Health Committee on May 8th, 2008

[Darren Praznik]

Mr. Chair, if I could address that as well, I would say, very simply, if we're looking for regulatory change.... We live in a world with regulation or a regulatory structure that is 50 years old, so if there's one thing we need, it's a modern regulatory structure that allows the department to do a couple of things. One is to structure its regulations, whether they're for NHPs, or drugs, or cosmetics, or food, what have you, in a way that assesses risk and applies the appropriate level of caution, concern, or oversight to the appropriate level of risk. Their hands are tied today. They're limited in what they can do, because Parliament hasn't empowered them with modern enabling legislation.

The second thing I would suggest is that as the science-based regulators in a world with changing product lines, changing knowledge of risk, they need the ability to adjust those regulations from time to time--with the oversight of cabinet, at the political level--to be able to respond in a timely way to emerging product lines, emerging risk, emerging levels of knowledge. Currently, we all suffer from a regulatory regime that is 50 years out of date because the Parliament of Canada has not dealt with that issue. So if you want a regulatory regime that works, it needs to be modernized to meet the modern world.

[Pierre Haddad]

I would say it's to add to your listing methods, because natural health products cannot be evaluated with the pharmacology model that Dr. Dionne mentioned. I think new tools are necessary, and new approaches need to be considered scientifically.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much. That was a very good question.

Mr. Fletcher.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Thank you, Mr. Chair.

I'd like to thank all of the witnesses for coming. In particular, I'd like to recognize Mr. Praznik, who was a former health minister in Manitoba and did a great public service for our province.

My questions are for Health Canada. After I have asked the questions, I would like to open the floor to comments on Health Canada's answers. You've been warned.

Could you expand on the initiatives and describe how they have sped up the review of licences and reduced the regulatory burden on industry, if that has indeed happened?

Also, I wonder if you could expand on what the standards of evidence for NHPs are and how they reflect the relative risk of the products.

I'd also like to ask about the issue that Mr. Praznik raised—the difference between the container protection between the two products. Why is that, and is it necessary?

[Philip Waddington]

Thank you for those questions. There were three, if I understood, and I'll answer them in the order you delivered them.

The first was whether you could have a little bit more detail on the processes we've been undertaking and what we're doing around that. There are many and they are varied, but I will summarize them.

Regarding the comment we heard earlier about a moving target, while I might have chosen different wording on that, I understand what's happening. It's a new directorate. We've been trying to work with industry to develop things that go forward. As we do that, we've been evolving in our understanding of what's coming in. As well, industry has been evolving in their understanding of what to deliver.

We've now come to a point where we think that moving target has been solidified. We have SOPs--standard operating practices--in place in-house for any application that comes in. What are the details that are required to be there up front? What are the things we can ask for? When would it be considered efficient for us to go out and look for information, and when should we turn to facts? We're much more consistent in the decisions we make, and therefore we spend less time debating whether we should be proceeding down one path or another.

We're also looking to expand what we're talking about as our risk-based approach. So instead of just looking into Canada for the information we can have within our walls, we're looking to other regulatory agencies. We look to Australia, which has a regulatory framework similar to Canada's--not the same, but similar--to see what kinds of decisions they're making and how we incorporate them into the decisions we're making here.

We're looking to groups in places like Singapore where they are regulating traditional Chinese medicine specifically. If we can look to the decisions they're making and incorporate them into Canada, we'll be able to process things much more quickly.

Probably the most significant thing we're doing to decrease the burden on industry is, as I mentioned, putting forward electronic processing. If companies are able to point to data we've collected, which summarizes for them the information that we believe is pertinent, and make an application based on that, then it really reduces the amount of work they will have to put forward. If a company wishes to use a dose beyond what we have collected, or to come up with a claim beyond what we have understood from the literature we've reviewed, they're not prevented from doing so. They would just have to provide additional data in doing so. So it allows for the variation that any applicant would want to have, but at the same time it could speed up the application and decrease the workload for those who wished to follow those routes.

On the second question, regarding standards of evidence, there is what we always refer to as the totality of evidence. We look at everything. We look at clinical trials. We will look at that data when it's presented. We look at meta-analyses in which data is brought in from a number of different trials and summarized together. We look to cohort studies or epidemiological studies that look at how products are used in people but not necessarily with the same randomized crossover consideration that you'd have for a clinical trial. We look at traditional use. We look at animal studies. We look at all of the data to determine whether there are indicators that there may be associated risks and whether there are indicators that the benefits there would outweigh those risks.

People often indicate to us that they believe there is a clinical trial required for every product. Now we do require the submission of data showing that the product is safe in humans, for sure, and that it's effective in humans, for sure. But there is not a clinical trial on every product. We've approved approximately 110 clinical trials over the regulations, and we've approved approximately 7,000 products. So clearly the linking of a product to a trial is not what's going on. We're really looking at the totality of evidence, what's available in the public domain, and what individual evidence a company can gather and bring forward as well.

With respect to the differences in the packaging, the regulations around natural health products are more modern than the regulations around other product categories out there. When we brought in the regulations, we decided there were a number of things we should be looking at. Tamper-evident packaging is something consumers want. If you're buying something, you want to make sure somebody else hasn't been using it.

We applied it across the full range of natural health products. We did not, as has been suggested, exclude one category from another, because there have been situations in which there can be concern around anything that can be tampered with. If it's going to be put on your body or consumed in your body, there can be differences. So we've looked at this, and we may be able to come to conclusions that will work for people. But as we stand right now with the more modern approach to this than the other regulations that apply, we have said that tamper-evident packaging is something that in general, from what we have heard, Canadians would still want.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much.

I'm sorry, that concludes the--

[Darren Praznik]

I can't defend my antiperspirant?

[The Vice-Chair, Liberal, Lui Temelkovski]

I think you've done a great job.

Thank you to all the panellists.

We'll move into the second panel now. We'll take a one-minute break to change the panels.

Thank you.

[The Vice-Chair, Liberal, Lui Temelkovski]

We will start with our second panel.

On the second panel we have the Canadian Health Food Association, Penelope Marrett and Anne Wilkie; Truehope Nutritional Support Ltd., Ian Stewart; the Canadian Coalition for Health Freedom, Trueman Tuck; the Natural Health Products Protection Association, Peter Helgason; and the Canadian Men in Nursing Group, with James D'Astolfo and Branden Shepika. Welcome.

We'll start with Penelope Marrett for five minutes, please. If you have additional information that you may not get through in the five minutes, please do supply it to us. We look forward to receiving more.

Thank you.

[Penelope Marrett, President and Chief Executive Officer, Canadian Health Food Association]

Good day, ladies and gentlemen. Thank you.

The Canadian Health Food Association, or CHFA, is Canada's largest national trade association dedicated to the natural products industry.

CHFA is Canada’s largest national trade association dedicated to the natural health and organic products industry. Our 1,300 members represent the entire supply chain, including growers, manufacturers, retailers, wholesalers, distributors, and importers. Our members are involved in a variety of subsectors, such as vitamin and mineral supplements; herbal products; homeopathics; sports nutrition products; and natural and organic foods, fibres, and health and beauty aids. Natural health products have become increasingly popular as Canadians look for better ways to manage their health. In fact, over 75% of Canadians purchase natural health products. The Canadian NHP industry is currently valued at over $2.5 billion.

I would like to speak immediately today about the challenges our industry currently faces as well as the recommendations we propose as the voice of the natural products industry.

Specifically, our members have serious concerns around the current interpretation and implementation of the natural health products regulations. The 1998 Standing Committee on Health's report, Natural Health Products: A New Vision, laid the groundwork for the creation of a unique framework for natural health products founded on the acknowledgement that natural health products were of low risk and were neither foods nor drugs. The government is to be commended for its timely implementation of some of the 53 recommendations from this report.

In 2004, the natural health products regulations came into force. However, the regulatory requirement to license some 50,000 products and over 800 domestic sites has led to serious disruptions in the marketplace, including decreased product innovation, loss of products, inability to advertise, and consumer confusion. In addition, the current instability of the marketplace is driving business away from Canada and restricting product choice.

The government is to be acknowledged and recognized for providing additional funds to the natural health products directorate--NHPD--in its most recent budget to assist in dealing with this enormous backlog. However, it will be important for these funds to be used in a manner that will enable the backlog of submissions to be reviewed and licensed in the most expeditious manner possible.

The CHFA is very concerned that with the increasing pressure on NHPD to deal with the backlog, an inordinate number of submissions are being rejected due to administrative issues that we believe could be easily solved with direct contact between the directorate and the applicant.

Further, changing and increasingly rigid policy interpretation continues to frustrate applicants and drive businesses away from Canada. As an industry dedicated to the health and well-being of Canadians, we want to ensure that Canadians can continue to rely on safe and effective natural health products. This can only be realized if the directorate has a clear direction on how to move forward, has the support of the department and stakeholders, and is provided with the necessary resources and expertise.

Furthermore, on the issue of the 53 recommendations, despite the implementation of many of these over the past 10 years, there are still many recommendations that our members have identified as being inconsistent with the standing committee's intent in the way they are interpreted and/or applied by the directorate. In CHFA's brief we discuss a number of recommendations that have not been addressed. I will highlight only one, the one that we believe is most critical to our industry.

Specifically, it is important that the government consider creating a separate category for natural health products, which is the very first recommendation in the 1998 health committee's report. Currently, natural health products are considered to be a subset of drugs; this is clearly contradictory to the findings of the Standing Committee on Health, which stated that NHPs are neither food nor drugs.

We believe this legislative classification places an unrealistic burden on an industry that manufactures, imports, distributes, or sells products that are of low risk. If the establishment of a separate category for natural health products is in legislation, we believe the low-risk nature of these products will be appropriately reflected in the implementation and interpretation of the NHP regulations.

Thank you very much.

Merci beaucoup.

[The Vice-Chair, Liberal, Lui Temelkovski]

We'll now move on to Ian Stewart.

[Ian Stewart, Director, Regulatory Affairs, Truehope Nutritional Support Ltd.]

On behalf of Truehope, we express our gratitude for being able to be here today and to be heard.

Truehope Nutritional Support Ltd. is an Alberta-based non-profit organization that provides a unique nutritional supplement and program to Canadians who suffer from bipolar and other mood disorders. Truehope has had a long struggle with Health Canada. Co-founders Anthony Stephan and David Hardy appeared before this committee on May 16, 2005.

Truehope was charged by Health Canada for unlawfully selling a drug without a drug identification number and appeared in 2006 before the Provincial Court of Alberta. The following is an overview of the principal points of the decision of Judge Gerard M. Meagher in awarding Truehope their defence of necessity and due diligence.

Point 1: The evidence presented by Truehope was credible and compelling. When the supplement was removed, violent behaviour, mood swings, and the possibility of suicide quickly returned.

Point 2: The Alberta head of the Canadian Mental Health Association expressed grave concern for the conduct of Health Canada, and there would be suicides if the supplement was prevented from reaching those in need. He testified that he knew of cases and even attended the funeral of one of the people who chose suicide rather than go back to the treatment Health Canada had directed him to do.

Point 3: The court found it reasonable that Truehope participants were in imminent peril or danger without the supplement.

Point 4: Ample evidence was presented to the court that Health Canada was aware of the possible harm to participants, especially evidenced in Health Canada's conduct in setting up a 1-800 crisis line.

Point 5: Truehope was overwhelmingly compelled to disobey the regulation in order to protect the health, safety, and well-being of participants.

Point 6: A double standard existed where Truehope could get no resolution. Yet the Canadian Mental Health Association was successful each time it intervened on behalf of its members.

Point 7: Health Canada's response to the public outcry was to encourage psychiatric treatment with medications that had negative side effects.

Point 8: Truehope was under a duty to provide the supplement as described in sections 216 and 217 of the Criminal Code of Canada, where complying with regulations is no defence to charges of criminal negligence.

Point 9: The harm that was sought to be avoided in disobeying the regulations was significant and severe. The harm inflicted in the circumstances of disobeying the regulations was insignificant when compared to the harm avoided. Truehope is granted a defence of necessity.

Point 10: It was evident that Truehope took all reasonable care to comply with the law in the circumstances and is awarded a defence of due diligence.

Point 11: While not the clearest case of abuse of process, the court found that some of the conduct of Health Canada would influence Truehope's belief that no legal alternative was left to it, and it had to disobey the regulations, although all reasonable care was taken to comply with the law.

I'll bring your attention to just some of the points in these excerpts from the court's decision.

In section 102, near the end of the paragraph:

They [Health Canada] were aware of the letter of March 6, 2003 from the Defendants [Truehope] to Health Canada voicing concerns that denial of the supplement would jeopardize the health of the participants in the program.... The Crown witnesses maintained that they were just taking orders and following the policies and directives of their superiors. The Crown witnesses were unaware of any mechanism to deal with circumstances where an enforcement action could be harmful to health nor did they investigate this matter further. Unfortunately, none of their superiors testified at the trial.

Section 103:

Another example of the conduct of Health Canada that contributed to an abuse of process was that representatives of Health Canada were not forthcoming with the Defendants by failing to tell them that it was not possible for the Defendants to obtain a D.I.N. [drug identification number] for the supplement under the existing drug approval regime, even though this belief was known at different levels of Health Canada. Health Canada had this knowledge as demonstrated in various emails and other dealings with Dr. Kaplan.

In closing, the conclusion by the court was this: the defendants are not guilty of count three in the information; the defendants are entitled to rely upon a defence of necessity and due diligence.

The questions we bring to the committee today are these. In light of the fact that a market authorization has not been granted to Truehope, recognizing their legal and moral duties to continue, what is Truehope to do? Second, can Health Canada and Truehope be summoned to appear before this committee to review and discuss this file and receive this committee's recommendations?

Although Truehope has engaged the new NPN process on all levels, a market authorization has not been granted. Communication has broken down, and Truehope continues to be characterized as non-compliant. Some may say, in reviewing the 2003-2006 struggle, “that was then and this is now”, but Truehope says that what was then continues now, only in a lesser degree.

Based upon the long history of this struggle with Health Canada, Truehope and the thousands of Canadians who rely upon the supplement and program feel vulnerable. If new laws were ever passed that gave sweeping new enforcement and seizure powers to Health Canada, Truehope is concerned that we would become subject to biased and retaliatory actions.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Mr. Stewart.

Now we move on to Trueman Tuck.

[Trueman Tuck, Coordinator, Canadian Coalition for Health Freedom]

Thank you very much.

The last time I appeared here was three years ago, on Bill C-420. I think it's very important that we understand that whether we're talking about what we're not supposed to talk about, Bill C-51 as Bill C-52, or whether we're talking about Bill C-420 and the natural health products regulations, we're talking about a continuous process that I first encountered, as did more than 10,000 small businesses and the million-plus consumers whom I represent....

I think it's very important that we understand that since I started in 1972 on a holistic, spiritual lifestyle choice--I did not believe in medical doctors, did not believe in pharmacists, did not believe in synthetic drugs--I've lived a lifetime. I'm 60 now and I work 14 hours a day, seven days a week. There are a million-plus consumers who worked with our Canadian Coalition for Health Freedom in 1997 to stop the July 1, 1997, attempt to make drugs out of our nutrient-rich foods, food extracts and food concentrates, and our foods that are rich to begin with, the healthy foods.

This whole world is upside down. We want people to be eating healthy foods, we want them to be eating nutrient-dense extracts and concentrates, we want them to be going to naturopaths, chiropractors, herbalists. We don't want big pharma ruling the world; we don't want the natural health products regulations to be forced on us, in complete contradiction to the 1998 study process.

I appeared last before this committee in 1998. If you check our coalition's message then, it was quite simple. We created the largest grassroots uprising in Canadian history, by the admission of the Liberals, and started working with the Liberal government. They did a great job. The 1998 report was one of the most extensive stakeholder consensuses in the history of this country. From a consumer and a micro small business point of view, the natural health products regulations are illegal, outside of authority, were never brought to this committee, and need to be cancelled immediately. The majority of our membership in small business is ignoring them. Increasingly, the large businesses are ignoring them.

Health Canada is a set of federal criminal investigative police officers. Their actual act started in 1884. All that is in federal jurisdiction is to charge people with a crime under the Criminal Code or under the criminal powers of item 27 of section 91 of the BNA Act, if there's a serious adulteration or harm causing serious national death or adverse events. That's all there is.

Eighty per cent of what Health Canada does, including the entire work of the natural health products directorate, is outside of federal jurisdiction. Of any party in this country, the Bloc have been the greatest champion of keeping the feds out of provincial jurisdiction, and I'm surprised they would allow the natural health products regulations and/or Bill C-51 and Bill C-52 to intrude upon exclusive civil property. There are a dozen things it's intruding on.

There won't be time for me to go through our paper, but we've identified in it the 12 reasons that no party and no member should support Bill C-51 or Bill C-52. It ties into getting rid of the natural health products regulations and ties into going back to the standing committee reports and getting this committee to do an update of that wonderful report.

Dr. Grant Hill, whom I worked very closely with, is highly respected. He introduced a private member's bill to create reverse onus to try to get control of Health Canada. Judy and Grant and others who were involved with me at that time, including the Liberals, all knew that Health Canada was out of control. There's no administrative review process for Health Canada, there's no police internal affairs process, and we have documented cases of criminal activities that the RCMP will not investigate, including what was raised here.

We're requesting that this committee reconvene the same type of format as in 1998 to give the victimized small businesses, the victimized consumers who are suffering because of this bureaucratic nonsense that exists illegally in Health Canada.... We would like the opportunity to bring this out into the open again, as was done in 1998.

Thank you very much.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you, Mr. Tuck.

We'll now go to Peter Helgason.

[Peter Helgason, Vice-President, Natural Health Products Protection Association]

I'd like to thank the committee for inviting me here today.

I apologize on behalf of our president, who was unable to attend. He's dealing with a legal matter in Calgary on Friday and was unable to be here. We got a late invitation, and I don't have a written submission because we were unable to get it translated.

The question that was asked is, sort of, why are we here? I'd reiterate very much what the CHFA had to say and much of what Mr. Tuck had to say, which is that about 10 years ago the largest public consultation in parliamentary history was held. A very thick report, called Natural Health Products: A New Vision was published, and synthesized from that report were the 53 recommendations.

The very first recommendation was that there shall be a new third category legislatively created by Parliament, not by regulation. If you go to the Health Canada website or the NHPD website, it will claim that this wasn't done because it was too complex procedurally to amend the act.

I note with interest the legislative history of a recently introduced bill, whose name shall go unmentioned; the process started in 1998. This was prepared by the Library of Parliament, presumably an objective source of information, which coincidently coincides with the publication of the New Vision report. Ten years, three prime ministers, and five ministers of health later, it comes out that the will of this committee, expressed as a policy expression by the Minister of Health's office in 1998, has been completely ignored.

Many of the members here weren't even elected to Parliament at that time, weren't privy to the consultations. I'm sure you could consult with your caucus members who were present for the consultations or have retired. It's pretty clear that what we're dealing with today was not the intent of this committee 10 years ago or the wish of the industry, the consumers, or the practitioners.

We have an opportunity, I believe, to go back to page one--not deal with the problems that have been created over the previous 10 years, but let's go back to page one and ask, where did we go wrong?

I'm deeply gratified to hear that the CHFA and the NHPPA are in complete agreement. I don't think we need to go any further than to look at the first recommendation of the committee from 10 years ago. Let's start fresh.

I thank you for the time.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Mr. Helgason.

Now to James D'Astolfo.

[James D'Astolfo, President and Founder, Canadian Men in Nursing Group]

Thank you to the committee for the opportunity to speak before you.

The Canadian Men in Nursing Group is a national organization that supports men in the nursing profession, educates the public, and is involved in supporting men's health and the health of all Canadians.

I'll be sharing my time today with Mr. Branden Shepika, our organization's chapter director, a nursing student from Sudbury, Ontario.

Nurses play an active role in all aspects of health and well-being of Canadians and in many different health organizations across the country. Because nurses are front-line health professionals, many of them come across patients taking natural health products. For this reason, we feel it is important that nurses should have an important role in all discussions surrounding natural health.

According to Health Canada in a recent survey, approximately 71% of Canadians use some form of natural health products. With this high percentage, it is important that government ensure that Canadians are well protected.

[Branden Shepika, Chapter Director, Canadian Men in Nursing Group]

Our recommendations are the following.

Recommendation 1, ensure that both the general public and health professionals are made aware, through educational programs, of interactions between natural health products and pharmacological drugs.

The public generally considers natural health products to be safe and beneficial. These substances are largely unregulated, and this contributes to the misconception that they are innocuous. Patients don't feel the need to tell their physicians that they are using them, and physicians do not often ask their patients if they are using them. Education in these areas should also help to increase the degree to which the public trusts the information they receive from their health care professionals with regard to natural health products. According to a 2005 study by Health Canada, less than half of Canadians trust information from their health professionals about natural health products.

Recommendation 2, create a reporting system so that front-line health professionals can report adverse reactions to Health Canada directly. Adverse reaction reporting is mandatory for companies that make natural health products. However, serious adverse reactions are generally dealt with by front-line workers such as nurses and doctors. The recommended system should also be mandated, since reporting is necessary to protect the best interests of the public.

Recommendation 3, because natural health products are being sold over the counter with little or no monitoring, both pharmacies and health food stores should be mandated by the government to have qualified health professionals at their disposal. Certain natural health products should be prescribed only by qualified health professionals who have knowledge and training in the area of nutraceuticals. Some natural health products can cause serious adverse effects if not used by individuals who require them or if used by patients who have allergies to the natural health product.

Recommendation 4, since 2004, Health Canada has employed the use of natural health product numbers and homeopathic remedy drug identification numbers to identify products. The public should be educated on how to find these numbers and what they mean. According to a 2005 study conducted by Health Canada, 60% of people do not look for drug identification numbers on homeopathic medicines, and 66% of people do not look for natural health product numbers.

[James D'Astolfo]

Recommendation 5, ongoing research in the area of nutraceuticals is important to ensure that the health of Canadians is protected. Companies should ensure that clinical trials are conducted on their products and that these clinical trials are safe and ethical. It is important that government increase funding in the area of nutraceuticals. Because of the high number of Canadians using well-researched natural health products, it is important that government work with provincial governments to ensure that the industry is reimbursed for health insurance plans and that costs are covered in part or in full.

I would like to thank the committee for their time in allowing our organization to put forth these recommendations on the subject of natural health products. We look forward to answering any questions you may have.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you.

Madam Fry.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Thank you, Mr. Chair, and my thanks to everyone for your submissions.

I think I'm hearing some clear lines coming out of this. One is that there should be a third category. The other is that there needs to be more resources for the health protection branch to be able to look at proper research.

Mr. D'Astolfo, you talked about front-line health care professionals reporting adverse reactions to natural health products. You said this reporting should be mandated. So you also want to make it a requirement for everyone to be asked if they are taking natural health products, because if people don't tell their physicians or their nurses, then no one knows. In the past, when anyone has suggested mandatory adverse drug reporting, the health care professionals have always argued that it would take up too much of their time. How do you see them making that time?

Second, you talked about 60% of consumers not looking for homeopathic drug ID numbers. Are you suggesting, therefore, that Health Canada do a public awareness campaign, or some sort of education campaign, to let people know that they should look for these numbers? Checking the numbers would allow people to know that the product is safe and has met the requirements of Health Canada.

With regard to the category, anyone can answer this who sees fit. If natural health products are neither food nor drug, establishing a separate category would seem a reasonable thing to do. I don't argue with you on that. But if a natural health product generates claims to therapeutic value, it could move out of the natural category and into a drug category. It would then have to be subjected to clinical trials. Do you see this as a possibility?

[Penelope Marrett]

Thank you very much. I'll respond to a couple of things, and then perhaps my colleague can further expand.

We believe it is important right now that there is a separate category for natural health products so that the lens for the interpretation of the regulations is appropriate for low-risk products.

We are also aware that it is possible to make therapeutic claims now within some restrictions of the various schedules, and there has been a demonstrated benefit for natural health products on claims.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Are you saying you shouldn't be required to do clinical trials if you're making major therapeutic claims? That was the question I asked.

[Anne Wilkie, Vice-President, Head of Regulatory Affairs, Canadian Health Food Association]

Clinical trials would be required, depending on the strength of the claim. The understanding with the natural health products regulations is that the level of evidence required is based on the strength of the claim. So if you're making it a structured function that basic calcium helps build strong bones, you can rely on textbooks, for example. If you want to go beyond that and start talking about treatment of cancer, for example, you would most likely need clinical trials. The concern now is that the NHPD is not looking at that broad range of evidence.