it has never worked for me.”

A voice: Back to the word “appropriate”.

The Chair: Judy.

Ms. Judy Wasylycia-Leis: I will just go back to that question on melatonin. The question was whether the problem is inadequate research being done and it not being recognized or a case of the feeling that you believe it's a proven product and therefore it doesn't need to go through the same scrutiny as the Health Protection Branch is requiring.

One of the reasons I ask is I remember a program on melatonin on CBC's The National about a year ago. They had witnesses with all kinds of claims: it was going to make you younger, it was an aphrodisiac, it was this and that. It's still a big question mark in my mind how you treat something like melatonin. I wouldn't mind just a quick answer on your sense of it.

Mr. David Chapman: In the United States, under the DSHEA situation, the FDA have to prove harm before something cannot be sold. With melatonin they have decided there's no harm to be proven, which is why they haven't acted against it in any way.

Several doctors around the United States and several now in Canada have done a lot of research on melatonin and absolutely love it. But we're dealing with a criterion. Health Canada have criteria for approving things.

We sent in what we thought was more than enough to prove to them melatonin was safe, but they decided that since it's sold only in the United States, they weren't going to... They basically had their minds made up before we came in. We could tell that.

For years we have attempted to get products on a new drug status, whether melatonin or whatever. Based on the doctors who are calling us for melatonin, since I am the one person in Canada who is now selling it legally, under the emergency drug release program, they are very frustrated at the whole system and concept. The research that's going on at places such as the Vancouver children's hospital, where they are doing a massive amount of clinical studies right now...the doctors are telling us they are thrilled with the results.

Now, about how appropriate melatonin is, I can't comment. I'm a business person. I just know it has been sold for several years in the United States and I have never heard of an issue or a problem.

All these amino acids sold for several years in the United States. There are 250 million people in that market. I've never heard of a problem, other than that tryptophan contamination.

This is the whole criterion issue we all have. We're sitting here as business people. In my company I've created 70 jobs in the last 12 years. I suspect I could have created an awful lot more if I could have had free rein to sell the products, make the claims for the products, whether melatonin or whatever, without restraint.

Ms. Donna Herringer: To answer your question, though, the document we have submitted—and I hope you all have a chance to...I'm sure you won't read all of it, but the document itself... We hired a scientist by the name of Dr. Christian Sood, who actually compiled the research that was available for the presentation. He is a scientist. He understands the science. He read all the research that was available internationally. That is what that document is compiled of.

We're not talking about advertising here. We're not talking about hype. We're talking about research that was submitted to Health Canada in August 1996, which was not so long ago. Because it didn't meet the kinds of standards of research a drug has to have and the amount of dollars it takes to do that, it was not considered at all.

Mr. David Chapman: They told us they would consider it. As an industry, we spent a considerable amount of money putting...we spent—

Ms. Donna Herringer: It was a joint venture.

Mr. David Chapman: Some of our companies put money in and whatever.

It was done very professionally. These are PhDs, people with a lot more education than some of the people we're dealing with at Health Canada, and it was just sloughed off. We didn't even get an answer for several months. It was a quick letter saying, well, we didn't like this and we didn't like that.

Mr. Lionel Pasen: You have to understand that we're not a cottage industry any more, but we're being treated as if we are.

Mr. David Chapman: We care deeply about what we sell. We care about the quality. We care about the efficacy. But efficacy needs to be proven to people who know what they are doing, the people who are our peers, the herbalists, homeopaths, or whatever, not people who don't have the training and the knowledge and the understanding.

Ms. Donna Herringer: Perhaps I could say just one more thing as a retailer. One of the things for retailers in Canada—I'm sure you've heard this over and over again—is that our regulation and our rules from Health Canada and the Canadian government are actually supporting American industry. We, as business people in Canada, as health food retailers, have to see our customers go. All of the major cities in Canada are very close to the 49th parallel, and there are health food stores situated and 1-800 numbers situated where Canadian consumers can get what they need.

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Our concern is that they're not always getting the best quality product. For 14 years I was with a manufacturer in our industry, and now as a major buyer in the industry I'm very aware of the Canadian standards and the Canadian GMPs, which are much higher than those of our southern friends. So as a buyer for health food stores, I'd like to support Canadian manufacturers, but we need made-in-Canada regulations and to support Canadian industry.

The Chair: Ms. Caplan, last question, and then I have two short questions.

Ms. Elinor Caplan: I'd like to quickly try to synthesize what I've heard and see if I got your presentation.

From your view, quality is a process during manufacturing and assessment. Safety, therefore, is a result of GMP standards and other standards that give you an outcome of a safe product if taken properly. That requires labelling and an understanding, through that quality and safety process, of risk assessment, toxicity, and so forth. Both of those are required in order to give you the proper information for labelling, warnings, and so forth.

On the issue of efficacy, the evidence appropriate would be possibly a literature review or research to assess whether it would be appropriate to the risk that's been determined from the safety and quality standards that have been established. What you need in Health Canada on the issue of efficacy is someone who understands the nature of the product in order to be able to make that assessment.

Mr. Lionel Pasen: We need someone who can read, understand, and evaluate the data as to its acceptability.

If the plant in which a product is manufactured follows good quality procedures and you put out a dud product—you're claiming it's going to make your nose smaller or it's going to turn the colour of your hair—believe me, that product, no matter what the quality, is not going to sell. It's not going to have much of a life. A normal manufacturer will not go that route.

That may have happened many years ago and that may be the attitude of Health Canada. That is not the case today. You have proper businessmen looking for a proper return on proper product being sold. They don't want to get involved in any sort of situation where their product is less than what the label claims. We are looking for regulations that allow us that route.

Ms. Elinor Caplan: In your view, is there any role for HPB in the testing, to verify...?

Ms. Donna Herringer: It has to be a cooperative event. We're looking for self-regulation in our industry, and to keep the costs down we can work with government for testing.

Mr. David Chapman: We can show them the results of our testing. Folks, when it comes to the end of the day, if you're having Health Canada continue to regulate us, we would like to have the ability to appeal to a board or a group of practitioners that can make the final determination.

Ms. Elinor Caplan: So you want an appeal procedure.

Mr. David Chapman: We want someone to appeal to, because it stops right now at Brian Gillespie's desk, and supposedly there's an appeal process, but frankly, it doesn't happen.

Ms. Donna Herringer: In the new model, which is what we're talking about, that would contain expertise right at the decision-making level, and hopefully an appeal process would not be necessary when we have proper people to evaluate the products.

The Chair: Thank you.

I have two very short questions. I'd like a yes or no to the first one, from Mr. Pasen.

Has anyone tried to test the legal authority of the inspectors by taking them to court, that you know of?

Mr. Lionel Pasen: Yes.

The Chair: Could you tell me when, or do you know?

Mr. Lionel Pasen: I would have Donna respond to that.

The Chair: Okay, I'll discuss it with you afterward.

Mr. Chapman, for those of us who aren't doctors, could you just talk about this emergency drug release? Just give us in one sentence or one minute what it is.

Mr. David Chapman: Health Canada has a provision that for products not normally sold in Canada because they haven't passed the regulations, a doctor will send in to Health Canada a request to sell this or that product, whether it's melatonin or some other new drug, and Health Canada will in turn say yes.

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DHEA is not on that group because it's in a controlled substance schedule. As a doctor, you can't get DHEA that easily. It's a lot harder to get.

The Chair: Okay.

Mr. Stewart Brown: HPB has used this as an escape hatch, but it's not as easy as they make out. They say, well, you can get melatonin through your emergency drug release, but it's not a simple process. Most doctors do not want to do the paperwork. They don't want to go to the trouble and expense.

Ms. Elinor Caplan: So you need an alternative process.

Mr. Stewart Brown: Yes.

Mr. David Chapman: What's happening is that it's being snuck into the country, or bootlegged in.

Mr. Lionel Pasen: Or mailed into the country.

Mr. David Chapman: Right. This mail-order piece, folks, said, “Attention Canadians”. I don't know if it's included in what we gave you.

Mr. Stewart Brown: I will leave this flyer. On this, I want to say that the HPB people were great. They were trying to help. They understood what the problem was.

The Chair: Okay.

Ms. Herringer, do you have the name of the person who challenged the...?

Ms. Donna Herringer: I have the name of the company. It was Quest Vitamins.

The Chair: Do you know when it was?

Ms. Donna Herringer: It was 1997.

The Chair: Okay.

Thank you very much for coming. I think we learned a lot today.

The meeting is adjourned to the call of the chair.