The definition of label in the Bill covers the label attached to the container (e.g. bottle, tube or blister pack) the primary pack (e.g. carton) and any printed information supplied with the container or primary pack.
The basic requirements are that a label must be:
- clearly visible
- written in English
- in lettering that is clear, distinct and legible
- durable and not readily damaged by normal handling.
The content of labels will be similar to the requirements in the Dietary Supplements Regulations 1985, which will be repealed when the NHSP Bill comes into effect.
Regulations will set out minimum requirements for information on labels. This will not prevent labels containing other information as long as it is not misleading or contradictory to other requirements of the regime. Product notifiers will have 2 years to comply with labelling requirements after the legislation comes into force.
The proposed minimum requirements for labels of natural health and supplementary products are:
- Product name and brand name
- Name(s) of all active ingredients in the product
- Quantity or proportion of all active ingredients in the medicine
- Description of the product including dose form or presentation
- Physical address of product notifier and/or importer including website
- Warning statements where applicable
- Declaration of certain ingredients, such as those known to cause allergies in susceptible individuals, eg ‘contains gluten’
- Batch numbers
- Expiry dates
- Storage conditions where applicable
- Net weight, volume or number of the contents of the package or container
- Directions for use (may be printed on package insert)
- Intended purpose of the product consistent with claims for which it has been approved
- Statement of recommended daily dosage for adults and children (if applicable)
- Maximum daily dosages
- Recommended duration of use
- Country of origin
Over-labels are labels that can be applied over the top of an existing label (for example, on a product manufactured outside of New Zealand) to ensure the product complies with local labelling requirements. Over-labels are permitted for medicines, and we propose that they should be permitted for natural health and supplementary products.
The proposed basic requirements, based on the Therapeutic Advertising Pre-vetting Service (TAPS ) guidelines, are that advertising must:
- be truthful, balanced and not misleading
- observe a high standard of social responsibility, and
- not encourage inappropriate or excessive consumption
- contain the mandatory information to encourage responsible use
- assist consumers to make informed decisions, advertisements must contain truthful and balance representations and claims that are valid and have been substantiated and be consistent with any allowed claims, as provided for by the Natural Health and Supplementary Products Bill
- ensure any comparisons with competitor products must be fair, balanced and reflect the body of literature.