The Natural Health Products Bill (Bill) went through its first reading on 15 September which proposes to set up a new regulatory system for low-risk natural health products in New Zealand. If the Bill is passed in its current form, it will place very stringent requirements on manufacturers, importers and distributors of natural health products. The Bill has been advanced on the basis of its wide-ranging consumer protection benefits. However, others are of the view that existing consumer protection legislation is sufficient and such measures will only place unnecessary burdens on the industry for a class of products which generally has a low risk profile.
Essentially, natural health products encompass products that contain only low-risk natural ingredients such as vitamins and minerals or other substances derived from nature. The Bill broadly defines a “natural health product” as something which is administered to a human being that brings about a “health benefit” to that person. These are administered in therapeutic dose forms such as tablets, capsules, creams, ointments and drops but are not intended for administration to the eye or by injection. For example, this may include dietary supplements, vitamins, herbal remedies, some cosmetic products, homeopathic medicines and aromatherapy products. However, the definition excludes food and drink, prescription and pharmacy-only medicines, and controlled drugs.
The natural health products industry is a significant contributor to the New Zealand economy. Although some natural health products are governed under existing regulation such as the Dietary Supplements Regulations 1985 (under the Food Act 1981), New Zealand (Supplemented Food) Standard 2010 or the Medicines Act 1981, these regulations are seen as outdated and ill-fitting to the current industry. The Bill has been designed to bring New Zealand standards in alignment with OECD standards, however, it would appear that a heavy-handed approach has been taken.
The Bill proposes to establish a Natural Health Products Regulatory Authority (Authority) within the Ministry of Health as the body in charge of administering the Act. All sponsors of natural health products, that being New Zealand resident importers or manufacturers, or those who arrange the import or manufacture of a natural health product, will need to complete a “product notification” to gain the approval of the Authority before their product can be released in the New Zealand market. This notification will then be recorded on an online register. The Bill requires the sponsor to provide the Authority with certain information regarding the product such as the ingredients, the manufacturer and the health benefit claims being made for the product which must be substantiated. Standards will set the levels of substantiation required for different types of claims and sponsors must certify that the requisite evidence is held to support the claims made.
At present, the regulations allow for any vitamin or mineral to be added to a product provided it is safe and suitable for purpose. One of the main areas of contention with the new Bill is that the Authority is to develop and maintain a list of prohibited ingredients and an open-ended list of permitted ingredients for natural health products. A prescriptive list means that any ingredients that fall outside these must be assessed and declared by the Authority as either safe or unsafe and in some cases, the burden of proving the safety of the new ingredients may fall on the sponsor. Some see this as imposing unnecessary hurdles on businesses wishing to introduce new products into New Zealand that contain new ingredients. The ability of the Authority to keep up with new product assessments has also been debated.
Further, a risk-based, New Zealand-specific code for the manufacture of natural health products is set to be developed. All manufacturers will be required to hold a manufacturing licence issued by the Authority who will need to be satisfied that the manufacturer complies with the specified code of practice and will be subject to regular audit.
Regulations will also set out mandatory labelling requirements and advertising requirements for natural health products. Many have supported greater clarity and consistency on supplement labels which would be enhanced by consistent labelling standards. Although, the current Advertising Standard Code for Therapeutic Products and Therapeutic Services is still intended to be the main port of call for complaints surrounding the advertising of such products.
The Bill provides for a three year transition period which is intended to help the natural health products industry to adjust to the proposed regime. The Bill is currently being considered by the Health Committee and it is taking submissions in this regard. As such, if the Bill affects your business, you may want to consider making submissions on the Bill, especially if you consider some of the proposed measures to be disproportionate for the regulation of seemingly low risk products.
Published in FMCG Magazine December 2011