New Zealand First have introduced a new Food (Health Supplements) Amendment Bill, to update the regulation of health supplements.
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.
Why do we need new legislation?
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.
What does the bill do?
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.
What products will this bill cover?
'Health supplements' includes any ingestible natural health product, such as vitamins, minerals, herbal medicines and traditional medicines.
What kinds of health claims can be made?
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”).
What evidence is required to make a health claim?
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.
Who must comply with the requirements for notifiable health claims?
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.
What manufacturing standards are required?
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.
Will the regulator have to approve every ingredient?
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.
Will the bill affect traditional practitioners?
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.
Are there any benefits for exporters?
Updated legislation will help to develop New Zealand’s reputation as a source of high quality health supplements that are true-to-label.
Who is behind the bill?
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.
What is a member's bill?
Check out this video explanation from Parliament on how the member's bill process works.
Where can I find a copy of the bill?
The Bill is available for review here.
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