Dietary Supplements Regulations 1985

Reprint as at 1 March 2016

Coat of Arms of New Zealand

Dietary Supplements Regulations 1985

(SR 1985/208)

David Beattie, Governor-General

Order in Council

At the Government Buildings at Wellington this 19th day of August 1985

Present:
The Hon G W R Palmer presiding in Council

Note

Changes authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint.

Note 4 at the end of this reprint provides a list of the amendments incorporated.

These regulations are administered by the Ministry of Health.

Pursuant to section 42 of the Food Act 1981, His Excellency the Governor-General, acting by and with the advice and consent of the Executive Council, hereby makes the following regulations.

Regulations

1 Title and commencement

(1)

These regulations may be cited as the Dietary Supplements Regulations 1985.

(2)

Regulations 2 and 4 to 11 shall come into force on 1 September 1987.

(3)

Except as provided in subclause (2), these regulations shall come into force on 1 January 1987.

Regulation 1(2): substituted, on 1 January 1987, by regulation 2 of the Dietary Supplements Regulations 1985, Amendment No 1 (SR 1986/378).

Regulation 1(3): substituted, on 1 January 1987, by regulation 2 of the Dietary Supplements Regulations 1985, Amendment No 1 (SR 1986/378).

2 Interpretation

(1)

In these regulations, unless the context otherwise requires,—

batch means a quantity of dietary supplement produced under essentially the same conditions during a particular period, and usually from a particular “line” or other identifiable processing unit

common name, in relation to a dietary supplement, means the name by which the dietary supplement is generally known, being a noun defined in a dictionary of the English language of authority and repute in New Zealand to mean that kind of dietary supplement; and also means any expression containing such a noun

container means any box, packet, or other receptacle in which 1 or more packages of dietary supplements are, or are to be, enclosed

dietary supplement has the meaning given to it by regulation 2A

incidental constituent means any extraneous substance, toxic substance, or pesticide that is contained or present in or on any dietary supplement; but does not include any preservative, antioxidant, colouring substance, artificial sweetener, flavouring substance, food conditioner, anti-caking agent, gaseous packing agent, propellant, or vitamin, or any mineral

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

principal display panel means the part of a label that is most likely to be displayed, presented, shown, or examined, under ordinary or customary conditions of display for retail sale; and, if such likelihood is equal in respect of 2 or more panels, means every such panel

printed includes written, typewritten, engraved, lithographed, or otherwise traced or copied.

(2)

In these regulations, the symbols specified in the first column of the table of this subclause shall have the meanings specified in relation to those symbols in the second column of the table.

Table of subclause (2)
SymbolMeaning
ggrams
mcgmicrograms
mgmilligrams
mmmillimetres
ppmparts per million

(3)

In these regulations, unless the context otherwise requires, all references to proportions (whether as percentages, parts per million, or otherwise) shall be references to proportions by weight in a dietary supplement as sold.

(4)

Nothing in these regulations shall prohibit the use of any symbol the style of which conforms with a specimen in the table of subclause (2), or with the conventional usage of metric measurements.

Regulation 2(1) dietary supplement: substituted, on 31 March 2010, by regulation 4(1) of the Dietary Supplements Amendment Regulations 2010 (SR 2010/5).

Regulation 2(1) foodstuff: revoked, on 31 March 2010, by regulation 4(2) of the Dietary Supplements Amendment Regulations 2010 (SR 2010/5).

Regulation 2(1) incidental constituent: amended, on 31 March 2010, by regulation 4(3) of the Dietary Supplements Amendment Regulations 2010 (SR 2010/5).

Regulation 2(1) ingredient: amended, on 31 March 2010, by regulation 4(4) of the Dietary Supplements Amendment Regulations 2010 (SR 2010/5).

2A Meaning of dietary supplement

(1)

In these regulations, dietary supplement means something to which subclauses (2) to (6) apply.

(2)

It is an amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin.

(3)

It is sold by itself or in a mixture.

(4)

It is sold in a controlled dosage form as a liquid, powder, or tablet (which might be described on the label as a cachet, capsule, lozenge, or pastille instead of as a tablet).

(5)

It is intended to be ingested orally.

(6)

It is intended to supplement the amount of the amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin normally derived from food.

Regulation 2A: inserted, on 31 March 2010, by regulation 5 of the Dietary Supplements Amendment Regulations 2010 (SR 2010/5).

Part 1 General requirements

3 Maximum daily doses

(1)

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

Table of subclause (1)
Dietary supplementMaximum daily dose
Minerals
Copper5 mg
Iron24 mg
Selenium150 mcg
Zinc15 mg
Vitamins
Vitamin A or retinol3000 mcg
Niacin (and salts) or nicotinic acid (and salts)100 mg
Vitamin B12 or cyanocobalamin or hydroxocobalamin50 mcg
Vitamin D25 mcg
Folic acid500 mcg in the case of a dietary supplement that the Director-General of Health has confirmed has been prepared in a way that accords with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods
300 mcg in the case of a dietary supplement that the Director-General of Health has not confirmed has been prepared in a way that accords with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods

(2)

Every dietary supplement described as or containing any mineral, other than a mineral specified in regulation 19(1), shall be so manufactured that each daily dose (for an adult) does not contain more than the maximum specified in the current edition of Recommended Dietary Allowances, published by the Food and Nutrition Board of the National Academy of Science and National Research Council, Washington DC, USA.

Regulation 3(1) table: amended, on 31 March 2010, by regulation 6 of the Dietary Supplements Amendment Regulations 2010 (SR 2010/5).

4 Dietary supplements not to be sold unless properly labelled

No person shall sell any package or container containing any dietary supplement, or any dietary supplement contained in a package or container, if the package or container—

(a)

does not bear a label containing all the particulars required by these regulations to be contained on a label relating to such package or container; or

(b)

bears a label containing anything that is prohibited by these regulations from appearing on a label relating to such package or container; or

(c)

bears a label containing any particulars that are not in the position, manner, and style required by these regulations in respect of a label relating to such package or container.

5 General requirements for labelling of dietary supplements

(1)

Every package and container containing a dietary supplement shall, unless otherwise provided in these regulations, bear a label that includes the following:

(a)

the common name of the dietary supplement, or a description (other than the brand name of the dietary supplement) sufficient to indicate the true nature of the dietary supplement, or a description of the dietary supplement including the common names of its principal ingredients:

(b)

a statement of the net weight or volume or number of the contents of the package or container, whichever measure is appropriate for retail sale of the dietary supplement concerned:

(c)

the trading name and business address of the manufacturer or seller or packer of the dietary supplement, or of the owner of the rights of manufacture, or of the principal or the agent of any of them:

(d)

a consumer information panel that complies with regulation 9:

(e)

the words “dietary supplement”:

(f)

a batch number:

(g)

a date mark, being an expression in one of the following forms:

(i)

use by (followed by a date); or

(ii)

not to be consumed after (followed by a date); or

(iii)

words of similar meaning (followed by a date);—

the relevant date in any case being no later than 5 years after the date of manufacture:

(h)

a statement of the recommended daily dosage (for an adult) both as to quantity and frequency, which shall not exceed the maximum daily dose permitted by regulation 3, and, if the dietary supplement is suitable for children, the recommended daily dose for children:

(i)

a warning in any case where a danger exists if an overdose is taken:

(j)

the method of preparation before use (where necessary).

(2)

Notwithstanding paragraphs (f) and (g) of subclause (1), no container containing a dietary supplement need be labelled with the batch number or with a date mark.

(3)

Notwithstanding subclause (1), where dietary supplements are packed in blister or strip packaging, the packaging shall be labelled with—

(a)

the common name; and

(b)

a batch number.

(4)

For the purposes of subclause (1)(c),—

(a)

a postal address, not being a telegraphic or code address or an address at a post office, shall be given:

(b)

the name and address of a person who is not ordinarily resident in New Zealand shall not be sufficient unless the dietary supplement is wholly manufactured and packed outside New Zealand:

(c)

in the case where the trading name is of a body corporate (whether registered inside or outside New Zealand), either the name of the town in which the body corporate has its registered office or the full postal address of the premises where the dietary supplement is actually manufactured or packed by the body corporate shall be given as the address.

(5)

Where a package or container of a dietary supplement is enclosed or wrapped in a transparent covering and the particulars with which that package or container is required to be labelled are clearly visible through that covering, that covering shall be exempt from the labelling requirements under these regulations.

(6)

No person who has in that person’s possession any package or container of a dietary supplement intended for sale by retail shall—

(a)

remove any label required by these regulations to be on the package or container; or

(b)

alter, erase, obliterate, or obscure any word or statement borne on such a label in accordance with any of the requirements of these regulations.

6 Form and manner of labelling

(1)

Every word or statement that is required by these regulations to be borne on a label shall—

(a)

be conspicuously printed and, for each statement separately required, be in uniform colour contrasting strongly with a uniform background; and

(b)

be clearly, legibly, and durably marked either on the material of the package or container or on material firmly and securely attached to the package or container; and

(c)

be presented with continuity.

(2)

The lettering of every word or statement required by these regulations shall be clear, distinct, and legible with no decoration, embellishment, or distortion that could interfere with the legibility of the words.

7 Size of letters

(1)

The lettering of every word or statement required by these regulations to appear on labels shall be—

(a)

all capital letters; or

(b)

all lower case letters; or

(c)

lower case letters with an initial capital letter.

(2)

In every case to which paragraph (a) or paragraph (b) of subclause (1) applies, the height of the lettering shall be uniform in every word or statement that is separately required.

(3)

In every case to which paragraph (c) of subclause (1) applies, the height of the lower case lettering shall be uniform in every word or statement that is separately required.

(4)

Except as otherwise provided in these regulations, the lettering of any word or statement required by these regulations to appear on labels shall be not less than 1.5 mm in height, except where the package or container to be labelled is so small as to prevent the use of letters of that height, in which case letters of not less than 0.75 mm in height may be used.

(5)

The height of the lettering for the common name or description that is required by these regulations to appear in the principal display panel of a label shall be not less than one-third of the height of the largest lettering appearing in that panel, and—

(a)

not less than one-twentieth of the height of the label, in the case of a label that is no longer than twice the width of the label; and

(b)

not less than one-thirtieth of the height of the label, in any other case.

(6)

For the purposes of subclause (5), the height of a label is the distance between the top and bottom of all printed or pictorial information on the label.

8 Principal display panel

(1)

The particulars that are required by paragraph (a) and paragraph (b) and paragraph (e) of regulation 5(1) to appear on a label shall appear in the principal display panel.

(2)

Every word or statement that is required by these regulations to appear in the principal display panel of a label shall be in lines that are generally parallel to the base on which the package or container rests as it is designed to be displayed.

(3)

In the case of a cylindrical package or container, the width of the principal display panel on the cylindrical surface shall not exceed one-third of the circumference of the package or container.

9 Consumer information panel

(1)

The following information, when required by these regulations to be on the label, shall be grouped together in one portion of the label (that portion being called the consumer information panel):

(a)

the statement of ingredients, which shall show—

(i)

the quantities or proportions of the claimed active ingredients in the package or container or in each dosage unit, or, where the dietary supplement is divided into a number of units, the quantity or proportion of the claimed active ingredients in each unit; and

(ii)

the inactive ingredients in the package or container, which shall be described either by their specific names or by their class names, being any of the following permitted class names:

  • antioxidants:

  • artificial sweeteners:

  • colouring or colour:

  • encapsulating aids:

  • flavouring or flavour:

  • minerals:

  • preservatives:

  • tabletting aids:

  • vitamins:

(b)

the storage instructions (where appropriate).

(2)

The consumer information panel may be any part of the label, but shall—

(a)

be conspicuously placed in relation to other information included on the label; and

(b)

be clearly differentiated from all other promotional material or illustrations.

10 Misleading statements

(1)

No printed, pictorial, or other descriptive matter appearing on or attached to or supplied or displayed with any dietary supplement shall include any comment on, reference to, or explanation of any word, statement, or label required by these regulations to be borne on any dietary supplement if that comment, reference, or explanation either directly or by implication contradicts, qualifies, or modifies that word or statement or the contents of that label.

(2)

No printed, pictorial, or other descriptive matter supplied or displayed with any dietary supplement shall include any false or misleading statement, word, brand, picture, or mark purporting to indicate the nature, suitability, quantity, quality, strength, purity, composition, weight, origin, age, effects, or proportion of the dietary supplement or of any ingredients of the dietary supplement.

11 Therapeutic claims

Except as permitted by the Medicines Act 1981 and any regulations made under that Act, no dietary supplement or package or container containing a dietary supplement shall be advertised or labelled with a statement relating to any of the following matters:

(a)

treating or preventing disease:

(b)

diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition:

(c)

altering the shape, structure, size, or weight of the human body:

(d)

otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating or reducing or postponing, or increasing or accelerating, the operation of that function, or in any other way.

Part 2 Specific requirements

12 Tabletting aids

(1)

In these regulations tabletting aid means a food grade substance that is added to a dietary supplement to constitute the form in which that supplement is sold; and includes an encapsulating aid.

(2)

The following tabletting aids or encapsulating aids may be added to dietary supplements:

  • alginic acid and its derivatives:

  • beeswax:

  • bone meal (sterilised); calcium phosphate:

  • carbohydrate sweeteners:

  • carnauba wax:

  • cellulose and its derivatives:

  • coating pigments:

  • enteric coatings:

  • gelatin:

  • gelatin capsule shells:

  • lactose:

  • lecithin:

  • light mineral oils:

  • monoglycerides, diglycerides, and triglycerides from edible oils and fats:

  • montan ester wax:

  • pectins:

  • polyethylene glycols:

  • polyvinylpyrrolidone and its derivatives:

  • shellac:

  • silicic acid and its salts:

  • starch:

  • starches (modified):

  • stearic acid and its salts:

  • talc (sterilised):

  • vegetable gums:

  • vegetable oils, and hydrogenated vegetable oils:

  • xanthan gum:

  • zein corn protein.

Regulation 12(2): amended, on 1 March 2016, by section 447 of the Food Act 2014 (2014 No 32).

13 Preservatives

(1)

In these regulations preservative means any substance that, when added to a dietary supplement, has the property of arresting or impeding fermentation, putrefaction, or decomposition.

(2)

Dietary supplements may contain any of the following preservatives and no others:

  • benzoic acid or sodium benzoate:

  • parahydroxybenzoic acid and its esters:

  • sorbic acid, or its sodium, calcium, or potassium salts:

  • sulphur dioxide, or sulphites calculated as sulphur dioxide.

14 Antioxidants

(1)

In these regulations antioxidant means any substance that, when added to a dietary supplement, has the property of arresting or retarding oxidative rancidity.

(2)

Dietary supplements may contain any of the following antioxidants and no others:

(a)

propyl gallate, dodecyl gallate, octyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), and tertiary butylhydroquinone (TBHQ), where the proportion of those antioxidants, singly or in combination, does not exceed 100 ppm:

(b)

ascorbyl palmitate, and ascorbyl stearate, where the proportion of those antioxidants, singly or in combination, does not exceed 500 ppm:

(c)

natural tocopherols, synthetic tocopherols, citric acid, and sodium citrate:

(d)

isopropyl citrate mixture, monoglyceride citrate, and phosphoric acid, where the proportion of those antioxidants, whether singly or in combination, does not exceed 100 ppm.

15 Colouring substances

(1)

In these regulations colouring substance means any substance that, when added or applied to a dietary supplement, is capable of imparting colour to that dietary supplement.

(2)

Dietary supplements may contain any of the colouring substances (and, where appropriate, their aluminium lakes) specified in the table of this subclause and no others.

Table of subclause (2)
Common nameIndex nameIndex number
Allura Red ACCI Food Red 1716035
Aluminium77000
AmaranthCI Food Red 916185
Annatto extracts (bixin, norbixin)CI Natural Orange 475120
Anthocyanins 40800
Beet red (betanin)
β-caroteneCI Food Orange 5
β-apo-8’-carotenolCI Food Orange 640820
β-apo-8’-carotenoic acid, and its ethyl and methyl estersCI Food Orange 740825
Brilliant Black PNCI Food Black 128440
Brilliant Blue FCFCI Food Blue 242090
Brown HTCI Food Brown 320285
CanthaxanthinCI Food Orange 840850
Caramel14720
Carmoisine (azorubine)CI Food Red 3
ChlorophyllCI Natural Green 375810
Chlorophyll copper complex75470
Chlorophyllin copper complex, potassium and sodium salts
Cochineal (carminic acid)CI Natural Red 4
ErythrosineCI Food Red 1445430
Fast Green FCFCI Food Green 342053
Gold77480
Grape skin extracts44090
Green SCI Food Green 4
Indigotine (indigo carmine)CI Food Blue 173015
Iron oxides and hydrated iron oxidesgraphic bracket CI Pigment Red 101 & 102
CI Pigment Yellow 42 & 43
CI Pigment Black 11		77491
77492
77499
Paprika (paprika oleoresin) (capsanthin and capsorubin)16255
Ponceau 4RCI Food Red 7
Riboflavin (lactoflavin)75100
Riboflavin-5-phosphate
Saffron (crocin, crocetin)CI Natural Yellow 6 & 19
Silver77820
Sunset Yellow FCFCI Food Yellow 315985
TartrazineCI Food Yellow 419140
Titanium dioxide77891
Turmeric (curcumin)CI Natural Yellow 375300
XanthophyllsCI Natural Yellow 2775135

Note: The index numbers specified in the third column of this table are the numbers allotted in the current edition of the Colour Index published jointly by the Society of Dyers and Colourists of the United Kingdom and the Association of Textile Chemists and Colorists of the United States of America.

16 Artificial sweeteners

(1)

In these regulations artificial sweetener means any substance that when added to a dietary supplement, is capable of imparting sweetness to that dietary supplement, and that is not a saccharide, polyhydric alcohol, or honey.

(2)

Dietary supplements may contain any of the following artificial sweeteners and no others:

  • aspartame:

  • saccharin and its sodium, and calcium and ammonium compounds:

  • sodium cyclamate and calcium cyclamate.

17 Flavouring substances

(1)

In these regulations flavouring substance means any wholesome substance that, when added or applied to a dietary supplement, is capable of imparting flavours to, or enhancing flavours in, that dietary supplement.

(2)

Dietary supplements may contain any flavouring substance, except the following:

  • cade oil:

  • coumarin:

  • nitrobenzene:

  • pyroligneous acid:

  • safrole and isosafrole:

  • sassafras oil.

18 Vitamins

(1)

The dietary supplements specified in the first column of the table of this subclause, or any compound of those supplements, and no others, may be described as vitamins, and the quantity of vitamins in those dietary supplements shall be calculated in accordance with the second column of that table.

Table of subclause (1)
Dietary supplement described as vitamins or containing vitaminsCalculated as
Vitamin A or retinolretinol in mcg
Vitamin B1 or thiaminethiamine in mg
Vitamin B2 or riboflavinriboflavine in mg
Niacin or nicotinic acidniacin equivalents in mg
Pantothenic acidpantothenic acid in mg
Vitamin B6 or pyridoxinepyridoxine in mg
Vitamin B12 or cyanocobalamin, or hydroxycobalaminvitamin B12 in mcg
Vitamin C or ascorbic acidascorbic acid in mg
Vitamin D2 or calciferolcalciferol in mcg
Vitamin D3 or cholecalciferolcholecalciferol in mcg
Vitamin Evitamin E in mg
Biotinbiotin in mcg
Vitamin Kvitamin K in mcg
Vitamin K1 or phytomenadionevitamin K1 in mcg
Vitamin K3 or menaphthonevitamin K3 in mcg
Folic acidfolic acid in mcg

(2)

If the quantity of vitamins in a dietary supplement is declared on a label, it shall be stated to an accuracy of not greater than 3 significant figures.

(3)

There may be marked on any package or container containing a dietary supplement, described as or containing a vitamin, a statement indicating—

(a)

the presence of vitamins; and

(b)

the quantity, calculated in accordance with the table of subclause (1), of that vitamin in that package or container or in each dosage unit, or, where the dietary supplement is divided into a number of units, the quantity of that vitamin in each unit.

19 Minerals

(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.

(2)

If the quantity of minerals in a dietary supplement is declared on a label, it shall be stated in milligrams or micrograms to an accuracy of not greater than 3 significant figures.

(3)

There may be marked on any package or container containing a dietary supplement described as or containing a mineral, a statement indicating—

(a)

the presence of minerals; and

(b)

the quantity of that mineral in that package or container or in each dosage unit, or, where the dietary supplement is divided into a number of units the quantity of that mineral in each unit.

20 Enzymes

The following enzymes may be added to dietary supplements:

  • amylase and protease derived from Aspergillus flavus oryzae or Aspergillus niger:

  • bromelin:

  • ficin:

  • invertase:

  • papain:

  • pectinase:

  • pepsin:

  • rennet and protein—coagulating enzymes:

  • lactase:

  • lipase.

Part 3 Offences and penalty

21 Offences and penalty

(1)

Every person who contravenes or fails to comply with any of the provisions of regulations 3, 4, 5(6), 13(2), 14(2), 15(2), 16(2), 17(2), and 18(1) commits an offence against these regulations.

(2)

Every person who commits an offence against these regulations is liable to a fine not exceeding $500, and, in the case of a continuing offence, to a further fine not exceeding $50 for every day on which the offence has continued.

P G Millen,
Clerk of the Executive Council.

Issued under the authority of the Legislation Act 2012.

Date of notification in Gazette: 22 August 1985.

Reprints notes
1 General

This is a reprint of the Dietary Supplements Regulations 1985 that incorporates all the amendments to those regulations as at the date of the last amendment to them.

2 Legal status

Reprints are presumed to correctly state, as at the date of the reprint, the law enacted by the principal enactment and by any amendments to that enactment. Section 18 of the Legislation Act 2012 provides that this reprint, published in electronic form, has the status of an official version under section 17 of that Act. A printed version of the reprint produced directly from this official electronic version also has official status.

3 Editorial and format changes

Editorial and format changes to reprints are made using the powers under sections 24 to 26 of the Legislation Act 2012. See also http://www.pco.parliament.govt.nz/editorial-conventions/.

4 Amendments incorporated in this reprint

Food Act 2014 (2014 No 32): section 447

Dietary Supplements Amendment Regulations 2010 (SR 2010/5)

Dietary Supplements Regulations 1985, Amendment No 1 (SR 1986 /378)