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Commonwealth legislation
This bill tightly regulates therapeutic vaping products in Australia, treating them as medicines rather than consumer goods. It restricts ingredients, flavours, nicotine strength, packaging and labelling, requires patient information and prescription-based access, and bans ingredients and designs that could appeal to youth.
It affects manufacturers, importers, pharmacists, prescribers and patients using vaping for smoking cessation. The aim is to enable harm-reduction for adult smokers while preventing youth uptake and nicotine initiation.
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Direct links to the current provisions in Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
(1) This instrument is the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021.
(2) This instrument may also be cited as TGO 110.
This instrument is made under section 10 of the Therapeutic Goods Act 1989.
Note 1: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) batch;
(b) British Pharmacopoeia;
(c) container;
(d) essential principles;
(e) European Pharmacopoeia;
(f) manufacture;
(g) medicine;
(h) primary pack;
(i) registered goods;
(j) sponsor;
(k) standard;
(l) supply;
(m) therapeutic goods;
(n) United States Pharmacopeia-National Formulary.
Note 2: The definition of container in the Act is as follows:
Note: container, in relation to therapeutic goods, means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion.
Note 3: To avoid doubt, the container of a therapeutic vaping substance or therapeutic vaping substance accessory is the bottle, cartridge, capsule, pod or other vessel that contains the therapeutic vaping substance, and not the blister pack, strip pack or other wrapper in which the container is supplied.
In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Regulations.
batch number means a number, or a combination of letters, numerals, or symbols, which is given by the manufacturer to a batch of relevant goods or therapeutic vaping packs, to uniquely identify that batch.
Note: The batch number may be used to trace the batch through all stages of manufacture and distribution.
batch number prefix means the prefix that precedes the batch number, and consists of any words or symbols that clearly indicate that the information following those words or symbols is the batch number.
Note: Common forms of the batch number prefix include the following (either in capital letters, lower case letters or a combination of capital and lower case letters):
(a) Batch number;
(b) Batch no.;
(c) Batch;
(d) B;
(e) (B);
(f) B/N;
(g) Lot number;
(h) Lot No.;
(i) Lot.
capacity means the volume of the empty container.
contact details, in relation to a sponsor, means information that would enable a person to contact the sponsor and that:
(a) includes the address of the principal place of business of the sponsor in Australia; and
(b) may also include a telephone number, website or email address of the sponsor;
but is not a post office, cable, telegraphic or code address of the sponsor.
expiry date has the same meaning as in the Regulations.
expiry date prefix means the prefix that precedes the expiry date, and consists of any words or symbols that clearly indicate that the information following those words or symbols is the expiry date (other than words indicating that the goods may be used after that date, including ‘Best by’ and ‘Best before’).
Note: Common forms of the expiry date prefix include the following (either in capital letters, lower case letters or a combination of capital and lower case letters):
(a) Expiry date;
(b) Expiry;
(c) Expires;
(d) Exp. Date;
(e) Exp;
(f) Use by;
(g) Use before.
fill volume means the volume of a therapeutic vaping substance that is present in a container.
flavouring agent means an ingredient or component, or mixture of ingredients or components, added to a therapeutic vaping substance or a therapeutic vaping substance accessory to:
(a) provide flavour to the good; or
(b) maintain the stability of the favour.
intermediate packaging means packaging which:
(a) encloses one or more containers; and
(b) is enclosed in a primary pack.
label means:
(a) in relation to a relevant good—a display of printed information on, or attached to, any of the following:
(i) the container;
(ii) the intermediate packaging (if any);
(iii) the primary pack; and
(b) in relation to a therapeutic vaping pack—a display of printed information on, or attached to, the pack.
main label means:
(a) the label, or part of the label, that is most likely to be displayed, presented, shown, or examined under ordinary or customary conditions of display; and
(b) if there are 2 or more labels:
(i) the label, or part of the label, where the name of the good is more or most conspicuously displayed; or
(ii) if the name of the good is equally more or most conspicuously displayed on more than one of those labels—each of the labels on which the name of the good is equally more or most conspicuously displayed.
MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
MDSO means the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023.
Note: MDSO is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.
menthol flavour means the taste or smell that a reasonable person would associate with menthol as a purified ingredient.
mint flavour means the taste or smell that a reasonable person would associate with herbaceous plants of a recognised species in the Mentha genus.
name, in relation to relevant goods and therapeutic vaping packs, means:
(a) where the name of the goods has been registered under the Trade Marks Act 1995—the registered trade mark for the relevant goods; or
(b) in any other case—the unique, invented, common or scientific name;
that is assigned to the goods and that appears on one or more labels of the goods.
nicotine means nicotine in salt or base form.
Poisons Information Centre contact information means information to enable a person to contact a Poisons Information Centre that includes:
(a) the national telephone number for the Poisons Information Centre in Australia (13 11 26); or
(b) the telephone number for another poisons information centre:
(i) that is attended by adequately trained staff for 24-hour emergency poisons information; and
(ii) where calls to the centre are logged and submitted for incorporation into the official collection of poisoning data.
Regulations means the Therapeutic Goods Regulations 1990.
relevant goods means any of the following:
(a) a therapeutic vaping substance;
(b) a therapeutic vaping substance accessory;
(c) a therapeutic vaping kit.
relevant indications means one or both of the following:
(a) in relation to a therapeutic vaping substance, a therapeutic vaping substance accessory or a therapeutic vaping kit, including a therapeutic vaping substance or therapeutic vaping substance accessory that is contained in a therapeutic vaping pack or therapeutic vaping kit—the use for smoking cessation or the management of nicotine dependence;
(b) in relation to a therapeutic vaping device or a therapeutic vaping device accessory that is contained in a therapeutic vaping pack—the purpose to administer, or contain, a therapeutic vaping substance for which the only indication is use for smoking cessation or the management of nicotine dependence.
small container means a container that:
(a) has a capacity of 25 mL or less; and
(b) is not a very small container.
stated content means the concentration of nicotine that is stated on the label to be present in a therapeutic vaping substance or therapeutic vaping substance accessory.
text size means the height of the following:
(a) capital letters or lower case letters, including an ascender or descender;
(b) numbers or numerals;
(c) symbols.
TGO 95 means the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).
Note: TGO 95 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.
therapeutic vaping device has the same meaning as in the MD Regulations.
therapeutic vaping device accessory has the same meaning as in the MD Regulations.
therapeutic vaping kit has the same meaning as in the Regulations.
therapeutic vaping pack has the same meaning as in the Regulations.
therapeutic vaping substance has the same meaning as in the Regulations.
therapeutic vaping substance accessory has the same meaning as in the Regulations.
tobacco flavour means the taste or smell that a reasonable person would associate with herbaceous plants of a recognised species in the Nicotiana genus.
very small container means a container that has a capacity of 5 mL or less.
(1) This instrument applies to the following goods for which the only indications are relevant indications: (a) therapeutic vaping substances; and (b) therapeutic vaping substance accessories; and (c) therapeutic vaping kits; and (d) goods in a therapeutic vaping pack; other than: (e) registered goods; or (f) goods manufactured in, or imported into, Australia for export only; or (g) therapeutic goods mentioned in item 1A of Schedule 5 to the Regulations where those goods are carried by the importer as a passenger on a ship or aircraft; or
Note: Item 1A of Schedule 5 to the Regulations relates to therapeutic vaping substance, therapeutic vaping substance accessories, therapeutic vaping kits and goods in a therapeutic vaping pack that are imported for use in the treatment of the traveller or another traveller in their care.
(h) therapeutic goods mentioned in item 16 of Schedule 5A to the Regulations; or
Note: Item 16 of Schedule 5A to the Regulations relates to nicotine in solution as a starting material for use in the manufacture of a therapeutic vaping substance, therapeutic vaping substance accessory or any other therapeutic good. Item 16 of Schedule 5A to the Regulations also relates to any other starting material that is an ingredient or component for use in the manufacture of a therapeutic vaping substance or a therapeutic vaping substance accessory.
(i) components or articles mentioned in item 2.18 of Part 2 of Schedule 4 to the MD Regulations; or
Note: Item 2.18 of Part 2 of Schedule 4 to the MD Regulations relates to components or articles imported for use in the manufacture of therapeutic vaping devices or therapeutic vaping device accessories.
(j) therapeutic goods mentioned in items 4, 8, 10, 11, or 12 of Schedule 5A to the Regulations, subject to compliance with conditions specified in those items.
Note: Items 4, 8, 10, 11 and 12 of Schedule 5A to the Regulations relate to therapeutic goods that are imported by particular persons or are part of the medical supplies of a visiting ship or aircraft.
(2) To avoid doubt, this instrument applies to: (a) therapeutic vaping substances and therapeutic vaping substance accessories that are contained in a therapeutic vaping kit; and (b) therapeutic vaping substances, therapeutic vaping substance accessories, therapeutic vaping device accessories and therapeutic vaping devices contained in a therapeutic vaping pack.
(1) The name of relevant goods must not:
(a) be in any way attractive to children or adolescents; or
(b) whether expressly or by implication—
(i) suggest that the goods are a food, beverage or cosmetic product; or
(ii) suggest that the goods have health benefits, including healing, vitalising, natural, organic or rejuvenating properties; or
(iii) suggest that the goods are safe, without harm or without side effects; or
(iv) promote the use or supply of the goods; or
(v) exaggerate, or be likely to exaggerate, the efficacy or performance of the goods; or
(vi) encourage, or be likely to encourage, inappropriate or excessive use of the goods.
(2) Goods in a therapeutic vaping pack must only be supplied in a therapeutic vaping pack where the name of the pack complies with subsection (1) as if the pack were relevant goods.
(1) Each therapeutic vaping substance and therapeutic vaping substance accessory in a therapeutic vaping kit or a therapeutic vaping pack must: (a) be a finished product; and (b) be indicated only for use for smoking cessation or the management of nicotine dependence; and (c) conform with the requirements for therapeutic vaping substances and therapeutic vaping substance accessories specified in this instrument (as applicable). (2) Each therapeutic vaping device and therapeutic vaping device accessory in a therapeutic vaping pack must: (a) be a finished product; and (b) be intended only to administer, or contain, a therapeutic vaping substance for which the only indication is use for smoking cessation or the management of nicotine dependence; and (c) conform with the following: (i) for a therapeutic vaping device or a therapeutic vaping device accessory to which the MDSO ordinarily applies—either the MDSO or the essential principles; (ii) for a therapeutic vaping device or a therapeutic vaping device accessory to which the MDSO does not ordinarily apply—the essential principles. (3) The goods in a therapeutic vaping pack must all be: (a) therapeutic goods; or (b) goods intended by the manufacturer of the goods to assist with the use of a therapeutic vaping device or therapeutic vaping device accessory.
All ingredients, other than flavouring agents that are not menthol, in a therapeutic vaping substance or a therapeutic vaping substance accessory must comply with one or more of the following:
(a) the British Pharmacopoeia;
(b) the European Pharmacopoeia;
(c) the United States Pharmacopeia-National Formulary.
(1) A therapeutic vaping substance or a therapeutic vaping substance accessory that contains nicotine must contain nicotine as the only active ingredient.
(2) The concentration of nicotine in a therapeutic vaping substance or a therapeutic vaping substance accessory must not be more than 50 mg/mL in solution (equivalent base form).
(3) The concentration of nicotine in a therapeutic vaping substance or therapeutic vaping substance accessory must be not less than 90.0% and not more than 110.0% of the stated content.
(4) A therapeutic vaping substance or a therapeutic vaping substance accessory that does not contain nicotine must not contain any other active ingredient.
(1) Subject to subsection (2), only those ingredients that are specified in column 2 of the table in Schedule 1 to this instrument may be used in the manufacture of a therapeutic vaping substance or a therapeutic vaping substance accessory.
Note 1: See section 15 for requirements relating to containers of therapeutic vaping substance accessories.
Note 2: To avoid doubt, this subsection applies to the manufacture of therapeutic vaping substances including those contained in a therapeutic vaping substance accessory.
(2) For each item of the table in Schedule 1 to this instrument, the ingredient specified in column 2 must comply with the requirements (if any) specified in column 3.
For each item of the tables in Parts 1, 2 and 3 of Schedule 2 to this instrument, the substance specified in column 2 must:
(a) not be added to a therapeutic vaping substance or a therapeutic vaping substance accessory; and
(b) if present in a therapeutic vaping substance or a therapeutic vaping substance accessory—be present at a concentration below the limit specified in column 3.
(1) A therapeutic vaping substance or a therapeutic
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