To: Natural Health Products, Ministry of Health
Subject: MY SUBMISSION ON THE CONSULTATION ON THE NATURAL HEALTH BILL
I refer to the Ministry's consultation paper The Regulation of Natural Health Products.
I do not intend to address the detailed questions because the regime is fundamentally flawed.
I oppose the Natural Health Product Bill and request that it be removed from the Order Paper.
My reasons for opposing the Bill include:
The Bill is a loopy law and nanny-state legislation
- The Bill is a loopy law (refer Rules Reduction Taskforce) and nanny-state legislation that imposes significant and unjustified new compliance costs on (what government accepts is) a very low-risk industry. The current regime regulates natural health products as foods. The Bill, however, takes a pharmaceutical-type approach to natural health products that is disproportionate to the de minimis risks they pose. The effect of the Bill will be to force consumers to buy online from companies such Amazon and Iherb rather than buy products in New Zealand.
The Bill is not light-handed regulation
- It is claimed that the Bill is light-handed regulation. However, for the reasons set out in this submission it is the opposite.
The Bill creates a new regulator with wide and arbitrary powers
- The Bill creates a new regulator with wide and arbitrary powers. For example, this regulator has to approve every ingredient that is included in a natural health product, including (bizarrely) even water and simple additives and flavourings. Unless a product is notified to the regulator (at a proposed annual cost of $195.50 per product) and contains only pre-approved ingredients it can't be sold. This is overly prescriptive and completely unnecessary
- The new regulator has to also approve the illnesses and ailments for which health benefit claims can be made. Even if good evidence exists to support the health benefit claim it can't be made unless the regulator says so. This restriction is not necessary because the provisions contained in the Fair Trading Act 1986 against misleading claims provide sufficient protection to consumers.
The Bill imposes significant new compliance costs on the industry
- The cost of getting a new ingredient approved on the permitted substance list is likely to be comparable to the cost of getting a substance listed in Australia (because the criteria appear similar). In Australia the cost to prepare an application for a new substance is approximately $40,000. These are principally the various consultants' costs to obtain and prepare the necessary supporting information, including literature searches and toxicological reports. If there is no toxicological data available, it could cost up to a further $150,000 to obtain that data. This cost could apply to an everyday food item that has a long history of safe use.
- As well as the cost of obtaining approvals for new substances and new illnesses/ailments, there are numerous additional new compliance costs including: the cost of notifying each product to the regulator, the cost of providing information on a website about any health benefit claims made about a product, the cost of obtaining a license to manufacture natural health products, and the cost to comply with the Code of Manufacturing Practice.
The Bill is likely to stifle exports
- The Bill is being justified on the grounds that it will dramatically increase exports. However, New Zealand already has a healthy and competitive export market under the current regime and there is no credible evidence as to how exports will be facilitated under the Bill. To the contrary the Bill is more likely to stifle exports. All exporters will have to comply with the proposed Bill and only products containing permitted substances (that have also been notified) will be able to be exported. As a result New Zealand will lose its enviable reputation of being able to provide products with ingredients that other countries want. And at the same time we will lose our competitiveness because of high compliance costs.
- An exporter has to manufacture and comply with the overseas country's rules. New Zealand's rules are irrelevant. Any claim that exports will be increased under the Bill appears loopy.
The Bill restricts health benefit claims
- Another claimed justification for the Bill is that it will permit health benefit claims to be made. However, health benefit claims (eg, Form and Function claims) can be made already, including arguably claims about certain illnesses and ailments. It is not apparent how the Bill makes it easier to make claims or improves the status quo. But there are many ways that the Bill makes health benefit claims more difficult. For example:
- The Bill requires information about all health benefit claims to be available on an internet site. This is a new obligation and is likely to be onerous.
- The Bill does not permit therapeutic claims and under the Bill it appears it would not be possible for natural health products to be approved as a related product under the Medicines Act 1981 as they currently can be.
The Bill is a solution looking for a problem
- There is no evident problem with the current regime that requires these draconian measures.
The solution is a regime based on a blacklist of ingredients
- An alternative and viable regime is one administered by the Ministry of Primary Industries that is based on a blacklist of ingredients only. Ingredients genuinely proved to be unsafe would be banned rather than all ingredients banned until they are proven to be safe. There is no need for the industry to pay to include everyday foods and ingredients like blueberries and water on a permitted substances list.
The Bill needs to be removed from the Order Paper
- This Bill offers no demonstrable benefits to industry and consumers but only imposes additional costs, bureaucracy and intervention. The Bill needs to be removed from the Order Paper for the good of the industry (particularly the small to medium enterprises) and consumers.