Natural health products under the Therapeutic Products Bill

The Therapeutic Products Bill (Bill), introduced late 2022, and currently before the Select Committee, if passed, will regulate how therapeutic products are manufactured, tested, imported, promoted, supplied, and exported. It will replace the current Medicines Act 1981 and the Dietary Supplements Regulations 1985.

Under the Bill, therapeutic products are medicines, medical devices, natural health products, and active pharmaceutical ingredients. Natural health products (NHPs) include vitamin and mineral supplements, herbal remedies, animal extracts, probiotics, enzymes, and essential fatty acids. Due to their lower risk profile, NHPs will be regulated as a separate category to medicines and medical devices and evaluated against different standards.

One of the cited shortcomings of current regulations governing NHPs is that they do not provide an appropriate level of assurance that products imported and supplied in New Zealand are safe or made to the appropriate quality standards. By providing for greater regulation of NHPs, the Bill not only looks to address this concern, but will provide producers of NHPs with the ability to make claims about the substantiated benefits of their products. Key means by which the Bill seeks do this are outlined below.

Market authorisation: Therapeutic products will require a market authorisation before they can be imported into, exported from, or supplied in New Zealand. The market authorisation process for NHPs will require applicants to make a self-assessment declaration to the regulatory authority demonstrating that they meet the specified criteria for authorisation. These criteria will include:

Market authorisation, however, would not be required for low concentration NHPs; these are products in which the concentration of every ingredient in it (other than an additive or formulation aid) is not more than 20 parts per million.

License/permit: A license or permit will also be required to carry out certain controlled activities involving therapeutic products. For NHPs these controlled activities are manufacturing and exporting, and importing low concentration NHPs.

Regulator: The Bill will establish a new therapeutic product regulator (replacing Medsafe), which will be responsible for ensuring the safety, quality and efficacy of regulated products across their lifecycle.

While the Bill will work to ensure that NHPs are safe and that they provide the benefits they claim, others in the industry are concerned that the more stringent compliance and higher cost regime, will stifle the industry, and lead to more expensive and fewer NHPs. However, according to the Hon Andrew Little (Minister of Health when the Bill was introduced), the industry potential of natural healthcare products, which account for $2.3 billion of our GDP, has been “stymied by piecemeal regulatory responsibilities spread across multiple Government entities”.

The Bill is complex and expected to take a few years to fully come into force. If you have interests that may be impacted by this Bill, it is advisable to seek legal advice to help navigate these changes.