In 2018, a dietary supplement for arthritis caused a nationwide scare after it was linked to serious liver damage. Well over 28 cases of liver harm relating to Arthrem were reported but it took a further 2½ years to get the company to withdraw it from the market.
This is a classic example of just how inadequate our regulations are with regard to natural health products. At the time, Medsafe was hamstrung because dietary supplements are not covered by the 1981 Medicines Act (largely based upon the British 1968 Medicines Act), but came under the equally outdated 1985 Dietary Supplement Regulations, which have much lower controls.
This type of thing would not happen under the Therapeutic Products Act (TPA) passed last year with a three-year phase-in period, which aimed to address the many failings relating to natural health products, including this one. Of course, the TPA is much more than natural health products legislation but it is this section that was in the sights of New Zealand First, which had succeeded in stymieing such legislation a number of times previously.
The coalition deal signed with National late last year listed repealing the legislation as a condition for NZ First, and this was also backed by Act. The reason? There are claims by some industry players that New Zealand consumers will lose access to thousands of natural health products once regulations take effect, and that increased costs to the industry would put companies out of business.
These claims, however, have never been substantiated and are unfounded. Before the TPA was passed into law last July, its wording was changed to exempt rongoā Māori practitioners and small-scale natural health products manufacturers from its requirements. In fact, much of the opposition comes from importers of overseas brands as the act would require these companies to change their packaging to comply with new regulations. This, however, is a small price to pay to improve product safety, traceability and accountability.
So what were the advantages /disadvantages of the TPA for consumers? Natural health products are gaining popularity for minor and serious illnesses and medical conditions, so the stakes for the end user can be high. Ensuring products sold are true to label, have been properly manufactured, are free from intentional or unintentional contaminants and adulterants, and that claims made are reasonable and evidence-based are fundamental needs.
The TPA’s pending repeal will mean manufacturers are unable to make therapeutic claims or even state the intended uses on labels (unlike competing American and Australian brands). This is confusing for consumers faced with a dizzying array of products in pharmacies, health food shops and supermarkets that seem to promise everything or nothing. It also gives imported products an unfair advantage over local products. Further tilting this non-level playing field, our outdated regulations are an impediment to local companies trying to export.
The TPA was the third attempt by successive governments since 2011 to regulate these products, yet each time, it seems a minority of industry and political interests have succeeded in derailing such efforts. How repealing this act will be good for the country is a mystery.
The challenge now to politicians who campaigned to repeal it is how will they ensure we don’t repeat the debacles of synthetic “party pills” (falsely sometimes called “herbal highs”) that were sold in dairies to schoolchildren from 2000 to 2007, or further serious safety concerns, such as Arthrem. The inadequacies and failures of New Zealand’s current regulations for natural health products are an embarrassment and a public health concern, plus a constraint on increasing the industry’s exports. l
Phil Rasmussen is a registered pharmacist and medical herbalist and was the founder of a NZ natural health product company.
