Direction about advertisements: Precision Pharmaceuticals Pty Ltd

Material findings of fact

I make the following material findings of fact.

The complaint and investigation

1. On 11 December 2018, the TGA received a complaint about the therapeutic goods advertising which is the subject of this Direction through the TGA's Advertising Complaints portal.
2. The complaint referred to the advertising by Evolution Supplements of products containing Schedule 4 substances, including Selective Androgen Receptor Modulators (SARMs or SARMS)
3. The complaint also referred to other therapeutic goods being advertised by Evolution Supplements which are not permitted to be advertised under the TG Act because they are not entered in the ARTG and because these products include Cardarine, a Schedule 10 substance.
4. In the course of investigating the complaint, the TGA identified a range of non-compliant advertising materials on the websites for Evolution Supplements, being [REDACTED WEB ADDRESS] and [REDACTED WEB ADDRESS], on the Facebook pages at [REDACTED WEB ADDRESS], and on the Instagram pages at [REDACTED WEB ADDRESS] (together, the Advertisements). The Facebook and Instagram pages were both linked to the websites for Evolution Supplements.
5. Among the Advertisements were a range of advertisements featuring substances, or goods containing substances included in Schedule 4 to the current Poisons Standard (the Schedule 4 products). The Schedule 4 products included:
   1. SARMs;
   2. S-4;
   3. S-23;
   4. Testosterone;
   5. Androsterone;
   6. SR9009;
   7. Mk-677 / Ibutamoren / Nutrobal;
   8. Yohimbine; and
   9. Aminophylline.
6. Section 42DL of the TG Act prohibits the advertising of substances, or goods containing substances, included in Schedule 4 to the current Poisons Standard, subject to exceptions which do not apply in this case. I have included relevant extracts from the websites and social media pages featuring the Schedule 4 products in Attachment E.
7. The TGA also identified Advertisements for substances, or goods containing substances included in Schedule 10 to the current Poisons Standard (the Schedule 10 products) on the websites and social media pages referred to above. The Schedule 10 products included:
   1. Cardarine / GW501516; and
   2. 1,3 Dimethylamylamine (DMAA).
8. A search of the ARTG conducted by the TGA on 22 January 2019 determined that neither the Schedule 4 products nor the Schedule 10 products featured in the Advertisements are entered in the ARTG. Section 42DL of the TG Act prohibits the advertisement of therapeutic goods which are not entered in the ARTG, subject to exceptions which do not apply in this case.
9. I note that substances are included in Schedule 10 to the Poisons Standard if they are 'substances of such danger to health as to warrant prohibition of sale, supply and use'. The advertising and supply of the Schedule 10 products presents a serious risk to the health of consumers.
10. I have included extracts from the website pages relating to the Schedule 10 products in Attachment F.

Communication between the TGA and Evolution Supplements

11. On 24 December 2018, the TGA sent you a warning letter stating that the TGA considered that advertisements on the websites [REDACTED WEB ADDRESS] and [REDACTED WEB ADDRESS] were in contravention of Part 5-1 of the TG Act.
12. The warning letter requested that you immediately take down all advertisements of the Schedule 4 products and the Schedule 10 products, including all advertisements or references to the products on social media sites, and invited you to make submissions to the TGA in response to the matters raised in that letter by 2 January 2019.
13. As the TGA did not receive any response to the warning letter, a departmental officer, [REDACTED], telephoned you on 17 January 2019 to confirm that you had received the warning letter. You confirmed to [REDACTED] that you had received the warning letter. You also stated that you did not wish to provide any written submissions in response to the warning letter, and that you would not take down the advertisements referred to in that letter.
14. In the absence of a response to the warning letter and your responses to the questions asked of you during [REDACTED]'s telephone discussion with you, the TGA sent a further letter to you by email on 18 January 2019 advising that the TGA was considering issuing a Direction to you pursuant to section 42DV of the TG Act requiring you to cease the Advertisements (the Proposed Direction Letter).
15. In the Proposed Direction Letter of 18 January 2019, you were invited to make submissions, or provide any further information or evidence which may have been relevant to my decision as to whether to issue a Direction. You were asked to respond to the Proposed Direction Letter by 12 noon on 22 January 2019.
16. As at the date of this Direction, you have not provided any response to the Proposed Direction Letter.

Statement of reasons for making this direction

17. Subsection 42DL(2) of the Act provides that a person commits an offence if:
    1. the person:
       1. advertises, by any means, therapeutic goods; or
       2. causes the advertising, by any means, of therapeutic goods; and
    2. subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement.
18. Section 3 of the TG Act defines therapeutic goods as goods 'that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be… for therapeutic use...', subject to exceptions which do not apply in this case. Therapeutic use is further defined as meaning use in or in connection with, among other matters, 'influencing, inhibiting or modifying a physiological process in persons'.
19. I am satisfied that the Schedule 4 products and Schedule 10 products fall within this definition, noting that they are being presented on your website as products which are capable of influencing physiological processes in persons, and am therefore satisfied that the Schedule 4 products and the Schedule 10 products are therapeutic goods within the meaning of section 3 of the TG Act.
20. The definition of 'advertise' in subsection 3(1) of the TG Act relevantly provides that:

    advertise, in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:

    1. is on the label of the goods; or
    2. is on the package in which the goods are contained; or
    3. is on any material included with the package in which the goods are contained."

21. I am satisfied that the references to the Schedule 4 products and the Schedule 10 products on the websites and social media pages referred to above meet the definition of 'advertise' under the TG Act, insofar as they consist of statements and pictorial representations which are intended to promote the use or supply of those products.
22. Subsection 42DL(10) of the Act applies to an advertisement:

    ... if it refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

23. I am satisfied that the website includes advertisements which refer to substances, or goods containing substances, included in Schedule 4 to the Poisons Standard, being the Schedule 4 products. In the absence of any authorisation or requirement by a government or government authority, I am therefore satisfied that subsection 42DL(10) of the Act applies to the Advertisements, to the extent that they refer to the Schedule 4 products.
24. Subsection 42DL(12) of the Act applies to an advertisement:

    ... if it refers to therapeutic goods that are not entered in the Register and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

25. Regulation 7(i) of the Therapeutic Goods Regulations 1990 (the Regulations) prescribes, for the purposes of subsection 42DL(12) of the Act, 'therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act'.
26. I am satisfied that the products referred to in the Advertisements are not entered in the ARTG. I am further not aware of any exemption, approval or authority which would apply to the products referred to in the Advertisements. Accordingly, I consider that subsection 42DL(12) of the Act applies to the Advertisements.
27. On the basis of my conclusion that the goods are therapeutic goods, that you have advertised the goods or caused those goods to be advertised, and that subsections 42DL(10) and 42DL(12) apply to the Advertisements, I am satisfied that the Advertisements are in contravention of section 42DL(2) of the Act.
28. I am further satisfied that the Advertisements create a risk of serious harm to the health and safety of consumers. In this respect, I note that Schedule 4 products are required by law to be supplied only by prescription issued by a qualified medical practitioner. The sale of such substances without appropriate medical supervision creates a real risk of abuse and substantial harm to consumers of the products.
29. Schedule 10 products are products 'substances of such danger to health as to warrant prohibition of sale, supply and use', and the continued advertising and supply of such products accordingly presents an extremely serious risk to the health and safety of consumers. I am satisfied, having regard to these health risks, that it is necessary to take steps to ensure that the Advertisements cease, and that it would be appropriate to issue a Direction for that purpose.
30. In coming to my decision, I have considered relevant parts of the Act, the Regulations, the ARTG and the Poisons Standard, as well as the warning letter, your response to the warning letter during the telephone discussion with [REDACTED] on 17 January 2019, the further letter dated 18 January 2019 and screenshots of the Advertisements.

Decision

31. For the reasons set out above, I am satisfied that the Advertisements are in contravention of subsection 42DL(2) of the TG Act. I am further satisfied that it is appropriate to make a direction requiring that you cease the Advertisements, noting that you have refused to do so to date, and that the continuing advertisement of the relevant products presents a potential risk to the health of consumers.
32. Accordingly, I make the Direction set out in paragraphs 1 and 2 of this Direction, together with the associated conditions identified in paragraph 3.

EFFECT OF NOT COMPLYING WITH THIS/THESE DIRECTIONS

If you contravene a Direction made under subsection 42DV(1) or a Condition of a Direction made under subsection 42DV(2) of the TG Act, you may breach criminal offence provisions under section 42DW or contravene a civil penalty provision under section 42DX which could lead to court action against you.

The TGA could also issue you an infringement notice as an alternative to these actions (Part 5A-2 of the TG Act).

In conjunction with pursuing civil or criminal sanctions, the TGA may also seek an injunction from the Federal Court of Australia to immediately cease your advertising (Part 5A-4 of the TG Act).

Please Note:

The TGA can alert the public to the TGA's concerns about particular therapeutic goods advertising through the use of public warning notices (section 42DY).

Further, subsection 42DV(6) of the TG Act provides:

As soon as practicable after giving a direction under subsection (1) or (2), the Secretary must cause the direction to be published on the Department's website.

Relevant extracts from the Therapeutic Goods Act 1989

Part 5-1 - Advertising and generic information

42DL Advertising offences - general

1. A person commits an offence if:
   1. the person:
      1. advertises, by any means, therapeutic goods; or
      2. causes the advertising, by any means, of therapeutic goods; and
   2. subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement; and
   3. either:
      1. the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or
      2. the use of the goods in reliance on the advertisement, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person.
   Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
2. A person commits an offence if:
   1. the person:
      1. advertises, by any means, therapeutic goods; or
      2. causes the advertising, by any means, of therapeutic goods; and
   2. subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement.
   Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
3. A person commits an offence if:
   1. the person:
      1. advertises, by any means, therapeutic goods; or
      2. causes the advertising, by any means, of therapeutic goods; and
   2. subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement.
   Penalty: 100 penalty units.
4. An offence against subsection (3) is an offence of strict liability.

Contravening provisions

5. This subsection applies to the advertisement if it contains a prohibited representation (whether in express terms or by necessary implication) about the goods and either of the following applies:
   1. no permission under section 42DK is in force in relation to the prohibited representation;
   2. a permission under section 42DK is in force in relation to the prohibited representation but the use of the prohibited representation is not in accordance with the permission or a condition of the permission.
6. This subsection applies to the advertisement if it does not contain a required representation about the goods.
7. This subsection applies to the advertisement if it contains a restricted representation (whether in express terms or by necessary implication) and either of the following applies:
   1. neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation;
   2. an approval under section 42DF or a permission under section 42DK is in force in relation to the restricted representation but the use of the restricted representation is not in accordance with the approval or permission or a condition of the approval or permission.
8. This subsection applies to the advertisement if it contains a reference to this Act, other than in a statement of the registration number, listing number or device number of the goods.
9. This subsection applies to the advertisement if it contains a statement, pictorial representation or design suggesting or implying the goods have been recommended or approved by or on behalf of a government or government authority (including a foreign government or foreign government authority), other than:
   1. a statement of the availability of the goods as a pharmaceutical benefit; or
   2. a statement, pictorial representation or design authorised or required by a government or government authority (not including a foreign government or foreign government authority); or
   3. a statement, pictorial representation or design prescribed by the regulations for the purposes of this paragraph.
10. This subsection applies to the advertisement if it refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).
11. This subsection applies to the advertisement if it refers to a biological, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).
12. This subsection applies to the advertisement if it refers to therapeutic goods that are not entered in the Register and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

Continuing offences

13. A person who contravenes subsection (1), (2) or (3) commits a separate offence in respect of each day (including a day of a conviction for the offence or any later day) during which the contravention continues.
14. The maximum penalty for each day that an offence against subsection (1), (2) or (3) continues is 10% of the maximum pecuniary penalty that can be imposed in respect of that offence.

Division 6 - Directions about advertisements or generic information

42DV Directions about advertisements or generic information

Advertisements

1. If, in relation to the advertising of therapeutic goods, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the therapeutic goods, or for causing the advertising of the therapeutic goods, to do one or more of the following:
   1. cease the advertisement;
   2. make a retraction;
   3. make a correction;
   4. recover any advertisement that is still in circulation;
   5. destroy the advertisement;
   6. cease making a particular claim or representation made by the advertisement.

Generic information

2. If, in relation to the dissemination of generic information about therapeutic goods to the public or a section of the public, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for the dissemination, or for causing the dissemination, to do one or more of the following:
   1. withdraw the generic information;
   2. make a retraction;
   3. make a correction;
   4. recover any generic information that is still in circulation;
   5. destroy the generic information;
   6. cease making a particular claim or representation made by the generic information.

Conditions

3. A direction under subsection (1) or (2) may be subject to conditions specified in the direction.
4. Without limiting subsection (3), the conditions may relate to one or more of the following:
   1. the period for doing a thing the subject of the direction;
   2. in relation to the making of a retraction or correction, either or both of the following:
      1. the form and manner of the retraction or correction;
      2. the period for which the retraction or correction must be made publicly available;
   3. the reporting to the Secretary of compliance with the direction.

Direction not a legislative instrument

5. A direction under subsection (1) or (2) is not a legislative instrument.

Publication

6. As soon as practicable after giving a direction under subsection (1) or (2), the Secretary must cause the direction to be published on the Department's website.

42DW Offences—contravening direction under section 42DV

1. A person commits an offence if:
   1. the Secretary has given a direction to the person under subsection 42DV(1) or (2) in relation to therapeutic goods; and
   2. the person does an act or omits to do an act; and
   3. the act or omission contravenes the direction or a condition of the direction; and
   4. either:
      1. the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or
      2. the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and
   5. the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because of the contravention.
   Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
2. A person commits an offence if:
   1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
   2. the person does an act or omits to do an act; and
   3. the act or omission contravenes the direction or a condition of the direction.
   Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
3. A person commits an offence if:
   1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
   2. the person does an act or omits to do an act; and
   3. the act or omission contravenes the direction or a condition of the direction.
   Penalty: 100 penalty units.
4. An offence against subsection (3) is an offence of strict liability.

42DX Civil penalty for contravening direction under section 42DV

A person contravenes this section if:

1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
2. the person does an act or omits to do an act; and
3. the act or omission contravenes the direction or a condition of the direction.

Maximum civil penalty:

1. for an individual - 5,000 penalty units; and
2. for a body corporate - 50,000 penalty units.

Request for reconsideration of an initial decision

This decision is a reviewable initial decision under section 60 of the TG Act. Under section 60, a person whose interests are affected by a 'reviewable' initial decision, can seek reconsideration of the initial decision.

As this document constitutes written notice of the making of an initial decision being given by the Secretary, a request for reconsideration of this initial decision must be given to the Minister within 90 days and be accompanied by any information that you wish to have considered. A request for reconsideration given to the Minister outside the statutory 90 day reconsideration period cannot be accepted.

The Minister may either personally undertake a request for reconsideration of an initial decision or delegate to an officer of the Department with the appropriate delegation.

Under section 60(3A) of the TG Act, the Minister (or the Minister's delegate) is not able to consider any information provided after the notification is made of a request for reconsideration of an initial decision unless the information is provided in response to a request from the Minister (or the Minister's delegate), or it is information that indicates that the quality, safety or efficacy of the relevant therapeutic goods is unacceptable.

Guidelines for requesting reconsideration of an initial decision

A request for reconsideration should be made in writing, signed and dated by the person requesting reconsideration, should be titled "<insert person/company name> - Request for Reconsideration Under Section 60 of the Therapeutic Goods Act 1989" and should include the following:

• a copy of the initial decision notification letter (or other evidence of notification);
• identify, and describe with as much specificity as possible, which component(s) of the initial decision should be reconsidered and set out the reasons why reconsideration is requested;
• any information/documentation in support of the request, clearly labelled to correspond with (any or each of) the reasons why reconsideration is requested; and
• an email address nominated for the purposes of receiving correspondence in relation to the request for reconsideration.

All requests for reconsideration should be given to the Minister by email:

Email: 'minister.hunt.DLO@health.gov.au' and copied to 'decision.review@health.gov.au'

Requests for reconsideration that include dossiers (or similar bulk material) that cannot easily be attached to the request given first by email, may then be submitted on a USB drive or CD sent by express post or registered mail to:

Mail:

Minister for Health
Suite M1 40
c/- Parliament House
CANBERRA ACT 2600

If upon reconsideration by the Minister (or the Minister's delegate), you are dissatisfied with that decision, you can apply to the Administrative Appeals Tribunal (AAT) for a review of that decision (see the Administrative Appeals Tribunal Act 1975 (AAT Act)).

NOTE: This initial decision remains in effect unless and until it is revoked or revoked and substituted by the Minister (or the Minister's delegate) as a result of a request for reconsideration under section 60 of the TG Act OR is set aside, varied or remitted by the AAT or is otherwise overturned or stayed.

Schedule 4 substances referred to in this Direction

Examples

(Note: These examples do not represent all instances where information relating to Schedule 4 substances is being advertised by Evolution Supplements.)

SARMS

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

Mk-677

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

TESTOSTERONE

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

YOHIMBINE

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

S-23

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

AMINOPHYLLINE

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

ANDROSTERONE

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

Schedule 10 substances not entered on the ARTG and referred to in this Direction

EXAMPLES

(Note: These examples do not represent all instances where information relating to Schedule 10 substances is being advertised by Evolution Supplements.)

CARDARINE

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

DMAA

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]

[REDACTED WEB ADDRESS]

[REDACTED SCREENSHOT]