This Supplementary Order Paper amends the Natural Health and Supplementary Products Bill. The Bill currently aims to regulate natural health and supplementary products, which by definition contain only permitted ingredients (which are Schedule 1 substances declared to be permitted ingredients by the Authority).
The definition of natural health and supplementary product is replaced with a definition of natural health product. The key difference being that a natural health product contains only Schedule 1 substances whereas a natural health and supplementary product contains only permitted ingredients.
The widening of the definition means that manufacturers of any natural health product must comply with the requirements of this Bill. However, the requirement for a natural health product to contain only permitted substances will continue to apply to natural health products for sale or export. The following table illustrates the proposed changes:
|Current definitions||Proposed definitions|
|natural health and supplementary product means any product, subject to subclause (2) of clause 6, that—|
is or appears to be manufactured for human use and for the primary purpose of bringing about a health benefit to users; and
contains only permitted ingredients unless it is a new approved ingredient or a dietary supplement; and
is not, or is not presented as, a food.
Subclause (2) of clause 6 excludes certain medicines, related products, and medical devices under the Medicines Act 1981 from the definition of natural health and supplementary product.
|natural health product means any product that—| natural substance means any substance or class of substance listed in Schedule 1
is, or is represented as having been, manufactured for human use and for the primary purpose of bringing about a health benefit to users; and
contains, or is represented as containing, only natural substances; and
is not a food, or is not presented as a food; and
is not or does not contain a medicine listed in Schedule 1 of the Medicines Regulations 1984 or a psychoactive substance.
permitted substance means any natural substance declared by the Authority to be a permitted substance.
|permitted ingredient means any substance that is or belongs to a class of substance listed in Schedule 1 and declared by the Authority to be a permitted ingredient.|
The effect of these changes is that dietary supplements will be regulated as natural health products. Accordingly, the word supplementary in the term natural health and supplementary product is no longer necessary and is removed.
The Bill would now regulate—
the manufacture of natural health products:
the sale, offering for sale, and export of natural health products.
This Supplementary Order Paper proposes that Part 2 of the Bill be comprehensively restructured for overall coherence. Substantive regulatory provisions will appear earlier in the Bill and provisions relating to administrative matters will appear in the latter part. New Part 2 carries over most of the provisions currently in Part 2 of the Bill with consequential changes as well as substantive changes being made to those provisions. Minor drafting and editorial changes are also proposed.
Manufacture of natural health products
The most significant change proposed to provisions relating to the manufacture of natural health products (clauses 13 to 20) is that the obligation to obtain a licence to manufacture has wider application, in light of the change to the definition of natural health and supplementary product. Previously, the obligation to obtain a licence applied to manufacturers of natural health and supplementary products (which by definition meant those products with permitted ingredients only). Natural health products (whether or not they contain permitted substances) must now be manufactured under a licence. The significance of this change is reinforced by incorporating the relevant offence provision into clause 13.
Clause 15 relates to the conditions of a licence to manufacture and enables the Authority to impose conditions on the licence as and when the Authority thinks fit.
Under the Bill, manufacturers of natural health and supplementary products for export who do not require an export certificate are exempt from the requirement to obtain a licence to manufacture. That exemption is not carried forward.
Natural health products for sale or export
Clause 21(1) contains the fundamental regulatory rule in this Bill. No person may sell, offer for sale, or export any natural health product unless—
it is a product described in clause 22; or
it has a valid product notification.
Clause 22, which lists natural health products that do not require product notification, no longer includes export-only natural health and supplementary products (see previous clause 13A).
Clause 26(4) and (6) relates to certain natural health products that do not require product notification. It is an offence for a person to make, on the label or in any advertisement for such products, any health benefit claim that relates to a named condition except as provided in regulations.
Clause 17, which requires product notifiers to notify the Authority of any serious adverse reaction to the product, is replaced by new clause 32. In paragraph (e) of the definition of serious adverse reaction, the words
“allergic reaction” (as in previous section 17) are now replaced with the words
“serious allergic reaction”.
Clause 33, which carries forward previous clause 18, sets out when a new product notification is required for a product. For products manufactured overseas, a new product notification will not be required if there is a change of manufacturing premises.
Clause 37 regulates the use of new substances (which are natural substances that are not permitted substances) in the manufacture of a natural health product for sale or export. The previous clause 23, which relates to safety assessments of new ingredients, is not carried forward. However, the processes and criteria for the declaration of new ingredients in previous clause 23 will continue to apply to new substances.
The previous clause 21, which relates to prohibited ingredients, is not carried forward.
The previous clause 24A, which sets out requirements for natural health products that are dietary supplements, is not carried forward.
New offence provisions are introduced. A person commits an offence if the person—
sells or offers for sale in New Zealand or exports any natural health product knowing that the product does not comply with clause 21(1) (the product must have a valid product notification or must be a product described in clause 22):
knowingly manufactures a notified natural health product that contains a substance other than a permitted substance:
knowingly sells or offers for sale in New Zealand or exports any natural health product that is different from its description in the product notification.
Clause 47 sets out offences for deceptive behaviour and contains a new offence provision relating to false representation of natural health products and notified natural health products.
The following offence provisions apply to all natural health products:
clause 43 (prohibited methods of administration):
clause 45 (endangerment of human health):
clause 46 (publishing of certain advertisements relating to natural health products).
Clause 55 is new, and allows the Authority to specify the manner in which a product notification is to be completed, and the manner in which certain applications must be made (see also clauses 14, 25, 27, 37, and 60).
Clause 60 allows the Authority to declare, in certain circumstances, a product or class of product to be a natural health product. Under the previous clause 45A, the power of declaration related to natural health and supplementary products, which was a narrower range of product.
Clause 61 includes a new power to make regulations prescribing requirements relating to advertisements of natural health products.
Clause 71 contains a new amendment to the Medicines Act 1981. Before declaring a medicine that is also a natural substance to be a prescription medicine, restricted medicine, or pharmacy-only medicine, the Minister must consult the Natural Health Products Regulatory Authority.
Schedule 1 contains the following changes:
item 2(b) is amended to remove the words “for preparation of the substance or mixture of substances in an active medicinal form”:
item 3 is amended by replacing
“folic acid” with
item 8 is replaced with
“An amino acid”.
Departmental disclosure statement
The Ministry of Health considers that a departmental disclosure statement is not required to be prepared for this Supplementary Order Paper.