Submission on Proposal for a Natural Health Products Bill

Name: Vicki Hyde, Chair
If this submission is made on behalf of an organisation, please name that organisation here: NZ Skeptics Inc.
Please provide a brief description of the organisation if applicable: For the past 25 years, the NZ Skeptics have monitored the claims and use of alternative health products and services to encourage critical thinking regarding such; the assessment of evidence supporting such; and to call for changes in position which reflect the provision of the positive or negative empirical evidence for such.
Address or email: [email protected]
Interest in this topic (for example, consumer of natural health products, health professional, manufacturer of natural health products, etc): Consumer protection issues relating to claims and evidence.

Questions on Proposals for a Natural Health Products Bill

Question 1

Do you support the proposed scope, purpose and principles for natural health product legislation?  If not, what other suggestions do you have?

NZ Skeptics Inc, in general, supports the scope, purpose and principles of the proposed legislation.

We consider it important that this industry has some regulatory oversight to support consumer protection, particularly in the area of claims and proof of efficacy, as well as safety, marketing material and labelling. The use of terms such as “natural” concerns us as it is used to imply benign, which is not a supportable claim.

In addition we are concerned that there appears to be very little in the way of supervisory oversight or quality control in this industry, particularly with regard to imported products. This is potentially of major concern as, on the rare occasion when such checks have been made, product quality has been found to be severely compromised, such as with the Pan Pharmaceuticals scandal in Australia in 2003.

http://www.nzfsa.govt.nz/consumers/food-safety-topics/recalls-and-product-advice/pan-pharmaceuticals/questions-answers.htm

Some “natural health products” have been found to have significant levels of contaminants such as heavy metals, or to contain pharmaceutical products, such as viagra and paracetamol, deliberately introduced to give the product a measurable effect not obtainable from the “natural” products.

See: http://www.medicine.ox.ac.uk/bandolier/band132/b132-6.html

We believe that informed choice for the consumer is critical in this area, as in all areas relating to health. Labelling requirements need to be clearly defined to ensure that the natural health industry does not use archaic, misleading or inappropriate terminology to boost its claims to the detriment of consumer understanding.

Question 2

Do you think the scope proposed for the definition of natural health product is appropriate?

Clearly the definition of “natural health product” will need careful deliberation. This industry has been seen in the past as quick to claim any and all modalities that suit their business. The Ministerial Advisory Committee on Complementary and Alternative Health sacrificed credibility with the definition of its interests as “all such practices and ideas self-defined by their users as preventing or treating illness or promoting health and well-being”. This universal claim was seen as rather self-serving, given that that five of the eight committee members were self-identified CAM practitioners, with business interests in iridology, naturopathy, natural medicines, traditional Chinese medicine, acupuncture, aromatherapy, massage therapy, counselling, sclerology, osteopathy, homeopathy, anthroposophy and culturally defined health sectors.

Such an all-encompassing definition does not help the consumer trying to decide if a recommended practice is safe and effective, and it reflects poorly on the industry as a whole. Two CAM practitioners who were members of the White House Commission on CAM Policy, were honest enough to warn that:

Generic recommendations neither serve the public interest nor protect the public health because they fail to distinguish between approaches, practices and products for which there is some scientific evidence and those that either stretch the realm of logic or are demonstrably unsafe.

“Natural health” should be regarded as a marketing term, not a scientific one. The extension of this business into “synthetic equivalents” gives this industry even more scope for misleading consumers (cf the claims of BZP as providing a “herbal” high).

The claimed health benefit/s should be specific and clearly defined, and noted on the product packaging with reference to publicly available evidential material supporting the claims. There should be consumer redress if such is not achieved.

There must also be a clear distinction made between the products which fall under this legislation and those which can be legitimately termed medicine. We note that the MOH questions and answers section regarding this legislation included “alternative, traditional or complementary medicines”. Co-opting medicine as a marketing term has led already to considerable consumer confusion regarding what products and practices are well supported with good evidence regarding safety and efficacy, and what is not.

We question the assumption that “natural health” thereby implies low-risk as a matter of course. Low-risk requires empirical evidence that such products, their derivatives and their synthetic equivalents are, in fact, low-risk. This information needs to come not only from the manufacturers and the industry but also from independent third-party sources or large meta-analyses for cross-checking outside the vested interests.

The problem of assessing this is well recognised as there exists little in the form of consumer monitoring. Alternative health practitioners have been notorious for not keeping accurate detailed customer records or undertaking follow-up. In addition, many consumers would not necessarily recognise or attribute a side-effect or interaction to a “natural” product, particularly if they are also using conventional medicine.

This has been a cause for concern where herbal supplements have interacted with prescribed medicines; such as where kidney and liver damage has resulted from the overuse of natural products. Black cohosh, for example, has been demonstrated to have, at best, inconclusive evidence for any benefit but definite risk of harm; thus while it may be termed a “natural” product, there is a strong case for it being prohibited for health applications.

The assumption that natural means low-risk has been exacerbated when consumers thereby assume that their use of such products does not need to be disclosed to medical professionals. Surveys have shown very high rates of non-disclosure, and this can be life-threatening due to the sorts of interactions, contaminations and deliberate “spiking” of products noted above.

The inclusion of ingested oral and topically applied products should be accompanied by a requirement that such are cleared as safe for use, as they are likely to pose a higher risk per se than, say, a hair rinse. If we require increased standards of care for cosmetics, then alleged health products should be held to a higher standard with greater testing, accountability and monitoring as a result.

In many instances, international experience and research would be able to provide useful information regarding product safety. For those which do not have any credible evidence, the manufacturer/seller should be required to demonstrate such, with a reasonable lead-in time before being released to the market.

Suitably qualified information resources should be identified as appropriate points from which to source information – a Cochrane collaboration (http://www.cochrane.org/) has much more weight than a “scientific tests proved…” press release from a manufacturer. There are some good quality resources available which assist the evaluation of specific products in the natural health area, such as the Natural Medicines Database (http://www.naturaldatabase.com).

The Australian National Prescribing Service has recently undertaken a review of information resources applicable to this health area, aiming to identify high quality resources for use by Australian health professionals and consumers on the basis of technical quality, content quality and clinical utility.

The NPS has strongly recommended that organisations responsible for providing information to consumers and health professionals ensure they have access to the best quality information resources so identified. While their primary focus was on complementary medicines, this review, or one based on similar grounds, should provide underpinning support for evaluation and use of information resources in the more generic “natural health” market.

http://www.nps.org.au/research_and_evaluation/current_research/complementary_medicines/review_of_info_resources

The NZ Journal of Primary Health Care has a regular column, entitled Charms and Harms, which covers the evidence for efficacy and safety of herbal remedies.

http://www.rnzcgp.org.nz/journal-of-primary-health-care/

For an example, see: http://192.168.100.45/assets/Uploads/JPHC/March2010/

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?

We believe that it is advisable to harmonise as much as possible with other related product approval schemes, given the global scope of the industry and the prevalence of imported products.

The “natural health” industry has a tendency to follow fads, introducing new products and therapies to gain market share and tap into consumer trends. Listing both acceptable and prohibited ingredients may restrict the amount of oversight that can be applied to new materials, unless there are clear avenues for assessment of such. There will need to be monitoring of the introduction of new products and claims so that such lists can be revised.

It will also be important to monitor the use of materials not typically associated with health outcomes, but which are nonetheless used by the industry. New Zealand authorities will need to ensure that regular monitoring is undertaken and databases updated as further research regarding risk and harm – or supportive evidence – is produced.

Colloidal silver, for example, is a metal with no known nutritional needs, well-known detrimental side effects and popular in the natural health market being marketed with therapeutic claims. In 2002, the Australian Therapeutic Goods Administration amended its Therapeutic Goods (Excluded Goods) Order to note this product use.

http://www.tga.gov.au/docs/html/csilver.htm

We are also concerned at the potential for Traditional Chinese Medicine to exploit endangered species, some of which have been introduced into their industry just within the past 50 years, rather than the centuries often attributed in the marketing associated with this approach. This involves not only conservation issues, but also well-publicised animal welfare issues, as with the case of bear bile production.

The actual and potential impact on biodiversity and attention to sustainability should be recognised, and exclusions made for products that are derived from unsustainable sources or endangered plants and animals. This may well be already covered by conservation and biosecurity legislation, but should be borne in mind with regard to the health sector too.

Question 4

Are there any other functions that you consider the advisory committee should have?

The general outline of the administration principles look acceptable.

It will be vital for the Advisory Committee to clearly avoid industry capture; MACCAH was seen to be stacked with vested interests which significantly limited its credibility and capability of making independent decisions. It will be important to have appropriate and independent experts represented on the advisory committee, and/or available to them, to ensure that advice, recommendations and regulatory decisions are solidly based on high quality evidence.

Question 5

Do you agree with the concept of a consultative body and its possible role?

We agree in principle with the concept of a consultative body so long as it is not captured by industry interests and maintains clearly independent representatives from consumer and health areas. That is a danger if it focuses solely on how to manage the implementation of the legislation and administration, rather than including a watching brief on the outcomes.

Question 6

Do you agree with the proposed self-certification scheme for product approval?  If not, what would you like to see instead?

In general we agree with the concept, as it provides advantages in streamlining the process and it recognises when other regulatory schemes have approved the relevant products. It also places the responsibility on the manufacturer for their product safety, quality and record keeping. However, prior experience with this industry, and examples of self-certification in others, indicate the importance of independent oversight with regular monitoring/auditing to ensure compliance.

We believe that supply chain issues need to be addressed as safety and efficacy depends significantly on the quality of raw source materials and how these are handled. This industry has already seen too many contamination and product quality concerns raised in its vaguely self-regulated environment. Product approval, for example, could require the manufacturer to provide information on their suppliers of raw materials; that those raw materials can be certified as being pure/fit for purpose; and what the manufacturer is intending to use in their product. Manufacturers should then be held to that, and this information should be made publicly available. Any documented lapse in product quality or manufacturing should also be publicly available, such in a section on the product approvals database.

We would like to see support for the reporting of adverse reactions extended. At present it can be very difficult to gain such information as there is no obvious body to report to. Consumer attempts to track such information tend to be sporadic and rely on media reports. See http://whatstheharm.net/ for one such initiative.

While the legislation suggests that reporting adverse reactions is the responsibility of the product approval holder, this does create concerns regarding the nature of the response, consumer redress, openness of reporting etc.

An independent reporting system would allow not only the manufacturer/product approval holder to collect and report adverse reactions, but also the consumer and/or other health providers to make reports and provide ready access to that information. This could be incorporated into a broader post-market surveillance scheme to ensure that any risk management approach is substantive. And, again, such information should be publicly accessible.

The product approval holder should be required to do more than simply assert that they hold evidence that their product claims are supported. They should be required to post that evidence so that it can be assessed independently or accessed by the public. We have consistently found over the past 20 years that many in this industry state that they have such evidence, but it is exceptionally rare for them to provide information when asked to do so.

On the rare occasions when they do provide such information, it is usually found to be of very poor quality. We have had one researcher at a Crown Research Institute note that his independent tests were ignored and then later misrepresented by the natural health manufacturer looking for evidence to support their product’s claims.

It would be valuable if the post-market monitoring included blind testing of claims and information provision to see that product approval holders meet their obligations. We would like to see such monitoring include the retail sector, as that is a large area with significant potential for consumer harm, but that may well fall outside the scope of this legislation.

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.

We do not believe that any such exemptions should apply. We have often heard that natural health products should be granted a free run as “they do no harm”, but monitoring of this industry indicates that that is not necessarily the case.

Even in the case where products are, in fact, completely harmless – such as the non-active water or sugar solutions that form the basis of the homoeopathic industry – there remains the potential for harm as such products/therapies can be substituted for evidence-based products/therapies that can actually work. Thus this form of special pleading should not be acceptable.

Question 8

Are there other situations in which it should be permissible to supply natural health products without a product approval?

Only if the product has passed a comparable or more rigorous evidence-based system in a jurisdiction that has been recognised as such, and that the product is exactly the same as the one that has obtained approval under such conditions.

We do not think that supply of products based on long-term use or cultural relevance should be grounds for avoiding product approval, proof of safety and efficacy or other requirements associated with responsible supply of a health-related product.

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.

The Therapeutic Goods Administration in Australia has a list of substances that may be used in listed medicines found at http://www.tga.gov.au/cm/listsubs.pdf

Presumably the advisory body will carefully assess the requirements of other jurisdictions and the basis for their provisions in determining whether additions or deletions should be made to the list. This should also be regularly reviewed to update as further understanding and evidence is obtained.

Question 10

Do you think there should be a list of prohibited ingredients, as well as a list of permitted ingredients?

Clearly where products are known to cause harm or have severe contra-indications for use with commonly prescribed and OTC medicinal products, those should be listed as prohibited. We would also want to see strong support for the prohibition of any products which are derived from endangered or threatened species, whether native to New Zealand or elsewhere. This is a significant concern in the Traditional Chinese Medicine industry, but other areas of “natural” health have been seen to be lacking in this regard.

The question of what is defined as low risk needs to be examined very closely. Length of use or lack of reported adverse effects are not sufficient to support presumption of low risk. Reference to other jurisdictions that have assessed such substances on an evidence-based basis would provide a starting point.

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.

Health Canada bases their allowable claims on Codex Alimentarius and states their principles on their website.

http://www.codexalimentarius.net/download/standards/351/CXG_023e_u.pdf

http://www.inspection.gc.ca/english/fssa/labeti/guide/ch8e.shtml

The Australian Therapeutic Goods Administration (particularly ARGCM Part I & II) has guidelines about levels and kinds of evidence required to support claims.

http://www.tga.gov.au/cm/cm.htm

These could form a reasonable starting point for assessing claims and gaining some international consistency. Clear definitions of what are low-level claims and minor/serious illnesses or diseases would need to be made to ensure that consumers are aware of what is being claimed and the industry knows where the boundaries are.

The evidence to support such claims should be assessed, as should the evidence held by the entity seeking product approval – assertion or merely claiming to hold such evidence is not adequate. Any additional health claims should be carefully examined, with recourse to information provided by well-regarded independent sources, such as the Cochrane Collaboration or igh-quality information resources such as those identied by Australia’s NPS.

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, this is very important. Such audits should be independent and unheralded. There should also be provision for blind audits to test the responsiveness to consumer-raised concerns as well as those from the regulatory body.

In addition to the holding of evidence, such evidence should also be evaluated to see that it meets evidence-based standards in terms of evidential reliability, methodology, applicability etc.

It would be good to see such audits also required at the retail end of the market. We are aware that many products sold by health shops and other outlets have enthusiastic, and often entirely incorrect or misleading, claims made verbally by sales staff. This can be a major factor in product purchase decisions, and cuts across informed consumer consent.

Question 13

Do you agree with the proposed list of labelling requirements?  If not, are there requirements that should/should not be included?

The list of required information on the labels looks as if it would address many of the concerns we have with natural health products in terms of consumer information and protection. We presume that labelling includes product information sheets that accompany these items within the packaging.

We are particularly keen to see the requirement for the name and quantity of active ingredients, and information on the “true nature” of the product. The definition of the latter could prove interesting, but we think that any health-related product should use recognised terminology that has clear and unequivocal meaning, baked up by evidence.

We have been concerned at, for example, the practice of the homeopathic industry in deliberately using archaic terminology in its labelling which disguises the true nature of the materials they use. The industry’s products also cite special homeopathic dilution factors (used to remove all active material from their products) which are not understood by the majority of even highly motivated consumers.

For example, Nux vomica is the archaic term used for an anti-nausea preparation; the ingredient is far more commonly known as strychnine. Presumably this term is not used as consumers would be far more familiar with the highly poisonous nature of the latter and potentially far warier of the product as a result.

In terms of homoeopathic dilution factors, a term such as 10x is used, with most consumers taking this to mean “ten times” something or other (typically assuming it refers to the ingredient noted on the label). However, 10x is a special homoeopathic term referring to a dilution factor of 0.0000000001; the more common larger dilution factors used in this industry result in the products not actually having any active ingredient in it. This lack of clarity is highly misleading.

Consumer consent issues are clear, as 94% of New Zealanders using homoeopathic products are not aware that homeopathy dilutes the initial material until none of it is left. Instead they believe that they are paying for concentrated medicinal products. Labelling which clearly spells this out would help to prevent such misunderstanding.

http://www.pharmacytoday.co.nz/news-details?objId=16F087C0-1C0C-4DAC-96FE-68CD1BC93D51

Product information sheets within commonly available homeopathic products skirt carefully around the lack of active ingredients. We would want to see both labelling and information sheets amended to make it clear that there are no active ingredients in these products, as recently admitted by the NZ Council of Homeopaths.

http://maryglaisyer.com/2010/01/press-release-mass-overdose/

Other health products in different sectors have similar issues with regard to clarity of labelling and the claimed basis for the efficacy of the products. It may be possible to establish a panel of health professionals (both conventional and alternative) and consumer interests to test label and advertising material to gauge the nature of the information and to provide guidelines on how to prepare and provide suitable material.

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?

It is disappointing to note that this question appears to be have pre-answered by fiat, as the MOH questions and answers section on this legislation states unequivocally that:

… the scheme will not apply to products “tailor made” by a practitioner to meet the needs of specific patients who have sought advice from that practitioner (whether or not the practitioner receives a fee from the patient).

We do not believe that any appeal to special practice, whether “tailor-made”, “universal energies” or “traditional cultural practice”, should be permitted in this area. This is special pleading and we see no reason why it should be permitted an exemption. A health product is a health product and should have to meet the same standards, regardless of how it is marketed.

No exemptions from labelling requirements should be made in general. All consumers accessing health services should have access to full information about what is prescribed to them; what is in the product; how much of it is in there; and what effects or side-effects may occur while using a product, whether an alleged natural health product or one produced by the large conventional pharmaceutical establishment. That forms the foundation of informed consent.

There is a reasonable argument for requiring any labelling for tailor-made products to be made more rigorous, as such practices can see significant variations in the use and amount of active ingredients, which could have serious ramifications on safety and efficacy. Given the difficulty of tracking such products and resulting product quality, such information should be even more detailed than mass-manufactured materials.

Question 15

Are there other situations where a labelling exemption should apply?

No. For consumer protection and informed consent, labelling should be clear and unequivocal regarding product contents, claims, possible contra-indications or side effects.

Question 16

Do you agree with the proposed minimum requirements for advertisements?  Is there any other information that should be included?

This section seems fairly light in terms of required information, and it would be important to see more concrete proposals.

It would be useful to define what a “balanced representation of the risks and benefits” is expected to include. In the media, we are aware that “balance” for broadcast purposes can be a 10-second soundbite in a 10-minute story touting a dodgy product/service in what is little less than an unpaid advertorial.

What redress would be made regarding concerns relating to balance? Does the term “misleading” presume intent? (See the comments re our concerns relating to the practices of the homoeopathic industry above. If 94% of industry consumers are not aware of the basic fundamental principle underlying homoeopathic beliefs, then it is clear that they are not being fully informed; one can argue that they are being actively misled by deliberately vague descriptions and omissions of fact.)

We have not seen a clear indication of where product information sheets, whether contained within the product packaging or on a display stand, sit within these proposals – labelling or advertising? Does the positioning make a difference? There is the clear intent in this particular material to imitate the legitimate product information sheets contained within medicinal products, so we would argue that they should be held to the higher standards proposed for the labelling requirements, rather than the more relaxed set proposed for advertising purposes.

In addition to cautions to “always read the label”, we would like to see an additional term encouraging people to seek medical assistance if their condition does not improve or if they think they are having side-effects. Although minimal, this could assist monitoring of adverse effects and provide a little more consumer protection in the advisory.

The Advertising Standards Authority has codes for therapeutic products; presumably natural health products making therapeutic claims should be required to follow such codes as a minimum:

http://www.asa.co.nz/code_therapeutic_products.php, weight management – http://www.asa.co.nz/code_weight.php

http://www.asa.co.nz/code_therapeutic_services.php

Any claims made should be valid and be able to be substantiated by the advertiser. They should be required to provide such information on request and in a timely fashion.

We are aware that advertising claims are easy to make but take considerable time and effort to challenge. There are a number of complaints currently lodged with the ASA by one industry analyst who has recently written 30 extensive reports based on the unsupported claims made by over 500 health-related websites. Previous efforts have been successful in both New Zealand and Australia in terms of rulings against the companies concerned, but this requires a large amount of time and money to support.

Question 17

What information should be required to be provided in radio and television advertisements?

The same minimum requirements should apply no matter where the advertising is taking place — the information should be factual and provide enough information for an informed decision by the consumer. This could be in a shortened form, to allow for time limitations.

There must be a clear separation between advertising/advertorial and genuine news material. This is particularly so in the area of celeb/personality endorsements, as we are aware that many alternative products and services are touted on air in chat shows, talkback etc with very little to no attempt at balance or informed discussion.

Question 18

Are there any other types of advertising for which different requirements should be set?

There should be no area that see a reduction in requirements and responsibilities. It would be good to see product manufacturers strongly encouraged to provide publicly accessible documentation of the evidence supporting their claims on their websites, with links to independent third-party research.

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?

Products which are well supported with good documentable evidence of their safety and efficacy relating to health and therapeutic claims should have their export potential boosted by this environment. What is recognised as acceptable for the New Zealand consumer should be acceptable to all, if based on such grounds.

Requirements for and costs of export certification and/or meeting the standards of the country to which products are exported should certainly fall upon the exporter, as with other exporters.

Question 20

How would having to obtain product approvals for different markets affect your willingness or ability to export?

This question clearly relates most to those with a vested interest in ensuring that product approvals are not rigorous.

We are well aware that any attempts to provide any form of regulation, oversight or consumer protection in this industry have been met in the past with very loud dissent, primarily focusing on the principles of consumer rights and freedom of choice. The industry is a large one, with highly vocal supporters, who attempt to position themselves as the underdog fighting against the large conventional pharmaceutical establishment. The common claim is that they will lose their livelihood if asked to be more responsible for their products and their sector.

We expect that these proposals will be greeted with similar complaints, and have already received emails indicating the development of an orchestrated campaign against any attempt at regulation.

Would we expect a small producer of children’s nightwear to say they can’t afford to test flammability of their products? We should not accept equally specious – and potentially dangerous – special pleading from this sector.

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?

A code of practice is a good idea, but it will require independent oversight and organised monitoring to ensure that more than just lip service is paid to it. We support the idea of annual audits and spot checks to ensure compliance.

Given the highly variable nature of products sourced from overseas, supplier certification should be supported, so long as this is backed up by the certifying body providing suitable audit trails and/or checks of the supplier on a regular basis. Ideally there should be spot checks of product quality, particularly given the concerns raised regarding contaminants and additional active materials, which may not necessarily be picked up by a local user/retailer.

We would like to see manufacturers required to undergo reapplication on a regular basis, rather than simply having a license revoked in the case of non-compliance. In this case, reapplication could take into account the results of audits and be required on a longer time-frame such as every five years following the initial approval.

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?

Staff should be qualified for the work done at the plant.

There should be adequate storage of raw materials for production.

The manufacturing plant should be designed to be clean and protect from cross-contamination from other product lines through to packaging/labelling.

Equipment should be appropriate for the task of preparing the final product (mixing/tableting etc) and a quality control system should be in place to ensure consistency in the end product.

Products need to be stored under appropriate conditions so they don’t deteriorate on storage.

Written records need to be kept and should be retained past the expiry of batches; this should include quality testing records to ensure consistency in batches.

There should also be records kept of any adverse events or quality issues and any subsequent recalls.

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.

This is aimed at the industry, so not relevant to our concerns. We would expect that a set levy would allow manufacturers to factor that into costs, particularly for the smaller companies involved in the industry.

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?

In principle such charges should be a part of their business planning. This is not membership of a club, where such reductions may be appropriate, but an important part of the industry in which they operate. That said, the industry will try to position itself as the underdog being penalised by big fees, so, if operationally prudent, a scale of fees may be appropriate to answer this likely complaint.

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?

Not relevant to us. A reasonable charge should go some way to funding necessary oversight operations.

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?

Not relevant to us.

Question 27

Should there be a cap on the number of new ingredient assessments undertaken each year?

Yes. These should be managed to allow the regulator to do the assessments in a thorough and systematic manner. This would also make costs of administration more quantifiable.

Question 28

Do you agree with the range of tools suggested for inclusion in the compliance and sanctions tool box?

They seem reasonable and would allow the regulator to respond appropriately depending on the triggering incident. This will, of course, be predicated on an adequate level of monitoring and auditing to ensure that the industry is compliant.

We would also like to see provision for public notification of non-complaint companies and products, and additional information relating to product safety and efficacy. This could most readily be addressed by notification of such actions on the advisory body website, in much the same manner as the BSA provides access to its complaints process and decisions.

Given the health focus of this area, timely responses and decisions would be very important.

Question 29

Do you think the legislation should include other types of offences?  Please specify.

At this stage, the legislation looks reasonable.

Question 30

Do you have any specific suggestions about how to manage appeals and dispute resolution?

It will be important that any review committee is seen to be balanced and reasonably independent. While industry representatives have a role to play, it is also important that independent, suitably qualified assessors are also involved.

We have been concerned in the past when, for example, we were told that the Health and Disability Commissioner will ask alternative health practitioners if a complaint made about their modality is in line with their own beliefs or not, rather than providing any independent assessment of whether the modality itself meets recognised standards for health treatment. This approach has been a surprise to many, including those making complaints who feel that this does not provide adequate redress or consumer protection.

If the legislation provides clear guidelines as to acceptable practices and requirements, then this problem may not arise, but the industry and the advisory body needs to accept independent oversight to maintain credibility.

Question 31

Do you think the proposed transition periods for product approvals and manufacturing standards would be adequate to give suppliers and manufacturers time to achieve compliance with the legislation?

Provided enough time is taken to get the regulatory agency set up and compliance requirements clear prior to the transition period commencing.

Question 32

Are there any other aspects of the proposed regulatory scheme for which transitional measures would be needed?  Please specify.

Not at this point.