3. Compositional Aspects

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Dietary Supplements
New Zealand

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

Please note that the information below is in the context of the current system, under the Dietary Supplements Regulations 1985 [1] which are in place until 1 March 2026.

Background on ingredients that are permitted

The Dietary Supplements Regulations [1] are not very detailed in regard to some ingredient permissions. Unlike the Complementary Medicines (= Dietary Supplements) regime in Australia, where there is a positive list of ingredients (both actives and excipients), New Zealand has very broad statements in [1] about product active ingredients:

Clause 2A (2) of Ref [1] 'It is an amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin' and
Clause 2A (6) 'It is intended to supplement the amount of the amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin normally derived from food.'

With respect to the active ingredients, there are some restrictions on vitamin and mineral levels and on enzymes (refer below) that can be used but otherwise, the permissions are not well described. The lack of a positive list has resulted in many products on the market that push the boundaries, and contain substances that would be considered to be Novel Foods under the FSC [2]. This will probably be addressed in the proposed new Natural Health Products Bill (refer to Section 2 for details on the proposal).

With respect to excipients, there are quite detailed lists in Part 2 of Ref [1], which many translate as meaning the named excipients are the only ones permitted. However, taken more broadly, the definition of an 'ingredient' in clause 2 (1) of Ref [1]: "ingredient means any substance, other than an incidental constituent, that is (a) used in the manufacture or preparation of a dietary supplement; and (b) present, whether in a modified form or not, in the final product" could be used to argue that this includes permission for food additives permitted in the FSC [3], so long as the lists in Part 2 of Ref [1] are not ignored. This also means that if a list in Part 2 states that these are the only ingredients permitted to do a particular function other food additives could not be used for that function. For example, no other additive could be used as a preservative as Clause 13 (2) states, "and no others". However, for tableting aids/encapsulating aids, Clause 12 (2) does not state, "and no others".

Background on ingredients that are NOT permitted

Dietary supplements cannot:

Contain controlled drugs, that is, ingredients that are scheduled under the Misuse of Drugs Act 1975 [3]. Examples of such substances are pseudoephedrine, cannabis, and codeine.
Contain substances listed in the First Schedule to the Medicines Regulations 1984 [4]. Examples include:
1. Prescription Only medicines: Amygdalin (sometimes marketed as a natural cancer treatment under the names laetrile or Vitamin B17), Calotropis gigantic (crown flower), and cholecalciferol in doses above 25 micrograms/day.
2. Pharmacist Only (Restricted) substances: Paracetamol in modified-release forms containing 665 milligrams or less, and Inositol nicotinate.
3. Pharmacy Only substances: Aloes for internal use (except when obtained solely from the mucilaginous gel of the leaf), and Folic acid for oral use (in medicines containing more than 500 micrograms per recommended daily dose).

3.2 Raw Material Requirements

Please refer to section 3.1 above.

3.3 Fortification

1) Dietary supplements containing Vitamins

Clause 3 (1) of Ref [1]:

Every dietary supplement described as or containing vitamins specified in the first column shall be manufactured so that each daily dose (for an adult) does not contain more than the maximum specified in the second column.

Notes:

There are special requirements for Folic acid, which are described in the Section “Dietary supplements containing folic acid” below.
Clause 18 (1) of [1] lists other permitted vitamins.

2) Dietary supplements containing Folic Acid

For folic acid, there are two maximum daily doses (for adults) permitted, based on confirmation of the manufacturing system for the product.

The maximum daily dose for a dietary supplement is 300 micrograms of folic acid per day. However, if the manufacturer has demonstrated to Medsafe that the product is manufactured in a Good Manufacturing Practice certified facility then the maximum daily dose of folic acid may be increased to 500 micrograms per day. The GMP must meet the requirements in Part 4 of the Guideline [5]. To demonstrate compliance, manufacturers must submit a declaration and evidence to the Compliance Management section of Medsafe as described in [6].

3) Dietary supplements containing Minerals

Clause 19 (1) of [1].

The following dietary supplements may be described as minerals:

Calcium
Chlorine
Chromium
Copper
Fluorine
Iodine
Iron
Magnesium
Manganese
Molybdenum
Phosphorus
Potassium
Selenium
Sodium
Zinc

Clause 3 (1) of Ref [1]:

Every dietary supplement described as or containing minerals specified shall be manufactured so that each daily dose (for an adult) does not contain more than the maximum specified in the second column.

For minerals that are not in the above table or the list from Clause 19 (1), the limits should be such that the daily dose (for an adult) does not contain more than the maximum specified in the current edition of Recommended Dietary Allowances, Food and Nutrition Board of the National Academy of Science and National Research Council, Washington DC, USA.

3.4 Other Permitted Ingredients

Refer to section 3.1 above.

3.5 Permitted Additives

Part 2 of [1] lists the permitted substances for various technological purposes. These are required to be food grade and the clause outlines the positive list in the case of tableting and encapsulating aids (Clause 12), preservatives (Clause 13), antioxidants (Clause 14), colorings (Clause 15), artificial sweeteners (Clause 16) and enzymes (Clause 20).

3.6 Permitted Flavors and Colors

Part 2 of [1] lists the permitted substances for various technological purposes. These are required to be food grade and the clause outlines the positive list in the case of colorings (Clause 15).