HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, February 26, 1998

• 0905

[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): I call to order the 23rd meeting of the Standing Committee on Health. We are studying natural health products.

I want to mention that in the last few meetings, if it appeared everybody was interested in an answer to somebody's question then I let the timeframe go. I think today, to start with anyway, unless we have somebody put their hand up and there's a consensus for some reason that they want to go over the five minutes, I'm going to stick to that timeframe. If you want to make a motion that you'd like five more minutes or something, then ask for it, but I'll stick to the timeframe in case there are a lot of questions. Sometimes the people at the bottom of the list don't get to ask their questions. If we stick to five minutes, everybody should probably get a second question or a second time slot.

Our witnesses today are from the Department of Health. We have Dann Michols, whom we've all seen before; he's the director general from the therapeutic products program. With him are Harry Conacher, acting director of the Bureau of Chemical Safety, whom we've also seen before; John Salminen, head of the additives and contaminants section; and Mary Carman, director of the Bureau of Pharmaceutical Assessment, therapeutic products program.

Welcome to all of you.

We also have Jean Lambert, who is the director for the Quebec region. Sorry, Jean. You are down here.

Could we keep it relatively brief? I think there are a lot of questions.

Dann, go ahead.

Mr. Dann Michols, (Director General, Therapeutic Products Program, Department of Health): I'm sure there are a lot of questions. I would, however, like to make a couple of opening comments.

First of all, we have prepared a small package to be handed out. In this package there are three briefing notes that we have prepared over a period of time. One of them is on DHEA, one of them is on melatonin, and one of them is on L-tryptophan. There are a couple of notes on various herbs that we have been tracking, and there is a note on a couple of enforcement activities.

We are simply tabling that with you as background information on a number of the substances that have been mentioned by various witnesses before you, for your information.

We've also included in that package a couple of press clippings from the United States. As you know, their regulations vis-à-vis dietary supplements are quite different from ours, but there is growing concern on that particular regime. So we have included a couple of articles that you may already have seen from ABC News and CNN on those subjects.

I'd like to make three comments just to start, before opening up to questions.

I'd like to remind the committee of the basis for the current regulatory framework, which is the regulatory framework we are mandated to enforce. As you know, it is based on the Food and Drugs Act, and in the case of some substances it is based on the Controlled Drugs and Substances Act. That is the foundation for the activities we undertake. I quote again from the Food and Drugs Act:

“drug” includes any substance or mixture of substances manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in man or animal,

—or substance used in—

(b) restoring, correcting or modifying organic functions in man or animal,

That is the basic foundation for the regulatory activities we undertake. I would submit to you that despite the concerns of some witnesses that natural health products are not drugs, according to the law in Canada, these products, if they make therapeutic, diagnostic or preventative claims, are drugs under the current regulatory framework. That is what we have to go on and it is the basis of our regulatory framework.

• 0910

The way we go about regulating these products is based on an assessment of risk and benefit. No product is approved by us for marketing in Canada if it doesn't have benefits that outweigh the risks. We attempt to put in place various mechanisms to mitigate the risks a particular product represents. We attempt to manage those risks relative to the degree of the risk.

Generally, on the drug side—and this is a comment that has been made by a couple of your witnesses—we do not ban substances. Our role is to approve products. What we do is to analyse a product or a submission from a manufacturer who wants to put a product on the market; determine whether or not there is sufficient evidence to prove benefit, to prove safety, to prove quality and effectiveness of the product; and then we approve the product.

There are six substances that we feel ought not be used in the manufacture of drugs. Those are public information.

It is not our role to ban substances. It is our role to approve products. It is the manufacturer's responsibility to submit the data to prove that the product has benefits and that the risks are under control.

So the enforcement activities our inspectors undertake across the country are aimed at dealing with unapproved products, not banned substances. Harry, in his opening comments, will comment on the approach the food directorate uses.

The second comment I would like to make is that we have been undertaking, for the last five years, a massive renewal and re-engineering program within the therapeutic products program, which is the regulator of drugs in Canada.

I have been responsible for the management of the program since 1993, following the Gagnon report, responsible for this renewal activity. The entire management team has changed in that period of time. The organization has changed. All of the regulatory frameworks have been reviewed and renewed. We have done this in conjunction with advisory panels and consultation mechanisms, with all of the stakeholders.

I realize that there have been anecdotes presented to this committee in terms of what may have happened ten years ago, or what may have happened twelve years ago. I cannot take responsibility, and my management team cannot take responsibility, for anything that has happened outside of the last five years.

Third, with regard to the competency of my organization, a number of witnesses have perhaps called that into question. I'd like to give you a couple of brief facts.

There are 750 people in the therapeutic products program responsible for the regulation of drugs and medical devices. Of those people, 575 are professionals to the extent that they have university degrees of one type or another, and 550 of those 575 have science degrees—many of them doctors of medicine and PhDs—germane to the regulation of drugs and medical devices. Of those people, 150 are employed in our labs. So 20% of our staff are employed in labs and undertake lab activities, either research activities or analysis and testing activities.

We are one of the most competent drug and medical device regulators in the world. We have been approached by regulatory agencies in Europe, the United States, Japan, Australia, and Switzerland to enter into mutual recognition agreements with them, because we are recognized as one of the best regulators in this area.

If we do not have the staff, or the competency within our staff in a particular area, we make very liberal use of expert advisory committees made up of external expertise in the practice of medicine or in science. We have five standing expert advisory committees, one of those in the complementary medicines area.

• 0915

We also make liberal use of contracts. We contract university staff and private physicians to undertake the evaluation of submissions from time to time, if we do not have that exact specific expertise on our staff.

We do not have all the staff I would like to have in some of the areas we are required to regulate. That is a function, to some extent, of the system, in terms of staffing and enticing people into public service. It is also a function of the resources that are made available to my organization. At any point in time, I'd be delighted to get into more detail in terms of the resource situation.

Those are my opening comments, Madam Chair. I believe Dr. Conacher has a couple of comments he would like to make on the food regulation side, and then we'd be delighted to answer any questions.

The Chair: Thank you.

Mr. Conacher.

Mr. Harry Conacher (Acting Director, Bureau of Chemical Safety, Department of Health): Thank you, Dann, Madam Chairman, ladies and gentlemen.

Madam Chairman, with your permission, I'd like to say a few words about the food program in Health Canada and particularly its relationship with the Canadian Food Inspection Agency. That's very important for the members to understand.

I'd then like to reiterate how food in general—not just herbs and botanicals, but food in general—is regulated in Canada in relation to health and safety issues. Then I'll give a brief description of how the current regulatory system functions with regard to herbs and botanicals sold as foods.

Finally I'll discuss these herbs and botanicals over which we have concerns when they are sold as food, illustrating by means of an example of what we take into account when we do an evaluation of such a substance. I have made available to the committee a list of those substances about which we have concerns and a one-pager attached to that list on how we do a health hazard evaluation, which I'll reach after some moments.

First of all, the control of food in Canada in relation to health and safety issues is a very complex matter involving a multitude of players, including the various components of the food industry and all levels of government—federal, provincial, municipal, and territorial. Despite this apparent complexity, Canada has achieved a worldwide reputation for safe, nutritious, and high-quality food.

At the federal level, considerable changes have occurred in the last few years with the formation of the Canadian Food Inspection Agency, which is an independent agency reporting to Parliament through the Minister of Agriculture. Thus food inspection compliance and enforcement activities, which were formerly provided by Agriculture Canada, Fisheries and Oceans, and Health Canada, were consolidated into this agency.

Under this new system, the food program of Health Canada has retained responsibility for policy-setting, food safety standards-setting, research in food safety matters, as well as auditing the food health and safety activities of this Canadian Food Inspection Agency. It would have been very helpful this morning to have representatives of the Canadian Food Inspection Agency here to address any queries I'm sure you will have relating to compliance and enforcement activities in the natural health products area, but I understand they were unable to be here this morning.

Turning to the mandate of the food program in Health Canada, in general terms it is to ensure a safe and nutritious food supply for all Canadians. The program derives its regulatory authority for health and safety from the Food and Drugs Act. The primary section under this act dealing with food safety is section 4, which states, among other things, that no person shall sell an article of food that has in it or on it any poisonous or harmful substance or sell a food that is adulterated.

Under this act, the onus is placed on the sellers of the food to ensure the safety of the food they are selling, and therefore the liability resulting from injuries to consumers of the food in question rests with the seller.

• 0920

In a certain number of instances in the food area, a pre-market review is required before the food or food component can be offered for sale in Canada. Pre-market reviews are required for food additives, infant formula, irradiated foods, veterinary drugs, and agricultural chemicals. In all those cases, strict regulations requiring pre-market evaluations have been established under the Food and Drugs Act and regulations. Consideration is also being given to specific regulations in the area of novel foods.

All other foods or food components can be offered for sale in Canada without pre-market assessment, unless there is a specific prohibition on their sale in the food and drug regulations or through some announced guideline. However, we in Health Canada still have the authority to make regulations or to take other measures to prohibit the sale of any food substance or food that is determined to be hazardous.

That is the general framework for food safety control in Canada.

Thus the situation with regard to herbs and botanicals, as I indicated during my last presentation, is as follows. When herbs and botanicals are sold as foods, there is no pre-clearance requirement of these substances. Health claims may not be made for these substances. The onus is on the vendor to sell a safe product, and Health Canada's food program, as I have indicated, may make regulations to prohibit the sale of hazardous substances.

That is the general situation and the situation with regard to herbs and botanicals.

During my last presentation in December, I briefly discussed the development of a list of herbs and botanicals that have been deemed inappropriate for unrestricted sale as foods, due to safety concerns. This list, as requested, has now been made available to the committee, and I do hope you have it in front of you. It's present in the form of a letter from me to Mr. Roger Préfontaine, the clerk of this committee.

This list, as you can see, comprises 64 substances identified by a committee of outside experts known as the Expert Advisory Committee on Herbs and Botanical Preparations—64 substances that in their opinion should not be sold as foods. As I mentioned previously, it was our intention to include those 64 substances as prohibited substances in the food and drug regulations. However, due to the significant opposition to this proposal from numerous sources, this amendment has never been promulgated into the regulations. The amendment is schedule 705. I hope I'm making this clear.

In addition to those 64 substances, we in the food directorate have identified 16 herbs and botanicals that, due to safety concerns—safety concerns assessed by us within the food directorate—are also considered inappropriate for unrestricted sale as food. This list of 16 is not a final list; it is not a comprehensive list. It is based on reviews initiated, as I indicated, in my bureau as a result of reports of adverse reactions received either directly from consumers in Canada; through the international literature; or at the request of inspectors, industry representatives, or consumers.

When news of this list became known, the opposition we had experienced with regard to schedule 705 continued unabated. This was primarily due to the freedom of choice issues and the restrictions that such regulations would place on the continued availability of herbal products.

At this point, if the committee has in front of them the letter to Monsieur Préfontaine, attached to that letter is an indication of how we do a health hazard assessment on one of those substances in the list, called chaparral. I hope the committee has this in front of them.

• 0925

Mr. Grant Hill (Macleod, Ref.): I do not have that.

Mr. Harry Conacher: You do not? It's right at the back of your package.

This is the process that we in the food directorate go through when we have a request for a health hazard evaluation of a particular food, whether it be a herb and botanical or not. I've illustrated by means of chaparral.

Chaparral is a bush found in southwest U.S.A. and Mexico. In folk remedies, the leaves and the stem are steeped to make tea. Chaparral contains a particular acid going under the acronym of NDGA, which, on the basis of research in the scientific literature and research conducted in our own laboratories, is a potent hepato-toxin that affects the liver adversely, and which has been also demonstrated to have toxic effects on the kidneys of experimental animals. This is a component of chaparral.

This component of chaparral, NDGA, was formerly used as a food additive. When that information became available regarding the toxicity of this component to the liver and kidneys of experimental animals, it was de-listed from the food additive tables in 1968.

With regard to chaparral itself, there are numerous reports in the scientific literature documenting an association of ingestion of chaparral with acute hepatitis—a severe liver illness.

In December 1992, the U.S. Food and Drug Administration issued a warning for consumers to stop taking chaparral or chaparral-containing products. Shortly afterwards, in January 1993, following evaluation of all these data on chaparral—chaparral itself and that particular component of chaparral of which I spoke—we in the food directorate advised that infusions of chaparral and other tea mixtures that may contain this should not be permitted to be sold as a food.

This illustrates to you the process we have undergone with regard to most or all of the chemicals on this so-called banned list. It's a scientific process. We have on our staff, similar to what Dann had indicated, professionals who are qualified in pathology, toxicology, biochemistry—the whole gamut of scientific disciplines.

They are the ones who undertake these assessments, and this is why we have concerns about the unrestricted sale of these components as foods. We do not go, in the food area, into the benefit side at all. It's purely the fact that these compounds may pose an adverse effect to the Canadian consumer.

That is in general what I felt I would like to convey to the committee this morning, prior to taking any questions. Thank you very much, Madam Chair.

The Chair: Thank you, Mr. Conacher.

Mr. Hill.

Mr. Grant Hill: Thank you indeed, and thanks for coming back to be in front of the committee.

First, to Mr. Michols. I talked with you in the prior meeting about melatonin, and your comments to me were, and I can quote them specifically; I have the quote here:

...melatonin...is not available on the Canadian market is not that we have banned it; it is that we have not approved it because we have not received a package from a sponsor following the guidelines we have set.

From that I took that no one had presented to the HPB a melatonin submission. I have today the submission made by the Canadian Health Food Association—a fairly reasonable submission, in my view. It went back and looked at the literature throughout other jurisdictions, and some of the claims and so on.

I noted very carefully your wording in here: “following the guidelines we have set”. Of course that's a subtle use of the English language, in my view. I missed that when you said it, but when I go back....

• 0930

I guess you're going to say to me, “Grant, the submission we got did not exactly follow all the criteria”. Fair, if that's going to be your comment, that it wasn't in the guidelines you have set.

Mr. Dann Michols: I would not say to you that it did not follow exactly the guidelines we had set. I would say to you that it did not contain the data we needed in order to analyse the substance for the indications that were being requested.

Mr. Grant Hill: Okay. Did you then go back to this group, and tell them “You need to do the following in order to allow us to properly assess this”?

Mr. Dann Michols: In the notes we have given to you in the package, there is one specifically on the subject of melatonin.

Mr. Grant Hill: I just got it moments ago, so....

Mr. Dann Michols: I understand. But there is reference in there. We are not in any way attempting to hide the fact that the Canadian Health Food Association did put together this submission of information.

Mr. Grant Hill: But you can see how that could mislead the committee. At least, it misled me. It sounded to me like “Well, if somebody came along and gave us a submission, melatonin would be no problem”.

Mr. Dann Michols: No. I'm sorry. If that was understood from my comments, it was never my intent. We have, as I have said, I hope very clear guidelines on what is required from a manufacturer in terms of data and information to indicate adequately the benefit and risk of a particular product. That varies according to the type of product, type of claim being made. Melatonin, because it is a hormone, is in the new drug category, and very clearly there are guidelines on what information is required.

We have encouraged organizations. They did put this submission together. Mary's operation did analyse it. We did get back to them in terms of our reaction to it. It did not contain the information we needed to approve the product.

Mr. Grant Hill: I'm sure you would answer me yes or no. Did you get back in touch with them and say “These are the deficiencies. Fill these blanks and we'll be okay”?

Ms. Mary Carman (Director, Bureau of Pharmaceutical Assessment, Therapeutic Products Program, Department of Health): We got back to them during a meeting with the Canadian Health Food Association and discussed with them what we felt the inadequacies of their submission were.

Mr. Grant Hill: So you did do that.

Ms. Mary Carman: We discussed with them. It is not in writing to them.

Mr. Grant Hill: I pulled off the latest information available to me. It's from the Canadian Medical Post of February 3, 1998, and I would just like to quote:

Some studies suggest melatonin can help people get over jet lag, but the evidence isn't overwhelming or particularly exciting.... There is a similar lack of compelling evidence for melatonin's effectiveness as a sleep aid.

So here, individuals are saying that the evidence is not overwhelming that it works. But it goes on to say:

But, nothing really shows it is dangerous either.

So it's a pretty balanced approach.

Melatonin is not available for sale in Canada through Canadian stores, but it is available for personal importation.

We have heard over and over again that that's completely inconsistent. How could a regulator allow a product they may have some concerns about not to be for sale in Canadian stores, and yet you can call a 1-800 number and bring it over? If you could explain that inconsistency to me, you'd go a long way towards giving me some confidence in the regulatory mechanism.

The Chair: Mr. Hill's time is up, so would you please give your answer?

Mr. Dann Michols: Let me attempt to explain that to you. The basis for our regulatory activity is the Food and Drugs Act, which lays out what it is we are responsible for doing, and it deals with products that are sold or represented for sale in Canada. We do not have the power under the current legislation to regulate the personal use of a product, and I think it's exactly the role of your committee to comment on that, if that is of concern.

We have a policy, and that policy is in the binder we distributed to you at the beginning, that explains our attitude, if you like—our policy towards importation for personal use. We don't have the power to regulate in that area, but we have set, for the purposes of guidance, the limitation of a three-month supply by a person who wants to import for personal use. But the act and the regulations deal with giving us the power to deal with sale or representation for sale.

• 0935

So I think the short answer is that we don't have the regulatory power at this point to deal with importation for personal use. It's not that I don't agree with you; I do agree with you that there is an inconsistency in how the products are available to Canadians and in our protective canopy, if you like, for the health and protection of Canadians. But we don't have the regulatory power to deal with that particular aspect.

The Chair: Mr. Michols, I'm sure that's not a complete answer, but you'll be back.

Mr. Myers.

Mr. Lynn Myers (Waterloo—Wellington, Lib.): Thank you, Madam Chair.

Mr. Michols, you talked about the 700 people in your employ and under your direction, of which 550 had science degrees. One of the things we've heard at this committee is that there's sort of a woeful lack of people who are experts in natural products and herbal medicine.

Is that a fair assessment? Is that something that makes sense?

Mr. Dann Michols: Yes and no, or perhaps no and yes. These substances and products are chemicals. We have the biologists, chemists, pharmacologists, and such to deal in many ways with the analysis of these particular products.

We do not have as many as we would like who have experience perhaps in the practice of complementary medicine. We have staffed a couple. We have expertise in homeopathy and such, but we do not have the resources in this area that we would like to have. But I don't think that equates to not having the expertise to be able to evaluate the safety, quality, and effectiveness of these products. In my opinion, they are chemicals, and we do have that capacity.

Mr. Lynn Myers: The other question I had was this. We heard, I think at this committee level, a disturbing sort of theme that keeps re-emerging. It's that, in effect, your branch is in collusion with the drug companies.

We heard testimony yesterday. Actually, two people were referenced in terms of what they had purportedly said in newspapers and such. There were things said, such as the drug company should not be in a situation where their competitiveness is compromised. Somebody else said the Health Protection Branch considers the pharmaceutical industry as its primary client. On and on it goes. I wonder if you could directly respond to that charge or allegation.

Mr. Dann Michols: The two people quoted in the presentation yesterday are not from my operation. I would, I guess adamantly, insist that there's no collusion between my organization as regulator and any aspect of the drug or medical device industry.

If it's any consolation, we are criticized as heavily by the major pharmaceutical companies as we are by the herbal manufacturers as we are by the medical device manufacturers, which tends to give me some indication that we're probably doing something right.

I don't know how to prove a negative. If proof can be given to me of collusion, I would be delighted to deal with it. But as for general accusations that somehow we are under the influence of major pharmaceutical companies or some other aspect of industry, I just can't deal with that.

I can tell you that every single policy development exercise or regulatory change exercise that we have run as a part of our renewal activity over the last five years has involved representatives of all stakeholders. We attempt never to get into a situation in which we are consulting on a bilateral basis with one type of stakeholder.

We think it's important that the industry, along with the health community, consumers, and consumer advocates, is in the same room talking about the same regulatory structure and reacting to that process. We don't engage in negotiations behind closed doors with any of the stakeholder groups. I don't know how better to react to those accusations.

Mr. Lynn Myers: I appreciate your clarification from your point of view.

I had another question to you and Mr. Conacher. We keep hearing that the need exists for a third category with respect to these products. I wonder if you have any reaction to that or comment on that.

Mr. Dann Michols: I do have a reaction. It's personal as well as professional.

• 0940

I do not believe there is a need for a third category. The Food and Drugs Act, by defining drugs.... I don't agree that “drugs” is necessarily the right term—that's why my organization is now called the therapeutic products program, because there are connotations to the word “drug”—but therapeutic products and food....

As you know, we are engaged in an exercise—and there are briefings in the binder—dealing with the products that fall on the cusp between food and drugs as defined by the act. These are defined variously as functional foods, or nutriceuticals, or whatever.

There is one grey area when you have therapeutic products and food. If you create a third category, you're going to have to deal with two grey areas, the difference between foods and this new thing and therapeutic products.

In my opinion, I do not think there is need for a third category. I believe the definition contained within the Food and Drugs Act is adequate to give us the regulatory base to deal with any product making claims for therapeutic, diagnostic or preventative activity. You then have to build the appropriate regulatory framework under that, and that is what we have attempted to do in dealing with the risk presented by these various products.

So if a product has a low risk—and many of the natural health products do, but so too do many of the over-the-counter drugs and such—then it ought to be dealt with using a lighter touch by the regulatory apparatus than something that presents a much greater risk. In my opinion, that is where the time and energy ought to be spent, in defining the risk presented by all of these substances and building the regulatory framework to deal with them, not creating a third category.

In the report of the advisory panel that was presented to you at the beginning of your witnesses, they do not state that there ought to be a third category. They do make the statement that natural products are unique and ought to be handled in a unique way, but as yet, the advisory panel has not been able to indicate sufficiently to me why natural products ought to be treated in a different manner.

So I would much rather come at the subject from the question of risk presented by all of these therapeutic products as opposed to trying to define some third category.

Mr. Lynn Myers: I want a quick response from—

The Chair: It will have to wait, because we're about two minutes over. Maybe you can come back on your next round.

Mr. Dumas.

[Translation]

Mr. Maurice Dumas (Argenteuil—Papineau, BQ): My question is directed to Mr. Conacher and is along the same lines as that of Dr. Hill. You talked about regulation and control. You said that below a given amount you cannot prevent people to buy a product through mail order for their personal use.

As far as drugstores or the manufacturers of these products are concerned, do you have any control over products on the shelf? I am thinking in particular about the warnings in your folder regarding three specific products. If these products are still to be found on the shelf of drugstores, do you have coercitive means to get them off the shelf?

Mr. Jean Lambert (Director, Quebec Region, Department of Health): The question is more on the therapeutic products program than on the food program.

To answer your question, if a product is on the shelf of a drugstore, that is if it is offered for sale to the public although it does not comply with the requirements of our regulations or the act, we can take measures to have it taken off the shelf.

Mr. Maurice Dumas: How far do your enforcement powers go? Can you charge somebody who nevertheless keeps on selling the product?

Mr. Jean Lambert: The act allows us to seize the product. We can also charge the merchant for selling an illegal product. Usually we much prefer more flexible measures to ensure compliance.

Mr. Maurice Dumas: I have another short question. Do you often issue such warnings? We heard this morning about three specific products. Does this happen frequently?

• 0945

[English]

Mr. Dann Michols: We could certainly give you exact numbers, but as a rough estimate, we would not have more than 20 alerts of this nature in a given year. Those alerts tend to be issued when we want to communicate with consumers or the general public.

If we can, we manage a particular case of non-compliance, through, as Jean has said, other methods, such as requesting that the manufacturer remove the product from the shelves itself. If it chooses not to do that, we go in and remove the product ourselves. But where we feel there is an instance where there might be broad usage across the country and that the public ought to be informed, then we would move to an alert of this nature.

[Translation]

Mr. Maurice Dumas: Thank you.

[English]

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you. I'd like to pursue some of the concerns that Lynn Myers raised and address some issues that we've heard about regularly throughout these deliberations. They have to do with the perception, at least, that the influence of the pharmaceutical industry over the Health Protection Branch is pervasive and that in fact it is hampering any move towards a more proactive approach around natural remedies and alternative medicine.

We haven't received any examples of blatant collusion, but we've heard from folks about different developments that suggest that in fact there is a pretty dominant hold by the pharmaceutical industry over government policy.

We've mentioned these before to you: the loss of the drug research bureau with the announcement by the minister that this function can be done by the industries themselves or by universities or external agencies; the changes in the C-91 report and the appearance, at least, of not reflecting public concern; now the changes with respect to the failure of this government to repeal the NOC regulations that generic companies are up in arms about; the move towards a cost-recovery system, and in fact statements by regulators in the branch suggesting that there is pressure to conduct speedy drug reviews; and the statements out of framework documents from the department suggesting that the move is towards cost recovery, towards third-party surveillance, towards deregulation.

So while we don't have direct examples of collusion or bribes or that kind of thing, we do have a pattern that is very disconcerting and begs the question. In the face of that kind of deregulation, apparent deregulation and obvious deregulation, in terms of the drug industry, the pharmaceutical industry, and the appearance, if not the reality, of a very heavy hand with respect to natural remedies, how do we deal with that whole perception or reality?

Specifically, we've had a call as late as yesterday for a public inquiry into the links between the industry and the Health Protection Branch. We've also had a call for a policy of recording and public disclosure of all contracts, formal or informal, between the industry and the Health Protection Branch. Would you have any problems if we pursued that suggestion? Would it not be helpful in terms of this whole approach?

Mr. Dann Michols: First of all, off the top, Bill C-91 and all involved with that...and the regulations for the linkage notice of compliance are not our regulations. They are the Minister of Industry's regulations. We administer the linkages that fall from that, but those regulations are not within our control.

Again, I would be delighted to take whatever measures we possibly could to end anybody's feeling that there is a pervasive industry influence on our activities. There is no doubt, and it holds across all the industry sectors as well as the public health sectors, that associations talk to us, do everything they possibly can to get their point of view across, and so on. My point is that we do not succumb, and there is, in my opinion, no evidence that we succumb, to any of that influence, unless it can be proven in a general all-stakeholder environment that it is in the best interests of the people of Canada.

• 0950

In our strategic documents our mission is the protection of the health and safety of Canadians. It is not to augment industry or to facilitate the competitiveness of industry or whatever. Our basic mandate coming from the Food and Drugs Act is protection of the health and safety of Canadians, and it is our job to figure out how best we do that. The first time I appeared I stated in my comments to the committee that our interest was in informing the people about...and ensuring the products they had access to, but they had informed access to, were safe and of high quality and effectiveness.

On the subject of cost recovery, that is a government policy. It is not something my organization invented. My budget was cut by 50% during the program review exercise and I was instructed to move into a regime of cost recovery following the Treasury Board and government guidelines on cost recovery. I think there are very real advantages to a regime of cost recovery, but I also know it is absolutely essential to ensure there are fire walls between the revenue collection activity and the therapeutic evaluation activity—and we have those fire walls in place.

A company—big pharmaceutical, small pharmaceutical, natural health product—pays a fee for us to review a submission. It does not pay a fee to us for an approval. We will get that funding for reviewing that submission regardless of whether or not the product is approved. If the product is not improved and the manufacturer still wants it on the market, they will come back to us and pay another fee. So to some extent you could say it is in our economic interest not to approve the submissions. Obviously it is not in the interest of the people of Canada for us to deny them access to medicines or medical devices that will benefit them.

We do not consider that we have speeded up the process. We do consider that we have made it more efficient. That has been primarily in reaction to the need to get these products to Canadians—after they have been proven to be of benefit and we have mitigated the risk—so they can use them in as timely a manner as possible. We use as benchmarks the performance targets and actual performance of our sister regulatory agencies around the world, not any influence manufacturers are making on us. We try to benchmark our activities against what the FDA does, or what the MCA in Britain does or what the TGA in Australia does, as a way of determining whether or not we are acting in a timely fashion. It is not speeding up the process. It is attempting to review these in a timely and efficient manner.

About our targets, we will take as long as required to analyse the benefit of a particular product and to analyse the risks of a particular product. If we have a target of 300 days for the analysis of a submission and it takes us 350, 370, 400 days, it will take us that, and the company will pay regardless.

The Chair: Thank you.

Ms. Bennett.

Ms. Carolyn Bennett (St. Paul's, Lib.): Obviously the committee is being asked to help with what is a perception. First I would like to know that the department doesn't think the status quo is okay.

Mr. Dann Michols: I can guarantee you the therapeutics products program and its management do not think the status quo is okay.

Ms. Carolyn Bennett: In my life it's always going back to case studies as the way I like to see things.

• 0955

I guess one of my favourite things is tryptophan, which I guess I still resented having to all of a sudden write prescriptions for, particularly for patients who had been using this happily for a number of times.

There was the case history of what happened to tryptophan in terms of what seemed to be one bad shipment where we ended up with eosinophilia in a couple of cases. Then it gets removed from the market. Then the only way patients can get it is by having doctors who may know nothing about it now prescribing it.

It just seemed like an unusual way to get around something that seems to be.... I guess in terms of problem-solving, I had a little trouble with how the department actually worked their way through this. I guess that would be the first case history.

I would love to understand melatonin and how that actually ended up being illegal.

Look at all we've heard in terms of the economics of these catalogues that were being showed and of all the stuff people were bringing in. There were millions of dollars worth of product. There's this whole industry.

People are not only buying the things that are illegal, or that we've called illegal, for personal use, but then they take up all the other boxes. So people are importing tons of stuff for their personal use, yet it's actually available here. This is just because of some wrinkle. I still haven't figured out why it's unsafe or that this has been proven or what we're actually doing for Canadians with these rules.

Ms. Mary Carman: I can answer the tryptophan conundrum for you, or I can at least attempt to do that. Tryptophan is a single amino acid that was first licensed in Canada in 1986. There's a very short paper in your folder today. It was licensed after evidence was submitted from clinical trials. There were the traditional safety profiles done on a product for the treatment of affective disorders or depression.

That product was available to you to prescribe from that point. Actually, it was earlier in clinical trials or through special access.

Clearly through a pre-market review process and quality control procedures the synthesis of tryptophan as an isolated amino acid—it doesn't occur that way in nature—is monitored, controlled, and documented. Changes are reviewed. The product is tested routinely through its manufacturing cycle.

When you had to—I'm using your example—start prescribing for patients who were otherwise obtaining it, they were not obtaining what we call a legal product. I'm not saying that the border is not permeable, but certainly the majority of the product that was being purchased was probably from a U.S. source.

When you felt the source dry up, or when your patients felt the source dry up, it was as a direct result of a medical catastrophe that happened in the United States. You're exactly correct that it was a contaminant within a fermentation process that involved the creation of tryptophan as an ingredient. That got carried through the manufacturing process and caused serious disease and death in a large percentage of the U.S. population.

They then eliminated tryptophan as a single active ingredient from their market and took corrective action. That really dried up the non-approved source of tryptophan. So the source that was left to you was the source that was well controlled on its quality side.

Somebody made a change in the fermentation process and didn't realize, didn't investigate, and didn't follow up on what changes it made in the process or in the product.

That type of issue is what may or may not happen in a number of the herbal or botanical ingredients that are regulated or are called natural health products.

• 1000

Often, our conundrum is whether or not it's the ingredient that's causing the problem, labelled as such. One of the examples in here is plantain, which is really digitalis.

That measure of quality control is something that is predictive of anything else or any further assessment that you make on the safety or effectiveness of that product. So that's sort of the baseline. I tried to explain that last time.

I'll let Dann or Jean address the personal import of melatonin.

The issue I wanted to address, however, was this. The regulatory regime for a drug in Canada is a pre-market approval process. We do not put together the data. We do not sponsor the data. It would rather compromise our judgment if indeed it was our data. That information on any substantive basis, risk-wise, may or may not be a problem with melatonin, but we're continuing to look at it. We have no quality information on melatonin from any source.

We have animal studies and laboratory studies. These were provided either through the literature or through the Canadian Health Food Association. There are limited small-scale studies. We couldn't even do a meta-analysis on it for any one indication.

On the clinical data, that information is not yet sufficient to say that the benefit of any product would outweigh the risk of the unknown quality and perhaps a legitimate safety profile based on animal data.

Mr. Grant Hill: I'll follow the line of questioning if I might, Carolyn.

Ms. Carolyn Bennett: Regardless of what we do, I guess the thing is that this isn't an herbal remedy; it will always be a drug. Will these three things always be a drug?

The Chair: Mr. Hill, can she have your time or not?

Mr. Grant Hill: No, I want to go in a slightly different direction.

Ms. Carolyn Bennett: Okay.

Mr. Grant Hill: It's still along the same line.

Mr. Dann Michols: Under the current legislation, these three things will always be drugs.

Ms. Carolyn Bennett: No matter what we at this committee decide.

Mr. Dann Michols: Well, no. You may decide to change the legislation, and more power to you, but under the current legislation, these three things, because they meet the criteria of the Food and Drugs Act, will always be drugs. It doesn't necessarily mean they won't be approved for marketing, but they will always be drugs.

Ms. Carolyn Bennett: Okay.

Mr. Dann Michols: One additional footnote: melatonin is not approved anywhere in the world. So Canada is not out of line as far as melatonin is concerned.

Mr. Grant Hill: This concerns the issue of the way you look at these things. These products that are coming on as new items don't have the benefit of years of history that many of the products have. A reasonable regulator in my view would lay out criteria and say that these are the sorts of proofs that we require. You're right that it would not be prudent for the regulator to provide the proof, but surely it would be so to look at the proof.

Once again, this goes back to the presentation that was made. I asked about this, but maybe I didn't give it plainly enough: if there were gaps in this, were they made evident to the presenters? The presenters tell me that this was at a stakeholders meeting. This was the information on melatonin. It was leafed through, looked at in a cursory fashion, and handed back. It was seen to be insufficient. There was no documentation or thorough look at it. These guys spent thousands of dollars with scientists. This one fellow is a PhD, MD, and FRCP. They spent thousands of dollars to do this, and they felt that the regulator was neither reasonable nor accepting of new information. I make that as a statement.

We have ongoing studies here. I've got two just in the last month from my own medical literature. These are human studies on melatonin. One says that a dose of 0.3 milligrams shortened the time it took healthy young college students to fall asleep compared with using a placebo.

This is the kind of study that we in the medical professions really look to. Are these things now being looked at by the regulator, or are you depending upon them to come back and hope that this will be sufficient?

• 1005

Mr. Dann Michols: Let me react generally and then I think Mary would like to react specifically.

In the binder we gave out at the beginning when we first appeared, there are some five or six documents that I think clearly outline what we require in terms of evidence for various types of submissions, new drug submission or traditional medicine and so on. I think we have issued the guidance documents that you are suggesting we should have issued in terms of what we expect from a sponsor or a manufacturer. That is quite clear.

This particular package was put together and brought to it. It did not meet the requirements of those guidances that industry was very much aware existed. They were attempting to come at us with a new approach. We took that.

I think Mary will make comments on how it was not a cursory examination whatsoever. It was examined in terms of whether or not it met the clinical, pre-clinical requirements we had, and there was no manufacturing involved because it wasn't a product. I don't think we have been—

Mr. Grant Hill: Let's leave the melatonin issue and go to one other as an example.

Mary, maybe if you have more comment on that you can write me on it, because the time is so tight.

Mr. Dann Michols: Let me suggest that if you haven't had a chance, read the note we've written on melatonin, and if you have further questions here or elsewhere we'd—

Mr. Grant Hill: I ripped through it, Dann. It was February 25 and late this morning.

We'll switch to another case study. Ma huang has been used for years and years in the traditional Chinese medicine. Those who know about the product know it contains ephedrine.

Thanks for your list, by the way. This list is the first list I have ever seen, and it's dated today. At least I have something I can go to now and look at, and I can't thank you enough for that.

But ma huang, to my understanding, was banned in a similar way to L-tryptophan. There was an untoward event in the U.S. with pseudo-ephedrine, a product that is not ma huang directly. A number of individuals, in much higher doses than this particular drug should be taken, and it's a pharmaceutical drug, had some problems. Ma huang has not to my knowledge had the same problem, because the substance ephedra is in much smaller quantities and it is in a much broader context. So ma huang gets turfed, in blunt language.

I have correspondence with the department from a number of individuals here who have tried to say you've made a mistake. You hit this with a baseball bat when ephedra wasn't the problem in ma huang. The response has been privately that ma huang is not the problem, but there has been no public retraction or putting ma huang back on the market, because the list says ephedra; no quantity of ephedra.

Are these individuals incorrect when they say ma huang has such a small amount of ephedra in it that it could not cause a problem?

The Chair: Give us a short answer.

Mr. Dann Michols: In the material we have presented to you, one of those things is a press release. It speaks to ephedra, the American experience with ephedra. It's one small paragraph; I would suggest that you read it. The Food and Drug Administration has 900 reports of side effects, including heart palpitations and psychosis, heart attacks and strokes.

We can tell you how we have handled ephedra, but again you have to be talking in terms of drug product versus food. The list you have now is a food list, not a drug list, because we don't ban substances. We analyse whether or not the product is safe, effective, and of high quality.

Ms. Mary Carman: Just to add to that, ephedra and ephedrine are both acceptable for use in the regulated product. There's a standard. You can get a DIN for it; you can be on the market.

There were concerns coming out of the U.S. This document is off their web site and gives their reasons for a decision on why they're trying to restrict and label appropriately ephedra-containing product: ephedrine, ephedra, ma huang in the Chinese literature.

• 1010

It's not innocuous. It's useful. It should be out there, and patients should know under what parameters they should use it. We believe our current regulation and labelling allows the patient to use it in that manner. It's one of the reasons you don't see the thousands of reports, even when associated with the population differential, being made in the United States.

The Chair: Ms. Caplan.

Ms. Elinor Caplan (Thornhill, Lib.): Thank you.

I guess the first question I have is on the whole ability of people to import by mail order that which is not available in Canada. How do you justify that?

Mr. Dann Michols: Again, the Food and Drugs Act gives us the powers to deal with drugs sold or represented for sale in Canada. If somebody is importing a product from somewhere else for the purposes of sale, we have powers to intervene and regulate that. If someone is importing a product for personal use, we do not have powers to deal with it.

You may very well want to examine the act and consider that a deficiency, in the mandate of your committee, but at the moment, we do not have powers to regulate the importation of product for personal use. If we can prove it's not for personal use—and in some instances, we can—we can go after that. We have defined personal use as the amount an individual would need for three months.

Now, we do that on our own cognizance, if you like, but if were taken to court, we would lose.

Ms. Elinor Caplan: I think the conclusion I've come to—and I know you've been reviewing the committee Hansards and following the hearings—is that what's at question here is what should be the role of the regulator—you—in the assessment of foods that make a claim on the basis of benefit, efficacy, effectiveness? For me, the issue, ultimately, is what is in the public interest in terms of protection of the public?

As you know from reading the Hansards, consumers want to know that the product is a quality product, that it contains what it says it contains, that it is safe according to a GMP standard, and that it has warnings. But we have seen some examples of that which is classified as a food, and makes no claim, next to a product on the shelf that says something innocuous like, “For joints”. Then it becomes a drug.

I think most of us would take issue...and I'm not sure whether it's the lack of ability, I guess, to give people information about possible benefit or traditional use of herbal products or foods for traditional, natural remedies, information they'd like to have about things. I'm not sure. In fact, I don't believe it's in the public interest to not let people have the warning and the information and the ability to try something to see if it works for them as long as it's not going to be risky and as long as they know what they have.

Do you want to respond to that? You've heard me make that point a few times.

Mr. Dann Michols: Let me make a couple of comments, and then Harry may want to as well.

I mentioned in response to an earlier question that we did not believe the status quo was adequate. A range of products, as I said, exists on the cusp between what is now defined as a food and what is now defined as a drug. We, in conjunction with the food directorate, set up an internal task force connected to an advisory panel made up of representatives of stakeholders to address that exact issue. There is considerable pressure from the food industry in this particular instance. They want to be able to make health claims for some foods. Right now they are limited to nutritional claims.

• 1015

We have an advisory panel on functional foods-nutriceuticals that has been advising us. We have run a consultation process. A discussion paper resulted from that. That has gone out to the general community for comment. We will be analysing those comments over the next couple of months. We hope we will be able to make recommendations that will result in regulatory change that will deal with those products on that cusp.

Ms. Elinor Caplan: I think the conclusion I'm coming to is that you need an alternative process, because of the cost-effectiveness argument, as opposed to the traditional process of it's either a food or a drug. I'm at the point where I'm not comfortable with the idea of a third category. I agree. I think you need to take a different approach to those things that are clearly not properly dealt with under the existing Food and Drugs Act. Maybe you need new legislation. Maybe you need a new section added to the existing act; although that makes me nervous, because I'm not sure by doing that you would ensure you do have the expertise within Health Canada, whereas if it were a separate act you might be assured it was assessed by people who understood the traditional use of the products.

Mr. Dann Michols: At this point I am not convinced we need changes in the legislation to get at this particular issue. I believe we have enough latitude within the Food and Drugs Act, in the definition of a food and the definition of a drug, to be able to develop a regulatory framework to deal with foods that want to make health claims. That is the process we are going through, in consultation with all the stakeholders, the medical community, the dietary community, if you like, etc., to try to work that through. We are in the process of doing that.

The other comment I was going to make to you about your question is that the advisory panel we have set up on natural health products, which is a second group, as you know—it has presented here to you—has presented an interim report. It will be meeting again Sunday and Monday next to finalize the report and to be able to come back to you, we hope. In that report they have developed a conceptual model where they have attempted to chart “conventional foods” against functional foods, against drugs with claims, against drugs without claims.

They are having some difficulty. One of the areas they are going to have to continue to work on is to develop a reasonable argument for why there would be products on the market in dosage form but not making claims. To me it doesn't make sense. If someone goes to the trouble of manufacturing a product in dosage form, then it ought to have on it whatever claims are being made for it, and it ought to have gone through some process to prove those claims, and so on. So there is one large quadrant in their four quadrants that they are going to have to do some more work on to determine why that quadrant should exist.

I think that speaks to the dilemma you have just spoken to, and have spoken to in the past, of why in a pharmacy or a health food store there were three bottles of the same product, one legal, because it has a drug identification number and claims; one illegal, because it has claims with no drug identification; and one legal, because it has no drug identification number but no claims, when in fact it is 5 milligrams of valerian or whatever.

We have to deal with that. We are dealing with that in both those advisory panels, in your work here, and I think under the present legislative framework we can come to terms with that.

The Chair: I'm going to butt in here and ask you a yes-or-no question. If I can buy a product from a shelf and it's not a manufactured product, it's a natural product, and the only thing that would happen is if I don't take it on a full stomach I'm going to get terrible pains, do you feel it would be okay for this product to have a label on it saying “Take on a full stomach”?

I just want yes or no. Is that contravening...? Is that a weird request, that I've been told ahead of time? It's not a manufactured product. It's just something ground up and put in a container, and I'm willing to take it. Are you going to say they can't tell me and I can't know I have to take it on a full stomach?

• 1020

Mr. Dann Michols: I have some difficulty with the basis of your question when you say it's not manufactured. If it is ground—

The Chair: It's ground and put in a container, and I don't want to get into—

Mr. Dann Michols: So it's a powdered substance of some type being sold as a food.

The Chair: Yes.

Mr. Dann Michols: Then I will ask Dr. Conacher what labelling would be required.

The Chair: We know there's no labelling allowed. I'm just asking your opinion. Couldn't I be told, without putting it into drugs, it's a good idea to have a full stomach if you take this? It's not going to kill you. If you want pain, fine, but it would be a good idea if you had a full stomach. Couldn't that be done without putting it over to drugs?

Mr. Harry Conacher: These are very difficult—

The Chair: As the law stands now you're saying it can't be done. I'm asking your opinion. Do you think it would be a good idea if they could tell me that?

Mr. Harry Conacher: I can only reiterate that when a product is sold as a food, you cannot make any health claims for that product.

The Chair: Do you think we should change the law so we could do that, or don't you want to answer that? I don't want a big line.

Never mind, I'm using their time, so I won't....

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: I have a couple of questions on several different areas. One is to follow up on the issue of the influence of pharmaceutical companies.

Yesterday at committee I think Dr. Bell referenced a study pertaining to nifedipine. I think he said it was a New England Journal of Medicine study comparing regulators and physicians who had some contact with the drug manufacturer and usage persons, physicians or regulators—I'm not sure who was in the actual study—who had no contact with the drug manufacturer. The result of the study was unequivocal that those with the contact certainly were inclined to prescribe nifedipine much more regularly.

On my other question, it seems that as we go through these committee hearings we're finding a lot of people's frustration with inconsistency, changing rules, and discretionary judgment being applied. I think that's emerging with an issue like melatonin. We heard yesterday from Dr. Bell and Dr. Woolf about how the rules keep changing. First it's not allowed at all and then it's not for sale in Canada but is allowed to be imported for personal use.

Is it the lack of clarity in this whole issue that's causing problems? Related to that question of importation, is it not the case that Canada is able to prohibit importation of products for personal use? Dr. Woolf mentioned to me this morning that DHEA is prohibited for importation purposes.

Related to that we have been looking for this list of prohibited, restricted food and drugs. You've provided us with a great deal of material. It's not a specific list, though, but a set of guidelines and fairly complicated criteria. Is there perhaps an issue here of regulators being trained properly in this area vis-à-vis those guidelines and criteria and leaving the possibility for discretion, uneven judgment, and the feeling on the part of consumers and retailers of natural remedies that there is some real unfairness in the system?

Mr. Dann Michols: Let me answer your second issue first. Then I'll ask Mary to speak to nifedipine and the study of influence.

We have done a lot, but obviously not enough. We will continue to do everything we possibly can to ensure that the regulations, the policies that support those regulations, and the guidances that exist in Canada and are our responsibility, eliminate discretionary action, are consistent within themselves, and are applied consistently.

• 1025

We have reorganized our compliance and enforcement operation within the last three years, when it became responsible to me. Prior to that, it was not responsible to me, but Jean Lambert has now been set up as the director of that operation. His task is to ensure that the inspectors have the education that's required, to ensure that they have the tools needed to do their job, to ensure that communication is adequate, and so on. That will always be a challenge, but I think we have it in hand.

Again coming back to the inconsistencies and referring to the witness who appeared yesterday, there are no inconsistencies, in my opinion. Going back to what I said before, if the product is to be sold or represented for sale in Canada, it is our responsibility. We regulate the manufacturers. We regulate the distributors. We attempt to make sure things are consistent.

We do not have the power to regulate importation for personal use. We don't have the power to deal with product that is brought in by you as an individual. We perhaps should have the power to deal with it, because it is an anomaly, if you like. We cannot guarantee...we cannot attempt to ensure the health and safety of Canadians if they are importing unapproved product from outside of the country. But we don't have the power to deal with that at this point, and I do believe it is a legitimate complaint on the part of Canadian industry that the public can do that.

What you have to wrestle with as part of your mandate is whether or not that would be interfering with the freedom of choice and accessibility of Canadians. Why should they not be able to import anything they want to import, etc.? Under the current legislation and regulations, our job is to ensure that, if they want a product manufactured in Canada or for sale in Canada, the product is safe, of quality, and effective.

Ms. Judy Wasylycia-Leis: What about DHEA?

Mr. Dann Michols: A particular product or substance, depending on what it is, is covered under various acts. DHEA is a steroid and is therefore controlled under the Controlled Drugs and Substances Act and cannot be imported for personal use. That is breaking the law. Prescription drugs cannot be imported for personal use without a prescription. That is against the law.

Over-the-counter medicines can be imported for personal use. That is not against the law. If we can prove that it is not for personal use.... If someone, such as a supplier, is attempting to import it under that act and then tries to sell it or distribute it, we can take action. As an individual wanting to import an over-the-counter drug from the United States or anywhere else, however, you can do that legally. We don't have the power to intervene. I don't think there's an inconsistency there.

Ms. Judy Wasylycia-Leis: In terms of how it was raised, if it's safe enough to not restrict importation for personal use, why are we so restrictive in terms of sale in Canada? That's being raised day in and day out.

Mr. Dann Michols: I think that comes to the.... Our mandate is to deal with the safety, effectiveness, and quality of the products for sale in Canada. The previous Parliament determined that there is a Food and Drugs Act, and it has laid out what we are responsible for doing. It did not include the responsibility for dealing with personal use of non-prescription medicines.

I don't think they are safe, effective, and of quality in some instances, but maybe you feel that regime ought to change. The rules by which we have to operate now are clear, however, and we are relating to them in a consistent fashion. If those rules need to be changed, that is your job.

The Chair: I'm going to cut you off now. She can come back if we have time.

Mr. Myers.

Mr. Lynn Myers: Madam Chair, I wanted to go back to my question. I had asked Mr. Conacher to give his opinion with respect to the third category. I would be interested in what he has to say.

Mr. Harry Conacher: I simply would just like to reiterate what Dann said. We have three major consultative efforts in this whole area right now to see if the current system can really handle this whole problem—the three consultative efforts being this committee, the committee on natural health products, and this functional food and nutriceutical initiative, which is a joint effort of the food program and the therapeutics program. Until I see the final recommendations of those committees, I don't think I'm really in a position to comment.

We recognize that there are problems associated with the current system. These initiatives were undertaken to see if we could get some advice as to how we might handle this. One suggestion has been the creation of a third category. That can create problems in itself in the sense Dann referred to: instead of having one grey area, you have a grey area on either side of this third category.

• 1030

I would like to defer any comment on it until I see the final reports from these committees, including this one.

Mr. Lynn Myers: Thank you.

Mr. Harry Conacher: Madam Chair, may I make a comment in relation to the question you asked? You caught me a bit unawares by that question. Could I maybe have a minute to respond to that?

The Chair: That's up to everybody else.

Is that okay?

Some hon. members: Yes.

Mr. Harry Conacher: Foods in general are assumed to be safe to consume for the general public. We feel relatively uncomfortable with claims such as “Take on a full stomach”, because it implies—

The Chair: What's that claiming?

Mr. Harry Conacher: “Take on a full stomach” is just—

The Chair: No, it's just telling us how to do it; it's not claiming anything.

Mr. Harry Conacher: Well, with a statement such as that—

The Chair: Okay, a statement. It's not a claim about a medical thing it can do.

Mr. Harry Conacher: Right. It implies that there might be some adverse health effect if it were taken on an empty stomach. So we have certain problems with warning labels on foods.

Nevertheless, we actually do have some warning labels on some foods. These warning labels are not for the benefit of the whole public; they are put on foods to address particular segments of the public. For example, on foods containing aspartame, there is a warning that this food contains phenylalanine, and this is for the benefit of individuals who exhibit adverse reactions to phenylalanine. There are claims on some foods for allergens. Not everybody is allergenic to certain components, so therefore it's for the benefit of a small component of people.

Generally, on foods that are intended for consumption by the whole population, we don't like to see warning labels, because it does imply that some adverse reaction is likely to occur.

The Chair: Is that in the regulations—we don't like to see labelling on there—or is it you personally who doesn't like to see it?

Mr. Harry Conacher: This is the policy under which we operate in terms of ensuring that foods in general—and I'm not talking simply about herbs and botanicals; I'm talking about all foods—don't pose a hazard to the health of the public.

The Chair: So you would feel more comfortable with somebody lying on the floor in pain or taking too much broccoli? I understand there's something in broccoli that's not good for you. I happen to like broccoli. You feel that's better, when it's not going to kill me, but it might have me on the floor? You're more comfortable with that than with having somebody write a little thing on the label saying, “Take on a full stomach”?

Mr. Harry Conacher: No. I would question in the first place if this indeed was a food. That's what I would question in the first place. I don't know what this product is that you're referring to, but I would question it being a food.

The Chair: They're products that are on sale. You're allowing them to be sold anywhere I want to buy them. You're saying I can only see a bottle with something in it and I'm allowed to buy it, but I'm not allowed to know that it might give me a headache or that it might give me a stomachache or it might do this or it might do that. It's not going to kill me, but I can be in agony. That's okay? Why don't you just say it can't be sold, period?

Mr. Harry Conacher: Well, you can either say that it can't be sold, or perhaps it's just simply you, Madam Chairman, who are exhibiting an adverse reaction to that particular food.

The Chair: No, because I've asked a number of people since, and they say you should take the product on a full stomach.

Mr. Harry Conacher: In that case, my advice to those individuals would be, if this product creates some adverse response in you, don't eat it. Freedom of choice.

The Chair: All right. I'm hogging a little time here, but when you get a choice and you have products that you can sell in the store with no proof of people ever dying, and then we get a list of 7,000 people who died in the United States last year from aspirin and all these other things that can be sold.... I know they're drugs, but the frustration seems to be from the fact that you can have drugs out there, they can be bought by anybody who walks into a drugstore, and people can die, but you can't put a little label on a product that's not going to kill you, but it will make you feel more comfortable if you did the right thing when you took it.

This is the frustration. How can we...? I don't know whether in your position, in your job, in what you're paid to do, you're allowed to say to us, “Well, maybe we could put a little bit more labelling on some of these things”—not any claims, but labelling. We've had a lot of requests about that.

Mr. Harry Conacher: Yes, Madam Chairman, and that may indeed may be one outcome from the consultative efforts that are going on.

The Chair: Do you think that's sensible?

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Mr. Harry Conacher: It could be. I would like to look at it when it's finalized.

The Chair: Okay. I think Ms. Bennett is next on the list.

Ms. Carolyn Bennett: One of the concerns we've also heard is the closing of the natural health products lab.

I think a lot of us were very happy Christmas Eve to see that the government was working on our behalf, getting rid of Sleeping Buddha. Those are the kinds of things that actually make people feel good that there is a regulatory body watching out for them, and those kinds of things. Certainly people were, as we said before, concerned that echinacea actually had Dristan in it, or those kinds of things.

What I want to know is, what have you done since the national health products lab has closed? You've obviously discovered something that was thought to be a natural health product but actually had drugs in it. How was that discovered?

I think you should be proud of that, because our understanding from committee is that less than 5% of things are actually being tested. If you had budgets and things.... Do you think a national health products lab is important, with people with serious expertise in these areas?

Mr. Dann Michols: Let me make a general comment and then I'll ask Jean to comment.

We have never had a national health products lab.

Ms. Judy Wasylycia-Leis: In 1991?

Mr. Dann Michols: No. We had an individual within the Bureau of Drug Research who had expertise in the area of herbs—an individual in the lab. We didn't have a lab per se.

What we did recently was close the Bureau of Drug Research. There were 68 people in the Bureau of Drug Research: 15 of them left; the rest of them stayed within my organization.

We strengthened our biologics lab. We eliminated our capacity for research on the pharmaceutical side. We did not touch the labs Jean was responsible for, which are across the country and are a part of our enforcement activity. It is their job to deal with these products such as Sleeping Buddha, to do the analysis. They have the capacity. We have labs in Montreal, Toronto, and Vancouver, basically, that have that capacity. We have not touched that capacity.

One of the reasons we did close the Bureau of Drug Research was because we felt we could get the in-house pharmaceutical laboratory research that was being done there from other sources, such as universities and such, and that what we really had to do was to enhance other areas, the biological research area and the compliance and testing activities. That is what we did and that is why we did it.

Perhaps Jean could speak to you about the capacity we have to find the benzodiazepines that are in the Sleeping Buddhas and other—

Ms. Carolyn Bennett: Before you answer, could I ask a supplementary. There seems to be articulated at committee some concern that the expertise or the ability to certify certain herbal products is not there at Health Canada. If you say it's this, is it that? Is it a weak version or a strong version? Is it all the stems and not the leaves? Do we have the ability to really say that what's on the shelf, which people are paying for, is really what's in the bottle? Other than this, obviously you've been able to pick up the contaminant, which was a drug or a lacing of it, but what about the actual ability to let Canadians know that the herbal products they're buying are actually bona fide herbal products?

Mr. Dann Michols: Let me say that the way we have approached exactly the question you are asking—and I think it's a legitimate question—has not been by sending every product that is available for sale in Canada to the analysis lab and having it analysed. That is a very resource-intensive way of regulating. We do not have the resources to be able to do that, even if it were a good idea.

• 1040

What we've attempted to put into place in Canada, flowing from the Food and Drugs Act and the regulations, is a regulatory framework based on two major activities. The first is a product licence of one type or another. It could be a notice of compliance. It could be a drug identification number. Before a product is allowed on the market it is analysed by Mary's bureau, and others, to see whether or not it meets particular standards. The chemistry and manufacturing of that particular product are included in that analysis. So there is a pre-market approval of the product.

The second is an establishment licence, which says any facility engaged in the manufacturing, distributing, importing, or whatever of a product for sale in Canada has to meet good manufacturing practices. It's enforcement of those good manufacturing practices that ought to ensure a company that is selling a product is manufacturing that product to the standards approved in the process Mary ran.

We then augment that capacity for approving product licences and issuing establishment licences with an auditing capacity, which Jean's operation is responsible for and which comes along and audits on a random basis to see whether or not the other safeguards we have in place, the requirement for a product licence and the requirement for an establishment licence, have in fact ensured that a particular product is produced.

One of the concerns we have at the moment is that the particular products you are investigating are exempt from the establishment licensing regime. They are exempt while you are undertaking your mandate, and we hope you will come to a conclusion on that. We are recommending that a regime that has some measure of pre-market authorization, some measure of ongoing monitoring of the facilities that are involved in the manufacture of that product, backed up by an audit capacity with a lab analysis capacity attached to it, will be sufficient to guarantee the health and safety of Canadians.

Ms. Carolyn Bennett: Even when you don't know there is an individual who has expertise in this area, or any individual with expertise in this area. That seems to be a recurring theme of people coming forward.

Mr. Dann Michols: No, because the individual who is being referred to was one person and the activity they undertook was quite limited. We have the capacity in Mary's operation, pre-market approval, and in Jean's operation, post-market, to analyse these products; to determine whether or not they are contaminated or they are in the strengths they are advertised as having, and so on. We have that expertise.

The Chair: We'll take a break now so people can just stand up and stretch for a minute.

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• 1052

The Chair: Mr. Elley, we'll start with you.

Mr. Reed Elley (Nanaimo—Cowichan, Ref.): Thank you very much, Madam Chair. I think one of the things I'm becoming increasingly concerned about as I participate in these hearings is that I think we have some great inconsistencies in the way we are managing this whole thing in Canada.

For instance, we recently talked in this committee today about the labelling of foods. I have a daughter who is very allergic to peanuts. If she gets even a minute trace of peanuts in her system she goes into anaphylactic arrest. I have yet to see a jar of peanut butter I would purchase in a super store labelled with the warning “this product could kill”. I think that's an inconsistency we have to address in this country about the labelling of foods.

That's not my main question here; it's just a statement that deals with a reality in my family of what could take place because of peanut butter. There are many people in this country who are allergic to peanut butter.

I would like to speak on behalf of a lady who appeared before our committee a number of weeks ago who has lupus. I wish you could have been here when she was, lady and gentlemen. She was very distraught, almost in tears. Two substances she has relied upon over the years, one particularly in the treatment of her disease and the other for other reasons, have been banned by your department. One is progesterone cream and the other is DHEA. I see some inconsistencies here in the way your department is handling this on the basis of her testimony. You can tell me whether she's telling me the truth or not, because one of the things we're after here is truth. We have to wrestle as a committee with who is telling the truth, quite frankly. That's the bottom line as we make up our decisions on this.

• 1055

You say that in the banning of progesterone cream, which I understand can no longer be prescribed by a naturopathic physician, for instance, you received a complaint about this product. Is that one complaint? Was it a multitude of complaints? Did the complaint have in it the problem of someone getting sick over this? Did someone die because of the use of it?

What was the nature of the complaint? Who made the complaint? I want you to answer that for me.

Secondly, about DHEA, the understanding I get from experts in the field is that your statement is not true here; that it is not an anabolic steroid, but instead it's a precursor of a steroid; that this indeed is not supported by the good science that is out there. But it has been banned.

This lady said the drug of choice she would be treated with for her lupus by conventional medicine is prednisone. She tells us if she continued to take that drug she would be dead today, because of its side effects. This is a drug that has been okayed by your branch. Why is this lady denied the substitute, DHEA, which she says has caused her to be alive today, when on the basis of what she tells us and what I hear from others your science is faulty on this?

Will you answer those questions for me?

Mr. Dann Michols: Let's attempt to deal with DHEA first. Then we can come back to the issue of the progesterone cream. I'll ask Mary to support.

To my knowledge, we have never received a submission from a manufacturer for a product containing DHEA. We have not approved a product containing DHEA. Consequently there isn't a product legally available for this person to use.

Mr. Reed Elley: That's right. She tells us she has to become a criminal.

Ms. Mary Carman: About whether or not DHEA is an anabolic steroid, after the Dubin inquiry a number of substances were reviewed and a decision was taken, based on advice given to us, that a list of substances should be listed and controlled as anabolic steroids. DHEA was one of those. In the past several months a question has been raised about that, and one of my colleagues has initiated a review—I'm sorry, I don't know the status of that review—of whether or not it is actually an anabolic steroid which requires the level of importation and trafficking control that has been put on it.

Mr. Reed Elley: Then I think it's very misleading to put this kind of statement out, that it is an anabolic steroid.

Ms. Mary Carman: That is our current assessment.

Mr. Reed Elley: Well, you're telling us something different.

Ms. Mary Carman: No, I'm saying our current assessment is that. We will always review a current assessment and listen to other opinions, and when that assessment changes, that will be advertised, published, and if in fact it changes, we would be obligated to remove it from that level of control.

DHEA could be prescribed, though not by the naturopathic physician the patient or your witness is being treated by. That person is probably not licensed to prescribe drugs in whatever constituency they live in. However, through a special access program, DHEA could be obtained for that patient quite legally. There's no reason for that person to feel they should become a criminal. I'm quite willing to say that if that is not known to the individual or the physicians who are advising her, then I guess I'm failing in communicating that on the website and in all the publications we do. It is available.

I would like to address your other point, on progesterone. The naturopathic practitioner never could have legally prescribed a progesterone-containing cream for his or her patient. Progesterone is a schedule F substance now. In Canada it is therefore limited to sale by prescription only.

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Mr. Reed Elley: But you say it's not illegal to sell creams containing these plant ingredients.

Ms. Mary Carman: Plant ingredients are not progesterone, sir.

Mr. Reed Elley: This is what this lady was saying. We can no longer get the ones with the plant ingredient—

A voice: Because it contained progesterone.

Mr. Reed Elley: —because it's not on the market any more.

A voice: That's right.

Ms. Mary Carman: But in all likelihood it wasn't the plant ingredients that were providing the benefit. The products that have been withdrawn—if you're speaking about Renewed Balance, that product was looked at. It contained standard levels of progesterone, the ingredient. Plant sterols are confusing in a laboratory, but can be differentiated from progesterone. The product did not contain just the plant sterols. Those—

Mr. Reed Elley: Are there products out there that just contain the plant?

Ms. Mary Carman: If you wanted to market a Mexican yam cream right now, without a claim as a cosmetic, we would not—

Mr. Reed Elley: Are you aware of products on the market that are like that?

Ms. Mary Carman: I'm aware of Mexican yam creams as cosmetics, and to the best of my knowledge we're not taking any regulatory action on those products.

Mr. Reed Elley: Who initiated the complaint?

Ms. Mary Carman: I don't know. We could provide you with that documentation. That is available.

Mr. Reed Elley: My understanding is that it was the Nova Scotia medical association. Is that correct?

Mr. Dann Michols: We would not provide the information on who made a complaint—not in any case, not on any issue.

Mr. Reed Elley: Why is that? Why is that not public information?

Mr. Dann Michols: We get the complaint. We investigate the complaint using our own expertise. We determine whether or not there is a legitimate problem. I'm not sure what purpose is served by knowing who made the complaint in any case—in this case or in any other case.

Mr. Reed Elley: I think it's because many Canadians feel there's some collusion among the medical associations, the medical profession, and the pharmaceuticals, and that if a natural product is withdrawn from the market, somehow the complaint has come from those who may be threatened with the manufacture of a conventional drug—

Mr. Dann Michols: That may very well be, but—

Mr. Reed Elley: I think the Canadian public needs to know that.

Mr. Dann Michols: —what I am saying—

Mr. Reed Elley: Canadians deserve to know that.

Mr. Dann Michols: —to you is that regardless of the source of the complaint, we investigate it, we determine whether or not the complaint has validity, and we take the regulatory action required. I don't think it is in the best interests of Canadians to start screening who might make complaints to us. It is in the best interests of Canadians for us to investigate all the complaints and to take the appropriate action.

Mr. Reed Elley: If you were on our end, Mr. Michols, hearing the complaints from Canadians, you would know why we feel it's in the best interests.

I'm through.

Mr. Dann Michols: Okay.

Mr. Reed Elley: I'm sorry I have to leave.

The Chair: That's all right. I'm sorry you have to leave too.

Mr. Reed Elley: I'm not in a rage. I'm glad to have your answers.

The Chair: I wasn't in a rage either, so you don't have to apologize for it. I might have looked like I was but....

Some hon. members: Oh, oh.

The Chair: Mr. Volpe, are you in a rage?

Mr. Joseph Volpe (Eglinton—Lawrence, Lib.): No, but I could be if you want me to.

Mr. Michols, if I could, just for a brief moment, touch on that last point, I think people have a general sense that part and parcel of the basic judicial process in this country is knowing who the accuser is. It might be worthwhile for us to know whether there are other reasons why we shouldn't follow that process.

More importantly, I think, if we don't have access to that kind of information, then the department—you—would leave itself open to some of the accusations and allegations I heard yesterday. I understand they were raised earlier on when I was out of the room.

There's a sense of collusion with other interests, so when one can't identify the accuser, the statement like the one I'm going to read from yesterday's blues gets a little bit more credence.

There was a phone call from, I guess, pharmaceutical retailers in Nova Scotia to the Health Protection Branch. Then, boom, the product's off the market. I refer to ma huang.

Then it is as follows, “This is clear evidence of collusion in that instance.” I might take the view that that's a little harsh, but I can see how someone could arrive at that conclusion, and I don't think it looks good for us as part of a system. That kind of thing lends itself to another description, that the reactions of the HPB are “completely arbitrary and capricious”. I'm still reading these quotes from the blues.

Those kinds of accusations rather distress me as a parliamentarian who's part of a process that's supposed to be transparent, above board, and just generally working for the good of the general public.

• 1105

At any rate, you might want to reflect on that, because a lot of circumstantial evidence gets a lot more credibility when people can't find out who is the individual making an accusation, or making a request.

For example—and again, I apologize if you've answered this already—one of the allegations yesterday was that tryptophan was pulled off the market because the producers of Prozac were feeling threatened.

It says here:

Interestingly, the time was crucial, because Prozac was coming on the marketplace at around the same time, acting similarly to tryptophan. The opportunity was there to ban the competition....

I don't know whether people who produce Prozac made the first phone call, but I think it would certainly dispel a lot of this...it's a cloud over the integrity of the system if we can't get access to the information.

You don't have to respond, but it just struck me, as the conversation developed here, that we might want to address that.

The Chair: Mr. Michols, do you want to comment?

Mr. Dann Michols: I'd like to make a couple of comments. First, the federal government has in place legislation, the Access to Information Act, that has procedures whereby people can seek to obtain information held by the federal government. There is nothing barring anybody from making a request, through the Access to Information Act, for that particular information, if they are interested.

It would then be processed through a mechanism we don't control, a general mechanism that seeks to ensure and protect the rights of all of the parties involved. That would include the rights of the party making the complaint as well as the rights of the parties being complained against and so on.

All I'm saying is, within our processes, we don't make that information available. We don't make that information available because—

Mr. Joseph Volpe: As a matter of course.

Mr. Dann Michols: As a matter of course. Right. Sorry. We would make it available through the Access to Information Act. Our current policy is not to as a matter of course, because we think that would, or potentially could, lead to people being intimidated not to make complaints.

Now, I would be delighted for you to talk amongst yourselves and come out with a position on that, and we would be delighted to take that into consideration, but I would ask you whether or not the interests of the public are served by making those complainants' names available, or by not making them available, and the pros and cons of the two approaches.

As it stands now, we believe it is in the best interests for us to get as many complaints as we can, unintimidated by whatever factors. Then it is our job to look into them. It is our job to make a decision. It doesn't matter who the complaint comes from; we will undertake the same process to determine whether or not it is legitimate.

I have some data here that I would like to read to you. We have within our program an incidents system, as it's called. When a complaint is made of one type or another, it is recorded on this incidents system, which Jean's operation manages. So that is what causes us then to look into it.

Over the last two years there were 112 incidents involving the drugs DHEA, melatonin, or tryptophan. We did a search against our system and picked up 112 hits, if you like, against that.

It doesn't really matter how many were on each one, although I have the information. Of those 112, 34 were received from consumers; 29 were received from the trade, which means potentially competitors, whether they're big pharmaceuticals or actual competitive natural health product manufacturers; 20 were raised by us in terms of our investigations or after one of our inspections and so on; 7 were raised by provincial governments; 8 were raised by the media; 4 were raised by professional associations; and 7 others didn't fall into any of the above.

Without specifically reacting to this one particular issue, this is a cross sample of sorts—112 hits over two years on three particular products and a breakdown of where those complaints came from. To me, it does not indicate that there were 112 from a large pharmaceutical concern or 112 from a medical concern. In fact, there is a wide range of sources.

• 1110

I would say to you that I believe it is in the best interests of Canadians to maintain that wide range of sources and to investigate each and every one of them regardless of where them come from. That's the regulator's job: to determine the validity. If you feel the policy we have in place is detrimental to our credibility—and I'm as concerned about the credibility of my organization as you are—then make a recommendation accordingly and we can take that into consideration.

Mr. Joseph Volpe: Those statistics that you've given us are helpful. I don't think the committee was seized of that kind of information prior to now. As I said, however, that simply reinforces what I indicated earlier on: in the absence of information, the information that's there has greater weight.

If I can take us back to some of the other data you gave us earlier on about the 150 people in your department who are directly involved in labs, those people are activated essentially in response to a request. They're not doing any proactive research; they're doing research for the purposes of evaluating, testing, making decisions on a process or product that's placed before them, either by way of application or by way of response to one of your 112 hits. Is that correct?

Mr. Dann Michols: Yes, I think that's fair. The mandate that we feel we have in the area of research obviously has to be quite heavily focused on our regulatory role, so we refer to it as regulatory research. They may be involved in answering questions that the scientists in Mary's bureau or in one of the other review bureaus raises in terms of taking a look at a submission that is before us. They may be involved in the monitoring activities of Jean's bureau or the Bureau of Drug Surveillance, raising a difficulty with a product that is already approved, is on the market, and so on.

But, yes, it is focused on research related to submissions that we have received or products that are on the market. We don't have the resources to be doing pure research, if you like, in the area of drugs or medical devices.

Mr. Joseph Volpe: I wonder if you would take another couple of moments and maybe walk me through this process. You have been called by 112 people. If I was one of them and I had called you about melatonin, would that have first prompted a response to check out or to test whether or not this product was compliant with the regulations? Would you have sent out inspectors to a site, or would you have sent out inspectors first and then done the testing afterwards? What's the process?

Mr. Dann Michols: I think it depends very much on what the particular complaint was. If we go back to the progesterone cream example, we received a complaint that there was a product on the market that contained progesterone. As Mary has said, progesterone is a prescription-only drug. We would send our inspector to look into that. In that case, we took a sample of that product, ran it through our laboratories, did determine that there was progesterone in it and that the progesterone is not produced by the Mexican yams that are in there, investigated the manufacturer of that particular product, and determined that the progesterone was in fact added in the manufacturing process, that it wasn't a natural progesterone but a chemical progesterone added to the product. The product was in violation of the Food and Drugs Act, and it was taken off the market.

There would be other examples—this is Jean's area and he may have them—but it would depend on the product. It may be that melatonin in and of itself is being sold within a store. It is an illegal product because it has not been approved. They could go in to deal with that. We wouldn't necessarily have to test to make sure it contained melatonin. If the label on the bottle claims it's melatonin, that would be sufficient for the violation.

The Chair: Just a second, Mr. Volpe.

Is it okay if he continues with his questioning for a couple of minutes longer?

Mr. Maurice Dumas: Yes.

Ms. Judy Wasylycia-Leis: Just as long as we have the same discretion.

Mr. Joseph Volpe: This is what I love about politics. There's never a quid unless there's a quo.

• 1115

Anyway, I wanted to take that just a little bit further, because many of the witnesses who have appeared before this committee have been rather strong in their description of the inspection process. It's probably fair to say their perception is that in the middle of the night there will be a Health Canada inspector, probably flanked by a couple of burly RCMP officers, and they will essentially take everything off the shelves. I don't mean to ridicule that process, but I think one of the descriptions came close to that.

We've been told the inspection process itself is very detrimental to the commercial activity, but even worse, it's very detrimental to the health component of that activity, because a lot of people rely on this product, and the inspection process is designed more to intimidate than actually to follow up on regulatory testing or to precede it.

Mr. Dann Michols: Well, my reaction is, why would we be interested in intimidating? What we are interested in doing is ensuring that the products that are on the market, available to Canadians, are legal products.

If a retail store is selling a drug that has been approved, has a DIN number, and meets the requirements, there is absolutely no reason it shouldn't be on the market, and we're not interested in taking it off the market. If a retail store is selling a product that is illegal, then the law requires us to take it off the shelves. I don't see why we are advantaged by intimidating or not.

And that's not really the inspection process. The inspection process has to do with establishment. That's the investigation process.

Do you want to add to that?

Mr. Jean Lambert: I really cannot add much to that. It's the investigation process. It doesn't happen in the middle of the night. If a situation like that has been addressed to this committee, I'd certainly like to hear about it.

There have been situations where police departments or municipal departments have taken action different from under the Food and Drugs Act, and sometimes they will come to us for advice on the products, but strictly that. We are then basically not involved. We usually do our business during normal working hours, and we are very reasonable in terms of working out voluntarily with traders to bring the products into compliance. However, if there is a major risk involved with a product, obviously we act very quickly to make sure the population is not at risk.

Mr. Joseph Volpe: For a store that's open 24 hours a day, what are business working hours?

The Chair: We're going to be having inspectors on the 19th, so maybe we can follow up on that then.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: I will come back to the issue of nifedipine for two reasons: one, because of the study showing influence of pharmaceutical companies over the process; but also, following up on Joseph's comments, because it's an example of what is clearly believed to be a double standard at play in the Health Protection Branch.

In fact nifedipine is a drug for which there are independent studies suggesting very serious side effects and possible death due to heart attack, yet it is a drug that is still on the market with a small warning, “Do not take in the case of cardiovascular problems”. Then we have an example such as progesterone yam cream, which is not allowed on the market because of some concerns identified. If you compare them, you wonder, isn't there a double standard at work here? Isn't the power of drug companies such that it allows for a speedy process with pharmaceuticals, and yet there are these huge roadblocks with respect to natural remedies?

Ms. Mary Carman: I can address the nifedipine influence review article. We are familiar with it; we did look at it. When the original news report came out, it was difficult to determine what exactly it was speaking to.

The majority of the articles that were being addressed and had been surveyed in this analysis were opinion or review articles, and they were authored by people who, at the outset or at the result of this review, had participated in studies, or who had, from the author's documentation, something to gain from it. They had participated in a study and they had been reimbursed by the company for the drug. That is a fact supported by that information.

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I don't think the MDs on this committee would argue that when you're familiar with a product you tend to use it and if you're comfortable with the product you may well promote it. That may be the case. I'm not offering a judgment on that.

What I want to emphasize is that review and opinion articles are not the basis of a review. They are not evidence; they are only opinion. Our assessments are not based on a weight of opinion of individuals, but rather on the case report, analysed information and documentary evidence. Those review articles may well be in the file, but they're ancillary to the decision-making process.

Further, when we do look to outside experts for opinion and expertise to augment what we have or to further elaborate the expertise we have in-house, we have conflict of interest guidelines. They are certainly available to you should you wish to have them.

On the nifedipine issue or calcium channel blockers, we have studied them. We convened an expert panel and that report is publicly available. Anyone who wishes can have it. The report concluded that while there were warnings and precautions that needed to be augmented, the currently approved product for those uses was appropriate. Once again, it reiterated that products that were being used and prescribed by physicians for unapproved indications should not happen. In fact, we've almost put a reverse provision in the labelling to practitioners saying, “Don't prescribe it for these unapproved indications”, but in fact those products were not approved for those indications.

By the way, that panel of experts was subject to our conflict of interest provisions and was assessed against them.

Ms. Judy Wasylycia-Leis: Nifedipine is an example of a drug for which there are some studies suggesting side effects. You've referenced that in terms of the warning label, but it's still on the market.

Progesterone yam cream you've identified as having some problems with side effects. It's not allowed on the market with a warning. Is that not a double standard? Is the same scrutiny applied to a pharmaceutical drug like nifedipine and a natural product?

Mr. Dann Michols: The short answer is no. The same level of scrutiny may not be applied because we attempt to apply a level of scrutiny commensurate with the risk. But as Mary has said, progesterone is a schedule F drug. It requires a prescription. Nifedipine is a schedule F drug and requires a prescription as well. The treatment is identical.

The particular product you were talking about, as I mentioned, had progesterone added to it. It was not a natural product. The claim that the progesterone was produced by the Mexican yam or whatever was wrong. It had progesterone, a prescription drug, added to the product during the manufacturing process. In my opinion, it's treated consistently. We treat prescription drugs the same way. The progesterone cream should not have been on the market. It was not approved to be on the market and was taken off the market. The people who were using it and benefiting from it could get the product through prescription.

Ms. Judy Wasylycia-Leis: I have one other example that is related to all of this. You mentioned that decisions are made after a lot of research and documented evidence. They're not based on review and opinion. It seems, from what we've heard over the past few weeks, that often an herbal product is removed on the basis of two or three reported incidents of problems that are never investigated and researched to the nth degree to get to the bottom of the situation. Was it the actual herb or was a contaminant, additive or substitute involved?

From what I've heard, there are those questions around chaparral, which is on the list of banned natural remedies. I think that's related to the fact that we don't have a major research capacity within the Health Protection Branch and we no longer have the drug research bureau, which did the independent research.

• 1125

I think that's related to the fact that we don't have a major research capacity within the Health Protection Branch. We no longer have the Bureau of Drug Research, which did the independent research. We don't have...even if it was one person who existed before 1991 for research on natural health products. How do these decisions get made, and do we truly do that in-depth research when it comes to a product like chaparral?

Ms. Mary Carman: I spoke about reviewing the evidence. We do not create the documentary evidence. We assess it, we validate it, we audit it, but we do not create it. The person who wants to put the product on the market develops that information. A multitude of individuals or studies may be done to develop a body of information that says yes, on balance this product is effective for what it's claiming, with these risks, and produced at this quality. But we do not create the data. We do not create it for the nifedipines of this world, nor do we create it for chaparral.

Ms. Judy Wasylycia-Leis: But at one point, through government, through the Health Protection Branch, we had the capacity to do research when a drug that was on the market proved to be causing some problems; to research what was causing those side effects and problems. We no longer have that capacity. Instead, in the case of a pharmaceutical drug, it seems we're doing a paper kind of scrutiny and drug companies are regulating themselves, but in the case of natural remedies, on the basis of a couple of reported incidents, we're banning a product without then having the capacity to research what actually caused the side effects or illness as a result of taking that remedy, such as chaparral.

As I understand it, chaparral was a case of some reported incidents in the United States. It was banned by the United States Food and Drug Administration. Since then there has been research to show that in fact what is at the heart of the problem there is not the actual herbal product but a contaminant added to the product. Now that they have got to the bottom of the problem, the remedy may in fact be back on the market for use.

We don't seem any more to have the capacity in the Health Protection Branch, on any level, to be able to respond to a reaction, a side effect, of a drug or a natural health product and get to the root of it and therefore make an appropriate judgment.

Mr. Dann Michols: I totally disagree with that analysis.

We have the capacity. We have strengthened our in-house capacity in the area of biological drugs—vaccines, blood, blood products—biotechnological drugs. We have strengthened that capacity for very legitimate reasons. Those are the drugs about which the least is known. They are the cutting edge of technological development. They are a niche, if you like, of Canadian drug development.

We have the capacity, undiminished, on the analysis side to test products we feel are in contravention through the investigation perspective. All we did was eliminate an organization called the Bureau of Drug Research. We maintained the capacity we had in the past.

We don't, however, on the pharmaceutical side, do in-house research. Our scientists in Mary's operation and in the sister review bureaux, which are made up of medical doctors and PhDs and so on, can contract that expertise from other sources. The capacity for us to do the examinations still exists, exactly as it was. On the pharmaceutical side we have chosen not to do it in-house, partly because of the economics, partly because alternatives are available. I think you had before you witnesses from research institutions, from hospitals, from universities, who have indicated the capacity they have to do much of this research work, so why would we not go to them to have it done?

There is no double standard. If you take a look at the actions we have taken, we probably have more actions against prescription pharmaceutical products, taking them off the market, than we do against natural health products.

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But I come back to you and say the premise of the current regulation is that a product must be approved before it comes on the market. If we take a product off the market, it is either because it did not receive that approval in the first place or a legitimate complaint has been lodged and we have determined it to be legitimate. It may be a contaminant within a particular product. It may be the active ingredient within that product. But we are dealing on a product-by-product basis in terms of the drugs in Canada.

The Chair: I'm not sure if Mr. Volpe wants a question. I'm just going to ask a short one.

We've had a number of comments about inspectors. Could you tell us what their qualifications are—that's the first question—and what their guidelines are when they go in to look for something? If a complaint comes from them, is the complaint about the way it's packaged? Are they qualified to say a certain product should go through a study that takes 30 months or 300 months or 300 weeks, or whatever, and spends a lot of taxpayers' money? Just what qualifications do these inspectors have?

I'm asking this partly because you have said that 20 out of the 112 complaints were from inspectors. Were those complaints from the inspectors about what it looked like in the container, or was it...? I know I'm going on and on.

Mr. Dann Michols: They weren't complaints from the inspectors. They were discovered by investigators in their ongoing auditing functions. They are within Jean's responsibility, so I'll let him explain.

The Chair: Mr. Lambert, I'll let you answer after I ask this one.

Is there a difference between inspectors? This is because you said 20 of your own inspectors. Is that the inspector on the road or somebody internal doing something else?

Mr. Jean Lambert: There's a distinction to make between inspectors and investigators. To come to the first question, the qualifications are basically the same. The minimum requirement is a baccalaureate in science, usually pharmacy, chemistry, biochemistry—

The Chair: Can I interrupt? Is this the person that goes into a little store and looks around to see if everything's packaged properly?

Mr. Jean Lambert: Yes.

The resources are divided between inspectors and investigators. Inspectors are the people who audit or evaluate the compliance of the establishments for good manufacturing practices. Investigators are the people who are looking, investigating the marketplace either following complaints or on specific projects that we have, as we become aware of different problems around the world or within Canada with specific products. These investigators have specific projects to go out and look for problems.

The resources are relatively small in terms of numbers. I would say most of our work in the investigations is reactive work, not proactive work. We certainly would appreciate having more resources to do proactive work. We don't have the luxury of doing as much proactive work as we do.... So most of it is reactive, but the people are well qualified to evaluate the different products.

Obviously, it's not by looking at a box that you have the answer. You need to go and investigate at the source of distribution. You need to find out from them where they're getting it, and what the specifications of the product are. You also need, depending on the type of information obtained, to send these products to our laboratory for confirmation of information or to look out for contamination, etc. We have the capacity to do very good work in terms of investigation of pharmaceutical products into the Canadian marketplace.

The Chair: Mr. Volpe, did you want to continue?

Mr. Joseph Volpe: No, thanks.

The Chair: Mr. Hill.

Mr. Grant Hill: I'd like to go back to ma huang and explore it a little bit more.

There were problems with ephedrine and pseudo-ephedrine-containing compounds in the U.S.A. Overdoses and some deaths were documented. Fair?

Mr. Dann Michols: Okay, yes.

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Mr. Grant Hill: Ma huang contains minute quantities of this same chemical. Now that chemical is available to anyone in this room, across the counter, in many cold remedies. It's very unrestricted. The relative amount of ephedrine in ma huang is much less than the OTC product. Is that a fair statement?

The Chair: We didn't get a response on the record.

Ms. Mary Carman: Yes.

Mr. Grant Hill: That was a yes.

Why then has ma huang been taken off the Canadian market when the quantity of ephedrine, or ephedrine precursor or it could become ephedrine, is so much less than the over-the-counter preparations that anyone in this room can buy in a pharmacy?

Mr. Dann Michols: I'm not sure. I think I'm going to toss this one to my friends in food. Again, I come back to say that on the drug side we deal with products. A product submission that came forward to us that contained ephedra we would analyse accordingly, take a look at what was being done in terms of its safety, quality, and effectiveness, and approve it; it could be on the market.

If you're talking about ephedra in the form of ma huang generally, it would be in the food realm, presumably. I come back to the fact that we don't ban substances.

Mr. Grant Hill: Your quote from the Calgary Herald of August 10, 1997—my paper from home—

Mr. Dann Michols: My home, as well.

Mr. Grant Hill: —says: “Sixteen deaths in the U.S. linked to the herb ephedra recently prompted its reclassification as a drug”. This was a follow-up to the health warning release. If Mary says to me that ma huang contains relatively smaller quantities of ephedrine than over-the-counter preparations that anyone in this room can buy, this would seem inconsistent to any reasonable Canadian. Please explain to me why ma huang is no longer available on the Canadian market.

Mr. Dann Michols: We're coming back to approved product. Mary will take a run at it.

Ms. Mary Carman: You're still talking about the ephedrine alkaloids being present, whether the source is ma huang or ephedra. The reports in the U.S. go through a broad variety of products. some of them are very hard to distinguish. We've gone over and over that data, but they are speaking about the risks from the ephedrine alkaloids and those are present in synthetically derived products, in your cough and cold remedies as your decongestants, and they are present in ephedrine and ma huang.

These ingredients are legitimately available after having gone through a pre-market process. You can get your DIN; you can be on the market. You can legitimately purvey your product through the regulatory system that is now in place.

Mr. Dann Michols: We would only take product off the market that had not been approved through this pre-market.... We don't have a general ban on ephedra, ma huang. What we do is take off the market product that has not been approved by us in advance.

Mr. Grant Hill: Do you see how this would seem inconsistent? I know you have done it because the regulations have allowed you to do it, but the average citizen in the street would say if the quantity is so much less....

I have a young man who wrote me this letter. He said:

I'll come in front of the committee and I'll take 50 times the regular dose of ma huang to show you how minute the quantity is. I'll do it right in front of you and guarantee to you that I won't be on a stretcher.

If you took 50 times the quantity of the traditional cold remedy, you'd get sick.

Mr. Dann Michols: Dr. Hill, I'm sorry, but I don't understand your point. What Mary has said is that both the over-the-counter drug, in whatever dosage, having gone through our process, would be approved and available for Canadians. The ephedra product, having gone through our process at one-fiftieth the dosage, or whatever, would be legal and would be on the market.

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Mr. Grant Hill: Here's the point, to put it as plainly as I can. One product has been taken off the market. I call it “banned”, and you call it “reclassified as a drug”. Ma huang is not available in Canada today. That's a fair statement.

Mr. Dann Michols: I'm not certain that is a fair statement. A product containing ma huang that was approved by us is perfectly available.

Mr. Grant Hill: If it were approved by you, but it's not.

Mr. Dann Michols: Well, that's not our fault. If it is not, it's because a sponsor hasn't come forward with a product we can approve.

Mr. Grant Hill: You said that about melatonin, and I don't buy that any longer. The submission was made for melatonin and the same comment was made. Ma huang is not available. We've heard this many times here: there are products off the market in Canada that were available before. It's not available now. The inspector would turf it. And because it's not available—

Mr. Dann Michols: The inspector would not turf ma huang. The inspector would turf a bottle containing ma huang that had not been approved by us for sale in Canada.

Mr. Grant Hill: Exactly.

The Chair: If it's labelled as a drug, you mean, it would be taken off?

Mr. Dann Michols: No.

Mr. Grant Hill: Help him out. Tell him that you're going to take ma huang off the shelves.

Mr. Jean Lambert: I think you have been aware, over the past few weeks, of the therapeutic products compliance guide we have established. You have a copy of it? I know it's a fairly thick document, but if you go through it, you will see that we have, specifically related to your work and to the work done on the regulatory framework for this product, established special conditions for some categories of products. That includes products such as ma huang.

At this point in time, for these products, the guideline to the staff is we will strongly encourage full compliance—that means go through the formal process of having the evaluation and the DIN. If we see in the marketplace some specific products, according to the guide—I won't go through every one of these, but I would include ma huang—we will go to the distribution level. We won't act at the retail level. We will go to the distribution level and again discuss with them what are the requirements and fully encourage compliance.

But until such time as the new regulatory framework for this product is established—I'm not talking about all products, but for the product you're specifically mentioning—we will not be taking action. That has been in force since January 1998. We will not take action to remove that product from the marketplace.

We still would very much like to have full compliance with the requirements.

Mr. Grant Hill: You're telling me then that the situation is in a state of flux. As of a month ago, you're not going to seize ma huang.

Mr. Jean Lambert: We're saying that we have, for the reasons that you are here, made a specific guideline to our staff—and it is available to industry through our web site—specifying what are now the compliance activities that will be taken if we find these products on the marketplace. It is done very specifically to permit the conduct of your work. Once we have the framework, we will readjust accordingly.

Mr. Dann Michols: Let me take this one step further, using ma huang as your example. Ma huang, without a claim in the compliance guide, is not considered a drug. Ma huang with a claim would be a drug. We have not approved it; it is an illegal product. As Jean has said, if that is the case, we are not taking it off the shelves of the retail stores during this period when you are reviewing the framework. We would go to the manufacturer and say, “You are selling to retail an illegal product. We strongly encourage you to stop doing it, to send that product with the supporting information through the approval process such that we can review it, approve it if possible, and then you would be selling a legal drug.”

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Mr. Grant Hill: Does that awareness go out to all the individuals who have previously been selling or distributing ma huang, or will you do it on a case-by-case basis?

Mr. Jean Lambert: I would say that we have done a fairly extensive communication outside of the program to let the associations, and even individual manufacturers and importers, know about the therapeutic complaints guide and what's in it.

Mr. Dann Michols: It is on our website and freely available to anyone who wants to reference it.

Mr. Grant Hill: I'll make you aware that this fact came to me from a very interested party last night, and he does not know. If anybody should know, it's this individual.

Mr. Dann Michols: Is he a retailer, a wholesaler or a manufacturer?

Mr. Grant Hill: He is a wholesaler, a distributor.

Mr. Dann Michols: Well, he should know. If he is in a business, he ought to know the rules and regulations governing that business.

Mr. Grant Hill: You're telling me that it changed January 1.

Mr. Dann Michols: No.

Mr. Grant Hill: That's what your enforcement guy just said.

Mr. Dann Michols: No, we're not saying that.

Mr. Grant Hill: As of January 1.

Mr. Dann Michols: The status has continued to be the same. The action we are taking vis-à-vis that status is changed while this committee is undertaking its examination. It doesn't change the status of the product. Without a claim, it is not a drug. With a claim, it is a drug. That is maintained. Jean has said that the action we will take at the retail level has changed while your committee is reviewing this subject.

Mr. Grant Hill: Well, if this doesn't suggest the inconsistency of the regulations, I've never, ever seen anything that does.

I'll stop there.

The Chair: Thank you, Mr. Hill.

I'll have to say that I thought I was getting this cleared up from the time when you were here before Christmas, but I think just the last fifteen minutes has left me more confused now than I was before Christmas about lists and what can be and can't be and how people are informed. Anyway, I'll have to try to straighten that out myself, but I just got all confused again.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: I'm going to change topics for a minute, because I'm also a bit confused. If someone wants to come back to this....

There are two other areas I want to touch on before time runs out. For now, forget the whole issue of what's regulated or not. Forget about the precise framework that we need to arrive at down the road.

Over the last number of weeks, a lot of the presenters have come to us and have talked about the wonderful opportunity natural health products and traditional remedies and so on afford to our health care system. They have spoken in terms of holistic health care approaches, in terms of cost savings to the established health care system and so on. To me, that requires a proactive response by government in a climate in which there is in fact a lot of pressure to downsize and offload, to deregulate and outsource. My question pertains to how you see the development of some capacity within the Health Protection Branch in this climate.

You're right, Dann, in terms of people coming before us and saying that we don't have to only rely on in-house research. There are other ways to do the research that is necessary. But I think everyone before us has said that if we want to pursue this proactive approach, we need within government the ability of some bureau, of a group of people with training and expertise, to carry out scientific surveillance, to carry out quality control, to oversee botanical authenticity, to be involved in ensuring that the proper warnings and labelling and so on are done in whatever new regime we come up with. How are we going to accomplish that kind of development at a time when everything is going in the opposite direction? You yourself have indicated that budgetary requirements have forced third-party involvement, cost recovery, privatization and so on. That's one question.

The other question to quickly throw in is the question of the panel, which you have mentioned. Specifically, from the draft regulatory framework that we got from the panel at the first sitting, it's clear the mandate has gone beyond natural health products, herbals, vitamins and so on, and into foods and nutriceuticals. The panel make-up, the membership on the panel, doesn't reflect that expanded mandate. Are you addressing that?

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Finally, how do you see the panel's report fitting into the work we're doing? How does it all measure up? Are we duplicating it? Or do you see it as being complementary? What direction is going to be followed by the minister? And where do we go from here?

Mr. Dann Michols: I have one minute left to answer that. Is that right?

Let me attempt to answer your three points.

Your first had to do with the wonderful opportunity. I presume that wonderful opportunity relates to the opportunity that is available to the health care system in Canada to begin to legitimately use these products and the various practices of medicine and so on.

I tend to agree with you, but that is not my mandate. My mandate within the overall health care delivery system is to attempt to ensure that the products that are available are safe, effective, and of high quality. The capacity that I develop and that I use my resources on is towards that end.

I don't believe it is the responsibility of my organization to be doing the research on what chaparral could or couldn't do, what melatonin could and couldn't do, and so on.

I believe—and I think it was an excellent summary and I will be delighted to read it in the blues—that what you are looking for is exactly what we are providing in terms of being a regulatory agency. It is our job to ensure that the products are safe, effective, and of high quality.

But it is not our job to develop the products and do the research leading to the development of the products. That belongs to other organizations, and if it should be within government.... The current paradigm is that it is up to industry or a commercial venture that wants to get into the business to do that job and to present us with the information. It is our job to audit that information in order to be able to tell the people that what the manufacturer is making claims about is safe, of high quality, and effective.

Secondly, with regard to the panel's mandate, it has not changed. When it was originally set up, it was called the advisory panel on herbal remedies, but we said at the time that we wanted it to deal with a wide range of products. The problem was that there was not a commonly accepted collector for that wide range of products. In their deliberations they said they would rather be called the advisory panel on natural health products. We said, fine, if that helps you in your deliberations. The panel was still dealing with the products that we call therapeutic products.

Further on in their deliberations they took a look at the work that the advisory panel on functional foods and nutriceuticals did. They liked the definitions that were developed in terms of functional foods, conventional foods, and nutriceuticals. When they designed their conceptual framework of the four quadrants and so on, in order for them to deal with what I consider their piece of the mandate, which is—perish the thought—drugs, therapeutic products, they needed to fit that into a construct. They did so by saying conventional foods, functional foods, drugs without claims, drugs with claims—and they proceeded to do that.

The advisory panel and the work that we're doing with the food directorate on conventional foods, functional foods, nutriceuticals, and what claims should be allowed still continues.

But they are right and you are right; it is all part of the larger issue of products. Hopefully the two groups can work together and hopefully we can synthesize the findings and the recommendations of the two.

Your third point was about the work of the advisory panel and how it fits in with this group. My reaction to this is that you are both addressing the same subject.

We had set up the advisory panel prior to the current Minister of Health coming to the position. We did that because we acknowledged, as was mentioned here, that there was a problem; we wanted to review whether we had the appropriate regulatory framework for these products and so on. When Mr. Rock became Minister of Health he took a look at the activity and decided he wanted to request you to undertake the “examination”, if you like. He didn't eliminate the advisory panel. He asked that the advisory panel make their deliberations available to you, which is what they did with the interim report and what they will do with the final report.

So there are two venues for looking at the same issue, two venues in which there are very different skills and perhaps responsibilities. The advisory panel is made up of representatives of stakeholders who are very much involved in the business of natural health products, be it manufacturing, the practice of medicine, or whatever. You are representatives of the Canadian people.

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We have said at the outset it is absolutely essential for us as regulators to have a regulatory regime in keeping with society's expectations. I think what you are getting is a good sounding on what the various aspects of society, and particularly the consumers, want in this regard. If society does not want us to deal with the safety, quality, and effectiveness of these particular products, then it should tell you, you should tell us through the mechanism of legislation and so on, and we will no longer have the liability of having to deal with those particular products.

But as things now stand, under the current legislation, the Food and Drugs Act particularly and the Controlled Drugs and Substances Act, these products are drugs. If that's not what it should be, then the parliamentary process must make that change. Within the current legislation, government will deal with the regulations that implement that legislation and we will deal with the administration thereof, but when push comes to shove we still must consider these products to be drugs, and we still have to undertake the processes to ensure they are safe, effective, and of high quality.

The Chair: I think we're almost finished. I have a very short question and I think Mr. Hill has a short question.

My short question is on ephedra or ma huang, which we've been talking about and which Mr. Hill has been asking about. We've heard from Dann Michols from the drug section about why it's not allowed as a drug. Could the food people tell us why it's not allowed as a food?

Mr. Harry Conacher: This resulted from a combination of discussions we had with the drugs people along with our own toxicological evaluation of the information.

We have evidence that ephedra is responsible for a number of adverse effects when consumed in large amounts. One has to remember that if this is offered for sale as a food with no restrictions on the amount that can be consumed, even though the levels of the potentially toxic constituents in that drug may be low, if that compound itself is consumed at a high level with no restrictions on it, the effect is the same; individuals will still be exposed to a rather large quantity of an undesirable component. That is why in the food area we have continuing concerns about ephedra.

Having said that, I would like to indicate to you that with regard to the list I provided to the committee—the 64 plus the 17, and ephedra is on the 17—no official action was taken to promulgate that list and put it into the food and drug regulations because of the big public outcry that came about and possible concerns regarding information such as you are providing to us right now, Dr. Hill. We intended to take that list and enter into consultations with the affected industry and other stakeholders. If during those consultations the affected industry and other stakeholders could have provided us with information indicating the situation had changed since those evaluations were undertaken by us, we would have taken all those factors into consideration.

Unfortunately, those consultations we were planning have been somewhat superseded by everything else that's going on right now. It's very difficult in a situation such as this to talk about the toxicology of specific herbs and botanicals. With regard to those things being used as foods—in some cases it's rather questionable whether they are really foods or not—there must be those detailed discussions. If there is information out there that would indicate that from a food perspective unrestricted consumption of this compound would not pose a problem, we would certainly be prepared to entertain that.

The Chair: Do you have a question or comment?

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Mr. Grant Hill: The comment I make is that I do hear evidence of the department becoming less restrictive. I hear enforcers talking about how the laws are still there, but they're not going to come down as hard on this product. I hear you saying, we're listening to industry now. I think that's an indication of a sea change in the department and also an indication that the public pressure has been quite vigorous.

When you say your list has gone from 64 down to 17, or whatever the numbers are—

Mr. Harry Conacher: It's not 17, Dr. Hill; it's 64 plus.

Mr. Grant Hill: All right, you haven't enacted on your big list because of public outcry and you were frank to say that.

Let me end by a comparison. We iodize our salt; that's something we have done in Canada for preventive purposes for years. Some parts of the country do not have enough iodine in the soil to give the iodine that is useful for thyroid function. There's no one talking about labelling iodized salt to say, don't take too much because you'll get too much iodine.

I will finish my commentary by saying there's a real parallel here. Don't treat small substances the same as you treat the really large, harmful substances. In all fairness, I think the regulations have forced you into a box and have not given you the latitude to do what a reasonable regulator would do.

My line of questioning was to show the inconsistency, not of you as individuals but of the department and the regulations you have. I'm firmly convinced that with better regulations you wouldn't look so inconsistent.

I'll stop. I'll shut up.

The Chair: Thank you very much, all of you, for coming. If we feel we need to we'll call one of you, all of you, or some of you back again. We are, as you suggested, trying to make things better for the public and make it easier for you people to do your job without having all the complaints.

Thank you very much.

The meeting is adjourned to the call of the chair.