The good news and bad news: natural health products legislation

Making a submission to a parliamentary committee proved to be a worthwhile exercise.

When the Natural Health Products Bill was introduced to Parliament in September 2011 with cross-party support it raised alarm among the natural health community. The Health Committee to which the Bill was referred received 870 submissions, of which only a handful supported it or made constructive suggestions to strengthen it. The vast majority were from users or manufacturers expressing varying levels of concern and outrage about the suggestion that natural health products should be under some form of control.

A notable exception was a personal submission from Sir Peter Gluckmanin in which he noted the Bill's title was misleading, drawing on the naturalistic fallacy that what is found in nature is somehow better, and using the word 'health' in a way which carried the presumption of proof of effect, which for many of these products would not exist.

In my own submission I applauded the intent of creating greater control and certainty regarding 'natural health products'. However, there are some features of the Bill that I found unsatisfactory or disturbing.

The hearing was an interesting experience. Sitting in the audience, I certainly did not feel that I was among friends. I had a very fair and attentive hearing from the committee, and they asked several perceptive questions. This meant that I ran over my allotted ten minutes, a fact that was pointed out strongly by a later impassioned opponent of the Bill, when the chairman tried to bring her to a halt.

At the time of writing, the committee has reported back with its conclusions and its proposed amendments to the Bill. As the Bill has cross-party support, it seems likely that it will become law in essentially the form proposed by the committee.

The committee has proposed that the Bill be retitled "Natural Health and Supplementary Products Bill", reflecting "the fact that the range of products dealt with in this bill includes natural and synthetic, and that these products might also be encapsulated, and contain binding agents and other excipients." This of course does not address Sir Peter Gluckman's criticism of the title.

The Bill's main provisions are a Natural Health and Supplementary Products Regulatory Authority, an advisory committee, a database, a product notification process, identification of permitted and prohibited ingredients, a code of practice and licence requirements for manufacture, authority to charge fees, and a regime of offences, sanctions and penalties.

There are three key parts to the Bill which together set the foundation for the remainder. These are:

1: Principles

The Bill as reported back includes the following basic principles:

"(a) that natural health and supplementary products should be fit for human consumption or use:

(b) that the regulation of natural health and supplementary products should be proportionate to the risks associated with their use:

(c) that natural health and supplementary products should be accompanied by information that -

(i) is accurate; and

(ii) tells consumers about any risks, side-effects, or benefits of using the product:

(d) that health benefit claims made for natural health and supplementary products should be supported by scientific or traditional evidence."

It is the last three words here that will no doubt raise eyebrows among skeptics. "Traditional evidence" is defined as "evidence of traditional use of a substance based on knowledge, beliefs, or practices passed down from generation to generation".

2: Definition of Natural Health and Supplementary Product

The main clauses of this definition in the Bill included:

"In this Act, unless the context otherwise requires, a natural health product means a product -

(a) that is intended by the sponsor of the product -

(i) to be administered to a human being; and

(ii) to bring about a health benefit to the person to whom the product is administered;"

(b) that, subject to section 22(2)(b)(i), contains only natural health product ingredients."

My submission on this noted the definition of a natural health product as one intended by the sponsor to bring about a health benefit. The problem I see is that the very people who should be the prime target of the legislation, those who knowingly tout useless medicines, have no intention of providing a health benefit, but only of relieving vulnerable people of hard-earned cash. The clause needs to be amended to clarify that it is a claim to provide a health benefit that is important, not an intention. It would be most unfortunate if a charlatan could escape the severe penalties in this Bill simply by admitting there was never any intention to provide a health benefit.

I also raised the need to ensure that homeopathic substances are captured by the legislation:

"The preamble notes to the Bill state that natural health products include homeopathic remedies. However, I note from Hansard that Sue Kedgely stated that 'low-risk products like homeopathy products will be exempt'. I believe that they must be included. While I agree that they pose a low physical risk, they do pose serious risks in other ways. Homeopathic products are displayed, marketed and often verbally promoted by staff in many pharmacies, providing them with credibility, and encouraging people to rely on them rather than conventional medicine. The website www.whatstheharm.net documents many cases worldwide where people have suffered or died through reliance on homeopathic treatments. The definition of natural health products currently in the Bill may not capture homeopathic products. Homeopathic products are prepared by sequential 1:100 dilution of the original substance, routinely up to 30 iterations (referred to by homeopaths as potencies(. In a press release on 30 January 2010, Mary Glaisyer, media spokesperson for the NZ Council of Homeopaths, admitted that: 'In homeopathic remedies above the 12th potency no molecule of the material substance remains.' (maryglaisyer.com/2010/01/press-release-mass-overdose). Homeopaths claim that, despite this, the water used retains a 'memory' of the original substance. The credibility of this claim is of course highly debatable, but for the purposes of the Bill the simple fact is that homeopathic remedies do not in fact contain the original substances in any material way. This means that homeopathic remedies contain no natural health product ingredients and are therefore not captured by the current definition."

I also raised the issue of deceptive presentation and marketing:

"A feature of the natural healing sector is that products are often presented or marketed in a manner that skirts around the requirements of fair trading and truth in advertising requirements by vague and misleading implications of efficacy. Also, as mentioned above regarding homeopathy, natural health products are widely displayed and marketed in pharmacies without specific or actionable claims of therapeutic properties, but in a manner that in many cases gives a false credibility and a false impression of efficacy."

To address these three issues, I proposed some amendments, including widening the definition of natural health products to include products "prepared by dilution of one or more natural health product ingredients".

The committee's response on homeopathic products is disappointing. In a later section that specifies products that do not require product notification, they have included:

"any natural health and supplementary product in which the active ingredient to be administered is in a concentration not more than 20 parts per million."

The committee has included clauses to clarify that the legislation does not cover food in its ordinary sense, or medicines registered under the Medicines Act.

3: Definition of 'Health Benefit'

The definition of 'health benefit' in the Bill as introduced was:

"(a) the maintenance or promotion of health or wellness: (b) nutritional support: (c) vitamin or mineral supplementation: (d) affecting or maintaining the structure or function of the body: (e) relief of symptoms of any condition that is not a serious condition."

Here is what I had to say about this:

"The definition of 'health benefit' is very puzzling. It includes '(b) nutritional support' and '(c) vitamin or mineral supplementation' as health benefits. These are not health benefits in themselves, but merely possible means to achieve a health benefit. In fact, many medical experts suggest that dietary, vitamin and mineral supplements are unnecessary to good health if a normal balanced diet is consumed.

Also, the inclusion of 'nutritional support' is confusing and contradictory, given that Section 6 specifically excludes food from the ambit of the Bill, and the definition of 'food' in Section 5 specifically mentions 'any ingredient or nutrient' and appears to clearly include dietary supplements. It is hard to conceive how nutritional support can be offered without the use of food.

(d) lists 'affecting or maintaining the structure or function of the body' as a health benefit. This seems ludicrous. If I drink a pint a day of whiskey (a natural product) for a long period, I will certainly affect the structure and function of my liver to the point where I will die."

I had no success with this. The only change proposed is to delete "of any condition that is not a serious condition" from (e).

The net result of this appears to be that vitamins, minerals and supplements will not be required to show evidence of health benefits as they are defined per se as health benefits.

The committee saw a need to clearly distinguish the substances covered by this Bill from food on the one hand and medicines on the other. They used honey as an example to illustrate the point. At one extreme, honey is clearly a food. However if, for example, a type of honey or an extract from it is shown by sufficient evidence to have genuine medicinal properties, it may become necessary to register it as a medicine under the Medicines Act. Between these extremes, there is a plethora of honey and honey products that are used as treatments for various purposes.

This raises the issue of the type of evidence that is acceptable for this 'grey area' category of products. The Bill requires a product's sponsor to hold evidence to support the health benefit claims made for it. Such evidence can be "based on traditional use of a substance or product". Brief consideration demonstrates that this is in fact ridiculous. If we look only in Western culture, we can find many examples of traditional uses that have been discarded in the light of modern knowledge. In my own childhood, the traditional treatment for burns was butter, and traditional treatments for wounds were mercurochrome or pure iodine. These are all now recognised as ineffective and potentially harmful. For this reason I urged that the Bill should specify that the only acceptable evidence for efficacy is double-blinded placebo-controlled scientific research.

"I should note also that alternative health providers frequently provide anecdotal accounts as supposed evidence of efficacy. This is also unacceptable. The body is a self-healing mechanism, so there will always be examples of apparent cures that are in fact not a result of treatment, whether alternative or conventional."

The committee's decision to include traditional evidence is, on first reaction, disappointing. However, the committee was faced with some 99 percent of submissions being opposed to rigid controls, and an attempt to require scientific proof only would not be politically possible. Also, on reflection, if only substances with sufficient scientific evidence of efficacy were to be brought under the ambit of the legislation, we would still be left with thousands of unproven quack remedies outside of its control.

A saving grace is that the nature of the evidence will be required to be disclosed. Also, the limiting of traditional evidence to "knowledge, beliefs, or practices passed down from generation to generation" should at least make life difficult for purveyors of New Age quack remedies such as detox foot patches.

Products prepared by practitioners

The Bill specifies that "any natural health and supplementary product that is made by a practitioner to be administered to a particular person after being requested by or on behalf of that person to use the practitioner's own judgement as to the treatment required", do not require notification.

This seemed illogical. Such products are less likely to be prepared under controlled conditions and less likely to be of proven effectiveness. I had no success with this, and the provision remains in the Bill. This is concerning, as it seems to leave a very wide loophole for backyard practitioners selling direct to customers.

The Authority and the Advisory Committee

The Bill provides for the establishment of a grandly titled Natural Health and Supplementary Products Regulatory Authority. However, the Authority is merely the Director-General of Health. Depending on the individual concerned, this could be a worry for people on either side of the fence.

The Bill as introduced provided for a Natural Health Products Advisory Committee. It is implied that members of this committee will be natural health products practitioners or producers. I commented that this is somewhat akin to having an advisory committee on drug abuse made up of drug producers and sellers. It would seem important that the committee includes people with the scientific and medical skills required to objectively assess the efficacy of products and the accuracy of any claims for their health benefits. I proposed that extending the functions of the Medicines Classification Committee would be a more effective and efficient solution.

The committee has introduced a change requiring "that there is at least one member with experience, expertise, and depth of knowledge in science." This is an improvement, but it would have been much better if the requirement was for specific expertise in medical science.

Conclusion

It is encouraging that there is a political consensus to impose some degree of control on unproven products. My submission focused on some serious anomalies, loopholes and weaknesses, but there is much in the Bill that is positive. We can only hope that if and when problems become apparent, there will be a commitment to make the necessary legislative amendments. Submissions processes inevitably become a numbers game. Faced with an overwhelming majority of submissions opposing control, I believe that the committee is to be commended for holding the line as well as it has. The lesson for skeptics is that we need to join in these processes to help ensure the best possible outcomes.