Federal Register of Legislation - Australian Government

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Orders/Other as made
This instrument amends the Therapeutic Goods (Declared Goods) Order 2019 by declaring certain goods for oral administration that are represented as being for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity (commonly known as "sport supplements") to be therapeutic goods when used, advertised or presented for supply for therapeutic use, or in a way that is likely to be taken for therapeutic use.
Administered by: Health
Registered 23 Sep 2020
Tabling HistoryDate
Tabled HR06-Oct-2020
Tabled Senate06-Oct-2020
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020

I, John Skerritt, as delegate of the Secretary of the Department of Health, make the following order.

Dated 18 September 2020

Adjunct Professor John Skerritt

Deputy Secretary

Health Products Regulation Group

Department of Health

 


Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Schedules................................................................................................................................. 1

Schedule 1—Amendments                                                                                           2

Therapeutic Goods (Declared Goods) Order 2019                                                                         2

 

 


1  Name

                   This instrument is the Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

30 November 2020.

30 November 2020

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under section 7 of the Therapeutic Goods Act 1989.

4  Schedules

                   Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments

Therapeutic Goods (Declared Goods) Order 2019

1  Section 4 (note)

Repeal the note, substitute:

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.

2  Section 4

Insert:

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 (January 2020) published by the World Anti-Doping Agency, as in force or existing at 30 November 2020.

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.

3  Part 2 of Schedule 1 (before table item 1)

Insert:

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