FOOD (HEALTH SUPPLEMENTS) AMENDMENT BILL.
We advocate for updated regulation of health supplements to support research and innovation, and to give consumers informed freedom of choice.
We believe strongly in the power of health supplements when used appropriately, however the current law prevents suppliers of health supplements from telling you about how their products can help you. We consider that people should have access to this information to allow them to be proactive in their health, and to take preventative measures against disease.
NZWA wants consumers to be able to make fast, smart choices in decisions that affect their health. To allow informed freedom of choice for consumers, NZWA believes that a law change is required and is working with industry, consumers and politicians to create sensible new legislation around the regulation of health supplements.
New Zealand First has put forward the Food (Health Supplements) Amendment Bill which is a great opportunity for the New Zealand natural health industry to work with Parliament to create a regulatory framework that is risk-proportionate and that allows consumers to make informed choices about the products they buy for their health.
Key features of New Zealand First's proposed model:
— Suppliers will be able to make some evidence-backed health claims.
— Suppliers will need to disclose the level of evidence to support a health claim, based on a 10-level reliability scale.
— The regulator will be able to undertake spot-checks for quality-assurance purposes.
— Suppliers will be able to share honest client testimonials.
— Suppliers will be able to include links to studies and research on their websites.
What the proposed model will do:
Updating the legislation will create positive change, making a real impact to the health of New Zealanders. The new model will achieve this by:
— Giving consumers informed freedom of choice in decisions affecting their health.
— Creating fair opportunity for New Zealand suppliers in an online market.
— Incentivising research and innovation.
— Ensuring greater accountability for accurate labelling of products.
PREVIOUSLY PROPOSED LEGISLATION.
With the help of our supporters, we managed to get the deeply flawed Natural Health and Supplementary Products Bill removed from the Parliamentary Order Paper. Thank you to everyone that signed the petition or donated.
The Natural Health and Supplementary Products Bill imposed high compliance costs that would have been very difficult for small businesses to meet, with the costs outweighing the benefits. It also imposed large barriers to entry, which was not supportive of New Zealand’s culture of innovation.
The removal of this bill eased pressure on access to natural health products and provided an opportunity for sensible regulation to take its place.
There have been a number of questions around the new bill, so we have set out answers below to some of the frequently asked questions.
Under current legislation, suppliers are severely restricted in what they can say about products, even when there is good quality research to support their claims. This presents a huge challenge for local suppliers competing in an online market, where offshore suppliers on sites like iHerb and Amazon are widely making these restricted claims. It also limits New Zealand consumers from receiving information from New Zealand suppliers that would help them in making their decisions of what products to buy for their health.
It creates a system for allowing for some evidence-backed therapeutic health claims to be made about health supplements (‘notifiable health claims’). All of these notifiable health claims need to be notified to the regulator and supporting evidence must he held. When notifiable health claims are used on a health supplement, the claim will need to clearly show the level of evidence available to support that health claim (based on a 10-level reliability scale).
It also updates the manufacturing and labelling requirements for health supplements.
'Health supplements' includes any ingestible natural health product, such as vitamins, minerals, herbal medicines and traditional medicines.
The current system continues, so that if you are making non-therapeutic claims about your product (i.e., claims to support and maintain normal function), then you are able to continue making those claims without any notification to the regulator required.
However, any claim that relates to the 'modification, restoration, or correction of physiological function' needs to be notified to the regulator prior to use and evidence to support that claim must be held. Such claims could include things like ‘[x] helps to restore hormonal balance’.
Any health claims that are currently able to be made for food under the Food Standards Code, will also be able to be made for health supplements (e.g. “Diets high in calcium and vitamin D may reduce the risk of osteoporosis”).
When making a notifiable health claim, the supplier must state the level of evidence available to support that health claim, based on a 10-level reliability scale. This scale ranges from a meta-analysis of all relevant randomized controlled trials at the most reliable end of the scale, through to traditional evidence, through to expert opinion and common public opinion at the least reliable end of the scale.
This approach gives consumers a clearer picture of the evidence available to support a claim, to help them make informed decisions in buying products for their health.
The 'responsible supplier' is the person that must comply with the requirements for notification of health claims. This is the first person that supplies the health supplement in its final-form packaging in New Zealand. For products manufactured overseas, the responsible supplier will be the importer.
A downstream supplier is able to rely on the responsible supplier's notified claims (in terms of the claim being substantiated) or they may make different claims, that must be notified to the regulator and that supplier is responsible for holding the evidence to support that new claim.
The bill takes a risk-proportionate approach to manufacturing standards, with the National Programme 3 applying to manufacturers generally and it anticipates that a bespoke Food Control Plan will be required for higher risk manufacturing. Of course, manufacturers are always able to voluntarily get certified for GMP for the domestic market or for export purposes.
Ingredients will be regulated under a disallowance system, rather than an approval system. This means that all ingredients that are currently allowed, will continue to be permitted, unless there is good reason for the regulator to prohibit or restrict the usage of a particular ingredient.
The regulator will maintain an online list of prohibited ingredients, and a list of restricted ingredients, with details of those restrictions. An ingredient is only able to be prohibited if the risks of that ingredient are not able to be managed appropriately by imposing restrictions of use.
The bill also updates the limits on levels of ingredients that were included in the Dietary Supplement Regulations, as some of the limits were very low and prevented consumers from receiving any therapeutic benefit of that ingredient, but did not reflect the actual risk of consuming that ingredient.
The bill maintains the status quo with natural health practitioners being exempt from the manufacturing and labelling requirements of the bill in the course of their consultations.
Risk-based manufacturing standards will apply to products that are supplied outside of a practitioner-client relationship.
Updated legislation will help to develop New Zealand’s reputation as a source of high quality health supplements that are true-to-label.
The bill is being driven by people in the natural health industry who are really concerned about how the current regulatory environment disadvantages local suppliers, and New Zealand consumers who are getting a bad deal with the current regulatory regime.
DISCLAIMER: This website and its contents do not constitute legal advice. For advice on your compliance obligations, please engage a legal professional.