Part 1Preliminary
1 Name
(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.
3 Authority
This instrument is made under section 10 of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) container;
(aa) essential principles;
(b) export only medicine;
(c) label;
(d) manufacture;
(e) medicine;
(f) primary pack;
(g) Register;
(h) registered goods;
(i) sponsor;
(j) standard;
(k) supply;
(l) therapeutic goods.
In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Regulations.
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.
nicotine means nicotine in salt or base form.
Regulations means the Therapeutic Goods Regulations 1990.
stated content means any amount or concentration of nicotine that is stated to be present on a label, including where the amount or concentration is stated as the equivalent base form amount or concentration of nicotine.
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.
5 Standard
The matters specified in this instrument constitute a standard for the following:
(a) therapeutic vaping substances;
(b) therapeutic vaping substance accessories;
(c) therapeutic vaping kits;
(d) goods in a therapeutic vaping pack.
6 Application
(1) Subject to subsection (2), this instrument applies to:
(a) therapeutic vaping substances;
(b) therapeutic vaping substance accessories;
(c) therapeutic vaping kits;
(d) goods in a therapeutic vaping pack;
that are finished products and the only indications for the goods are use for smoking cessation or the management of nicotine dependence.
(2) This instrument does not apply to:
(a) registered goods; or
(b) goods manufactured in, or imported into, Australia for export only; or
(c) 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 1: 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.
(d) therapeutic goods mentioned in item 16 of Schedule 5A to the Regulations; or
Note 2: 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.
(e) components or articles mentioned in item 2.18 of Part 2 of Schedule 4 to the MD Regulations; or
Note 3: 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.
(f) 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 4: 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.
Part 2Therapeutic vaping substances and therapeutic vaping substance accessories
7 Ingredients
Active ingredients
(1) A therapeutic vaping substance or therapeutic vaping substance that contains nicotine must contain nicotine as the only active ingredient and:
(a) where the nicotine is in base form—the base form concentration of nicotine must be not more than 100 mg/mL; or
(b) where the nicotine is in salt form—the equivalent base form concentration of nicotine must be not more than 100 mg/mL.
(2) The amount or concentration of nicotine in a therapeutic vaping substance or therapeutic vaping substance accessory must be not less than 90.0 per cent and not more than 110.0 per cent of the stated content.
(2A) A therapeutic vaping substance or therapeutic vaping substance accessory that does not contain nicotine must not contain any active ingredient.
Prohibited ingredients
(3) A substance specified in Schedule 1 must not be added as an ingredient to a therapeutic vaping substance or therapeutic substance accessory.
Flavour
(4) A therapeutic vaping substance or therapeutic vaping substance accessory may only contain ingredients or components that produce the taste or smell that a reasonable person would associate with:
(a) mint or menthol flavour; or
(b) tobacco flavour.
(5) A therapeutic vaping substance or therapeutic substance accessory must not contain ingredients or components that produce a combination of flavours.
Note: Examples of flavour combinations that are not permitted include cherry mint, chocolate mint and tobacco mint.
8 Labels
(1) A therapeutic vaping substance or therapeutic vaping substance accessory must be labelled in accordance with this section.
(2) Where a therapeutic vaping substance or therapeutic vaping substance contains nicotine, then the information specified in an item in the table in Part 1 of Schedule 2 must be:
(a) on or attached to the container or the primary pack of a therapeutic vaping substance or therapeutic vaping substance accessory; or
(b) supplied with the container or the primary pack of a therapeutic vaping substance or therapeutic vaping substance accessory.
Note 1: A label, in relation to therapeutic goods, is the display of printed information on or attached to the goods, on or attached to the container or primary pack in which the goods are supplied, or supplied with such a container or pack: see subsection 3(1) of the Act.
Note 2: Labels include displays of printed information on stickers placed over the container or primary pack of therapeutic goods, and information sheets supplied with the container or primary pack of therapeutic goods.
Example: A therapeutic vaping substance or therapeutic vaping substance accessory that contains nicotine complies with this subsection if the information specified in items 1 and 2 of Part 1 to Schedule 2 is printed on a sticker placed over the container of the substance or substance accessory and the information specified in item 3 of Part 2 to Schedule 2 is printed on an information sheet supplied with that container.
(3) Where a therapeutic vaping substance or therapeutic vaping substance accessory does not contain nicotine, then the information specified in an item in the table in Part 2 of Schedule 2 must be:
(a) on or attached to the container or the primary pack of a therapeutic vaping substance or therapeutic vaping substance accessory; or
(b) supplied with the container or the primary pack of a therapeutic vaping substance or therapeutic vaping substance accessory.
Note 1: A label, in relation to therapeutic goods, is the display of printed information on or attached to the goods, on or attached to the container or primary pack in which the goods are supplied, or supplied with such a container or pack: see subsection 3(1) of the Act.
Note 2: Labels include displays of printed information on stickers placed over the container or primary pack of therapeutic goods, and information sheets supplied with the container or primary pack of therapeutic goods.
Example: A therapeutic vaping substance or therapeutic vaping substance accessory that does not contain nicotine complies with this subsection if the information specified in items 1 and 2 of Part 2 to Schedule 2 is printed on a sticker placed over the container of the substance or substance accessory, and the information specified in item 3 of Part 2 to Schedule 2 is printed on an information sheet supplied with that container.
(3) All of the information that is displayed on the label of a therapeutic vaping substance or therapeutic vaping substance accessory must be:
(a) in English; and
(b) legible; and
(c) visible and not obscured; and
(d) durable.
9 Child-resistant packaging
(1) A therapeutic vaping substance or therapeutic vaping substance accessory must comply with the requirements specified in the following sections of TGO 95 (child-resistant packaging requirements):
(a) section 8 (general requirements); and
(b) where the product is in a reclosable package—section 9 (reclosable packages), other than subsection 9(6); and
(c) where the product is in a non-reclosable package—section 10 (non-reclosable packages).
(2) A therapeutic vaping substance or therapeutic vaping substance accessory is taken to comply with the child-resistant packaging requirements if one of the following paragraphs applies:
(a) the product is packaged for supply in Canada and complies with the requirements in relation to child-resistant packaging specified in sections 50 to 54 of the Vaping Products Labelling and Packaging Regulations of Canada, as in force or existing from time to time;
(b) the product is packaged for supply in the European Union and complies with the requirements in relation to child-resistant packaging specified in Article 20(3)(g) of the Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014, as in force or existing from time to time;
(c) the product is packaged for supply in New Zealand and complies with the requirements in relation to child-resistant packaging specified in regulations made under the Smokefree Environments and Regulated Products Act 1990 (NZ), as in force or existing from time to time;
(d) the product is packaged for supply in the United Kingdom and complies with the requirements in relation to child-resistant packaging specified in paragraph 36(7) of the Tobacco and Related Products Regulations 2016 of the United Kingdom, as in force or existing from time to time;
(e) the product is packaged for supply in the United States and complies with the requirements in relation to child-resistant packaging specified in 16 CFR § 1700.15 of the Poison prevention packaging standards of the United States, as in force or existing from time to time.
Note: To avoid doubt, a paragraph of this subsection only applies where the laws of the relevant jurisdiction specify requirements in relation to child-resistant packaging.
10 Record-keeping
(1) Records in relation to a therapeutic vaping substance or therapeutic vaping substance accessory must be maintained by the sponsor of the product.
(2) The records must contain sufficient information to demonstrate that the therapeutic vaping substance or therapeutic vaping substance accessory conforms with this standard.
(3) This section does not apply in relation to a therapeutic vaping substance or therapeutic vaping substance accessory that is imported into Australia in accordance with item 1A of Schedule 5 to the Regulations.
11 Alternative conformity
(1) A therapeutic vaping substance or therapeutic vaping substance accessory that contains nicotine is taken to comply with the requirements specified in sections 7, 9, and 10, if the product:
(a) is a new tobacco product within the meaning of section 910(a) of the Federal Food, Drug, and Cosmetic Act; and
(b) is the subject of an order issued under section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act; and
(c) complies with all requirements specified in the order mentioned in paragraph (b).
Note 1: An order issued under section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act is commonly referred to as a premarket tobacco product marketing order.
Note 2: A premarket tobacco product marketing order may only be issued in relation to a new tobacco product that is the subject of a premarket tobacco product application for which a premarket review has been conducted by the United States Food and Drug Administration, determining that the marketing of the product is appropriate for the protection of public health in accordance with section 910(c)(4) of the Federal Food, Drug, and Cosmetic Act.
Note 3: The United States Food and Drug Administration publishes a list of premarket tobacco product marketing orders on its website at www.fda.gov.
(2) For the purposes of this section, a reference to the Federal Food, Drug, and Cosmetic Act is a reference to that Act of the United States, as in force or existing from time to time.
12 Therapeutic vaping substance accessories
A therapeutic vaping substance accessory must comply with the following:
(a) for a therapeutic vaping substance accessory that, if it did not contain a therapeutic vaping substance, would be a therapeutic vaping device accessory to which the MDSO ordinarily applies—either:
(i) the MDSO; or
(ii) the essential principles;
(b) for a therapeutic vaping substance accessory that, if it did not contain a therapeutic vaping substance, would be a therapeutic vaping device accessory to which the MDSO does not ordinarily apply—the essential principles.
Part 3Therapeutic vaping kits
13 Goods in a therapeutic vaping kit
Each therapeutic vaping substance and therapeutic vaping substance accessory in a therapeutic vaping kit must comply with Part 2.
Part 4Therapeutic vaping packs
14 Goods in a therapeutic vaping pack
Therapeutic vaping substances and therapeutic vaping substance accessory
(1) Each therapeutic vaping substance or therapeutic vaping substance accessory in therapeutic vaping pack must comply with Part 2.
Therapeutic vaping device, therapeutic vaping device accessory and therapeutic vaping substance accessory
(2) Each good in a therapeutic vaping pack, other than a therapeutic vaping substance, must comply with the following:
(a) for a therapeutic vaping device or therapeutic vaping device accessory to which the MDSO ordinarily applies—either:
(i) the MDSO; or
(ii) the essential principles;
(b) for a therapeutic vaping device or therapeutic vaping device accessory to which the MDSO does not ordinarily apply—the essential principles.
Part 5Transitional provisions
15 Transitional
(1) In this section:
former TGO 110 means the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021, as in force immediately before the commencement of the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Amendment (Vaping) Order 2023.
(2) Despite the amendments made by the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Amendment (Vaping) Order 2023, the former TGO 110 continues to apply in relation to therapeutic vaping substances, therapeutic vaping substance accessories, therapeutic vaping kits, and goods in therapeutic vaping packs that are imported or manufactured before 1 March 2024.
(3) Subsection (2) ceases to apply on 1 July 2024.
Schedule 1—Prohibited ingredients
Note: See subsection 7(3).
Prohibited ingredients |
Column 1 | Column 2 |
Item | Ingredient |
1 | 2,3-pentanedione |
2 | acetoin |
3 | benzaldehyde |
4 | cinnamaldehyde |
5 | diacetyl |
6 | diethylene glycol |
7 | dl-alpha-tocopheryl acetate |
8 | ethylene glycol |
Schedule 2—Labelling information
Note: See section 8.
Part 1—Therapeutic vaping substances and accessories that contain nicotine
Labelling information |
Column 1 | Column 2 |
Item | Information |
1 | a list of ingredients contained in the therapeutic vaping substance or therapeutic vaping substance accessory as follows: (a) the name of each active ingredient; and (b) the name of each other ingredient, other than the ingredients or components of a flavour; and (c) where the product contains mint or menthol flavour, or tobacco flavour: (i) the word “flavour” or a description that includes the word “flavour” (such as “mint flavour”); or (ii) the name of each ingredient or component producing that flavour |
2 | the concentration of nicotine contained in the therapeutic vaping substance or therapeutic vaping substance accessory as follows: (a) where the nicotine is in base form—the base form concentration of nicotine in mg/mL; or (b) where the nicotine is in salt form— the equivalent base form concentration of nicotine in mg/mL |
3 | the following warning statements: (a) “KEEP OUT OF REACH OF CHILDREN”; and (b) “Avoid contact with eyes”; and (c) “Avoid contact with skin” |
Part 2—Therapeutic vaping substances and accessories that do not contain nicotine
Labelling information |
Column 1 | Column 2 |
Item | Information |
1 | a list of ingredients contained in the therapeutic vaping substance or therapeutic vaping substance accessory as follows: (a) the name of each ingredient, other than the ingredients or components of a flavour; and (b) where the product contains mint or menthol flavour, or tobacco flavour: (i) the word “flavour” or a description that includes the word “flavour” (such as “mint flavour”); or (ii) the name of each ingredient or component producing that flavour |
2 | a statement that the therapeutic vaping substance or therapeutic vaping substance accessory does not contain nicotine Note The statement may be in the form of words or alphanumerical characters, for example “zero-nicotine”, “0% nicotine” or “0 mg/mL nicotine”. |
3 | the following warning statement: (a) “KEEP OUT OF REACH OF CHILDREN” |
