Public Consultation On Natural Health Products. A Media Statement from Hon Jonathon Coleman.
Wednesday, March 24th 2010
The Ministry of Health today launched a two-month public consultation period on a proposed regulatory scheme for the fast-growing natural health products industry.
Associate Health Minister Jonathan Coleman said the results of the public consultation process will guide the drafting of a Natural Health Products Bill, which is expected to begin later this year.
“I would like to encourage both consumers and industry representatives to take this opportunity to have their voices heard,” says Dr Coleman.
Under a Memorandum of Understanding signed last year, the Green and National Parties agreed to work together on three shared policy initiatives. One of these initiatives is to develop a regulatory scheme for natural health products that will give the public confidence that such products are safe and true to label.
Green Party Health Spokesperson Sue Kedgley says, "I am delighted that at long last we are developing a stand alone New Zealand based regulatory system for natural health products."
Dr Coleman says the current legislation governing natural health products is outdated, inadequate and quite restrictive.
“A regulated industry will give consumers increased confidence about the safety of products. It is expected that providing assurance about the safety, efficacy and quality of the products will also facilitate the uptake of natural health products within the primary healthcare setting,” he says.
Ms Kedgley added, “A regulatory scheme will help industry increase sales and expand into export markets.”
There are around 450 companies that currently supply some 6,600 natural health products in the New Zealand market. About a third of these companies have a turnover of between $5 million and $20 million, whilst 14 per cent have a turnover of more than $20 million. The rest of the companies have a turnover ranging from $100,000 to $5 million.
The consultation paper on natural health products is now available on the Ministry of Health’s website (www.moh.govt.nz). Submissions on the paper close on 17 May 2010.
Questions and answers from the ministry
1. What are natural health products?
Natural health products encompass products with a history of human use, that are presented in therapeutic dose forms and contain ingredients such as vitamins and minerals, or other substances derived from nature.
Such products are often referred to under a variety of alternative "umbrella" terms, such as nutraceuticals, or alternative, traditional or complementary medicines. They are used mainly for the relief of symptoms of minor, self-limiting conditions and to maintain good health and well-being.
They are presented in a wide variety of dose forms such as tablets, capsules, tinctures, solutions, creams, ointments and drops.
2. How are natural health products currently regulated?
Natural health products in orally administered dose forms (for example, vitamins, minerals, amino acids and herbs sold as tablets, capsules, or in powder and liquid form) are currently sold as dietary supplements under the Dietary Supplements Regulations 1985.
Products intended for application to the skin or hair (such as creams, lotions, gels and shampoos) are regulated by the Environmental Risk Management Authority as cosmetics, provided therapeutic claims are not made about them.
3. What is wrong with the current regulation of natural health products?
Natural health products are currently inadequately regulated, posing potential risks to public health and constraining industry growth.
Many natural health products in oral dose forms are regulated as dietary supplements under the Dietary Supplements Regulations 1985 (which sit under the Food Act 1981). The regulations, which are now outdated, are quite restrictive. For example, therapeutic claims cannot be made, even where there is evidence, and there are restrictions on ingredients based on what was commonly used at the time the regulations were made.
All products used for a therapeutic purpose are regulated as medicines or related products under the Medicines Act 1981. However, obtaining an approval for a natural health product under the Medicines Act is not seen as a viable option as the costs and other regulatory barriers are too high.
There is general agreement that a modern, risk-commensurate regulatory scheme is needed to provide assurance to the public that natural health products are safe, true to claim and true to label, and to support industry growth.
4. Aren’t natural health products safe?
Natural health products are relatively low risk compared with medicines, but they are not without risk to public health. Risks can arise from:
poor quality in manufacture (for example, contamination, incorrect ingredients, incorrect dosage);
distributors making unsubstantiated claims which can lead to consumers taking inappropriate products for their health condition;
inadequate information for consumers to make an informed choice (for example, incorrect instructions or inadequate warnings that a product may not be suitable for certain groups such as pregnant women);
interaction with prescription drugs or with other natural health products.
5. How do we know that natural health products are relatively low risk compared with medicines?
Natural health products will be required to comply with certain criteria (for example, they will be able to contain only ingredients from a list of approved ingredients; they will not be able to contain ingredients from a list of prohibited ingredients; and product sponsors will be required to hold evidence their products are safe and effective). The regulator will undertake random testing as well as respond to any complaints.
6. What will the proposed regulatory scheme cost?
The scheme will be costed once its parameters have been decided. At this stage, it is estimated that it will cost about $1.4 million to set up and $4.25 million each year to run. Most of this would be recovered from the industry through fees.
7. How will it affect rongoā Māori practitioners and other practitioners (such as herbalists and naturopaths) who make products for their patients?
It will not affect these practitioners. The government intends to maintain the status quo position under the Medicines Act 1981. That means 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).
However, if a practitioner decided to manufacture products in commercial quantities for retail sale or distribution to other practitioners, then such products would come under the proposed scheme.
8. Does this mean that the joint scheme with Australia for the regulation of therapeutic products is off the table?
The government is still considering its overall approach to the regulation of therapeutic products. However, it intends to regulate natural health products under a New Zealand-only scheme. If a joint regulatory scheme for the broad range of therapeutic products is agreed with Australia, New Zealand will still separately regulate natural health products on the New Zealand market.
9. Why and how are we conducting a public consultation?
Results of the public consultation will guide the drafting of a Natural Health Products Bill, which is expected to begin later this year. The Natural Health Products Bill will provide the legislative framework for a regulatory scheme for the natural health products industry.
A consultation paper has been disseminated and is available on the Ministry of Health’s website (www.moh.govt.nz). People are encouraged to make written submissions.
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Disclaimer: The health information presented here has been written for the New Zealand health consumer. It is of a general nature and is only intended to provide a summary of the subjects covered. The information is not intended to be comprehensive or to provide medical advice to you. While all care has been taken to ensure the accuracy of the information, no responsibility or liability is accepted, and no person should act in reliance on any statement contained in the information provided. All health ailments should be treated by a qualified health professional.
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