The Natural Health Products Bill and Regulations Update

September 2016

In this issue:

• Current situation
• Issues raised from the latest consultation
• Timeframes

The Natural Health Products Bill aims to keep consumers safe by making better product information available and improving oversight of production processes.

Under the Bill, products can be accompanied by claims about their health benefits (not currently allowed under the Dietary Supplements Regulations 1985). It is important for people producing or selling products to be clear about whether their product is a medicine or a natural health product. A product is a medicine if it contains prescription medicines.

Current situation

The Natural Health Products Bill is currently waiting for its third (and final) reading in Parliament before it becomes an Act. Once the Act is passed by Parliament, the Government will have the power to refine the detail of the Regulations. The Regulations must always stay within the framework allowed by the Act.

Our role is to think about the detail in the Regulations and gather information about how they will work in practice. For example, the Natural Health Products Bill (Act) would specify that products must be labelled, while the Regulations and guidelines would specify what the label must contain.

We are currently gathering information on the Regulations, Notices and guidelines. Our most recent consultation document from November 2015 entirely focused on the Regulations and Notices that will apply to the Natural Health Products Bill (Act) and we are testing our thinking with industry. There will be plenty of opportunities to fine-tune the details, even after the Bill passes into law.

The Government is committed to ensuring that the Regulations will ultimately help rather than hinder businesses. As is the case with any new regulatory system, there are many different views to consider. The consumer is the main focus, while making it fair, workable and affordable for small and large companies alike.

Issues raised from the latest consultation

The latest consultation raised a number of issues.

Intellectual property: We are confident that the revised system will not require any company to reveal their intellectual property. We are working with industry to resolve any issues.

Exports: We fully support the growth of exports from New Zealand. We believe we can establish a system to allow ingredients in export products to either: be included on the permitted substances list with an export only note; or to be considered in some way that allows exporters to continue current trade and grow trade in new products. This is still being designed and we will discuss it further with industry.  

Herbal extract definition: We are confident we will resolve the proprietary ingredients issues and satisfy consumer, notifier and regulator needs. We are working closely with industry to ensure the new system will regulate natural health products in line with the risk of harm posed by these products. This includes ensuring that regulatory issues related to processed extracts are addressed appropriately. We hope to have a proposal on this out to industry shortly.

Permitted ingredients and labelling: Although the permitted substances list is based on the ingredients permitted by the Australian Therapeutic Goods Administration and Health Canada, anyone can request that other ingredients are added to the list. If the ingredients are generally regarded as safe they will be added to the list of permitted substances.

Labelling requirements have not yet been finalised but we want to make sure that they will meet the needs of consumers while minimising any over-labelling or relabelling required by aligning (where possible) with overseas market requirements.

Synthetic permitted ingredients: We acknowledge that many people are uncomfortable with describing synthetic versions as ‘natural’. Using synthetic versions of natural ingredients is often more cost effective for industry. The Bill allows the use of such ingredients because:

• the body is unable to distinguish the difference between the two
• product testing cannot distinguish between synthetic and natural versions of ingredients.

The proposed approach therefore benefits industry without affecting the health or safety of consumers.

Costs: We acknowledge that the new system is likely to increase some costs to industry. This is usual when new regulations are introduced. For products that are only sold in small volumes, we are considering ways to ensure that these products remain available and viable by reducing costs to industry (and therefore the consumer).

The fees associated with cost recovery will be reviewed within three years to ensure that they are set at the right level.

Timeframes

Here is what to expect over the coming months.

Summary of the consultation document’s submissions: This will be made available to the public on the Ministry’s Natural Health Products webpage and that link will be sent to everyone registered on our contact list.

The Bill’s enactment: This is a political process that is outside our control. The Bill may be passed later in the year, with a commencement date sometime in 2017.

Deadlines after the Bill’s enactment: Once the Bill comes into force and the Regulations have come into effect, then the following deadlines will apply to all natural health products.

• Twelve months to notify on the register.
• Twenty-four months to comply with labelling requirements.
• Thirty-six months to comply with manufacturing requirements.

Permitted Substances List Subcommittee: Minutes will be published on the Ministry’s Natural Health Products webpage and will show progress on additions or changes to the draft Permitted Substances List.

Draft Permitted Substances List: We are preparing an updated draft which we hope to publish soon. We will also publish a list of the substances that have been requested for addition to the Permitted Substances List. This can be used by people to determine whether or not they need to submit a request.

Medicines Classification Committee: We are using existing processes to address concerns about ingredients used in both medicines and natural health products. It has been difficult to schedule meetings dedicated to discussing substances that may be reclassified as natural health products, as the definition of a natural health product is not official until the Bill has passed. However, some changes can be made. Find information on upcoming meetings at www.medsafe.govt.nz under News and Events; this includes agendas and the process for making submissions. The next meeting is in November.

Of interest to industry may be the proposals for betaine to be restricted when used for homocystinuria, and for melatonin to no longer be a prescription medicine (these submissions have been submitted to the Committee by companies). We encourage you to make submissions if you feel a proposal may affect you or your business.

Requirements for products containing active ingredients at less than 20 parts per million: Products that only contain active substances that are present at less than 20 parts per million (ppm) do not need to be notified. Therefore, if your product contains any active substance present at less than 20 ppm and it is not on this list, you do not need to ask for the substance to be included. However, your product cannot contain scheduled medicines, even if they are present below 20 ppm. Under the Medicines Regulations, most substances are not scheduled medicines below 10 ppm, but some substances remain scheduled medicines at lower strengths or at all strengths. To check if your substance is restricted by the Medicines Regulations 1984, please check the legislation at www.legislation.govt.nz (search for Medicines Regulations 1984 and then select Schedule 1).

Feedback from the Ministry

We are committed to taking all views into account. We are listening and will keep you informed on progress on the Bill and the Regulations.

If you have a question or concern

If you have a question or concern please contact: naturalhealthproducts@moh.govt.nz

Remember that if you want to receive our regular communications, register on our contact list at: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/natural-health-and-supplementary-products/subscribe-updates