Direction about advertisements: ESR You Pty Ltd

Material findings of fact

I make the following material findings of fact.

The complaint and the investigation

1. The TGA received a complaint on 27 February 2019 about the advertising of Schedule 4 substances and products not entered in the ARTG, on various webpages.
2. The TGA investigated the complaint and examined the advertising material provided by the complainant. As part of the investigation, the TGA also identified relevant additional advertising materials on the ESR You website ([REDACTED WEB ADDRESS]) (the Website) and ESR You Facebook page ([REDACTED WEB ADDRESS]).
3. I have attached examples of the relevant extracts from the website in Attachment E.
4. References were made in advertisements of products on the Website to a number of Selective Androgen Receptor Modulators (SARMS), including:
   1. RAD 140;
   2. LGD-4033;
   3. SR9009; and
   4. YK11.
5. These products continue to be advertised on the Website, however I note that references to the specific SARMs identified above have been removed from the relevant advertising material.
6. The TGA has identified a range of further advertisements of therapeutic goods which are in contravention of the TG Act because they include references to:
   1. SARMs, including as a part of the term 'Pro SARMs'; and
   2. Testosterone.
7. The advertisements of therapeutic goods which contain references to the above substances are prohibited under Part 5-1 of the TG Act (see subsections 42DL(10) and 42DLB(7)) because the substances referred to are included in Schedule 4 of the current Poisons Standard (schedule 4 substances), or belong to a class of goods contained in Schedule 4.

The advertising of products which are therapeutic goods

8. I am of the view that all of the products currently described on the website as 'Capsules', 'Nano Peptides' and 'Pro SARMS' (the products) are therapeutic goods, including but not limited to:
   1. Y3 One a day
   2. E1 Endurance
   3. R1 Pro SARMS
   4. Y1 Pro SARMS
9. The products referred to in paragraph 8 above meet the definition of therapeutic goods because they are represented to be for therapeutic use, within the meaning of subsection 3(1) of the TG Act and none of the potentially applicable exclusions apply to that requirement. No order under section 7 has been made declaring these goods not to be therapeutic goods for the purposes of the TG Act. There is no applicable food standard or tradition of use of any of the goods as a food in Australia or New Zealand in the form of capsules and/ or the active ingredients as presented. There are likewise no determinations under subsections 7AA(1) of 7AA(2) of the TG Act relevant to these goods.
10. A search by the TGA of the ARTG on 10 July 2019 found that none of the products are included in the ARTG.
11. Therapeutic goods for commercial supply in Australia are required to be included in the ARTG prior to supply, unless exempted or excluded from this requirement. I am not aware of any relevant exemption or exclusion applicable to the Products.

Communication with the Advertiser

12. On 17 May 2019, the TGA sent a letter to you by email, advising you that the TGA was of the view that advertisements present on the website [REDACTED WEB ADDRESS] were in contravention of Part 5-1 of the TG Act (the Warning Letter).
13. Paragraph 11 of the Warning Letter requested that you immediately remove all advertisements for therapeutic goods not included in the ARTG from the website, cease supplying such goods, and remove all references to schedule 4 substances from your advertising.
14. In the same paragraph of the Warning Letter, you were advised to determine whether any of your social media channels, including but not limited to Facebook, Instagram and YouTube, contain references to schedule 4 substances or otherwise contravene the TG Act, and immediately remove all references to those products from your social media channels.
15. The Warning Letter noted that the TGA was considering making a direction that you cease advertising the Products, and invited you to make any submissions which are relevant to a decision as to whether to issue the Direction, or provide any further information or evidence, by 24 May 2019.
16. On 18 May 2019, the TGA received an email from an ESR You representative, who identified themselves as the business partner for ESR You and the person with responsibility for the supplements side of the company (the Business Partner). The email from the Business Partner confirmed receipt of the Warning Letter, and stated that a response to that letter would be provided by the due date of 24 May 2019.
17. On 24 May 2019 the TGA received an e-mail from the Business Partner, to which you were copied, requesting an extension to 28 May 2019, due to extenuating circumstances. The TGA subsequently wrote to you to note that the TGA reserves its rights to take further action at any time, noting that the Website remained online and the relevant contraventions of the TG Act were ongoing.
18. At the date of my decision, no response has been received from ESR You Pty Ltd, and advertisements depicting the Products continue to be unlawfully displayed on the Website and on ESR You Pty Ltd's social media channels (the Advertisements).

Statement of reasons for making this direction

19. Under section 42DV(1) of the TG Act, where the Secretary is satisfied that there has been a contravention of the TG Act in relation to the advertising of therapeutic goods, the Secretary, or her delegate may issue a direction to the person apparently responsible for that advertising or for causing the advertising of the therapeutic goods to do a number of things, including ceasing the relevant advertisements.
20. For the reasons set out below, I am issuing the above Direction to you on the basis that the Advertisements are in contravention of s 42DL(3) of the TG Act, and that you are the person apparently responsible for, or for causing, the Advertisements.
21. Subsection 42DL(3) of the TG 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.
22. 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...'. 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'. I am satisfied that the Products are therapeutic goods within the meaning of section 3 of the TG Act, noting that they are being presented on your website as products which are capable of influencing physiological processes in persons, and they do not appear to be the subject of any of the exceptions set out in that definition.
23. I am further satisfied that you have advertised, or caused the advertising of, the Products, to the extent that you have made statements in the Advertisements that are 'intended, whether directly or indirectly, to promote the use or supply of the goods' within the meaning of the definition of 'advertise' under s 3 of the TG Act.
24. Subsection 42DL(10) of the TG 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).

25. I am satisfied that a number of the Advertisements refer to substances included in Schedule 4 to the Poisons Standard, being the substances listed at paragraph 5 above. In the absence of any authorisation or requirement by a government or government authority, I therefore consider that subsection 42DL(10) of the TG Act applies to the Advertisements to the extent that they refer to Schedule 4 substances.
26. Subsection 42DL(12) of the TG 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).

27. Regulation 7(i) of the Therapeutic Goods Regulations 1990 (the Regulations) prescribes, for the purposes of subsection 42DL(12) of the TG 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'.
28. I am satisfied that the Products are not registered on the ARTG. I am further not aware of any exemption, approval or authority which would apply to the Products. Accordingly, I consider that subsection 42DL(12) of the TG Act applies to the Advertisements. On the basis of my conclusion that the Products are therapeutic goods, that you have advertised the Products or caused the Products to be advertised, and that subsections 42DL(10) (to the extent that the Advertisements refer to Schedule 4 substances) and 42DL(12) apply to the Advertisements, I am of the view that sufficient evidence exists that the Advertisements are in contravention of section 42DL(2) of the TG Act. Accordingly, I consider that there are grounds to issue this direction, under section 42DV of the TG Act, requiring you to immediately cease the Advertisements.
29. In coming to this view, I have considered relevant parts of the Act, the Regulations, the ARTG and the Poisons Standard, and screenshots of the Advertisements.

Summary

30. For the reasons set out above, I am satisfied that various contraventions of the TG Act to which I have referred have occurred. Accordingly, I make the Direction set out in paragraphs 1 and 2 of this letter together with the associated conditions.

EFFECT OF NOT COMPLYING WITH THIS/THESE DIRECTIONS

If you contravene a direction or a condition of a direction made under subsections 42DV(1) or (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.

In conjunction with pursuing civil or criminal sanctions, the TGA may also seek an injunction from a Federal Court to immediately cease your advertising.

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

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.

Additional contraventions of the Act

The specific products listed in this Directions notice are not intended to represent all the products that are being advertised in contravention of the TG Act by ESR YOU Pty Ltd.

You should perform a review of the website to ensure that you remove all products which are being advertised in non-compliance with the Act. You may wish to seek legal advice, or advice from a regulatory consultant, in connection with this issue.

If further action is required, including if the products listed in Annexures E and F (and/or other non-compliant products) continue to be advertised, the Department reserves its rights to pursue enforcement action, including escalating this matter to civil penalty proceedings or criminal prosecution, with respect to all of the contraventions of the Act by ESR YOU Pty Ltd in this matter.

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 nameγ - 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.

Products not entered on the ARTG and referred to in this Direction

Schedule 4 substance(s) referred to in this Direction