HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, March 24, 1998

• 0912

[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): Order, please.

This is meeting number 30 of the Standing Committee on Health. We are doing a study on natural health products.

We welcome our witnesses this morning. From the Canadian Food Inspection Agency we have Gerry Reasbeck and Bruce Bowen. We asked that somebody from Health Canada come in case there were any questions we needed to refer to them. From Health Canada we have Harry Conacher and John Salminen. They are here in case any of the members would like to ask questions through cross-reference, but it's the Canadian Food Inspection Agency that we're really here to hear from.

Mr. Reasbeck.

Mr. Gerry Reasbeck (Director, Food Division, Canadian Food Inspection Agency): Thank you, Madam Chair.

I would like to introduce my colleague, Mr. Bruce Bowen, who is a food biologist and food program officer with the Canadian Food Inspection Agency. He will be assisting me today in our discussions.

Mr. Harry Conacher (Acting Director, Bureau of Chemical Safety, Department of Health): Good morning, Madam Chair and ladies and gentlemen.

My colleague John Salminen heads the group that undertakes the risk assessment of these natural health products.

We've appeared here before and have explained what we do and how we do it. As the chair said, we're here to provide any back-up to the agency's presentation and any questions that arise from it.

Mr. Gerry Reasbeck: Madam Chair, we have a brief presentation we would like to deliver this morning. We think it might go some distance in answering some of the questions that have come out of prior committee meetings.

We're pleased to have the opportunity this morning to meet with the committee and to present the position of the Canadian Food Inspection Agency on this subject. If we can be of any assistance in your examination of the issues, we intend to do that.

This is clearly a matter of considerable interest to the Canadian public, and it is important to many consumers. In our presentation today we hope to cover two particular aspects. First, we want to outline the general role of the Canadian Food Inspection Agency with respect to the inspection and regulation of all foods, which of course includes herbal and botanical products and other natural health products when they are being represented and sold as foods. Second, we'd like to set out for you the kinds of regulatory problems associated with herbal- and botanical-based products, the principal requirements of the federal legislation that the agency enforces and administers to protect the Canadian public, and the inspection measures we are now taking.

• 0915

As you probably know, the Canadian Food Inspection Agency is a new agency. It officially opened its doors on April 1, 1997, and in doing so it took on the very sizeable task of delivering all federal food inspection activities for four previous parent departments—Agriculture and Agri-food Canada, Fisheries and Oceans Canada, Health Canada, and Industry Canada.

This is a very large task force. We have something in the order of 13 federal acts and associated regulations, not all of which deal directly with food inspection, but it is a major legislative requirement for us.

Agency responsibilities involve many thousands of foods, and, against the reality of finite inspection resources, it certainly demands a strategy of strict priority setting for us. We have to ensure the greatest public benefits will be realized by the agency compliance measures.

The agency is now beginning to develop a strategy that, as proposed, will be based on the identification, assessment, and prioritization of relative risks to the public presented by different types of public threats, such as risks to health and safety, risks arising from deception, fraud and misrepresentation, and trade-related risks. It's within this context that the agency must consider the relative inspection focus and emphasis to be given to individual regulatory issues such as compliance problems in respect of herbs and botanical products versus that for all other staple-type foods.

As you've heard from earlier witnesses, many herbal products have had a long history of use as traditional medicines, but the expanding public interest in them is a relatively recent phenomenon. We understand that historical federal enforcement activity for this category, which we've inherited from Health Canada, has largely focused on a case-by-case assessment of the potential safety risks of individual herbal products.

We noted that in Canada there is increasing consumer interest in herbal products. It's generating a strong market that is being met by a growing number of importers and distributors, including major pharmaceutical companies. Many of these products are now readily available in mainstream retail food stores and pharmacies.

This expanding market, however, creates increased potential for public harm from unsafe, toxic or misidentified products, as well as from economic losses to consumers arising from fraudulent practices and claims.

At this point I would want to emphasize that for herbal and botanical products, the agency's inspection mandate applies only when they're being represented and sold as food. This is defined in the Food and Drugs Act. Alternately, Health Canada representatives have advised the committee that Health Canada is responsible for undertaking compliance measures when such products are represented to the public as drugs.

As you are all aware by now, a crucial issue in the whole matter is whether individual products are to be treated as foods or as drugs. Under current legislation they must fall under one or the other of these two categories. Foods are commonly considered to be for nutritive purposes and to be safe regardless of the amount consumed.

Alternately, drugs are considered products for the treatment of a disease, disorder or abnormal physical state. They have pharmacologically active ingredients, are normally to be sold in dosage form, may make therapeutic claims, and carry information such as directions for use, contraindications, and so on. Many are recognized as being toxic when over-consumed.

Unfortunately, from a compliance perspective and as a problem for us, for many herbal and botanical products the differentiation between foods and drugs has become blurred. While in terms of their labelling and advertising they are most often represented to consumers as foods, they are at the same time being actively promoted by importers, distributors, and retailers as medicinal remedies. In short, they're being sold as drugs or as having therapeutic properties, which is in direct contravention of the Food and Drugs Act. From our perspective, clarification is required to ensure that these products are properly regulated.

• 0920

I want to turn to the compliance issues the Canadian Food Inspection Agency addresses with respect to herbal and botanical products. I'll also say that these compliance issues are common to all foods. These are the kinds of issues that we deal with generally across the food area.

Before discussing that, I want to point out that while herbs and botanical products are becoming increasingly important to many consumers, when sold as food they constitute an exceedingly small proportion of the total food universe available to Canadians. They are also considered to represent a low health or safety risk to the general Canadian population relative to many other risk issues associated with processing, manufacturing, importation, distribution, and consumption of staple foods. For these reasons, as was formerly the case at Health Canada, the agency has continued to allocate a lower inspection priority to these products.

There are three main areas of concern to the Canadian Food Inspection Agency—the sale of unsafe foods, the use of prohibited product claims and general labelling violations, and economic fraud.

With regard to the sale of unsafe foods, foremost for us is the issue of health and safety and whether any of these products, when sold as foods, could pose a risk to human health and should not be offered for sale to the public. Health Canada has advised the committee that it is the Food Directorate of the Health Protection Branch that makes such decisions for all foods and upon whom the agency relies for health policy direction. Health Canada has also outlined for you the difficult history of schedule 705, which in part is intended to comprise a list of herbs and botanicals and which, because of potential health risk, should not be sold as foods. As you know, this listing has never had regulatory status and of course is not being enforced.

They have also advised that prior to schedule 705, over the years they had provided a number of case-by-case opinions to inspectors, consumers, importers, and manufacturers as to the safety of specific herbal products. Documents in our possession that were transferred over with the responsibility from Health Canada indicate that nine such herbs were identified in these assessments as potentially harmful to consumers, and the agency is continuing to take action in relation to these products.

However, in taking on this new responsibility and to determine the exact safety status of these particular products today, the agency recently asked Health Canada to reconfirm for compliance purposes which products are considered to be unacceptable for sale to the Canadian public. We have subsequently been advised that Health Canada now considers that there are 16 products that are potentially problematic. I believe the committee has been given copies of this information from Health Canada.

In relation to this latest advice that we have received, we have requested further information and guidance from Health Canada on a number of key aspects of this matter. One of the issues is whether such foods are unsafe when sold as foods in and of themselves, or perhaps when they're sold as ingredients or components of multi-ingredient foods. Certainly many of these products are available in that form as well.

It is also our understanding that before the agency could proceed further with enforcement action respecting these additional seven products, and particularly in light of these hearings and pending recommendations, Health Canada plans to hold further consultations with interested stakeholders. In the interim, we have taken a national survey to determine the extent to which all 16 products are now available to the Canadian public as food, in order that we might develop an effective follow-up compliance strategy when required and when indicated.

• 0925

A further complicating and confusing factor, particularly for the public, is that many of these products such as ephedra, senna, cascara sagrada and horsetail are also being retailed to consumers as drugs and therefore bear legitimate drug identification numbers issued by the Therapeutic Products Directorate.

Whatever the number of herbal products ultimately determined by Health Canada as being unsafe as consumption as food, the Food and Drugs Act does provide the agency with adequate authority to act against potentially harmful foods, including herbs and botanicals. Paragraphs 4(a) and (b) of the act prohibit the sale of any food that has in or upon it any poisonous or harmful substance or is judged to be unfit for human consumption.

Turning now to prohibited product claims, for many years, Canadian legislation has prohibited disease treatment claims for food. The rationale has been that claims of this kind have not been proven and could potentially increase public health risk by leading consumers to self-medicate with uncertain remedies and possibly avoid medically proven treatments or advice.

Subsections 3(1) and (2) of the Food and Drugs Act prohibit the advertisement or sale of any food to the general public as a treatment preventative or cure for any of the diseases, disorders or abnormal physical states referenced in the regulations.

Accordingly, in cases where herbal and botanical products being represented as foods are being promoted, advertised or sold as potential medicinal remedies for diseases or disorders, such representations are in violation of section 3 of the Food and Drugs Act and are subject to compliance action by the agency.

Looking at these products yourselves on the retail shelves, you may well have noticed that such drug and disease-related claims are not normally present on the product labels themselves, because the products are being represented as foods. If the claims were present, they would either have to qualify as a drug and qualify for a drug identification number and go that route.... But in fact many of these are offered as herbal remedies, as medicinal treatments, and they are represented as foods by not carrying any claims of this kind.

The problem claims, however, are either made orally to consumers or in associated advertisements or in promotional materials, brochures, and publications. While this complicates our compliance life somewhat, the agency is taking case-by-case action against herbal and botanical products that are in violation of section 3.

I'd also add that the Internet is complicating our lives because it is presenting new challenges. While it certainly does present a wealth of information, and useful and helpful information to the public, it is also a significant source of exorbitant and misleading health and disease treatment and prevention claims for herbal products.

We have included some examples of these types of materials in your briefing package. Some of these are truly amazing kinds of claims. It makes one wonder, really, which herbal product one should use, since all of them are being touted as being very, very beneficial.

Thirdly, and last, is general labelling violations and economic fraud. Subsection 5(1) of the Food and Drugs Act prohibits the labelling, packaging, treatment, processing, sale or advertisement of any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. You can see there's considerable scope in this particular provision, which is very, very useful to us across the whole range of possible misrepresentations for food.

The food and drug regulations also, as you will know, prescribe fundamental, bilingual labelling requirements that are applicable to all foods sold in Canada. These include information such as the common name, list of ingredients, declaration of food additives, net quantity, name and address of the responsible party, and so on.

Herbal and botanical products, when sold as food, are entirely subject to these regulations. We have been finding that many herbal products, particularly imports, are being found in extensive violation of basic Canadian labelling and informational requirements. At the present time, consumers cannot be absolutely certain that they are receiving the desired herbal product. Mistakes and errors can and do occur in the industry, and deliberate product substitution and adulteration is also a possibility. Corrective measures are being taken by the agency within the capabilities of available resources and inspection priorities.

The Canadian Food Inspection Agency looks forward to the review and recommendation of this standing committee and to the ongoing work of the Therapeutic Products Directorate of Health Canada and its advisory panel for guidance as to the future regulatory framework for these products. In the meantime, the agency will continue to enforce present legislation and policies to provide protection to the Canadian public in the distribution and sale of these foods.

• 0930

Madame Chair, that concludes our introductory remarks. I hope this brief outline will set the stage for further discussions this morning. Thank you.

The Chair: Thank you very much.

I want to ask a question because you just read something here that I don't understand. On page 5 it says “The Food and Drug Regulations also prescribe fundamental, bilingual labelling requirements which are applicable to all foods”. I've been buying food for some 50 years and I haven't seen any labelling on anything. There's very little. You said they're required to indicate the “common name, list of ingredients and components, food additives, net quantity, the name and address of the responsible manufacturer”.

Mr. Gerry Reasbeck: Yes. All multi-ingredient foods and all foods in general must have certain mandatory information provided on them and it must be bilingual. A list of ingredients, for example, must be on all foods. It must be bilingual. The common name of the food must be bilingual. Virtually all foods out there have that information.

The Chair: I'll come back to that, but that's not the case in the stores I shop in. I guess I don't shop in the right stores.

Mr. Hill.

Mr. Grant Hill (Macleod, Ref.): Thank you, Madame Chair.

One of the things we've heard in prior testimony is that identical products would be inspected both by your agency and by Health Canada, the HPB. In fact someone came in with a little container and the container was from the same lot, the same day. The difference between the two was simply that on the one container there was a claim that this would help a sniffy nose. It doesn't make sense to me that two agencies would be and could be inspecting the very same product in the very same store. I wonder if you feel that is inappropriate.

Mr. Gerry Reasbeck: I would say so. I think you're speaking to the heart of part of the difficulty we have, which is that the definitions and requirements under the food and drug regulations for food versus drug really do require clarification. We believe it's important that those definitions be clarified.

I think it is quite true that the claim, or lack of a claim, can be of interest to either or both of the agencies. We understand that the Therapeutic Products Directorate of Health Canada is prepared to take action in cases where, based on the guidelines—and I believe they've tabled their guidelines with the committee—they would make a checkpoint assessment as to whether any given product of that kind is in fact a drug and therefore would fall within their purview and require a drug identification number. Alternately, it would be a food, in which case they would say to us this is simply a food, which requires—

Mr. Grant Hill: You have answered my question. You don't think this is sensible and would like to see it changed.

Mr. Gerry Reasbeck: I certainly think it requires a look.

Mr. Grant Hill: You've also said this has been a low priority for you in terms of your inspection activities. Yet there have been people from this industry who have come in and said they feel like they're being singled out; they feel like they are being almost persecuted. Would that be your division or HPB?

Mr. Gerry Reasbeck: That is a difficult question to answer.

Mr. Grant Hill: You guys are involved in that then?

Mr. Gerry Reasbeck: Yes, we are.

Mr. Grant Hill: That's enough. I don't want to prolong that.

You say your main concerns are unsafe foods, prohibited claims, and the labelling violations and economic fraud. Those are the three things you do concentrate upon. Does the current act provide you with enough recourse? Is the act clear and plain and suitable for you going after those three major concerns?

Mr. Gerry Reasbeck: Yes. Basically these three sections, sections 3, 4, and 5 of the Food and Drugs Act, are very clear for our purposes. They are sections that we apply universally across all products represented as foods.

At this point in time when it comes to interpreting whether these natural health products are a food or a drug, that's the difficulty. The sections themselves have adequate authority and are generally without problem when we apply them to all other foods.

Mr. Grant Hill: There are those who say there's a vacuum in terms of legislation or an act or regulations. In your view that is not correct? You feel they're clear, plain, and easy to understand?

• 0935

Mr. Gerry Reasbeck: As far as the existing prohibitions that exist under the Food and Drugs Act are concerned—and, as I've said, these apply to all food—these are operable and certainly cause no difficulties for us.

As I mentioned earlier, and as you've referred to it yourself, the problem here is identifying whether a herbal and botanical product fits within the categories of food.

If it fits the categories of a food, we have no problems administering this legislation.

Mr. Grant Hill: All right. You've laid out the problem here, and we've heard this quite often. Can you take it to the next step and suggest the direction in which the Food Inspection Agency figures we should move? You've listened to the committee; that's great. But give us your solution, if you can.

Mr. Gerry Reasbeck: Okay. First—and you've raised the question yourself—this is the issue of drug versus food. The existing definitions are reasonably clear under the Food and Drugs Act. But perhaps we could use a clarification of their application with respect to herbs and botanical products. That clarification would be very helpful to the Canadian Food Inspection Agency and the Canadian public.

Mr. Grant Hill: Is there expertise in your department in this area? Do you have people you can draw upon to give us some advice here? Do you have any natural-product experts in your agency?

Mr. Gerry Reasbeck: We have a lot of expertise in the area of foods in general. With respect to herbs and botanical products, I would say that we're on a learning curve, as are many others involved in this new and developing industry.

This is a new area for us, so at this point we do not have a great deal of expertise in this particular area.

The Chair: Mr. Myers.

Mr. Lynn Myers (Waterloo—Wellington, Lib.): Thank you very much, Madam Chair. I wanted to pick up on the inspection question. We've heard testimony that often in terms of retailers, importers, or whatever, a number of inspectors come in at any one time. I wonder if there is coordination in that regard. Does somebody take the lead in those areas? Is there discretion built into the system? If so, who has it?

Mr. Gerry Reasbeck: As was pointed out earlier, there are two agencies involved—the therapeutic products people and ourselves—and liaison goes on at the field level. If issues arise that have to do with regulatory concerns in an ongoing way, discussions are held between inspection staff in the regions. So discussions are going on, and this is one way of preventing this type of situation.

In terms of our own involvement in this, we are not terribly active in enforcing regulations as they apply to herbs and botanicals. I've indicated that it is a lower priority for us. So it isn't the case of tripping over one another in retail or manufacturing facilities. It's a case where primarily most of our focus is with respect to staple foods and whether foods are meeting the regulatory requirements.

In terms of the retail area, most of our enforcement focus is reactive, and most of it is related to import inspections, border management, if you will—68%. I can indicate to you that since April 1, 1997 to March of this year, 68% of our interventions have taken place at the border at import. Only 1.8% have taken place at retail.

Now, we do also go into distribution and manufacturing, but in both cases they're something in the order of 18% at manufacturing and 12% at distribution levels.

So it's highly unlikely that we're going to be butting heads when it comes to arguing whether a particular product is or is not in compliance.

Mr. Lynn Myers: Thank you. I wanted to go to our good manufacturing practice for a minute. Remind me again, is there a different standard between food and drugs in terms of GMP?

• 0940

Mr. Gerry Reasbeck: In the case of foods there is no legislation or regulations in place that establish GMP for foods. There is a guideline that was produced a number of years ago by Health Canada. It does provide general provisions for the use of food manufacturers and inspection staff, but there are no rules in place that are regulated. These are voluntary guidelines.

In addition to these guidelines for food, there are a number of voluntary and more specific GMPs dealing with a particular issue, such as low-acid canned foods, and so on.

From the therapeutic product side, I can't really comment on their particular GMP situation.

Mr. Lynn Myers: Just on that issue, in answer to a previous question on the second page, you make the point that clarification is required, and it has become blurred between food and drugs. You maintained that again a minute ago.

You went on to say that the clarification of application is required. Does that include the necessity for a third category, or are you not prepared to comment on that?

Mr. Gerry Reasbeck: Well, I think we are really looking forward to the deliberations of this committee. Certainly a number of other consultative and advisory groups are operating at Health Canada. I think we would want to reserve judgment in terms of a third category.

As the committee is probably aware, the United States does have a third category, and this was introduced under special legislation in 1994. Their particular experiences might be of interest to the committee. I don't know whether the committee might be interested in having some kind of testimony from the United States representative.

But at this time we're looking for a scheme that works. We're looking for a system that will work and will certainly facilitate our enforcement activities.

Mr. Lynn Myers: I was interested to read the second-to-last paragraph on page 5, under the section for labelling violations and economic fraud. It states that corrective measures are being taken by the agency. I wonder if you could elaborate on that in light of the testimony we've heard from people who say, look, we need to know if there are adverse reactions, if there are problems. We want labelling in place that helps us in that regard.

I wondered if you could outline the current system and how you're now proposing to change it, or if corrective measures are being taken. Could you elaborate on that?

Mr. Gerry Reasbeck: Okay. The corrective measures—and this is with respect to misrepresentation and fraud in general—we're now taking for herbal and botanical products are essentially the same as those we're taking for any other food out there.

If there are complaints raised or if inspectors become aware that there is potential misrepresentation and fraud, we do an investigation. We will examine the product. We will examine the product label. We may visit the facility where the product has been produced to determine whether the information on the label is in fact representative of the product analysis.

So essentially our role for these is the same as it is for any other food. It's an investigative approach where we will look into whether or not the product is what it purports to be or is not.

There is certainly no way the Canadian Food Inspection Agency could undertake a quality control or oversight for this industry. Food production is essentially the same as any other process. We are in the business of ensuring that there is compliance and providing oversight, but certainly not providing any kind of quality control or ongoing analytical testing process.

Mr. Lynn Myers: At the present time, are there any data collected in Canada on the negative effects of herbs? Are you aware of anything like that?

Mr. Gerry Reasbeck: Negative effects?

Mr. Lynn Myers: Adverse reactions.

Mr. Gerry Reasbeck: Not that I'm aware of. I could pass the question to my colleague, Dr. Conacher.

The Chair: Mr. Myers, did you want an answer from Mr. Conacher?

Mr. Lynn Myers: Well, yes, I would be interested in any data collected on adverse reactions as a result of herbs.

The Chair: A short answer, please.

Mr. Harry Conacher: There's no system in place to collect that information, any more than there is for any other food.

Obviously when we do our health hazard assessments on these products, we depend very heavily on the type of information you're referring to. Epidemiological information can come from Canada and it can come from any other country, and that is built into our risk assessments. But there is no system in place in Canada for acquiring adverse reactions to herbs and botanicals sold as foods.

Mr. Lynn Myers: Should there be?

• 0945

Mr. Harry Conacher: It would be nice to have such a system in place for all foods so that one could track what the adverse reaction is attributable to.

You may have heard that the Health Protection Branch is undergoing renewal. Part of that renewal is to look at developing surveillance systems to report human illnesses and trace them back to food, or wherever they come from. That is under development right now within the Health Protection Branch renewal, and it is a three-year process. We've finished the first year and we're heading into the next two years of that process. Hopefully by the end of that some system will be in place.

The Chair: Thank you.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you.

As you mentioned in your paper, the establishment of the Canadian Food Inspection Agency is relatively new. As I understand it, it was part of an overall restructuring within government, partly driven by the need to find efficiencies and cost savings.

On and off we've heard concerns about the adequacy of our system now to actually guarantee the safety of our foods. So whether we have the infrastructure in place to actually guarantee that the goods coming into this country are at all times safe does relate directly to whatever we do as a committee about natural health products.

There is a sense that the process we now have is a reactive one. We wouldn't have sufficient inspectors to go out on an unsolicited basis. The way in which the safety of foods is determined is largely a result of meeting criteria on paper.

There's a sense from people that we've lost something important in terms of our ability to identify problems before they occur and to be able to act, rather than waiting for something to happen. Some have suggested that we don't even have the capacity in this country to handle the chicken problem that happened in China. I don't know if that's an exaggeration. I'd like to hear your views on capacity now.

Related to that are a number of concerns that people have raised about food now on the market that is genetically altered. We don't have a system that either requires labelling, or is based on a thorough body of research in terms of safety.

Related to that is an issue I was raising last week on bovine growth hormone. Talking to some dairy farmers, I understood that in fact this product is now being widely used, even though it's not approved.

So I raise all of that to get a sense of our capacity now, with respect to foods and changes in food products, to give us a better understanding of what we need to do with respect to natural health products.

Mr. Gerry Reasbeck: Thank you. There are a very large number of issues there.

First, yes, the agency is new. The agency is a consolidation of the activities of four federal agencies. Certainly efficiencies, economies of scale, were a major reason for that major rationale.

One of the other major reasons for that was to get away from four separate jurisdictions that were involved in food inspection, to bring these all into one camp, and certainly to resolve differences of interpretation, differences of rule application that tended to creep into systems over many years. As you know, some of these agencies were 75 years old.

Now we have a new agency. We now have a good opportunity to deal with those types of issues and to deal with the kinds of things you're concerned about. We now have within our control the ability to bring those resources to bear in ways that will focus, for example, on more effective monitoring of imports, more efficient rule application.

You did ask whether we are reactive rather than proactive. In Canadian food inspection regulatory history it has never been possible for regulatory agencies to be everywhere and to inspect all foods. There are certainly a large number of registered and non-registered facilities across the country, a large number of importers.

So it has always been the case, and it will probably continue to be the case, that the agency will identify the bad actors through an inspection process, through complaints, and through marketplace intelligence. We will then focus on those bad actors and ensure that their situation is corrected.

• 0950

We can't be everywhere. We are trying to go through the process of inspecting the system, the manufacturing facilities and importers. But we do try to focus specifically on certain areas.

HACCP is identified as a future way of being able to ensure that the industry itself is taking appropriate measures to protect the public. Given that we can't be everywhere, nor do we have the resources to be everywhere, the introduction of HACCP....

HACCP is hazard analysis critical control points. Individual companies will identify critical control areas within their processing. They will then have a plan to monitor them, and the agency will then ensure that this is happening in fact. So it's a way of perhaps extending our reach by ensuring that these companies will deal with adequate systems in place.

I will now move to biotech labelling. Certainly this is a very controversial area. As far as labelling is concerned, the Canadian Food Inspection Agency is responsible for developing the Canadian approach and consultations with members of the public as to the direction in which we should be going.

We have had three major consultations up until now. These consultations have involved virtually all stakeholders in Canada. As will be the case in these consultations, both ends of the bell curve appear where you have people who have said that laissez-faire is the best way to go; we don't need a lot of labelling. In the other case you'll see people advocating blanket labelling where everything would be covered.

Generally what has happened through our consultation.... This is a position we have communicated internationally through the Codex Alimentarius Commission. The Codex committee on food labelling is in fact looking at this very issue, and I understand you did have a presentation on the Codex system.

The approach we are proposing at this point has to do with a health or safety issue that arises through the introduction of, for example, a food allergen from peanuts introduced into a tomato. In those circumstances there would have to be labelling, because segments of the Canadian population would be sensitive to that type of problem.

The second approach is that if there are significant nutritional or compositional changes from the traditional or conventional food, then here again the Canadian public and consumers have a right and a need to know that this product has been changed. For example, let us say you had a product that is traditionally low in monounsaturated fat. If by virtue of a genetic modification, it became high in saturated fats, the fatty acid profile has changed and consumers would need to know that.

So we're focusing on key issues respecting health and safety, rather than calling for blanket labelling. One of the reasons for not calling for blanket labelling is that there are a great number of foods that have been modified. If you use a food in a multi-ingredient food, ultimately the marketplace could very well be covered with labels that say that even though it might be a component or an ingredient that makes up a very small amount of the food, this food has to be identified.

Europe is certainly struggling with this question as well, and it will be interesting...at the Codex committee on food labelling in May. We host it in Canada. This issue will be coming before the committee again in May.

With respect to bovine growth hormone, we would be interested have some information as to who is using this product. It is certainly not permitted for sale or use in this country. It has not been approved by Health Canada. So if anyone has information we might be able to follow up, we would be interested in having that.

The Chair: Thank you.

Mr. Szabo.

Mr. Paul Szabo (Mississauga South, Lib.): Thank you, Madam Chair.

Thank you for your presentation, Mr. Reasbeck. The issue of labelling seems to be very fundamental to the subject matter before the committee. If I can, I would like to get an idea from you...maybe some quick questions.

Despite the consolidation, etc., which seems to make sense to me, are you prepared to confirm to the committee that the philosophy, foundations or principles applied in regard to the matters of labelling, etc., are identical or will remain in harmony between Agriculture Canada and Health Canada?

• 0955

Mr. Gerry Reasbeck: I'm not entirely certain of your question.

Mr. Paul Szabo: Are we singing to the same songbook?

Mr. Gerry Reasbeck: When it comes to collaborating on the development of regulation and policy setting, health and safety policy setting is within the purview and responsibility of Health Canada. We are very interested in the development of these policies and are taking an active and very keen interest in the deliberations that are ongoing with respect to herbs and botanicals. We have, and always have had, a very cooperative relationship with Health Canada, and we expect that will continue.

Mr. Paul Szabo: Okay.

What you said reinforces a concern of mine that there is a risk that one element of the food inspection or health of Canadians will be driven by one agenda and within another department it will be something totally different, so there could be different standards and different principles.

With regard to labelling, you have used terminology such as “the right and the need to know” on behalf of consumers, and you talked about health and safety. When you talk about labelling, are you talking simply about information on ingredients, contents, etc., or are you also including in your labelling requirements or authority cautions or warnings to consumers about the potential problems that may occur if a particular consumer product is used in a certain way?

Mr. Gerry Reasbeck: Again, the division of responsibility between Health Canada and ourselves has to be brought forward. When the agency was formed, Health Canada retained absolute authority in terms of health and policy setting and regulation making with respect to health. Warning statements such as “may contain traces of peanuts” or “may contain a potential food allergen” are within their authority to determine as to need. It is their decision, in order to protect the health and safety of the public, whether a label declaration of this kind is needed. They would make that decision and we would enforce it.

Mr. Paul Szabo: So Health Canada is still going to be the root, as it were.

Mr. Gerry Reasbeck: Yes.

Mr. Paul Szabo: All right.

Is alcohol a food or a drug?

Mr. Gerry Reasbeck: It's food.

Mr. Paul Szabo: It's food?

Mr. Gerry Reasbeck: Let's put it this way. Division 2 of the food and drug regulations does establish standards for alcoholic beverages, and there are labelling requirements applicable to alcoholic beverages. When we are in an enforcement mode, we are looking for fundamental information on the label and we are looking to ensure that the product is what it purports to be. So from our perspective we are enforcing those provisions in the context of it being a food.

Mr. Paul Szabo: Mr. Reasbeck, at the very beginning of your presentation you described what constituted a food and what constituted a drug. You said foods are safe regardless of the amount consumed, whereas drugs are toxic if overconsumed. On the basis of what you told this committee, alcohol is a drug, not a food, but now you've told us it's a food. Which direction are we going to go here?

Mr. Gerry Reasbeck: I'm not sure it's my decision as to whether it's a food or a drug. What I can tell you is that there are compositional standards established under the food and drug regulations for alcoholic beverages. There are also labelling rules for the purposes of alcoholic beverages. As the food inspection agency, we are involved in enforcing those rules. The distinction between whether an alcoholic beverage can have drug-like characteristics or drug-like properties is not a decision that we take. It's a decision that Health Canada would have to take.

Mr. Paul Szabo: You have talked about consulting with the public on what their perceptions are. I think it's useful. Under the national drug strategy a survey is done.... As I recall, in the last one something close to 70% of Canadians, when asked, said they would support health warning labels on the containers of alcoholic beverages. Yet Health Canada does not require health warning labels on the containers of alcoholic beverages, even though public support is very high—extremely high when you consider the intrusiveness of that kind of label.

• 1000

Given the current policy with regard to the labelling of alcohol, how relevant do you think consulting with Canadians is if Health Canada won't even act when you have 70% support from the public?

Mr. Gerry Reasbeck: I don't think I would be prepared to comment on the activities of Health Canada or whether their particular consultation was or was not effective. We were not really party to that.

Mr. Paul Szabo: Finally, on the specific issue of the generics, do you feel the labelling that may be required with regard to alternative medicines and all the other products presently before the committee in terms of generics—from your perspective, would labelling be advantageous not just from the standpoint of content, but maybe more importantly from the standpoint of cautions or warnings?

Mr. Gerry Reasbeck: Again, this is a decision for Health Canada to make.

Mr. Paul Szabo: Okay.

The Chair: I'll use my prerogative to ask a question here.

The reason I was questioning what you said earlier—on page 5 you say all foods, but you mean all packaged foods, don't you? When I was asking you before about that fourth paragraph from the bottom, all packaged foods.... I don't think grapes indicate there might be pesticides on them. Do you mean all packaged foods?

Mr. Gerry Reasbeck: Yes, all packaged foods.

The Chair: Okay.

Mr. Gerry Reasbeck: You're thinking of food sold in bulk.

The Chair: I'm thinking of grapes that have pesticide on them, or where they are imported or things like that. When you said all foods, it got me a little confused, because my grapes have never been labelled.

Is there any way or do you have the resources to check labelling for things like all the additives that go into food? I'm thinking about the health of Canadians who take these things, people who might be allergic to additives, food flavourings, dyes, hormones that are put into animal feeds. We don't know what will happen to people when they eat meat from animals that have had these hormones. Antibiotics that are sprayed on foods and given to livestock and on fruit, and preservatives....

Do you have the resources or can you see any way of checking these things? Can you see a way these things could be labelled so that Canadians would know, when they're eating meat, what has gone into the food these animals have eaten? Pesticides do get into Canada. We ban it here but it's on the food we eat.

I'm asking this because it's been brought up by people who have allergies and things like that, and they don't know what they're eating. Also, the general feeling among people who use herbal products is that some of these might have very serious effects on everybody in the world in a few years, yet there doesn't seem to be a rush out there to take all these products off the market because they contain something that could affect pregnant women or our future generations.

You seem to be zealous about controlling herbal products but not too concerned about these big things that could affect all of us when we're not touching a herbal product but we're eating an everyday food.

I've asked a big mass. It probably could be a four-year study, but these people come before us and say they are being picked on because of these other big problems out there that don't seem to be looked at. Is there any way you can start any reaction about all of this?

There's a big question for you.

Mr. Gerry Reasbeck: First of all, there are and have been for many years ongoing monitoring programs with respect to things like chemical residues. We have laboratories that undertake analyses and we have ongoing analytical projects to look at areas where there could be potential problems—chemical residues, pesticide residues, and that sort of thing.

• 1005

The Chair: There have been a lot of studies by a lot of people in a lot of countries, but we consumers don't know about these things. Nothing is labelled. Is there—

Mr. Gerry Reasbeck: We don't undertake to label—the difficulty is that the food and drug regulations apply to the ingredients, components or food additives that are in the food itself. The difficulty here is that having the food and drug regulations apply to something that would indicate on the label all of the things that might have been done during the growth of a particular crop or production of a particular animal—the current food and drug regulations would not have the scope to do that.

The Chair: Even if it's known that it's bad for us or could be bad for us?

Mr. Gerry Reasbeck: The question is whether it's universally recognized as being bad to the point where legislation or authority would be put into place.

For example, minimum residue levels have long been established under the food and drug regulations for levels of residue or chemicals that are present in a food. These establish very large safety margins, and we're doing that type of analysis.

The Chair: How many people do you have doing this in all of Canada?

Mr. Gerry Reasbeck: We have 51 staff from our four laboratories across the country. I would have to get the exact number for you as far as.... People who are involved in the laboratories?

The Chair: Just the people who are looking out for my health.

Mr. Gerry Reasbeck: We're all looking out for your health.

The Chair: I'm not sure.

We'll go on. It's a big, vague question.

Mr. Gerry Reasbeck: I'm sorry, I may not be getting to the heart of your question.

The Chair: There are a lot of bad things out there that people don't seem too concerned about.

Mr. Gerry Reasbeck: You're very concerned, I can see.

The Chair: Mr. Elley.

Mr. Reed Elley (Nanaimo—Cowichan, Ref.): Thank you, Madam Chair.

Let's suppose I decided to become a health food store owner, and after seeing great demand from the public I decided I was going to stock and sell progesterone cream in my store. What would happen to me?

Mr. Gerry Reasbeck: Progesterone cream...?

Mr. Harry Conacher: Progesterone cream—I imagine the Therapeutic Products Directorate would be discussing that with you.

Mr. Reed Elley: What would they do? What steps would you take?

Mr. Harry Conacher: I think you would have to ask the Therapeutic Products Directorate for that information. We are here representing the food program, both from Health Canada and from the agency. With regard to issues such as that, my understanding is that is treated as a drug, but you would have to ask Dann Michols and his colleagues that type of question.

Mr. Reed Elley: So you would have nothing to do with that in food inspection.

Let's take a look at the list of things that comes right after your submission. Herbs and botanical preparations evaluated by the food directorate and considered inappropriate for unrestricted consumption as foods—you have a list of nine things and then you have more recent additions to the list. Are those other seven things now prohibited?

Mr. Harry Conacher: The nine and the seven comprise the sixteen I discussed the last time I appeared before you. I also gave you an example, using one of them, of how we went through a risk assessment. I also indicated that depending on the outcome of the deliberations of this committee, and assuming all those things don't become drugs, we would be entering into consultations with the stakeholders, not only regarding those 16, but also those appearing on schedules 705 and 64, with a view to expressing our concern about these being consumed as foods and what might be done about this whole situation.

• 1010

This is what we would plan to do following the deliberations of this committee, whatever comes out of it. If they are no longer considered to fall into the food area, then we would not be involved. Presumably it would be the Therapeutic Products Directorate that would do most of that.

Mr. Reed Elley: If somebody was actually selling these things in a health food store, would your people go into the store and talk with them about it?

Mr. Gerry Reasbeck: Certainly if we came upon that particular product, we would draw that to the attention of the Therapeutic Products Directorate.

Mr. Reed Elley: Would they be involved in confiscation at that point?

Mr. Gerry Reasbeck: They would have to take a decision on what particular action they would take.

Mr. Reed Elley: I understand that most of the top nine came to the attention of Health Canada mainly on the basis of anecdotal information. Do you know of any extensive studies that have been done on these top nine that would indicate they are a serious threat to Canadians?

Mr. Harry Conacher: I wouldn't say they are all based on anecdotal information.

Mr. Reed Elley: So there have been some studies done.

Mr. Harry Conacher: There have been some studies done—not necessarily at Health Canada, but elsewhere. I think I indicated that we get the information from the scientific literature and from reports from the Food Inspection Agency, from inspectors contacting us directly about their concerns. It's as much information as we can get from whatever source we can get it from. We base our evaluation on what we have, and in many cases it's not a great deal of information that we have.

Mr. Reed Elley: That's the information I have—that most of Health Canada's information on the top nine is not from extensive studies, bodies of work or serious health risks. It's mostly anecdotal, particularly for chaparral and ephedra. I have information that there's more ephedra in something like Dristan, which is sold over the counter, than there is in the ephedra you get at the health food store.

I think there are some serious inconsistencies in the way we handle things in this country. We're addressing those inconsistencies, and hopefully we'll come up with something and get out of this crazy situation we have in this country right now.

I know I sound like a broken record at this committee, but I will go back to peanut butter as an example. I have a daughter who is highly allergic to it. She goes into an anaphylactic state of collapse when she ingests it, but I have yet to see a jar of peanut butter give that kind of warning to people in this country. I think that's a disgrace. It shows the inconsistencies in our approach to foods and their possible harm to Canadians. I don't know how we're going to address it, but we have to do something about it.

Mr. Harry Conacher: To respond to that question in a general sense, about seven years ago we recognized allergens in foods as being a potential problem. We didn't know much about it at that time.

We started a research program within my bureau. We established a working group between the Food Inspection Agency and ourselves to look into the possibility of labelling foods containing not just peanuts but any of the other food allergens that have been identified as being of concern. We established a list of allergens that we considered to be of high priority, especially those associated with anaphylaxis. This has been an ongoing program for the last six or seven years and has been given fairly high priority in our respective departments.

I would point out that many of the food recalls that have occurred in the last four or five years have been associated with trace levels of allergens in foods. We're not talking about peanut butter. We're talking about trace, minuscule quantities that are still associated with illness and death, so we have been addressing that. It certainly has been a higher priority in the food part of Health Canada than have the herb and botanical products.

• 1015

Mr. Gerry Reasbeck: I might add a couple of points to this.

The food allergen area is an extremely important one, and it is one that the agency clearly recognizes as a pressing one.

My own organization particularly is involved in probably 90% of the food recalls. This is something we inherited from Health Canada, and we deal with issues of undeclared and trace contaminants that are food allergens.

The Codex Committee on Food Labelling is also looking at a mandatory requirement for the declaration on all food labels of a list of about eight key food allergens that can cause anaphylaxis. Certainly Canada, and we ourselves, are very proactive in pushing for an active declaration on a list of ingredients of hazardous food allergens, and we are making that case internationally at the Codex Committee on Food Labelling.

Mr. Reed Elley: I would think one might take a look at tobacco in the same category, especially chewing tobacco.

Mr. Gerry Reasbeck: Chewing tobacco—that's something we could take under advisement.

Mr. Reed Elley: We don't prohibit the sale of it.

The Chair: Lynn Myers.

Mr. Lynn Myers: Thank you, Madam Chair.

I had a further question of Mr. Reasbeck.

During the course of our hearings we've heard a lot from industry people and consumers with respect to what they perceive to be the economic effects of moving natural health products into a regulated sphere, and moving especially foods into drug areas.

I wondered if your agency or you are aware of whether any other data have been collected. Has your agency, or any other agency for that matter, collected the data? Are there any other data related to the kind of economic impact that, say, industry people would feel as a result of licensing or consumers would see as a result of higher costs for these products? Have you done any studies along those lines, or are you aware of any?

Mr. Gerry Reasbeck: No, not really, and it's not something we've been focusing on.

Certainly if a regulation were to be set in place, there would have to be a regulatory impact analysis. There would have to be a front-end assessment, as it were, of proposed regulations. It would be part of the proposals for regulations, so it would take into consideration impacts of that nature.

Mr. Lynn Myers: Would you or your agency be part of that?

Mr. Gerry Reasbeck: Probably not. It would likely be Health Canada.

Mr. Lynn Myers: Good. Thank you very much.

The Chair: Grant Hill.

Mr. Grant Hill: I'd like to follow up on your basic definition of what is approved, which is commonly something you'd take for nutrition that is safe regardless of the amount consumed. That in my mind is a significant problem. Take bran, for instance, which is a food. Bran flakes taken in excess can be extremely harmful.

If that's your definition, and alcohol certainly fits into it as an inconsistency—and I'm not going to ask you to comment on that; I'm making it as a statement—I don't think you're on solid ground with your definition.

Mr. Gerry Reasbeck: May I make a comment?

Mr. Grant Hill: You may make a comment, as long as it's short.

Mr. Gerry Reasbeck: No, I don't think you should take what I've said literally. Obviously if one consumed apple sauce in excess, you could perhaps—

Mr. Grant Hill: Indeed.

Mr. Gerry Reasbeck: Don't take it too literally.

Mr. Grant Hill: I won't take it too literally.

I want to branch off now into the issue of additives to foods. We have in our country long accepted the additive to salt of iodine. We have accepted additives to cereal of vitamins and minerals. We expect those to be labelled, and you have said you don't have the capability to go out and inspect for quality control. You presume industry will do that. You watch it, you monitor it, but the industry itself regulates it. Is that fair?

Mr. Gerry Reasbeck: The industry is responsible under federal regulations for following and abiding by requirements. They're ultimately responsible. The government does not run quality control programs for the industry.

Mr. Grant Hill: Exactly. Yet when we talk about health foods, you seem to move toward a far more restrictive regime. I'm not sure why, and I pose it as a question. I think this industry is fully capable of doing exactly the same thing you expect the cereal manufacturers to do, which is to follow the quantity of vitamin they have put in. You might well come along and tell them to show you their records. And I say that as a statement.

• 1020

The other thing that concerns me is that there's a new move toward what I would call fortified fruit juice. These juices are available in some other jurisdictions. A fortified fruit juice, for instance, could be a fruit juice that adds calcium, and calcium is useful for the menopausal woman who has bone density problems.

In Canada we seem to be very reticent in that direction, and I'm not sure why. It's a continuum, if you will, going from a very natural fruit juice to something that's fortified, to the health food product. Can you explain to me why we would be relatively reticent in Canada to go that route?

Mr. Gerry Reasbeck: I think I will pass that to my colleague, Dr. Conacher.

Mr. Harry Conacher: I think the reticence is primarily based on the same issue you were raising earlier. Is it the dose that makes the poison? You're not only concerned about how much calcium is required to be beneficial to your health, you're also concerned about being exposed to too much calcium. So you have to do a risk assessment, again at the upper end, as to how much calcium you can take in. Once you start adding those things to all sorts of foods, you start getting a little bit concerned that you may be taking too much in.

Those considerations are being taken into account, and it does take some time to come up with an appropriate policy in this area. It's that type of consideration.

Mr. Grant Hill: That's fair enough, and it would seem to me a reasonable regulator would do exactly as you've said. If there's evidence that it could be harmful to take too much...a warning, even a disclaimer.

Mr. Harry Conacher: Again, that raises another issue. Do you specifically want to add something to food? Then you may be faced with a potential problem and have to put a warning on it. It becomes a very complicated issue.

Our whole food certification policy is undergoing review right now, and it's an ongoing review. First it's calcium, then it's something else, then it's something else. It's not an easy issue at all.

I don't know if I've answered your question.

Mr. Grant Hill: All right. It's obviously not an easy issue, or you wouldn't be here.

Mr. Harry Conacher: No, not at all.

Mr. Grant Hill: In my view, the informed consumer is still a far better judge, an individual who has access to the Internet—we've heard how the Internet is far more available—and can go in and find out for himself. Surely the individual is the ultimate judge of this. If people are giving something to their children and there's a potential harm, they can be very cautious, far more cautious than regulators.

The Chair: I'm going to ask another question. I have researchers here asking questions to fill in holes too.

You mentioned the work done by the Codex Committee on Food Labelling. You seem to be in favour of what the nine nations are doing, and perhaps some of these things I've mentioned, such as generically altered foods, will be studied by them. When do you expect to have their report, are you waiting for the report before making any decisions about what we're going to do with cautionary labelling on food, and could this cautionary labelling be used by the natural food product industry?

Mr. Gerry Reasbeck: Perhaps in reverse order, cautionary labelling is still a responsibility of Health Canada when we're talking about potential risk.

In terms of the Codex Committee on Food Labelling, there are a number of high profile key issues that these 152 countries are looking at. The labelling of bioengineered foods is one of them. A proactive declaration of food allergens is a second one. A third one of course is organic.

These, if you're familiar with the Codex, tend to proceed relatively slowly. Getting large numbers of countries to agree on an international labelling rule, for example, for the declaration of food allergens is going to take some time. However, at this particular time there is a general agreement in principle of the allergens that should be declared.

There is a joint expert committee on food additives and contaminants, which has been tasked to look at how you would add to the list and how you would take away from the list. In other words, is there some kind of international approach to saying what should be on the hit list and what should not?

At the last meeting we had, there was a lot of argument. Australians said to put royal jelly on it because they've got problems with royal jelly. Other people said to put sesame seeds on.

• 1025

We find that allergens tend to vary with populations. They tend to vary with the kinds of foods and the nature of foods that people are consuming. We have a lot of peanut allergens in North America. They don't have them that much in Europe.

Basically, I don't think you can expect an immediate decision. We are very proactive ourselves; we're pushing it ourselves. We don't have to wait for the Codex. We can, under our own national legislation, put rules in place without the Codex. But it is good, certainly now, to have parity with the international direction.

The Chair: If you had the will, you could go ahead and do it. We could do it here.

Mr. Gerry Reasbeck: Yes.

The Chair: Okay.

Madame Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): Madam Chair, please accept my apologies for being late. Good morning to you all.

Mr. Conacher, I would like to ask you a question. You are familiar with the famous natural product known as melatonin, a synthetic natural hormone that, according to the experts or the studies that have been carried out, could replace Valium, Ativan and various other products that help people to relax. It is also said that melatonin is an antidepressant.

Melatonin is sold all over the United States; it is on the shelves everywhere. People can easily purchase it. It is a product that Americans like for the very reason that it replaces chemicals.

Here, in Canada, melatonin is prohibited. Since you stated that your studies are based on other studies , on trials carried out in other countries, and namely in the United States, I would like you to tell me who decided that this product should not be allowed into Canada, why it was refused and what reasons are given by boarder inspectors to refuse its entry into the country?

I would also like to know if you share my views on the following issue. Given that thousands of people, especially older people, the ranks of whom are ever growing, are given prescriptions for valium and Ativan, this is a very paying proposition for pharmaceutical companies. Would you agree with me to say that the pharmaceutical companies that produce these drugs have a very powerful lobby that exerts a tremendous amount of influence on Health Canada?

[English]

Mr. Harry Conacher: Again, Madame Picard, I find it difficult to respond to that question since melatonin is considered by our therapeutics products program as a drug and within the confines of the food program. To my knowledge we have never been involved with melatonin at all.

The question you asked would have to be directed to Dann Michols, the head of the therapeutics product program.

I'm sorry, but that's the only answer I can give.

[Translation]

Ms. Pauline Picard: Thank you.

[English]

The Chair: Madame Picard, are you finished?

Do you want to follow up on that, Mr. Szabo?

Mr. Paul Szabo: This kind of question is precisely the dilemma I was concerned about earlier. There is shared responsibility in some aspects, but also unique responsibility. If we're going to have businesses that want to get on with doing business, being sent to one department and being told no, you have to talk to somebody else, I think is a frustration Canadians and businesses are going to have if they can't get the answers regardless of where they go.

I'm not sure whether it's helpful to not know or not be able to pass on that answer. It's almost like jurisdictional responsibilities, and I don't know how we deal with that, Madam Chair.

We're still talking about labelling, and I'm a little unsure as to whether or not the warning part is Health Canada and the information part is food inspection. But on labelling generally you must have some research, some knowledge, or a departmental policy position, which gives you some sort of certainty that consumers actually read labels, they understand labels, and they in fact achieve the purpose for which they were intended. Do you have any evidence, any knowledge whatsoever, about research that deals with the usefulness and success of labelling?

• 1030

Mr. Gerry Reasbeck: Certainly there are ongoing studies of this nature. I know the National Institute of Nutrition did a study in the area of nutrition labelling.

As you know, nutrition labelling from the U.S. perspective is a very proactive requirement, whereas in Canada nutrition labelling is primarily one that provides information triggered by a claim. If you made a low-in-fat claim, you would be required to provide information on the label with respect to the amount of fat that's present, but you would not be required to talk about carbohydrates, or protein, or any of the rest.

I know they have done some studies on consumers' understanding and awareness of nutrition labelling.

As far as recent studies by our own department are concerned, I'm not aware of any that have been done recently, but I can tell you that under regulatory review, which has to do with the ongoing review of regulation requirements, mandated several years ago for departments to conduct, there was a great deal of consultation with the Canadian public on mandated information for things such as lists of ingredients, whether they wanted more information or less information. That involved consumers; it involved all stakeholders. We are continuing to proceed to make regulatory changes to follow up on those identified consumer requirements.

An example I can give you is that the list of ingredients under Canadian rules does provide for certain types of exemptions for class names. Instead of identifying all the various oils that might be in a product, you can say vegetable oil, whereas in the United States you would have to be able to identify the specific vegetable oils that are present.

Eliminating those kinds of exemptions, extending things like best-before dates to products that have a longer shelf life than 90 days—that type of thing was certainly garnered through our consultations on regulatory review.

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: I'd like to return to the issues of safety and scientific surveillance to get a better understanding.

I appreciate what you said earlier about it certainly being beyond the realm of possibility to have enough inspectors go out and check on every food and product in this country. It therefore becomes more critical to understand what processes are in place to make sure that the stuff on the market is safe.

The first question is, what process is in place for allowing a new food product on the market? Is that also a way in which HACCP is used, or is HACCP used strictly to inspect after a product is on the market?

Related to all of this, if and when a problem is identified—and I'm thinking now not just in terms of a case of salmonella poisoning, which you would inspect and deal with, but something much more complex, perhaps involving something unknown, perhaps interaction between a food and another food, or a food and a drug, or a food and a natural health product—what capacity do we have to get to the bottom of that problem and then put in place the necessary steps to deal with it?

Related to that is, when or if the moratorium on the Health Protection Branch is lifted and we still proceed with cuts to the food research bureau, who does that work? How does it get done? Where would you take a problem like that to get it resolved?

Mr. Gerry Reasbeck: I think I'm going to have to ask Dr. Conacher to comment on this particular thing. They do have processes in place called health hazard evaluations, which are used to look at potential health hazard issues of the kind you're raising.

Dr. Conacher, would you like to comment?

• 1035

Mr. Harry Conacher: Yes. I suppose the best way I could comment on that would be by way of an example. One of the most difficult situations we found ourselves in, which you may recall, was some years ago when there was this contaminant in Prince Edward Island mussels. This was a natural contaminant that was appearing in the mussels and causing illness and death to several hundred people and we didn't know what it was.

At that stage the resources of every federal department that was involved in food or seafood at all were put together to address that incident. The number one thing was to identify what it was. It took about two months to identify what that compound was and there was a lot of confusion in that two-month period. It's very difficult to put in place controls when you don't know what you're dealing with.

Once it was identified, then the controls started going in place. Once that compound was identified, we had a look at that compound. It was a known compound as it turned out, a natural compound. Once we had done a risk assessment, we could come up with a level in the mussels or in any of the other seafood items it was involved in that would not pose a hazard to humans. Below that level there would not be a problem.

We then developed methodology to enable us to assess whether it's there below the level or above the level. Then you can put your regulatory process in place to control it. Monitoring programs were then put in place by the then fisheries and oceans department to ensure that products containing the compound above that level did not get onto the market. Once those monitoring programs were in place, they could show an increase because it was naturally occurring due to some plankton increase in the water. As soon as you saw the levels going up in the mussels, there was no more sale of those mussels. This was applied not only to mussels in Canada but imported mussels as well.

It involves an identification of a problem by a whole myriad of people. In actual fact the group that was primarily responsible for doing the identification was the National Research Council in conjunction with ourselves. Once they identified it, then the regular regulatory mechanisms fell into place.

That is how we handle situations in Canada. In many cases we know what the contaminant is and it's relatively easy to handle. In the cases where we don't know what's causing the problem, that's where the difficulty arises. It doesn't matter what country you're in; you never have enough resources to handle that.

I don't know if I've answered your question.

Ms. Judy Wasylycia-Leis: Partly. I'd still be concerned about whether we would have the capability to respond to an emergency or a critical situation if in fact we reduce the research capacity within the Health Protection Branch. I'm still worried about whether, if the direction that was earlier proposed goes ahead, we could actually come together and respond. It doesn't matter if the National Health Research Council took the lead; we still need that capacity in government.

The reason I'm asking is what if we move to classify all natural health products as foods? What kind of capacity would we need to be able to respond when a problem emerges? What if our chair gets deathly ill because she took zinc and echinacea? Who would respond then? In a serious situation who would do that work? What capacity would we need in government? I still need to hear a little more on that.

The first part of my question was what process do we now have for approving new foods on the market? Is it like drugs, where there's an evaluation, the company pays a fee, and you get something approved that meets a certain set of criteria, or is it different for foods?

Mr. Harry Conacher: Again, you had several questions there. First of all, let me address the cuts that were meant to occur within the food directorate, the food program. That food program was no exception to any other program when it came to addressing the program review cuts.

There was a priority-setting exercise conducted and certain projects were identified as being of lower priority than others. When you're dealing with food safety or any other safety issue, this is a very difficult exercise, but it did result in the identification of a number of projects that were lower priority. These happened to be in the areas of nutrition, food additives, chemical contaminants, and so on.

• 1040

Following the announcement of those cuts to the staff in July 1997, a process was put in place to close down the laboratories and to find alternative positions for the affected employees. The employees were not out of work, but we had to find positions for them; a very unpleasant exercise altogether.

Then, following a really extreme reaction to these cuts in the media, within the department, and by the scientists themselves, the minister—and I'm sure Minister Rock indicated this to you—put a moratorium on further cuts. He ordered the reinstatement of all those affected projects and established the Science Advisory Board, which is meant to give advice to the department as to what type of research programs and areas we should be involved in for the future. As you probably are aware, the Science Advisory Board has now been established under the chairmanship of Dr. Bondar. Again, it's an ongoing process.

With regard to the cuts, as far as I can recollect, 90% of those areas that were declared affected have now been reinstated. There is no intention at the moment of undertaking any further cuts until we get the advice from the Science Advisory Board.

With regard to the resources we had before the cuts, we still have those resources right now. So whatever position we were in before the cuts to handle any crisis that arose, we're in the same position. We can still do it. We have the same resources and the same facilities to do it, the same expertise.

On that account, certainly within the food program—and that's all I can talk about—I don't see there is a problem at the moment.

Ms. Judy Wasylycia-Leis: But what about the two other questions I raised? First, if we do move towards a change in the way in which we deal with natural health products, what capacity would we need to be able to provide that kind of safety check and scientific surveillance? I would assume you'd need something equivalent to the kind of research capacity we have in the food area if we're going to broaden this at all.

As well, what do we now do with foods in terms of before they come onto the market? Is there a process by which...or do they just come on the market and then we react?

Mr. Harry Conacher: You were talking earlier about bioengineered foods. This isn't particularly my area, but—

Ms. Judy Wasylycia-Leis: Any foods.

Mr. Harry Conacher: —bioengineered food is a new food. We have an office of biotechnology and a notification procedure. If anyone in Canada or elsewhere wants to bring a bioengineered food onto the market, they have to notify the office of biotechnology. Following that, there is a full assessment of the safety of that particular new component.

This involves molecular biologists and the usual gamut of toxicologists, chemists, and nutritionists as to whether or not that food is any different from the food that hasn't been bioengineered. So there is a full assessment undertaken of the safety of this product.

I think my colleague referred earlier to the fact that if there's no difference between this particular bioengineered product and a product that already is in existence, why is there any need for labelling? There would only be a need for labelling, as far as we can see, if there has been some change, other than what was desired in the food, that may put some portion of the population at risk or not—for example, allergens. So there is a process in place for bioengineered foods.

With regard to herbs and botanicals used as foods, there is no pre-market clearance involved at the moment. There is none whatsoever involved. There's no legal requirement for those foods to be screened before they go on the market.

Essentially, what we have to do is to react, as I indicated earlier, to reports—scientific reports that have appeared in the literature, that come from our inspectors, or that come from our colleagues in the U.S.—that there are concerns about certain ones. Then we start trying to acquire the information we need to make a safety assessment of it.

• 1045

If we were required to do pre-market evaluations of such compounds as have botanical preparations, I'm not altogether sure that we would need to increase our research component. What we might have to increase is our assessment evaluation component, as opposed to our research component, because if that were the case, we would be asking the individuals who were requesting permission for those to be approved to provide us with a lot more information than we get just now. Because we don't get any just now. There is no requirement to do it.

I'm not sure if I've answered your question.

Ms. Judy Wasylycia-Leis: It begs a lot more questions, but I'm afraid I—

The Chair: Yes. We probably should have set aside three hours for this.

Just in closing, if the committee were to recommend a separate bureau or area or category, if we were to do that, who would take the responsibility for the enforcement? Would it fall under Health Canada for drugs or the Canadian Food Inspection Agency for food? Which inspectors do you think would be best suited for it in terms of training and knowledge of natural health products? Or should somebody be training a whole new set of inspectors if we do this?

Mr. Reasbeck, since you're doing the inspections....

Mr. Gerry Reasbeck: I think you certainly have hit on some very key questions as to what might result from the outcome of these discussions. In part, the answer to your question has to come from whether or not there is in fact a third category created and—

The Chair: If we should or would—

Mr. Gerry Reasbeck: If you should, yes—

The Chair: If we did.

Mr. Gerry Reasbeck: The decision as to whether we should or not is really something that has to come out of recommendations that your committee would make.

The Chair: But if we did do that, how would you cope with inspection?

Mr. Gerry Reasbeck: If we did do that it would probably be wise to have the regulation of these products under one agency so that the appropriate controls and rule making would be in one place. Whether that's feasible under the existing organization between departments is a question that would have to be looked at.

The Chair: Okay. Thank you very much for appearing. If we need to hear from you again before we make our final decisions, we'll let you know.

Mr. Gerry Reasbeck: Thank you very much. I'm very pleased to be here.

The Chair: We'll take a two-minute break.

• 1047

• 1101

The Chair: I'll call the meeting to order, please.

We have one individual, an expert, from the LDI Group, and he's the executive director of the Utah Natural Health Products Association, Lorne Israelson. From the International Development Research Centre we have Roger Finan, Gilles Forget, and Chusa Ginés. We'll just start in that order.

Mr. Israelson, try to keep it relatively short, because they want to get their questions and answers in.

Mr. Lorne Israelson (Individual Presentation): Thank you, Madam Chair. Members of the committee, I'm delighted to be here.

As a brief introduction, I've been involved in the botanical industry for nearly twenty years. I have served as president of Nature's Way products, which is one of the largest herb companies in the United States and was intimately involved in the creation and passage of DSHEA.

I've also had a chance to read all of the prior testimony presented before the committee, which took awhile but was very helpful to me. I have some perspective of various views. The main lesson for me is that all of the issues and many of the emotions expressed here are virtually identical to those expressed in the United States prior to DSHEA's passage, and because of that I think I can offer a few perspectives that may be helpful to the committee in its deliberations.

I think first I should give you a very quick background on DSHEA. There have been a number of references to it, not always correct, and I think it's important to do two things for you, one of which is to review quickly the findings section of the law itself. This is something that's often forgotten but is extremely important, because it really speaks to the heart of why this law was passed.

I'll quickly read this. You do have two copies, which I gave to the clerk. You can refer to this later if you'd like, but this is what the Congress said in passing this law:

Improving the health of the U.S. citizenry is a top national priority.

Dietary supplements have been shown to be useful in preventing chronic disease, and their appropriate use will help limit incidence of chronic disease and long-term healthcare costs.

Consumers should be empowered to make informed choices about preventative healthcare programs based on scientific studies relating to dietary supplements.

Consumers are placing greater reliance on non-traditional healthcare providers due to the high cost of traditional medical services.

The Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers (but should take swift action against unsafe products).

Legislative action is necessary to protect the consumer's right of access to safe dietary supplements to promote wellness.

And finally:

A rational federal framework must be established to supersede the current ad hoc patchwork regulatory policy on dietary supplements.

To me that sounds very similar to what you're grappling with as well.

Our solution was DSHEA, and not everybody is happy with it. I should tell you that this was the single-largest constituent issue before the U.S. Congress since the Vietnam War. What that means is that more consumers called, wrote or spoke to a member of Congress on this issue of the regulation of herbs and supplements than anything else since the war. That's astonishing, but it also speaks to the heart of the issue, which is that this is fundamental to many people. I believe what we learned is that people's perspective about their right to make personal choices in health care is a very deep and fundamental one. Basically they do not want the government interfering with their right to make those personal choices.

It also underlies the notion that government, industry, and consumers must collaborate to assure that products are indeed safe and that whatever information is available is truthful and not misleading.

• 1105

To that extent, DSHEA did the following: it created a definition of “dietary supplement” that includes vitamins, minerals, herbs, amino acids, and a wide range of other ingredients that can be consumed to improve or supplement the diet; it created a special and different safety standard for botanicals and other dietary supplements; it created a special class of information that can be made available to consumers to increase the flow of knowledge so that consumers can make better and wiser choices; it created our famous structure function claims, which allow you to describe on the label of a product how a dietary supplement, herbal products, etc., can affect the structure or function of the body or how it affects mechanisms of action that affect structures and functions of the body; it created a new requirement for good manufacturing practices specific to dietary supplements but based on food, and it specifically intended that we not approach it through HACCP, which is a hazard analysis critical control point, a different approach to GMP; it created a presidential commission to further evaluate how to present information on the labels of dietary supplements—and that commission has recently issued its findings to Congress and the President; and finally, it created an Office of Dietary Supplements to become a house for information and collaboration with other government agencies, because it was felt that there was a great deal of disparate and uncoordinated information and resources that were being wasted.

The law itself has been viewed as a tremendous success in many respects. It has given consumers very broad access to dietary supplements, and it has certainly increased the flow of information. This is evidenced by the growth of the dietary supplement industry in the U.S., which is currently running at about 18% to 20% per year, on a current base of about $9 billion. That is remarkable growth for any industry, and it certainly evidences how important this is to consumers.

If I can share a few lessons of what we've learned and what I think it might mean for this committee, the first is that the food-drug dichotomy is largely a fiction. Consumers do not understand the world by our legal and regulatory definitions of “food” and “drug”. They purchase and use products based on benefit, and frankly they don't care what we call it. They frankly disregard what we call it. One of the amusing parts of our law is that certain members of Congress felt that if a disclaimer was put on the label saying, “This product has not been evaluated by the Food and Drug Administration”, this would discourage consumers from using the product. In fact, it had precisely the opposite effect.

As mentioned, people don't want the government interfering in their personal matters of health. Informed consumers usually make good choices. There is a fundamental question of how a democracy should operate, whether the government should make decisions on behalf of people in a paternalistic sense, or whether you provide them with the tools to make their own choices, letting the consequences follow from that.

To me, a very crucial issue here is the notion of risk-benefit assessment. In my judgment, that equation is built on two premises: first, that benefits are a matter of personal choice and decision—that's not a government decision, that is a personal decision; and second, that risk is a collaborative decision that involves government, industry, and private consumers. When you combine these two, in my judgment, it speaks to err on the side of granting to consumers the right of choice of products and information and evaluating risk in accordance with the basic principle of letting people make a judgment of what they believe is beneficial for them.

Further, the role of government is not to superimpose its judgment of what is beneficial. That is something consumers have to take responsibility for, and that is where the flow of information becomes particularly important. To that extent, it's very important that the Health Protection Branch or Health Canada have the required expertise to basically know if the industry is cheating or not. That is something we have learned: that prior to DSHEA, the Food and Drug Administration simply did not know enough about herbal products to know whether something was alfalfa or heroin, to use a gross example. The FDA has now gained a great deal of expertise, has invested heavily, and has hosted a number of conferences and symposia, privately and publicly, to educate themselves as well as the industry.

It's also a basic premise in my mind that the industry itself, that which is selling herbal products and dietary supplements, has a fundamental responsibility to sell safe products that are properly labelled and manufactured to good manufacturing standards. Part of this is born out of a sense that all products of nature are not benign. I'm aware that this is a controversial issue in many people's minds, but I believe a distinction should be made between chamomile and morphine. They should be treated differently, and have to be. The question is, where on this continuum do you draw those lines?

• 1110

That seems to be a continuing theme before this committee. There are those who advocate the absolute freedom of choice and that there should be no government regulation whatsoever, and there are those who feel the government should take largely full responsibility to decide what should be made available to consumers.

A number of proposals have been presented before this committee. I'm persuaded that one of the most useful models is a continuum of relative risk. That bears in mind this whole notion of risk and benefit. If we move away from this distinction of food and drugs, we can get down to the heart of the matter, which is: what really are these things?

Coffee is sold as a food and largely consumed as a drug. Its intended use is as a stimulant. Prune juice would be the same. We really do live in a false world if we choose to regulate both as foods when in fact we really know that each of them is being used for something different.

All societies make these value judgments. We allow the sale of tobacco and alcohol products because these are cultural choices we have made.

Whatever Canada does with respect to the further regulation of these products, I urge you to do several things.

One is to look at the models that have been developed elsewhere in the world. I'm in the midst of a four-continent trip, and I'm dealing with governments on this very issue. I can tell you that you're not the only ones having a hard time figuring out what to do here, if that's any consolation.

Reference has been made to Germany and the Commission E system. That works very well in Germany, but that's a very different culture from that of Canada or the United States.

Reference has been made to Australia, which has an excellent program that works well there, particularly with respect to good manufacturing practice inspection. I urge you to look at that. They do a very good job of that.

In the U.S., of course, we have DSHEA. That works well for Americans. We have a different sense of personal rights and freedoms.

I think you would be advised to take the best of each of these systems and then build something that would really work well for Canadians, because you have your own culture. This is also a very multicultural country, and you have to recognize that a number of subcultures and populations, if you will, have long and very well-developed traditions of using herbal products.

I personally believe it's inappropriate for the government to superimpose its own set of values on peoples who have used these plants for hundreds or thousands of years. They know what they're doing; they really don't need the government's help. That has been my experience worldwide.

I am delighted to be here and would be very happy and willing to provide any further advice or help. A great deal of information has been generated in the U.S. since the passage of DSHEA. I think the presidential commission report would be a very valuable resource for you because it gives guidance on many of these same issues you're struggling with.

We have also, as an industry, written a set of good manufacturing practices for dietary supplements. We recognize that there are differences between vitamins, minerals, and herbal products, how they should be manufactured, and in the issues that surround those things. The United States Food Advisory Committee, which is an adjunct of the Food and Drug Administration, has commissioned several subcommittees that will now begin to evaluate consumer perceptions of how and why they use supplements.

We'll also look further at good manufacturing practices and the question of post-marketing surveillance. One of the issues that continues to be troublesome is: do we really know what happens when people use these products? Is there a way to capture data and information that tell us if there are bad things happening that we don't know about? What do we do about that if that is the case?

Let me conclude by saying that I personally believe, based on my own experience, that the Congress was right that dietary supplements can be used and are being used safely by millions of consumers worldwide everyday. There is really not a need for government to step in and overregulate, but it's important and appropriate to assess the relative risk of these products and to step in and make judgments where people simply cannot make those judgments on their own.

So I believe, with all of the evidence before you and that will be presented, there is an opportunity for Canada to create what could well be perhaps the most well-conceived and well-designed system for the regulation of supplements. But I suspect that will require a fairly fundamental change of current law and policy to do that.

That will be controversial. It will be an interesting ride, but I think it's one worth taking, because the use of natural products, herbs in particular, isn't a fad, in my judgment; it's a trend that's here to stay. Millions of people believe that these are very important in their personal health.

• 1115

The acute-care system that we call modern medicine works well in certain instances, but it is unresponsive to the needs of those people who have concerns about long-term health care.

We frankly know too much. We have genetic histories we can now look to, and we have some sense of what we are very likely to suffer from as we age.

This is where self-care becomes important. Herbals and natural products are a very important part of that. With that, I will end. Thank you very much for the chance to appear before you.

The Chair: Thank you very much. I'm sure you'll have a lot of questions in a few minutes.

From the International Development Research Centre, we have Mr. Forget. Maybe you could give us a little idea before you start of who pays for you to exist and what you do, etc. This is politically speaking, so we know who you are.

[Translation]

Mr. Gilles Forget (Program Manager, International Development Research Centre): Thank you, Madam Chair.

[English]

The International Development Research Centre, IDRC, is a public corporation that was created by the Parliament of Canada to assist researchers and communities in the developing world to find solutions to their social, economic, and environmental problems. IDRC aims to connect people, institutions, and ideas to ensure the results of the research it supports are shared equitably among all partners, north and south.

[Translation]

IDRC recognizes the importance of medicinal plants and herbal medicines to the social and ecological well-being of the developing world, and has been supporting research in this complex area since 1974. Currently, under the Sustainable Use of Biodiversity Program Initiative, IDRC has developed a comprehensive and multidisciplinary programme of support to herbal medicine research.

[English]

In this context, I would like to outline three issues that are critical to IDRC's program of support to herbal medicine research that have direct implications for our southern research partners.

First, there are ethical considerations of safety and efficacy, which are critical to the use of herbal medicines.

Second, there's a need for strategies to conserve and sustainably manage the biodiverse resources that supply the herbal medicine market.

Third, we need equitable benefit-sharing practices between industry and local communities that recognize the contribution of local and indigenous knowledge and practices in the development of herbal medicines.

First then, it is well known that medicinal plants provide accessible and culturally relevant sources of primary health care to a majority of the world's human population. Marginalized people, who are unable to financially or logistically access formal health systems, are especially dependent on herbal medicines.

Also, southern governments that find it difficult to meet the costs of pharmaceutical-based health care are increasingly interested in the value and efficacy of medicinal plants and local health systems as a means of meeting current and future health care needs.

Unfortunately, people sometimes use an herbal remedy without adequate knowledge of its potential harmful effects, or they may have false information regarding its curative properties. IDRC has prioritized critical ethical concerns regarding safety and efficacy and is supporting research activities that scientifically validate that specific preparations and usages of herbal medicines are not harmful and do not falsely proclaim health benefits.

[Translation]

One IDRC supported project which has been particularly successful in applying this approach is TRAMIL. Traditional Medicine for the Islands is a multi-disciplinary research network based in the Caribbean which promotes the popular use of medicinal plants through applied scientific research.

Through standardized laboratory testing and extensive literature analysis, the TRAMIL network scientifically reviews the medicinal, curative and toxic properties of an herbal remedy based on specific local preparation and use. The Network only recommends those plant-based remedies which are proven to be non-toxic and biochemically effective to treat a specific health condition. Significantly, these treatments are for common ailments, and do not attempt to treat life-threatening conditions such as AIDS, diabetes, malaria or cancer.

Dissemination and application of research results at the community and the national level are key aspects of the TRAMIL programme. TRAMIL's research results have been incorporated into Cuban and Nicaraguan national Primary Health Care strategies, and to the educational curriculum of the Faculty of Medicine and Nursing of the National Autonomous University of Honduras.

• 1120

In the context of Africa, more support is needed for local researchers to conduct studies on traditional formulations and applications, and to publish the results in order to provide relevant regulatory boards with accurate information for their consideration of integrating locally developed remedies in national health care strategies.

[English]

The second point of concern is the need for the conservation and sustainable use of these biodiverse resources. Many species and local populations of medicinal plants are threatened with extinction through habitat loss and non-sustainable harvesting. The rising global demand for plant-based remedies has intensified the urgent need for conservation policy and action at local, national, and international levels.

However, increasing volumes of plants used in the development of herbal medicinal products are traded through both illegal and sanctioned channels from the south to supply European and North American markets, in addition to meeting local demands. The resulting environmental degradation from this uncontrolled and unsustainable harvesting is enormous, particularly as wild sources are believed to have a higher level of potency than cultivated species.

Moreover, due to the increasing difficulty in obtaining some of these plants, adulterated and spurious materials are entering the market, resulting in potential contamination, toxicity, and a lower quality of developed products.

IDRC supports research to develop community-based strategies for the sustainable management of these biodiverse resources, including locally relevant in situ conservation methods.

IDRC's medicinal and aromatic plants program in Asia, MAPPA, has actively supported research to address these concerns, which are especially pertinent in the context of south Asia. Similarly, policies in northern countries, including Canada, that regulate the trade and use of medicinal plants or herbal medicines, may have direct impacts on local-level production and the livelihoods of small-scale producers in the south, and these need to be examined taking this into account.

Finally, I would like to highlight the need to promote equitable benefit-sharing practices. Many herbal remedies are based within, or derived from, the knowledge, innovations, and practices of local and indigenous communities. However, these communities, which often have poor economic conditions, derive few or none of the economic benefits from the development and trade of herbal medicine products.

Industry and consumers need to recognize the role of local and indigenous knowledge in the development of herbal medicines and of local people's right to defend against or share in any attempt to patent the constituents of their traditional remedies or varieties of plants.

This recognition includes fair and equitable sharing practices in which material and non-material benefits that are derived from the development of herbal medicines are shared between industry and communities. National and international policies regulating herbal medicines should actively support the development of ethical and equitable commercial development.

IDRC supports research to develop alternative working models for equitable benefit-sharing practices and other mechanisms that support local communities to maintain, evaluate, and continue to develop the knowledge of herbal medicines.

In conclusion, I would like to emphasize to the committee that decisions taken regarding the development and regulation of herbal medicines in Canada may not only have impacts in Canada, but may also directly affect people in the south.

I hope the committee will take into consideration these three issues I have discussed today: critical ethical concerns regarding safety and efficacy and the contribution of the scientific validation of local preparations and usages of herbal medicine to primary health care strategies; the impacts of the commercialization and trade of herbal medicines on local people's access and use of biodiverse resources; and the need to promote equitable benefit-sharing practices between industry and local communities that recognize local people's contributions to the development of herbal medicines.

My colleagues, Chusa Ginés, who is the team leader for the sustainable use of biodiversity program initiative at IDRC, and Roger Finan, who is our regional director for our regional office in South Asia, will be happy to answer questions, as I will. Thank you.

The Chair: Thank you very much.

Mr. Elley.

Mr. Reed Elley: Thank you very much, Madam Chair.

Thank you again, all of you, for coming and sharing with us this morning as we continue our look at this very important subject.

I am particularly interested in your testimony to us, Mr. Israelson. As someone coming from outside the Canadian experience, sometimes you have the unique capability to be more objective than we are in the midst of all the emotion this kind of subject generates.

• 1125

I'm very interested in some of the comments you've made about how the American government has tackled this issue. I have some questions I would like to ask you about that.

Around this table we've had a lot of debate about whether there needs to be a third category. I would like to have your comments on whether you think there is a need for this in any kind of legislation we finally arrive at here in this country.

Another question is this. As a result of DSHEA having been passed, has there been any significant cost to the consumer when they purchase herbal remedies now, and have any restrictions occurred that would make it more difficult; or does it make it easier to purchase these products?

The third question is how does DSHEA in a practical sense incorporate the culturally diverse systems that are common to both our countries, such as Chinese medicine, East Indian medicine, American indigenous aboriginal medicine; those kinds of things?

Those are three questions for you to start things off.

Mr. Lorne Israelson: About a third category, I've debated this myself. Under DSHEA, dietary supplements are not a distinct category. They are a subset of the food category. So in the U.S. we still have only two, foods and drugs. There's a common misconception that dietary supplements are a separate third class. That is not the case.

Mr. Reed Elley: You're all right with this?

Mr. Lorne Israelson: DSHEA was such a fundamental change of law. So much more went along with it than just that it created a new subset of foods that it almost became a third category. In fact, for practical enforcement purposes it really is a third category, because different standards of safety, claim structures, and information flow apply, and they are different from those for conventional foods. In that respect, realistically, we do have a third category. But from a legislative, legal standpoint we still have only two.

That said, dietary supplements were granted separate recognition in section 201 of the Federal Food, Drug, and Cosmetic Act, which formally recognizes them as a defined class. That's where people are confused and believe it became a third class.

I guess my judgment is that you don't have to have a third category to make this work, but I do believe you have to recognize them and somehow approach them with a distinctive set of rules and understandings. That could be done through a third category or it could be done through a continuum, I believe, where you essentially dismantle the current structure altogether and rebuild it. There have been several presentations here on how you could do that. You would assess things based on relative risk and benefit. Essentially that would lead you to three classes, I believe.

I would like it. I personally am attracted to that notion of having separate categories.

On the second question, the costs to consumers have gone down, as best I can judge, partly because there is a higher degree of open-market competition. That would normally drive prices down, and that is indeed the case. It's very easy to purchase supplements. They are broadly available. Certainly sales in the larger mass market type of outlets have increased substantially.

Mr. Reed Elley: Could I ask you a supplement on that particular point? You say costs to the consumer have gone down. Why has this occurred? You say increased competition. What has gone on in the industry since this law was passed to make that possible?

Mr. Lorne Israelson: Two or three practical, commercial things have happened. One is simply volume or scale. As you purchase more, you purchase better, at a cheaper price. As you produce more, the cost of production goes down. These savings are passed on to consumers. In a highly competitive market inevitably that's what will happen. More companies are competing for the same customer, so you have to offer something better, newer, or cheaper; and cheaper is certainly one of the attractive features to consumers.

• 1130

The second thing is that the costs of distribution have gone down as it has moved into broader mass market channels of trade. The margins that normally have been charged through the health food sector are relatively high because it's a smaller volume of the market. Those numbers have gone down, so let's say a product that sold for $10 in a health food store can now be sold for $6 in a mass market venue.

That's a significant issue within our own industry, but there's concern about the well-being and survival of the health food retailers, as they've traditionally been known. But the fact is the prices have gone down, in my judgment. They've settled down to where I think they're going to stay. There was one step down and I think we're probably fairly close to where it will remain now.

Mr. Reed Elley: So I take it you haven't found any restrictions on the consumer from the passage of this law.

Mr. Lorne Israelson: No. It has opened it up.

Mr. Reed Elley: It has opened it up dramatically.

The last question was about integrating the different kinds of systems of medicine.

Mr. Lorne Israelson: We have struggled with that. There are those who would like to see a formal recognition of traditional Chinese medicine, for example. Ayurvedic medicine is not large in the U.S., but it's becoming more popular.

All of these products, no matter what their cultural origin, are now being sold under DSHEA as dietary supplements. So whether it's a traditional Chinese medicine, an ayurvedic preparation or a native American product of some kind, ultimately it ends up as a dietary supplement because that's the only place it can really go.

In the materials I have left with the clerk, there are two or three pieces I think you'll find helpful in that respect. There is some interest in developing an OTC category for traditional medicines.

The Chair: What does that mean?

Mr. Lorne Israelson: It means over the counter. That would be done through a series of monographs. That's more the Commission E monographs approach from Germany. Botanicals are monographed, and if you produce a product in conformance with the monograph, you go straight to market. You don't have to go to the government asking for permission.

There's a lot of interest in some quarters to develop that system so you can make more frank claims about the nature of these products that have been sold for thousands of years in various parts of the world as traditional medicines. We don't know where that's going to go in the U.S. It may go nowhere. It may actually happen.

Mr. Reed Elley: Okay, thank you.

The Chair: Madame Picard.

[Translation]

Ms. Pauline Picard: I am not very familiar with IDRC. Please forgive my ignorance. I would like to know if you come under a governmental international development organization such as CIDA. Or are you an autonomous organization conducting its research in various parts of the world, in countries in Asia, Africa and Central America? Could you first of all answer this question?

Mr. Gilles Forget: IDRC is a Crown corporation that reports directly to Parliament. It is not directly supervised by a department but it uses nevertheless the good offices of the Minister of Foreign Affairs and International Trade as a spokesman. We report directly to Parliament.

Ms. Pauline Picard: You say that the community research you undertake has an impact on national and international strategic objectives. In your area of expertise or knowledge, how do we benefit from your research here in Canada?

Mr. Gilles Forget: IDRC is an organization that funds research. We do not conduct research ourselves. We are a funding agency that allows Third World researchers and institutions to undertake their own research to solve their development problems.

In this sense, Canada, in its foreign policy, targets between 15 and 20 per cent of its foreign aid dollars to essential human needs. A large part of the research that we fund deals directly with these essential human needs.

Ms. Pauline Picard: Are you looking only at the needs of Third World people? If somebody found a plant like aloe that grows in Mexico and which is useful for treating burns, would it be your mandate to disseminate here in Canada the results of research funded by you?

• 1135

I imagine you keep in touch with the laboratories that you finance. What do you do when they find botanicals or medicines that could be beneficial for the health of Canadians and people throughout the world?

Mr. Gilles Forget: Let me answer indirectly. One of the main things we do is to ensure dissemination and publication, even in scientific journals, of the research we fund. It is very high-level research that deserves to be published and we do everything we can to make it happen. We also facilitate dissemination of the results everywhere, including in Canada. Many organizations use IDRC to facilitate this dissemination of results.

Further, regarding botanicals, I cannot give you specific examples although they exist. In several areas funded by IDRC, the research is done in co-operation with Canadian institutions, which facilitates the transmission back to Canada of data or results of research done in the Third World.

Ms. Pauline Picard: Thank you very much.

[English]

Ms. Chusa Ginés (Team Leader, Sustainable Use of Biodiversity, Programs Branch, International Development Research Centre): Especially on this last point Gilles made about the collaboration with Canadians, the benefits work both ways. For instance, if researchers at the University of Ottawa have collaborated with researchers in Mexico to look at the properties of guava to treat diarrhoea, this is of benefit to the commercialization, distribution, and standardization of this herbal remedy in Mexico, where diarrhoea is a very common problem, but this information is also useful for Canada, where guava has now been introduced and people are commonly using it.

Similarly, you may have herd of cat's-claw. Cat's-claw is becoming a very popular remedy and immunostimulant. Again, researchers at the University of Ottawa have looked at the toxicological and biological activity of this compound. This information will be published in a scientific journal very soon and it will allow better information to get to the public about the effects and the safety of this product. This is a product that comes from the south, especially from the Amazonian Andes, but it is being imported now.

So this collaboration is beneficial both ways.

The Chair: Mr. Myers.

Mr. Lynn Myers: Thank you, Madam Chair. I wanted to start with Mr. Israelson.

I was interested in your comments on risk-benefit assessment. I just want to be clear. About the benefit side and about what a drug is claimed to be able to do, you're saying there is no role at all for government. Is that what you're saying?

Mr. Lorne Israelson: No. In my judgment there are clearly substances that require review and approval before they are used by the public. My sense is that it's this middle ground part, that people, when they are making choices about conventional foods, are making value judgments about benefits. They choose certain things and not other things, and for reasons. Whether it's low-fat foods or low-cholesterol foods or more fruit or more grains, something is going on where they are making a value judgment. As you push that continuum to the middle area of botanicals and vitamins and minerals in dosage form, that benefit ratio goes up in the mind of the consumer. They have higher expectations for that. My concern is that the government ought not to impose its sense of benefit on top of the consumer's.

I bring an American perspective. If the consumer wants to buy a 500 milligram or 1,000 milligram tablet of vitamin C, that would be their choice. Governments—this is true in many parts of the world—say they choose to treat that as a drug; for reasons, frankly, I don't understand. There really isn't a safety issue in vitamin C at 500 milligrams or 1,000 milligrams per dose. That's what I would regard as a benefit assessment by the government, saying it chooses to make that more expensive and less available to you for its own reasons and your own judgment is secondary to that.

I don't believe with new drugs or really powerful drugs this free market approach to risk-benefit should be applied. It's too dangerous.

Mr. Lynn Myers: Let me deal with the risk side for a minute. You said there should be a continuum.

Mr. Lorne Israelson: Yes.

• 1140

Mr. Lynn Myers: Who decides the risk with respect to where that's placed on the continuum? Who gets involved in that?

Mr. Lorne Israelson: That's the golden question, of course.

Mr. Lynn Myers: Is there an answer?

Mr. Lorne Israelson: Really, I see it as requiring...ultimately the government has to play a role in this, and the industry has to play a role, as do consumers. DSHEA was kind of a melding of all of that. It was kind of a palace revolt, though, in our case. The government was relegated to a secondary role and industry and consumers were given a more important role in that respect.

This was done in several ways. A basic judgment was made that dietary supplements are generally safe—and that's a really basic judgment—and therefore should be widely available. The risk assessment was quite low. There really isn't much risk in taking most dietary supplements.

But the industry has elected not to sell a number of botanicals simply because they're too dangerous to consumers. That was a deliberate choice by the industry. To preserve its right to continue to sell a lot of things, it agreed not to sell a few things. That was really the industry's initiative.

In Canada, there's a list of botanicals that are regarded as unsafe for sale as foods. In the U.S., some of those things, we would agree, should not be sold as foods. I know there are those who believe all botanicals should largely be available. I personally don't think that's wise, for two reasons. There are a lot of new consumers coming into the use of herbal products and you're asking a lot of them to make value judgments when they just don't know enough.

Mr. Lynn Myers: Just on that point, how do people in the United States find out? Is it just word of mouth or—

Mr. Lorne Israelson: Word of mouth, certainly. There are so many sources of information now. The national media has taken up natural products and herbs as a darling. There was a major program on St. John's wort recently, which got huge national attention.

Mr. Lynn Myers: You also made a comment about bad things happening, but we just don't know what they are or we haven't, I assume, quantified them. Is that in fact—

Mr. Lorne Israelson: I asked the question. That was a rhetorical question that's often asked. The critics of DSHEA and of dietary supplements generally always ask this question. They say that because we don't have a mechanism to capture that data from consumers, there may be bad things going on and we simply don't know about it. I'm not persuaded by that personally, but it's an important question to ask if—

Mr. Lynn Myers: So there is no body of knowledge quantified on this point in the United States. Thank you.

I wanted to ask this very quickly, Mr. Forget. I was really interested in what you were saying about the movement of plants from south to north. Just out of curiosity, is there any movement of plants from north to south?

Mr. Gilles Forget: I'd like to direct this question to my colleague, Chusa.

Ms. Chusa Ginés: Thank you. Yes, obviously. There was a traditional movement, if you like, of plants that were taken by the colonizers in the Americas. And of course there's a long history of movements of plants, including tobacco, coffee and some of these plants, and a lot of the spices.

In actual terms right now there is also some movement. The typical example is Canadian west coast yew, but now the active compound has been synthesized—taxol—so that is how it's being commercialized, if you like. Not so much these plants...but there are other examples. I don't have them right now, but I could provide you with them if you would like.

Mr. Lynn Myers: I would actually like to see a list. I'd be interested.

Mr. Forget, you made a really good point about the knowledge, innovations, and practices of indigenous and local communities. I wondered how you tapped into that. You mentioned the Caribbean pharmacopeia and I suppose that's one example of it. Are there others? How are you formally tapping into that kind of knowledge?

Mr. Gilles Forget: Let me answer your question about the Caribbean one. In this particular case, the whole project is based on meeting families, so what is being garnered here is not so much traditional practitioners' knowledge as it is family knowledge, from mothers or fathers, like what they use when they have a headache or when their child has boils or something like that. That's the kind of information being garnered, which is far more home-based and at the community level.

As for what is being garnered right now from the more traditional knowledge of a community, which might be represented by traditional healers or practitioners, I think, again, that Chusa could answer that much better than I could.

• 1145

Ms. Chusa Ginés: The approach that IDRC has been following has been very concerned with the ethical issues, so most of the research that is being supported deals with some of the common knowledge. Nevertheless, some of that common knowledge can be very new.

For instance, if you're dealing with the Afro-Caribbean populations of Central America, which is what this program, TRAMIL, is basically focusing on, you'll still find that there is quite a range of local endemic plants that are traditionally used for those communities but are not known to the north.

Because these researchers have made it a principle to publish that information, such as through the pharmacopoeia, it can be accessed through the north very easily. So we in the north, in Canada and North America, can have access to new information about new plants that can be used as safe remedies for common ailments.

There is also, of course, some other work, and this happens more commonly in Africa, where the knowledge rests more frequently with shamans and local healers. So this is the way we're working, through local healers associations. The emphasis there is not so much to discover new plants but to improve their practices so that they're safer and more accessible.

I will give you an example that I think is quite illustrative of the importance of that knowledge. You might have heard the name Shaman Pharmaceuticals. It's a well-known—for people living in this area—company in the U.S. whose modus operandi rests on the principle that if you work with these shamans or traditional healers or indigenous peoples of the remote communities that have longstanding practices of using traditional remedies, especially herbal medicines from some medicinal plants, the research you need to be able to discover a new remedy is significantly decreased.

The tradition was that you would normally have to screen 10,000 plants to be able to come up with the one you're looking for. For a specific application—let's say an anti-viral—the position was that you will go as low as 1 in 100 instead of 1 in 10,000 if you are working through this indigenous knowledge.

The reality is, they can go as low as 1 in 6 plants to be able to discover one that has tremendous potential in the application they are seeking, such as an anti-viral. That gives you an estimation of the actual value of that knowledge.

The critical element here is: how do you compensate these local people for that knowledge, for that contribution they have made, either through the community or in some cases individually through the years? This is where we are also supporting some work to try to look at fair and equitable formulas. But also not so much for the actual monetary compensation, which is very difficult to estimate.... Of course there are several agreements that have been signed between, let's say, a pharmaceutical company and an indigenous community, or a country, and so on, and there is a standard percentage that they're being dealt in terms of the distribution of the royalties, and so on. There is a lot of work that needs to be done to see how these agreements work, and of course there is the fairness element of it.

The Chair: Has that given you enough of an answer, Mr. Myers?

Mr. Lynn Myers: Yes, that's very insightful.

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Thank you very much, and I want to thank everyone for appearing before us today.

I want to direct my questions to the IDRC representatives, because I think you've brought a whole new perspective to the committee that we haven't talked about at all. As I read your paper and listen to the comments, my understanding is that if we look at this whole area—because it's growing in terms of a market issue, it's driven by market forces more and more, and it's a lucrative opportunity—we as a committee have to start looking at questions of sustainability, conservation, the harvesting of the actual herbs, the jobs that local people will have or will not have as a result of these market forces, and the benefits and who gets access to the products. It is still part of a pay-as-you-go health care approach.

• 1150

My questions are very broad. I hope I'm getting at the issues, but correct me if I'm not. What can Canada specifically do to live up to paragraph 8(j) of the Convention on Biological Diversity? Is there an international body dealing with these issues in any serious way? Is Canada playing a role in it, or should it be playing a role?

As for my last question, it seems that everything we've heard about at the international level has to do with harmonization of standards to the benefit of these large corporations that want to make the most of this lucrative opportunity, as opposed to applying international standards that are in the best interests of indigenous peoples and our natural environment. Is that the case, and how can we address it?

Mr. Gilles Forget: In relation to the biodiversity convention and what Canada does, I'll ask Chusa to answer. First, though, I'd like to just put a caution that as we deplete the natural biodiversity, as we start overcollecting the wild plants that are used for herbal medicines, we find—and I think we will find this more and more, as well—that practitioners or collectors in the south who prepare these things for export are turning to fillers, are turning to plants from the same family, ones that look the same but do not necessarily contain the active principles we're looking at. This is something that should really concern us in the sense that it could have direct repercussions on the kinds of things that are coming into Canada. This could really be fixed—if I can use that term—if we care to protect the biodiversity and to ensure a sustainable harvesting and production of these things.

I'd like to turn to Chusa on the biodiversity convention.

Ms. Chusa Ginés: Thank you.

I must say that your reading of the situation is excellent. In terms of what Canada can do to live up to paragraph 8(j), Canada is very actively participating in the discussions of the Convention on Biological Diversity. There is a meeting, the COP-4, a conference of the parties taking place in May, at which this article is going to be very prominently discussed.

Through the Department of the Environment, Canada's biodiversity convention office initiated a wide process of internal consultation, especially with indigenous group representatives, to put forward a perspective that is considered rather progressive. As a matter of fact, Canada did negotiate or did lead the introduction of a position of an indigenous focal point person at the biodiversity convention secretariat, which is in Montreal. So I would say that Canada has generally been pretty active in taking this responsibility seriously.

In terms of the international world in dealing with this issue, this has been dealt with obviously under the convention, but also under the WTO because the GATT TRIPS agreement relates to the responsibility of governments to pass regulatory systems for the preparation of plants. These are intellectual property rights systems, and it is paragraph 27(a) that actually deals with either a patent system or appropriate legislation.

IDRC has been very active in supporting multi-stakeholder discussions on the implications of these agreements and the harmonization between the different conventions. I can say we've been pioneers in this, if you want, in terms of supporting these discussions and putting forward policy recommendations, so that in Canada and in other countries policy-makers have a wide range of options and are well-informed about the different pros and cons of each option.

• 1155

In terms of the harmonization of the standard for local companies, this is obviously a very critical issue. Again, it's a question of deciding what we want. In our case, and given our mandate to look at the interests of marginalized communities in the south, the approach we have been following on the research is to ensure that these communities have the right information on the safe and effective use of these plants.

We have to be very concerned that when the major players of the industry get involved in this area, they do not claim intellectual property rights protection over some of these remedies, which will affect the ability of some of these people in the south to have access to those remedies they depend on for primary health care.

So that's a consideration to be taken into account here.

I don't know if that answers your question.

The Chair: We still have two people who have questions.

Mr. Szabo and Mr. Hill.

Mr. Paul Szabo: I will get right to the question.

Obviously, Mr. Israelson, when we're dealing with this issue there are a number of vested interest groups. The debate is really fascinating, and they all have some interesting things.

The U.S. experience obviously is very interesting to Canada. I think it's important for us to understand whether or not there are differences, whether it be governmental attitude or cultural attitude, towards approaching problems like this.

As an example, the U.S. army has a very interesting approach to testing the safety of products, etc. It's a statistical sample, and it's very...but they do that. A more direct example would be the Pinto case, where it's okay to have a car that is sort of dangerous because the cost of blowing up will be less than the cost of making them safe.

Is there a difference between Canada and U.S. attitudes, where the U.S. is prepared to be a little bit more lax in terms of the rigour of checking things? My concern would be that if Canada were to open up the floodgates, as it were, to the number of products that people would want to use, our system wouldn't be well-enough prepared to either check or defend itself and may be thrown into massive rounds of legal disputes and all kinds of other challenges.

Are Canada and the U.S. different enough in terms of fundamental, basic culture that this can't be easily transferred in terms of the approach to alternative medicines?

Mr. Lorne Israelson: I think the cultures of the two countries are very similar. If there are two countries that are similar, it's probably the U.S. and Canada. The big difference, first, is that you're having this type of deliberative process. This did not happen in the States. It was FDA—to use the vernacular—throwing industry down the stairs time after time, refusing to talk about these issues, dictating, telling industry, “This is the way it's going to be. You can't sell this. End of conversation.”

That was despite a number of approaches by industry, and ultimately led to this convulsion of public response that was a legislative solution, not an administrative solution.

I would like to believe that this process suggests a much more thoughtful way of approaching it, recognizing that if you do open up the supplements market to consumers, you will recognize what the cost will be to government, what resources will be required on the part of HPB, in particular, and build up to that, if you will.

That has been FDA's experience; they were overwhelmed by DSHEA. It took them three and a half years to really recover and understand what this law meant and how to begin to deal with it.

In summary, no, I don't think there are significant cultural differences between the peoples of the U.S. and Canada. I think their essential interests are the same in wanting access to these products. The difference I see is how the government is approaching this.

On the U.S. side, it was not a very happy experience for the regulators. Here, despite the controversy one sees in the testimony presented, I think this is a wonderful tool to try to help you realize what you need to do if you're going to open things up.

• 1200

The Chair: Mr. Hill.

Mr. Grant Hill: Mr. Israelson, you mentioned the latest commission on labelling had just presented information to the Congress and to the president. Could you give us a little hint of what that commission suggested? Or do you know?

Mr. Lorne Israelson: Sure. I'm very familiar with the report.

I didn't bring one. I should have brought one with me, but I didn't. I'll see that you get one.

The Chair: You could send one up to the clerk and we'll get it.

Mr. Lorne Israelson: I will do that.

The commission affirmed a number of things. First, there needs to be a continued diligence in ensuring the safety of dietary supplements. That's a platform issue in their mind and it's coupled with the inherent safety of the substance together with how it's manufactured and how it's labelled. These are the three components. It affirmed that if there are products that are simply regarded as unsafe to be sold in any way as a supplement, that decision should be taken and clearly made between government and industry.

It also affirmed that labelling has to be clear and explicit so consumers know what they're doing—I share that view—and that good manufacturing practices are essential. It further affirmed that the FDA should examine this whole area of OTC drug status of certain botanicals and the traditional medicines category. With regard to what our structure-function system now allows us to do, they believe you can put certain types of claims on a label. An example would be that valerian helps promote restful sleep. Clearly in Canada I think it's a drug claim. In the U.S. that's a structure-function claim, which can be put on a dietary supplementary sold as a food. They held that if those claims are made, there has to be adequate substantiation to support that claim. How to collect and manage that substantiation was an issue taken up by the commission. They had some specific ideas of what should be done by companies, since it's an honour system, if you will.

They had some recommendations on assessing consumer attitudes and understanding how and why they used dietary supplements so that expectations can be properly met and realized.

It's an interesting report. Like you, they went through a series of public hearings, and, boy, they heard everything.

Mr. Grant Hill: My final question is in relationship to the size of the FDA and the number of resources that went into this area. You talked about an upheaval. It was almost like someone threw a dynamite blast in there. What has come out now in terms of numbers of regulators, the expertise in FDA in relationship to this area?

Mr. Lorne Israelson: Two things have happened. The FDA is broken down into the food side and the drug side, as most FDAs are. On the food side they created an office of special nutritionals, which was charged with dealing with dietary supplements. They have brought in expertise, people who have a broader knowledge about nutrition and have learned a lot about how the industry operates. They are responsible for receiving and evaluating structure-function notices. That has taken a fair amount of resources. They would say they're terribly understaffed and simply can't keep up the pace with the volume of new data being presented to them.

There really hasn't been a resource increase in terms of total people; it's simply the same people being given more responsibility, and they feel overburdened.

On the drug side there's been a much more significant change, for two reasons. There are approximately 25 new drug applications in FDA as we speak for botanicals, so FDA is having to deal with each of those very substantial applications and review them for new drug approval.

Separately, FDA has committed a lot of resources to understanding the role of botanicals as potential drug products or therapeutic products. I would say they have co-sponsored five conferences over the last two years, and each conference is attended normally by between 50 to 75 FDA staffers. Together it's been organized and managed by FDA itself. It was inconceivable five years ago that FDA would actually organize a meeting to discuss botanicals and future policy.

The reason they're doing all of that is they're shortly going to issue a policy statement on what FDA believes are requirements for industry with respect to submission of data and applications for botanicals as therapeutics. That's an area of interest on a wide range of fronts—not just from the supplement industry, but from all over the world. People now want to come into the U.S. with botanical products that they think have therapeutic value.

• 1205

The question is, what will the FDA do now that it has gained all this new knowledge and the position to do something with it? That will require a lot more resources than what it has done so far. It was not given any additional funding or full-time equivalent staffers to implement DSHEA. It regarded it as a significant burden that it had to handle that within its existing budget.

Mr. Grant Hill: You said there were some naysayers about DSHEA. Generally, I think you said it was acceptable. Who are the people who don't like it, if you can lump them together?

Mr. Lorne Israelson: There's an ideological mindset, if you will. There are people who simply believe supplements generally aren't useful and if you eat a well-balanced diet there is no need to take additional vitamins and minerals. You're wasting your money. There are those who believe botanicals simply have no value in modern society. I think it's very ideological.

The Chair: Thank you very much. I just have a couple of short questions here the researchers would like answered.

Are homeopathic preparations covered under the DSHEA?

Mr. Lorne Israelson: No, they're not. They're regarded as drugs.

The Chair: Okay. Could you explain the distinction between structure-function claims and an OTC drug claim?

Mr. Lorne Israelson: A structure-function claim is designed to explain how a dietary supplement affects a structure or function of the body. It's unusual language. It was modelled after the food law. Everyone accepts that foods affect the structure and function of the body. This is taking that concept one step further and explaining more explicitly how that would be.

To give you a spectrum, you can say milk builds strong bones. Then you can go on to say that saw palmetto helps support prostate health. That would be a typical structure-function claim that very generally describes how this berry would affect the prostate or how valerian would help improve sleep. That's the type of claim that was envisioned. They're not intended to go to symptomology or a therapy per se. They have to stop short of that.

The Chair: That maybe answers the second question. Should both types of claims be assessed in the same fashion?

Mr. Lorne Israelson: What do you mean by both types?

The Chair: I mean the structure-function and the OTC claim.

Mr. Lorne Israelson: They have different end points. OTC claims are designed to deal with symptoms and a certain short-term or medium-term regimen. But again, I have to say I believe this food-drug distinction is a false reality. When you look at the whole spectrum of things, you look at dietary supplements making structure-function claims and OTC drugs making drug claims. It's hard to tell the difference in many respects.

This is why I think consumers frankly don't care. If one thing says “helps promote restful sleep” and the other says “as a night-time sleep aid”, that's the same thing in the minds of most consumers.

The Chair: Okay. Thank you all very much for appearing. Sorry we were a little late starting your session.

The meeting is adjourned to the call of the chair.