It has once again urged the New Zealand government to adopt the health claims that the Australian and Canadian authorities have introduced for their supplement industries – one which regulate supplements as therapeutic goods.
The industry body was responding to an announcement by the government that NHPs will not be regulated as therapeutic products and can only make health benefit claims.
The NHPs will be regulated under a new bill known as the Therapeutic Products Bill.
Examples of NHPs include garlic capsules, glucosamine capsules, magnesium tablets, herbal products such as echinacea, and herbal teas.
“NHPs are a broad group of products intended to support health and wellbeing, that are not medicines or foods,” the NZ Ministry of Health said in the announcement.
The bill, meant to differentiate between NHPs, medicines, foods and cosmetics, will replace the existing Medicines Act that has been running since 1981.
Under the Medicines Act, natural health products are not able to make therapeutic claims since they are not categorised as medicines.
Dietary supplements such as vitamin and mineral tablets, on the other hand, are regulated under the Dietary Supplements Regulations 1985. Under this regulation, dietary supplements cannot have a stated or implied therapeutic purpose – meaning those that are associated with preventing, monitoring, or alleviating a disease.
The drafting of the new bill has been closely watched by the local NHPs industry, with the hope that the regulatory reforms will allow NHPs to make therapeutic health claims.
Responding to queries from NutraIngredients-Asia, Samantha Gray, Natural Health Products NZ’s government affairs director has expressed disappointment with the new announcement by the government.
“The Ministry of Health's clinical health benefit claims don’t go far enough to enable all of the therapeutic claims that other regulatory other country's regulatory authorities do, such as Health Canada and Australia’s TGA (Therapeutic Goods Administration),” Gray said.
“It would likely mean that for example, for joint products, claims around symptomatic relief and reducing inflammation etc may not be permitted.
“We don’t have the details from the government, and we have asked for clarity," she said.
She is concerned that some of the claims that might not be permitted include 'helps reduce occurrence of muscle cramp', 'helps reduce occurrence of muscle tension/stiffness', 'helps reduce occurrence of medically diagnosed cystitis', 'anti-inflammatory/relieve inflammation' etc.
Gray said that NHPNZ has been urging the government to adopt the health claims permitted in Australia and Canada.
“We have been urging the government to enable all the claims that the regulatory authorities in Australia and Canada have made and we don’t understand why they wouldn’t want to do this, because otherwise, its going to restrict consumers’ ability to find out all the information about the products that they are buying.
“It is also more difficult to compete internationally,” she explained.
Responding to queries from NutraIngredients-Asia, New Zealand's Ministry of Health says that it is still working on the definition of health benefit claims.
"We are still working on our definition of a health benefit claim for natural health products and how it will differ to therapeutic claims. Part of this includes consulting with other jurisdictions on the claims that are able to be made and how they are substantiated.
"We want to deliver a robust regulatory regime for natural health products that provides for acceptable safety and quality of products while also providing for a range of claims that are substantiated by scientific and/or traditional evidence. We are designing the regulatory regime for natural health products to ensure there is a clear distinction between natural health products and medicines," a spokesperson from the ministry said.
The new Bill is set to be introduced to the Parliament before the end of the year.
It will then undergo public consultation and further consideration as part of the parliamentary process before enactment, said the spokesperson.
Overseas regulations
In Australia, nutraceuticals are regulated as complementary medicines by the Therapeutic Goods Administration (TGA).
The products can make therapeutic indications without evaluation by the TGA; however, the indications must be supported by scientific evidence and the information must be made available to the TGA upon request.
In Canada, NHPs are defined as probiotics, herbal remedies, vitamins and minerals, homeopathic medicines, traditional medicines, and products such as amino acids and essential fatty acids.
The NHPs can make preventative health claims for diseases or conditions listed in schedule A.
Under the schedule A, health claims can be made for products meant for 1) minor disease 2) major disease or 3) serious disease.
For instance, a product for a major disease can claim that it helps to reduce/prevent macular degeneration. A product for serious conditions can claim to treat depressive disorders, prevent diabetic neuropathy, and treat diabetes.
