Regulation of Dietary Supplements in New Zealand has been a long time coming. The original proposal in the mid 2000’s was a grueling Trans Tasman Scheme, regulated by the now-defunct Australia New Zealand Therapeutic Products Agency (ANZTPA), which was to replace the TGA in Aussie and Medsafe in NZ. This would have ceded control of all therapeutic products to an Australian based joint agency, and saddled New Zealand industry with the heavy-handed regulation which had proven disastrous for the Australian Supplement industry, especially small companies.
ANZTPA met with heavy resistance from industry and the Green Party and in 2011 a bill describing an NZ only scheme had its first reading in parliament. Originally called the ‘Natural Health Products Bill’, it then went to select committee and had its second reading in March 2013, where the name was changed to the more descriptive ‘Natural Health and Supplementary Products Bill’. The major difference between readings appears to be the addition of a ‘whitelist’ of permitted ingredients (you can only use what is on the list) rather than the industry-preferred ‘blacklist’ (you can use anything not on the list) and the ability to make some health claims for certain diseases.
The legislation will be overseen by the newly-formed Natural Health Products Regulatory Authority, which is within the New Zealand Ministry of Health. The period of consultation resulted in over 700 submissions from public and industry, which have been considered, and the bill could feasibly have its third and final reading before our next election. In any case, a change of government likely won’t affect progress as it has cross-party support.
The (very briefly summarised) basics of the bill are:
Manufacturers must adhere to a new code of compliance.
Product notifiers (companies marketing supplements) must register their supplements in an online database and provide scientific evidence of efficacy which must be available online. ‘Traditional use’ evidence may be acceptable. The required period of traditional use will probably be >75 years.
Products must only contain ingredients which appear on the Permitted Ingredient List of over 7000 ingredients. Manufacturers may only use ingredients which can be shown to meet the identity requirements of an approved pharmacopoeia (these are listed in Schedule 2 of the bill for anyone interested).
Product labels and advertising may make health claims pertaining to the oddly named ‘List of Conditions about which Claims can be Made’.
The legislation covers over-the-counter sales and excludes practitioner-made products. It excludes homeopathy and rongoā Māori.
There is a grace period of one year for existing products to be notified, two years for labels to comply and three years for manufacturers to comply.
• Regulation of supplement manufacturers. At the moment there is disparity within the industry, with some manufacturers holding an expensive, audited quality license, and some manufacturing under a City Council hygiene certificate. Beyond basic hygiene, it is self-regulation, and unless you ask, you wouldn’t know what license your supplements were made under, or what product testing has been done. The new code is a GMP system (Good Manufacturing Practices) somewhere closer to pharmaceutical level, but more risk appropriate.
• Fixing up some of the illogicalities of the Dietary Supplement regulations. For example the restriction on B12 dose has been lifted, and Stevia has been added as an accepted sweetener.
• Being able to make some health claims for conditions which are considered suitable for self-treatment. At the moment you can’t make any claims at all for Dietary Supplements and so you see companies ‘massaging words’ to try and imply what their supplements will do. The resulting word cloud can sometimes be less than clear.
• Establishment of an internationally recognised scheme could help the export market.
• Expense. Complying with the new code for manufacturers requires expensive product testing, documentation and audits that are not required now. There is also a yearly cost (expected to be around $200 per product) to maintain a product in the database. There is no way around the fact that most supplements are going to cost more.
• Not all ingredients currently in use are on the permitted ingredient list and some that are there still have overly-restricted doses, for example zinc is restricted to 25 mg a day (however this is an improvement on the current limit of 15 mg) and potassium is limited to 100mg/day. Some ingredients are not on the list, for example Vanadium and Octopamine. The Ministry of Health has said that the list will continue to be revised during the transitional period.
• There is some concern that the mandate to make claims from the list may prevent companies from stating clearly what their product should be taken for, even if there is a strong evidence base. There is also some concern that claims may not be allowed for conditions not suitable for self diagnosis (for example, high blood pressure). There are a number of conditions still being considered by the advisory committee and the list should be revised during transition. There are also some conditions on the list which seem.. somewhat illogical. ‘Acquired deformity of the toes?’… is there a supplement for that??
• As has happened in Australia, innovation may be stifled. If a company sees an exciting new product, it will most likely be a time-consuming process to get it entered into the Permitted Ingredients list. The approval fee is expected to be around $800. Then there is the additional problem that once it’s there, anybody can use it.
What we don’t know yet...
• The bill states that manufacturers may be ’deemed compliant’ if they already operate a registered quality control program, however the Ministry of Health has yet to clarify which programs will be deemed compliant.
• What will happen to very small volume supplement companies that currently manufacture small volumes or sell bulk produced product under their own label? This is common practice in the industry and the costs of registering each item may be prohibitive. The new code of compliance for manufacturers will mean that small product runs become financially unfeasible. There is some indication in the consultation document that there may not be ‘price breaks’ for low volumes, as this would raise costs for everyone else.
• What will happen with food products in controlled dose form? For example, blackcurrant powder. If it’s in a packet it’s a food that you can pack in your registered kitchen, but if you put it in a capsule does it suddenly becomes a ‘natural health or supplementary product’ that needs to be manufactured under a GMP at huge expense?
• Imports. If imported for sale in New Zealand, they will need to be notified, which creates a problem for small volume importers. It is unclear whether there will be an exemption for personal use.
I hope this adequately explains the situation somewhat. Like most things to do with government no one group is going to be completely happy and it’s always a matter of compromise. The bill in its current form can be read on the link below, and the consultation documents are available in the second link on the Ministry of Health site.