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Latest news from the Natural Health Products team
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Keeping the conversation going


It’s great to be in touch with you again and many thanks for the feedback on our new look newsletter.

The Natural Health Products Bill is awaiting its turn to be considered by the Committee of the Whole House and then have its third reading. A timeframe for this has not yet been set. Please note this committee is not a select committee and the public cannot make submissions on the Bill at this time.

I’m pleased to tell you that the summary of submissions on the Natural Health Products Regulations consultation and an update on proprietary ingredients, is due to be published on the Ministry of Health’s website early next month. The submissions will also be published.

In this issue, you can read about the new Permitted Substances List Subcommittee, some clarifications about the Food Act and, in case you missed it, the Medicines Classification Committee will be meeting in July to reconsider substances such as folic acid, iron and iodine as natural health products. You can be involved in this process; read on to find out how.

If there is anything you'd like clarified, please do drop me a line.

Kind regards,
Alison Cossar
Ministry of Health
Email: Naturalhealthproducts@moh.govt.nz

Permitted substances committee established

A team of well-regarded natural health product experts has been put together to give advice to the Ministry of Health on the draft Permitted Substances List.
 

A working group of the Interim Technical Expert Advisory Committee, the new team is called the Permitted Substances List Subcommittee.

Subcommittee members have expertise in herbal, complimentary, general practice and integrated medicine, anthroposophic, ayurvedic and traditional Chinese medicine, research, safety monitoring, native plants, rongoā Māori, nutrition, pharmacognosy, pharmacy, toxicology, homoeopathy, microbiology, the manufacture of natural health products, industry and consumer representation.

The subcommittee held its first meeting in Wellington on 4 May to discuss a work plan and an approach to review the large list of substances being considered. The list of requested substances will be published on the Ministry's Natural Health Products website by the end of the month.

Subcommittee members are Phil Rasmussen (chair), Sandra Clair, John Reeve, Jaine Kirtley, Corene Humphreys, Gerald Tannock, John Brooks, Albert Zhang, Tim Ewer, Shirish Karnik, Donna Kerridge, Ron Geiger, Bridget Seque, Karen Silvers, Joanne Barnes, Rob Shaw, Linda Sinden and Joseph Liava’a. Read the subcommittee member’s profiles 

We would like to clarify a few things...

A recent press release said that health claims are not permitted under the Food Act 2014. 


The Australia New Zealand Food Standards Code has some allowances for health claims to be made, for example, there are about 200 pre-approved health claims permitted in the code. The requirements for health claims for foods are set out in Standard 1.2.7 of the code. A food-like product may be considered a natural health product provided that it meets the requirements of the bill and the relevant provisions for health benefit claims.

The press release also implied that the operating costs for the natural health products regulatory scheme would be similar to the annual budget of Australia's Therapeutic Goods Administration (TGA) of $170 million and that this cost will be borne by New Zealand consumers. This is incorrect.

We’d like to point out that the Australian TGA regulates medicines, medical devices, biologicals, organs and tissues, and conducts testing of therapeutic goods and inspections of facilities. These tasks will not be undertaken by the Natural Health Products Regulatory Authority.

Practitioner clarification
Natural health practitioners can make and use natural health products that contain substances that aren't on the permitted substances list, as they can now. Therefore, there is no change due to the bill.

However, finished products sold to practitioners, and that are given to clients without any intervention from the practitioner, are proposed to be required to be notified; this was part of the consultation. 

Submit on the list of permitted substances

While the formal consultation period for this bill has now closed, there are two components you can still give feedback on.
 

Namely the draft list of permitted substances and the draft list of conditions about which a claim can be made.

Please get in touch with us by emailing naturalhealthproducts@moh.govt.nz
or post your feedback or request to:

Natural Health Products
Ministry of Health
PO Box 5013
Wellington 6145

All feedback or requests relating to the two lists are due by 31 May 2016 at 5pm.

Note: After commencement of the legislation, a formal process will be established for requests to add or change an entry on the draft permitted substances list or conditions list. There will be a fee charged for reviews of these.

Permitted versus unpermitted substance list

The Ministry of Health has been receiving questions about the white list, also known as the permitted substances list.


The bill stipulates that you can only sell products that are on the white list. We have had some queries about why we aren't also creating a black list, or simply just have a black list.

The main reason is that a white list provides certainty. Whatever is on the white list is permitted and there's no ambiguity.

A black list is also often retrospective, eg, we need to wait for people to have adverse reactions before adding a substance to a black list.  

We are aware the white list is incomplete, and continue to seek additions to it. We are keen to have as complete a list as possible.
 

In case you missed it… 7 June deadline

If you would like to give feedback on classification or dosage changes to substances such as folic acid, iodine or iron, you can now submit comments to the Medicines Classifications Committee for consideration at its July extraordinary meeting.


As noted by the Ministry of Health's Regulatory Practice and Analysis Team in the previous newsletter, contrary to claims being made, the Natural Health Products Bill will not ban access to certain substances.

The substances in question are scheduled medicines. Access to these substances is controlled by the Medicines Act and not by the Natural Health Products Bill.

As promised, the Regulatory Practice and Analysis Team has made requests to the committee on behalf of the natural health products sector for some of these substances to be reassessed in the context of their use as natural health products. The substances put forward for consideration are: boron, folic acid, iodine, iron, lithium, natamycin, potassium, selenium, vitamins A and D, and zinc.

For more detail on the proposed changes, have a look at the committee’s agenda.

You can be involved in the process of reconsideration by providing evidence in support, or against, the requested changes to current daily recommended doses and, in some cases, changing a substance from a prescription medicine to an unscheduled medicine. Please fill out the comment template and email it to committees@moh.govt.nz by 7 June.
 
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