Therapeutic Goods (Declared Goods) Order 2019
made under section 7 of the
Therapeutic Goods Act 1989
Compilation No. 4
Compilation date: 1 March 2023
Includes amendments up to: F2023L00135
About this compilation
This compilation
This is a compilation of the Therapeutic Goods (Declared Goods) Order 2019 that shows the text of the law as amended and in force on 1 March 2023 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
1 Name
3 Authority
4 Definitions
5 Declared goodstherapeutic goods
6 Declared goodsnot therapeutic goods
Schedule 1—Therapeutic goods
Part 1—Therapeutic goods
Part 2—Therapeutic goods when used, advertised, or presented for supply in a particular way
Schedule 2—Not therapeutic goods
Part 1—Not therapeutic goods
Part 2—Not therapeutic goods when used, advertised, or presented for supply in a particular way
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
1 Name
This instrument is the Therapeutic Goods (Declared Goods) Order 2019.
3 Authority
This instrument is made under section 7 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) advertise;
(b) current Poisons Standard;
(c) manufacture;
(d) presentation;
(e) supply;
(f) therapeutic goods; and
(g) therapeutic use.
In this instrument:
Act means the Therapeutic Goods Act 1989.
capsule has the same meaning as in TGO 101.
pill has the same meaning as in TGO 101.
Prohibited List means the World Anti-Doping Code International Standard Prohibited List 2023 published by the World Anti-Doping Agency, as in force or existing on 1 March 2023.
Note: The Prohibited List is published on the World Anti-Doping Agency (WADA) website at https://www.wada‑ama.org/en.
relevant substance means any of the following substances, where the substance is not included in a schedule to the current Poisons Standard or expressly identified on the Prohibited List:
(a) dendrobium (Dendrobium nobile);
(b) methylliberine.
tablet has the same meaning as in TGO 101.
TGO 101 means the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.
Note: TGO 101 is a legislative instrument published on the Federal Register of Legislation at https://www.legislation.gov.au.
Trefriw Wells mineral water means naturally-occurring mineral water sourced from Trefriw Wells Spa in the United Kingdom.
5 Declared goodstherapeutic goods
(1) The goods or classes of goods specified in Part 1 of Schedule 1 to this instrument are declared to be therapeutic goods.
(2) The goods or classes of goods specified in column 2 of an item in the table in Part 2 of Schedule 1 to this instrument, when used, advertised, or presented for supply, in a way specified in column 3 of that item, are declared to be therapeutic goods.
6 Declared goodsnot therapeutic goods
(1) The goods or classes of goods specified in Part 1 of Schedule 2 to this instrument are declared not to be therapeutic goods.
(2) The goods or classes of goods specified in column 2 of an item in the table in Part 2 of Schedule 2 to this instrument, when used, advertised, or presented for supply, in a way specified in column 3 of that item, are declared not to be therapeutic goods.
Schedule 1—Therapeutic goods
Note: See section 5.
Part 1—Therapeutic goods
Goods that are therapeutic goods |
Column 1 | Column 2 |
Item | Goods or classes of goods |
1 | goods that are or contain Cellasene |
2 | goods that: (a) contain fibre; and (b) are manufactured in the dosage form of a tablet, capsule or pill |
3 | goods that: (a) contain, or are promoted to contain, isolated b-hydroxy-b-methylbutyrate (HMB) or its salts; and (b) are manufactured in the dosage form of a tablet, capsule, pill or powder |
4 | goods that: (a) contain shark cartilage; and (b) are manufactured in the dosage form of: (i) a tablet, capsule or pill; or (ii) a powder, where that powder is not a wholesale product for use as an ingredient in food |
Part 2—Therapeutic goods when used, advertised, or presented for supply in a particular way
Goods that are therapeutic goods when used, advertised, or presented for supply in a particular way |
Column 1 | Column 2 | Column 3 |
Item | Goods or classes of goods | Use, advertising or presentation |
1A | goods for oral administration that are represented (expressly or by implication) as being for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity, and that: (a) contain, or are represented (expressly or by implication) to contain, one or more of the following substances (however described or named): (i) a substance included in a schedule to the current Poisons Standard; or (ii) a substance expressly identified on the Prohibited List that is added as an ingredient to the goods; or (iii) a relevant substance that is added as an ingredient to the goods; or (iv) a substance with equivalent pharmacological action to a substance mentioned in subparagraph (i), (ii) or (iii), including those that may be characterised as an active principle, precursor, derivative, salt, ester, ether or stereoisomer; or (b) on or after 30 November 2023, are supplied in the dosage form of a tablet, capsule or pill, other than those goods containing glucose only | when the goods are used, advertised, or presented for supply: (a) for therapeutic use; or (b) in a way that is likely to be taken to be for therapeutic use; including, but not limited to, one or more of the following therapeutic uses: (c) gaining muscle; (d) increasing mental focus; (e) increasing metabolism; (f) increasing stamina; (g) increasing testosterone levels, reducing oestrogen levels or otherwise modifying hormone levels; (h) losing weight or fat; (i) preparing for workout; (j) recovering from workout |
1 | goods that are labelled or promoted for cosmetic purposes | when used, advertised or presented for supply for oral consumption |
2 | goods that contain Trefriw Wells mineral water | when used, advertised or presented for supply for therapeutic use: (a) as an iron supplement; and (b) in a single use sachet |
3 | goods that: (a) contain one or more of the following folate substances: (i) folic acid; or (ii) folinic acid; or (iii) levomefolic acid; or (iv) any other form of folate that may be characterised as an active principle, precursor, derivative, salt, ester, ether or stereoisomer; and (b) are represented as being food for special medical purposes, or being for dietary management of a disease, disorder or medical condition; whether or not the recommended single dose of the goods contains sufficient macronutrients to feed, either exclusively or partially, the person for whom the dose is intended | when used, advertised, or presented for supply: (a) for therapeutic use; or (b) in a way that is likely to be taken to be for therapeutic use; including, but not limited to, one or more of the following therapeutic uses: (c) preventing, curing or alleviating depression; (d) curing or alleviating an inborn error of folate metabolism; (e) preventing, curing or alleviating folate deficiency; and that therapeutic use can be taken to relate to a substance mentioned in paragraph (a) in column 2 of this item |
Schedule 2—Not therapeutic goods
Note: See section 6.
Part 1—Not therapeutic goods
Note This Part is reserved for future use.
Part 2—Not therapeutic goods when used, advertised, or presented for supply in a particular way
Goods that are not therapeutic goods when used, advertised, or presented for supply in a particular way |
Column 1 | Column 2 | Column 3 |
Item | Goods or classes of goods | Use, advertising or presentation |
1 | deodorant preparations | when used: (a) for dermal application; or (b) with therapeutic devices |
2 | depilatory preparations | when used for dermal application |
3 | non-prescription spectacles | when used solely for: (a) magnification of images; or (b) sun protection |
4 | non-sterile apparel including fitted support or insulating garments | when used solely to: (a) aid physical comfort; or (b) relieve discomfort |
6 | soaps and detergents, other than medicated soaps and detergents | when used for cleansing skin or hair |
7 | spa water or natural mineral water | when the goods are not used, advertised or presented for supply for therapeutic use |
8 | substances for use in the purification or treatment of drinking water | when the goods are not used, advertised or presented for supply for therapeutic use |
9 | unmedicated dental chewing gum | when advertised or presented for supply, the only benefits claimed to result from the use of the goods are consequential on improvements to oral hygiene |
Endnotes
Endnote 1—About the endnotes
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.
If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.
Endnote 2—Abbreviation key
ad = added or inserted | orig = original |
am = amended | par = paragraph(s)/subparagraph(s) |
amdt = amendment | /sub‑subparagraph(s) |
c = clause(s) | pres = present |
C[x] = Compilation No. x | prev = previous |
Ch = Chapter(s) | (prev…) = previously |
def = definition(s) | Pt = Part(s) |
Dict = Dictionary | r = regulation(s)/rule(s) |
disallowed = disallowed by Parliament | reloc = relocated |
Div = Division(s) | renum = renumbered |
exp = expires/expired or ceases/ceased to have | rep = repealed |
effect | rs = repealed and substituted |
F = Federal Register of Legislation | s = section(s)/subsection(s) |
gaz = gazette | Sch = Schedule(s) |
LA = Legislation Act 2003 | Sdiv = Subdivision(s) |
LIA = Legislative Instruments Act 2003 | SLI = Select Legislative Instrument |
(md not incorp) = misdescribed amendment | SR = Statutory Rules |
cannot be given effect | Sub‑Ch = Sub‑Chapter(s) |
mod = modified/modification | SubPt = Subpart(s) |
No. = Number(s) | underlining = whole or part not |
o = order(s) | commenced or to be commenced |
Ord = Ordinance | |
Endnote 3—Legislation history
Name | Registration | Commencement | Application, saving and transitional provisions |
Therapeutic Goods (Declared Goods) Order 2019 | 21 Oct 2019 (F2019L01352) | 22 Oct 2019 | |
Therapeutic Goods Amendment (Declared Goods) Order 2019 | 4 Nov 2019 (F2019L01419) | 5 Nov 2019 | |
Therapeutic Goods Amendment (Declared Goods) Order (No. 1) 2020 | 23 Apr 2020 (F2020L00465) | 24 Apr 2020 | |
Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020 | 23 Sep 2020 (F2020L01204) | 30 Nov 2020 | |
Therapeutic Goods (Declared Goods) Amendment (Prohibited List) Order 2023 | 23 Feb 2023 (F2023L00135) | 1 Mar 2023 | |
Endnote 4—Amendment history
Provision affected | How affected |
s 2……………………………….. | rep LA s 48D |
s 4……………………………….. | am F2020L01204; F2023L00135 |
Schedule 1 ……………………… Schedule 2 ……………………… | am F2019L01419; F2020L01204 am F2020L00465 |