In April 2009, the National Party and the Green Party announced they'd work together to develop a New Zealand-based regulatory system for natural health products that are sold in New Zealand.
We're not in favour of the proposals as set out in the consultation document. It is our position that the proposals are heavy handed and unnecessary. It seems very likely that the proposed regulation would greatly increase the expense and difficulty of producing natural health products in New Zealand and reduce the range of natural health options available to Kiwi consumers. We don't see the need for excessive regulation of an industry which is having an overwhelmingly positive effect on the health of New Zealanders and doing very little harm.
HealthPost’s answers to the questions posed by the Natural Health Products Bill Consultation Paper, March 2010:
Question 1
Do you support the proposed scope, purpose and principles for natural health product legislation? If not, what other suggestions do you have?
We agree that the level of regulatory control of natural health products should be commensurate with the risks associated with their use. Evidence shows there is minimal risk associated with their use, so there should be minimal control.
Consumers do not need to be ‘supported’ to make informed choices about their use of natural health products. This is nanny state condescension. The internet has made personal research, to whatever depth, easy and affordable.
Our main suggestion would be to accept the status quo, which lets the public take responsibility for their own health maintenance by selecting from a wide range of safe supplements at the best prices i.e. if it ain’t broke don’t fix it. USA has had a fine system for many years along these lines. If a natural product causes problems e.g. Ephedra, it is simply banned. Misleading labeling, advertising etc is covered by existing legislation.
If the above suggestion is not accepted we would suggest the addition of the following Purpose: To foster and encourage an innovative, internationally competitive natural products industry.
Question 2
Do you think the scope proposed for the definition of natural health product is appropriate?
In trying to define natural health products for regulation you are drawing arbitrary distinctions which will, for instance, include most cosmetics which contain functional plant extracts. Similarly having a ‘white’ list of permissible ingredients will inevitably exclude many useful or innovative products whose cost of registration and annual fees cannot be justified by the size of the NZ market.
Question 3
Are there products that would fall outside the definition that you think should be included? Conversely, are there products that fall within the definition that should be excluded?
These questions highlight the arbitrary nature of the lines that are attempted to be being drawn around this industry.
Question 4
Are there any other functions that you consider the advisory committee should have?
This question presupposes that we support the concept of regulation by a ‘small unit within the Ministry of Health’. This ‘small unit’ is likely to be composed of individuals with a background in allopathic rather than naturopathic medicine, with the inherent prejudices and bias this implies. It is suggested they would be advised ‘when appropriate’ by a group of technical experts ‘appointed by the Minister of Health’.
Question 5
Do you agree with the concept of a consultative body and its possible role?
If this legislation goes ahead, yes, but only if the consultative body is made up of experts in the field of natural medicine appointed by the professional natural health practitioner and industry groupings and only if it has the power to instruct (and not just advise) the ‘small unit’ that is proposed to be the regulatory authority.
Question 6
Do you agree with the proposed self-certification scheme for product approval? If not, what would you like to see instead?
We do not agree that it is necessary for each product to go through an ‘approval’ process. We believe the status quo, mirrored in the USA, has been shown over many years to be safe, inexpensive and efficacious. Existing legislation protects consumers from dangerous products and misleading advertising.
Question 7
Should an exemption from product approval apply to any particular types of natural health products (for example, certain homoeopathic preparations or aromatherapy products)? If so, please specify which types of products and indicate why you consider an exemption should apply.
Again this question indicates the arbitrary and artificial nature of the distinctions that are being drawn and the struggles of those from outside the natural health world to describe and delineate it, in an attempt to control it.
Question 8
Are there other situations in which it should be permissible to supply natural health products without a product approval?
All situations, so long as they compile with existing consumer protection legislation.
Question 9
Are there specific lists of substances used in other jurisdictions that you think should become part of New Zealand’s list of permitted ingredients? If so, please specify.
This loaded question presupposes the acceptance of a ‘white’ list of permitted ingredients; it indicates the agenda and prejudices of those who have drawn up this ‘Consultation Paper’ (and whom will presumably make up the ‘small unit’ of regulators). Some issues: it will be impossible for the regulator to stay current with the continuous development of natural product science; safety assessments by the regulator for any new ingredient will make many uneconomic to introduce to our small market; the regulatory incentive will be towards dinosaur companies with dinosaur products.
Question 10
Do you think there should be a list of prohibited ingredients, as well as a list of permitted ingredients?
There should only be a list of prohibited ingredients; this would be manageable, protect the public and incentivise research and innovation.
Question 11
Are there specific claims used in other jurisdictions that you think should become part of New Zealand’s list of allowable claims for natural health products? If so, please specify.
The structure/function claims allowed in USA (if supported by documentation) along with the standard disclaimer, have been show to work well. The Consultation Paper excludes out of hand claims about preventing or treating serious disease (regardless of the evidence) when it is well established that some simple supplements (folic acid, vitamin D) can do just this. The inbuilt assumption that only pharmaceutical products can be effective ‘medicines’ reveals again the background and prejudices of those who have drawn up the Paper, and the potential regulators.
Question 12
Do you believe that the regulator should conduct audits to assess compliance with the requirement that sponsors hold evidence to support natural health product claims?
Yes, provided the regulators are drawn from, and understand, the natural products industry and do not impose requirements from the pharmaceutical/medical industry.
Question 13
Do you agree with the proposed list of labelling requirements? If not, are there requirements that should/should not be included?
We support greater clarity and consistency on supplement labels. We suggest that the natural products industry could be asked to reach a consensus on consistent labelling standards.
Question 14
Do you agree that an exemption from the general labelling requirements should apply to products that are ‘tailor-made’ by a natural health practitioner for supply to an individual? If so, what do you think the labelling requirements for such products should be?
Yes.
Question 15
Are there other situations where a labelling exemption should apply?
Don’t know.
Question 16
Do you agree with the proposed minimum requirements for advertisements? Is there any other information that should be included?
Existing legislation covers misleading advertising. Legislating that the brand, uses, name of advertiser and ‘Always read the label before use’ go on every advertisement would not only disadvantage NZ distributors overseas and waste money on unnecessary policing; it is also insulting to the intelligence of the consumer.
Question 17
What information should be required to be provided in radio and television advertisements?
You do not have to reinvent the world – it is okay at the moment – truly.
Question 18
Are there any other types of advertising for which different requirements should be set?
As above.
Question 19
What impact do you envisage the proposed regulatory scheme will have on the ability or willingness of businesses to export natural health products?
We export thousands of different products to many countries and it would be impossible for us to stay current with their ever changing standards, as proposed. We rely on the importing consumer or company to check their own country’s standards and our website carries a disclaimer to this effect. The proposed rule would make us completely uncompetitive with natural product exporters from Australia, USA and elsewhere.
Question 20
How would having to obtain product approvals for different markets affect your willingness or ability to export?
As above. We have been carefully building our export sales for many years and any internal regulation or approval regime (for our 4000 different products?) would require us to shift at least our export operations offshore to remain competitive. Why would you even be proposing such a thing?
Question 21
Do you agree that a code of practice for the manufacture of natural health products should be developed? If not, what standards do you think should apply?
No. Again this question carries the implicit assumption that there is a problem that will be fixed by more rules. Has there ever been a NZ contamination scare? All you will do is add layers of non productive cost. All NZ manufacturers currently need to comply with the food manufacturing standards and most also with various GMP.
Question 22
What key risk management principles do you think should be included in a code of practice for
the manufacture of natural health products?
As above.
Question 23
Would you prefer the costs of post-market activities to be recovered through an annual
product approval maintenance charge or an annual levy based on company or product turnover? Please give reasons for your preference.
If you go ahead with this unnecessary regime, on product turnover or it would be likely be uneconomic to manufacture small or specialist lines (if they incur a set levy).
Question 24
Should there be an exemption from, or reduction in, the annual charge or levy for small businesses or those supplying low-turnover products? If so, who should qualify and how should ‘low turnover’ be defined?
A percentage of turnover would be fair across the board. Of course it will disadvantage NZ manufacturers and cause export manufacturing to go offshore.
Question 25
What would be the impact on your business if there were to be an annual product approval maintenance charge of $500 or $1,000 or $2,000? What do you consider would be a reasonable charge?
Anything over $500 and our smaller ‘own brand’ lines (approximately 12) would become uncompetitive internationally and would cease to be made. All lines are for sale in NZ and internationally.
Question 26
Do you agree that the costs of completing new ingredient safety assessments should be largely recovered through levies paid by all product approval holders? If not, what cost-recovery mechanism would you prefer?
Perhaps half paid by applicant; half by levies would be fair. The Consultation Paper is already flagging the likelihood of not being able to keep up with new product assessments, with the result that New Zealanders will lag behind in the availability of new ingredients and products. An inevitable consequence of over-regulation.
Question 27
Should there be a cap on the number of new ingredient assessments undertaken each year?
Question 29
Do you think the legislation should include other types of offences? Please specify.
Excessive bureaucracy, punishable by writing by hand the entire NZ Statutes.