Secretary, Department of Health v Evolution Supplements Australia Pty Ltd

Federal Court of Australia|2021-07-29|Before: Ms J, Burley J

Solicitor for the Applicant: Norton Rose Fulbright

Counsel for the Respondents: The Respondents did not appear

BETWEEN: SECETARY, DEPARTMENT OF HEALTH Applicant

order made by: BURLEY J DATE OF ORDER: 29 JULY 2021

Pursuant to s 42Y of the Therapeutic Goods Act 1989 (Cth) (TG Act), the first respondent is to pay to the Commonwealth of Australia a pecuniary penalty in the sum of $11,000,000 in respect of the contraventions of s 42DLB(1) of the TG Act set out in orders 1 and 2 of the orders made on 8 February 2021.
Pursuant to s 42Y of the Therapeutic Goods Act 1989 (Cth) (TG Act the second respondent is to pay to the Commonwealth of Australia a pecuniary penalty in the sum of $1,000,000 in respect of the contraventions of s 42DLB(1) of the TG Act set out in orders 3 and 4 of the orders made on 8 February 2021.
The first respondent and second respondent pay the applicant's costs of and incidental to these proceedings. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

INTRODUCTION [1] 1.1 Background [1] 1.2 The contraventions [6] 1.3 Summary of conclusions as to penalty [15]
THE EVIDENCE [16]
THE SECRETARY'S SUBMISSIONS [20]
FACTUAL FINDINGS [25] 4.1 The Register [25] 4.2 The impugned conduct [38]
ASSESSMENT OF PENALTY [46]
THE PENALTY AND DISPOSITION [85]

1.1 Background 1 In Secretary, Department of Health v Evolution Supplements Australia Pty Ltd [2021] FCA 74 (liability judgment) I made declarations to the following effect: (1) That from 6 March 2019 to 2 March 2020 inclusive (relevant period) the first respondent, Evolution Supplements Australia Pty Ltd had contravened s 42DLB(1) of the Therapeutic Goods Act 1989 (Cth) (TG Act) by advertising goods on its Website at the URL www.evolutionsupplements.com.au in circumstances where s 42DLB(9) of the TG Act applied to those advertisements. This was on the basis that the therapeutic goods referred to in the advertisements are not, and were not during the relevant period, entered on the Australian Register of Therapeutic Goods and also that they were goods that were prescribed by clause 7(i) of the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations); (2) That during the relevant period, Evolution contravened s 42DLB(1) of the TG Act by advertising therapeutic goods on the Website and such advertisements contained references to substances, or goods containing substances which are and were during that period, included in schedule 4 to the current Poisons Standard, with the result that s 42DLB(7) of the TG Act applied; (3) That during the relevant period the second respondent, Cumhur Keskin contravened s 54B(3) of the TG Act by failing to take all reasonable steps to prevent the contraventions by Evolution referred to in (1), in circumstances where Mr Keskin knew that the contraventions would occur and was in a position to influence the conduct of Evolution in relation to the contraventions; (4) That between 31 January 2019 and at least 2 March 2020 inclusive, Mr Keskin contravened s 42DX of the TG Act by failing to cause Evolution to cease advertising all therapeutic goods not entered on the Register via the Website and failing to cause Evolution to cease the advertising of and the publication of references to all substances entered on Schedule 4 of the Poisons Standard on the Website. 2 I also made orders restraining Evolution from advertising or causing to be advertised therapeutic goods if such advertisements refer to therapeutic goods which are not entered in the Register and are prescribed by r 7(i) of the TG Regulations, or are substances or goods containing substances included in schedule 4 of the current Poisons Standard unless otherwise authorised to do so, and that Mr Keskin be similarly restrained. 3 The orders made in the liability judgment did not address the question of any penalty arising from the contraventions of Evolution or Mr Keskin. Orders made in the preparatory phases of the proceedings provided for the question of penalty to be determined separately and after the question of liability. After the delivery of the liability judgment a timetable was set in place for the preparation of the proceedings for hearing on the question of penalty. Despite being served with the relevant documentation, Mr Keskin has not participated in that process and did not participate in the hearing. 4 It may be noted that the sections of the TG Act relied upon by the Secretary are civil penalty provisions. He bears the onus to prove the case that he has advanced to the requisite civil standard having regard to the gravity of the matters alleged: s 140 of the Evidence Act 1995 (Cth) and the principles set out in Briginshaw v Briginshaw (1938) 60 CLR 336 (Dixon J) at 361 and 362; see Australian Competition and Consumer Commission v We Buy Houses Pty Ltd [2017] FCA 915 (Gleeson J) at [44]. 5 These reasons assume familiarity with the liability judgment. Unless otherwise provided, the definitions used in the liability judgment apply to these reasons.

1.2 The contraventions 6 Section 42DLB of the TG Act is a civil penalty provision. Relevant parts of it are set out in the liability judgment at [28]. In summary, s 42DLB(1) provides that a person contravenes that sub-section if that person advertises or causes to be advertised, therapeutic goods, and subsections (7) or (9) apply. 7 Subsection (7) applies to an advertisement if the advertisement refers to substances or goods containing substances included in schedule 3, 4 or 8 of the current Poisons Standard, other than a reference authorised or required by a government or a government authority. 8 Subsection (9) applies if the advertisement refers to therapeutic goods that are not entered on the Register and that are prescribed by the TG Regulations, unless otherwise authorised. 9 As explained in the liability judgment (at [21]), Evolution maintained the Website during the relevant period, on which it advertised certain products. Between 28 October 2019 and 9 January 2020 it also promoted products, at the same URL, between the hours of 8pm and 4am (which is defined as the After Hours Website). 10 All of the products so advertised are referred to below as the impugned goods. All were "therapeutic goods" within the meaning of s 3(1) of the TG Act, and the representations made in the advertisements were to the effect that each of the impugned goods was capable of influencing, inhibiting or modifying a physiological process in persons. As a result the impugned goods were advertised for a "therapeutic use". None of the impugned goods were entered in the Register or the subject of any exemption or approval under the TG Act or the TG Regulations. As a consequence, s 42DLB(9) of the TG Act applied and accordingly each such advertisement amounted to a contravention of s 42DLB(1) of the TG Act. Evolution advertised a total of 97 impugned goods during the relevant period. 11 In addition, 70 of the advertisements promoted on the Website and the After Hours Website referred to substances or goods containing substances included in schedule 4 of the current Poisons Standard. None was authorised or required by a government or a government authority, and therefore s 42DLB(7) applied. Accordingly, each of those advertisements also amounted to a contravention of s 42DLB(1) of the TG Act. 12 In relation to Mr Keskin, s 54B(3) of the TG Act provides that an executive officer of a body corporate contravenes that subsection if the body corporate contravenes a civil penalty provision and the officer knew that the contravention would occur, was in a position to influence the conduct of the body in relation to that contravention and failed to take reasonable steps to prevent the contravention. These requirements were satisfied insofar as Mr Keskin was concerned, as set out in the liability judgment at [31] to [38]. Section 54B(3) is a civil penalty provision. 13 Mr Keskin was also found to be liable for contravention of s 42DX of the TG Act, a civil penalty provision that is contravened if the Secretary has given a direction to a person under s 42DV of the TG Act with which the person fails to comply. The Secretary gave Mr Keskin a s 42DV notice requiring him to ensure that Evolution cease advertising in breach of s 42DLB, but he failed to comply during the period from 31 January 2019 until 2 March 2020. 14 I consider the conduct of each of Evolution and Mr Keskin in more detail in section 4 below.

1.3 Summary of conclusions as to penalty 15 For the reasons set out in more detail below, I have determined that: (a) Evolution is liable to pay $11,000,000 as a penalty pursuant to s 42Y of the TG Act for its breaches of s 42DLB(1); and (b) Mr Keskin is liable to pay $1,000,000 as a penalty pursuant to s 42Y of the TG Act for his breaches of ss 42DX and 54B(3).

THE EVIDENCE 16 The Secretary relies on the evidence read in the liability hearing of the proceedings (with the exception of the affidavits of Ms Sabatino), which I summarised at [6] of the liability judgment. He also relies on further affidavits given by Ms Deigan on 21 April 2021, Mr Sullivan on 23 April 2021 and Ms Sanderson on 23 April 2021, as well as affidavits of service given by Ms Sabatino on 4 April 2021, 2 May 2021 and 9 May 2021. 17 Professor Burke was instructed to consider screenshots of advertisements of each of the impugned products on the Website maintained by Evolution. She gave evidence as to whether or not the impugned products could in her view be said to achieve "anything from a sports nutrition perspective", and, if so, what that would be. She considered each of the 97 impugned products and their lists of ingredients, and found none to be formulated to achieve anything from such a perspective. For example, in relation to the "Life Extension - Optimised Ashwagandha Extract capsules" impugned product, Professor Burke observed that each capsule was claimed to contain 125mg of Sensoril Ashwagandha extract, as well as inert ingredients such as rice flour, maltodextrin and silica. She considered that in order for a product to be specifically formulated to achieve something in sports nutrition it should either (a) enable a person to meet at least one nutrient need or nutritional goal in a practical way, or (b) address a medical issue relating to a nutrient need or deficiency, or (c) directly or indirectly support a performance goal. Professor Burke considered that the only active ingredient in this product, namely Ashwagandha extract, did not meet (a) or (b). In relation to (c), she noted that it is not included in the Australian Institute of Sport's Sports Supplements Framework. She also identified some peer-reviewed studies of chronic supplementation with Ashwagandha in conjunction with resistance training, but considered those studies to be limited and concluded that she had insufficient information to form a conclusion about the use of this product by athletes, and therefore could not identify any purpose which the product was specifically formulated to achieve from a sports nutrition perspective. 18 Dr Brent was instructed to consider a list of 14 named substances that appear in the Poisons Standard and to identify what dangers and risks are or may be associated with their use. He was also asked to consider screenshots of the advertisements on the Website and identify any dangers or risks associated with the impugned products having regard to the ingredients listed in the advertisements. Finally he was asked to explain what dangers and risks might be associated with the use of therapeutic goods which are not entered on the Register. He provided a comprehensive report pointing to significant health risks, aspects of which are summarised in section 4.1 below. 19 In addition, pursuant to s 50 of the Evidence Act Exhibit 2 was admitted into evidence, being a summary of financial evidence prepared by Tristan Dimmock, an officer of the TGA. Exhibit 2 summarises financial documents obtained by the Secretary pursuant to s 42YE of the TG Act, which allows the Secretary to require third parties to give the Secretary information relevant to an application for a civil penalty order. The financial documents were obtained from the Commonwealth Bank of Australia, Afterpay Pty Ltd, Zipmoney Pty Ltd and Web Active Corporation Pty Ltd (eWay), and relate to transactions in accounts held by Evolution and Mr Keskin between January 2019 and September 2019.

THE SECRETARY'S SUBMISSIONS 20 The Secretary submits that there were numerous breaches of civil penalty provisions of Part 5-1 of the TG Act. He calculates the number of contraventions, and their statutory maximum penalties, as follows: (1) In respect of Evolution's contraventions of s 42DLB(1): (a) Each day on which the impugned advertisements appeared on the Website or After Hours Website is considered a contravention. By his calculation, there were a total of 13,103 contraventions. That number comprises 8,929 contraventions on the Website and 4,174 contraventions on the After Hours Website; (b) The maximum penalty for each contravention of s 42DLB(1) by a body corporate is 50,000 penalty units. At the relevant time, s 4AA of the Crimes Act 1914 (Cth) provided that a penalty unit meant $210. Accordingly, the maximum penalty for each contravention of s 42DLB(1) is $10,500,000; (c) The maximum potential pecuniary penalty for 13,103 breaches of s 42DLB(1) is therefore over $137 billion; (2) In respect of Mr Keskin's contraventions: (a) Each day on which he failed to take reasonable steps to prevent Evolution's contraventions of s 42DLB is considered a separate contravention of s 54B(3). As this failure persisted from 6 March 2019 until 2 March 2020, being 362 days, there were 362 contraventions; (b) Each day on which he failed to comply with the s 42DV direction was a contravention of s 42DX. This failure persisted from 31 January 2019 to 2 March 2020, being 396 days, and there were therefore 396 contraventions; (c) Both s 42DX and s 54B(3) carry a statutory maximum penalty of 5,000 penalty units for an individual. The maximum penalty for each contravention of each of those sections is $1,050,000; (d) Therefore Mr Keskin engaged in a total of 758 contraventions, which have a potential combined statutory maximum penalty of more than $795 million. 21 The Secretary submits that there are in effect eight different courses of contravening conduct in which Evolution has engaged, which may be divided by reference to the categories listed in annexure A to these reasons (explained further in [40] below). He submits that a contravention occurred on each day that the advertisement remained published and has calculated the number of contraventions accordingly, and he submits that the appropriate range of penalties for Evolution in relation to the courses of conduct is as follows: (1) Website advertisements of products not claiming to contain schedule 4 or schedule 10 substances, but which contained other substances not entered on the Register - 1984 contraventions and $1-1.5 million; (2) Website advertisements of products claimed to contain schedule 4 substances - 2361 contraventions and $2.25-3.5 million; (3) Website advertisements of products claimed to contain schedule 10 substances - 1484 contraventions and $2.75-4 million; (4) Website advertisements of products claimed to contain both schedule 4 and schedule 10 substances - 3100 contraventions and $4-6 million; (5) After Hours Website advertisements of products not claiming to contain schedule 4 or schedule 10 substances, but which contained other substances not entered on the Register - 792 contraventions and $1.5-3 million; (6) After Hours Website advertisements of products claimed to contain schedule 4 substances - 2056 contraventions and $4-7 million; (7) After Hours Website advertisements of products claimed to contain schedule 10 substances - 283 contraventions and $3-5 million; and (8) After Hours Website advertisements of products claimed to contain both schedule 4 and schedule 10 substances - 1043 contraventions and $6-10 million. 22 The total range of penalty for Evolution proposed by the Secretary, after having regard to totality and deterrence, is $15-25 million. 23 In respect of Mr Keskin's contraventions, the Secretary submits that prior to considerations of totality the appropriate range of penalties is: (1) Contraventions of s 54B(3) - 362 contraventions and $750,000-$1.15 million; and (2) Contraventions of s 42DX - 396 contraventions and $1-1.6 million. 24 After having regard to totality and deterrence, the Secretary submits that the appropriate combined range of penalties for Mr Keskin is $875,000-$1.4 million.

4.1 The Register 25 In his report, Dr Brent set out relevant background information going to the operation of the Register. 26 The TGA regulates therapeutic goods and determines whether it is appropriate for individual therapeutic goods to be entered on the Register. The first step in the TGA's assessment of a therapeutic good is consideration of whether the good in question poses a high risk (as in the case of prescription and over-the counter medicines such as painkillers and allergy tablets) or a low risk (as in the case of vitamins, minerals, sunscreens and herbal complementary medicines) to human health. This initial determination then informs the degree of scrutiny the therapeutic good will be subjected to in assessing whether, and under what conditions, it should be entered on the Register, including the amount and type of information that will be reviewed. In assessing a therapeutic good, the TGA will also consider: the amount of regulatory oversight needed to manage risks associated with the good, including the nature and intended use of the good; compliance with nonclinical guidelines including the OECD's Good Laboratory Practice; the approach of the TGA's comparable international regulatory counterparts to the good in question; and, although not mandated in Australian legislation, will often also consider whether technical data requirements meet the requirements set out in the European Union Guidelines and Guidelines issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 27 Where the benefits of human use of a good outweighs the risk of adverse reactions, the good is entered on the Register. 28 High risk products are registered on the Register, while lower risk products are listed on the Register. Registered products are subject to a detailed evaluation of risk, and data submitted in support of a new registered medicine must establish the quality, safety and effectiveness of the proposed product for its proposed usage ("indication"). If approved, registered medicines are registered on the Register for their specified indications only. 29 In relation to listed products, a lesser degree of evaluation is conducted. These products are listed on the Register provided that the applicant for listing certifies that: the claims made about the effectiveness of the product are accurate; relevant quality, labelling and packaging standards are followed; the medicine contains only approved ingredients; and manufacturing facilities and processes had been assessed for compliance with standards of Good Manufacturing Practice. Low risk medicines cannot claim to treat serious diseases, and can be removed from the market if the claims made for the product are inappropriate or any of the applicant's certifications are incorrect. 30 Part 5-1 of the TG Act establishes a regulatory regime for the advertising of therapeutic goods, including prohibiting the advertising of goods containing substances not entered on the Register, substances listed in schedule 4 to the Poisons Standard, or therapeutic goods not the subject of an exemption, approval or authority under the TG Act or the TG Regulations. The Introduction to the Poisons Standard explains that a substance listed in schedule 4 of that standard is a substance which should only be used or supplied pursuant to a prescription from an appropriately qualified professional. A substance listed in schedule 10 to that standard is considered to be of such danger to health as to warrant prohibition of sale, supply and use. 31 Dr Brent explains that a substance listed in schedule 4 to the Poisons Standard has been subjected to a comprehensive assessment of the quality, safety and efficacy of the therapeutic good. If a substance is listed in schedule 4, but not entered on the Register (for example, because it is still under research, where its precise effects are unknown, or where there are no products in the Australian market containing the substance), the TGA has decided that the substance should nevertheless be restricted under schedule 4 because of the potential risk to human health and safety. 32 By way of illustration, Selective Androgen Receptor Modulators (SARMs) are a general entry in schedule 4 to the Poisons Standard. Dr Brent explains that there is a large body of international peer-reviewed literature regarding possible initial research uses of SARMs in therapeutics and potential positive uses in various human diseases. Early clinical studies have demonstrated potential uses for SARMs in treatment of breast cancer, cancer-related cachexia, benign prostatic hyperplasia and hypogonadism. However, the literature also identifies potential toxic side effects of illicit use, including liver toxicity and increased risk of heart attack and stroke. The long term effects on the body are unknown. Dr Brent concludes that the use of SARMs presents a risk of adverse effects, and a serious risk to human health and safety, if not used within the TGA framework as schedule 4 goods, and finds support for that position in the information available from the literature and the fact that there are no therapeutic goods containing SARMs entered on the Register. 33 Testosterone is another substance listed in schedule 4. It is included in the World Health Organisation's list of essential medicines, and is available as a generic medication. In addition to its role as the primary male sex hormone testosterone is used as a medicine, for example in treating low testosterone levels in men, in transgender hormone therapy for transgender men, and to treat breast cancer in women. However unwanted effects of the use of testosterone as a treatment can include infertility, adenocarcinoma of the liver, as well as salt and water retention leading to oedema. Some athletes use testosterone in the expectation of increasing strength and performance, however studies have shown that this effect is not necessarily achieved in healthy individuals. Dr Brent concludes, based on the large amount of available clinical data in relation to both the short- and long-term effects of testosterone intake by humans, that use of testosterone outside the TGA framework, including in products such as supplements and stimulants, presents a high risk of adverse effects. 34 In the case of substances listed in schedule 10 to the Poisons Standard, Dr Brent explains that the TGA has determined that the advertisement and use of a substance listed in schedule 10 outside of the existing legal framework poses such a danger to health as to warrant prohibition of its sale, supply and use. Unlike schedule 4 substances, which may be entered on the Register, schedule 10 substances are not appropriate for entry in the Register. 35 By way of illustration, Dr Brent was asked to consider what, if any, dangers and risks to humans may be associated with the use of certain substances listed in schedule 10, including 1, 3 dimethylamylamine (DMAA) and cardarine. 36 In relation to DMAA, Dr Brent observed that it was originally developed as a nasal decongestant, and is an amphetamine derivative that has been marketed in sports performance and weight loss products, many of which are sold as dietary supplements. Use of DMAA has not been shown to have any health benefits. It is considered a toxic substance and taking it can result in raised blood pressure, psychiatric disorders, bleeding in the brain, and cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack. Its long-term safety has not been demonstrated. Sale of dietary supplements containing DMAA is prohibited in several countries, including the United States, Canada and New Zealand. No therapeutic goods containing DMAA are registered or listed on the Register, and in conjunction with information from peer-reviewed scientific literature and from international regulators, Dr Brent considers that its use in supplements and stimulant products constitutes a serious risk to human health and safety. 37 In relation to cardarine (known on the black market as endurobol), Dr Brent observed that it is a member of a class of substances called Peroxisome-Proliferator Activated Receptor agonists. Animal testing of the drug in about 2007 showed that it caused the rapid development of cancer in several organs in both mice and rats, and there is insufficient clinical data available to assess the long-term health risks associated with its intake by humans. Cardarine is not authorised in Canada for any use, and the World Anti-Doping Agency has prohibited the use of cardarine. Dr Brent further commented that it has no therapeutic use and is not an ingredient in any good entered on the Register. He concluded that it presents a high risk of adverse effects in humans and its claimed use in products such as supplements constitutes a serious risk to human health and safety.

4.2 The impugned conduct 38 The contravening conduct of Evolution involved the advertising of the impugned products on the Website during the relevant period, and on the After Hours Website between 28 October 2019 and 9 January 2020. As I have noted, all of the advertisements amount to a contravention of s 42DLB(1) of the TG Act, by reason that s 42DLB(9) applied. Section 42DLB(7) also applied to many of the advertisements because not only did they refer to therapeutic goods, but they also referred to goods that were listed in schedule 4 of the Poisons Standard. 39 It is also relevant, for the purposes of assessing penalty, to note that many of the advertisements referred to goods containing substances were listed in schedule 10 of the Poisons Standard and which accordingly could not by any means have been permitted to be entered on the Register because of the harm that taking such substances could have to human health. 40 The Secretary provided as an aide memoir to his submissions a 54 page schedule. A simplified version of the schedule is in annexure A to these reasons. Annexure A identifies the product names for each of the 97 impugned products, and assigns each a unique product number. For each product, it identifies the substance or substances which ought not to be advertised as present in the impugned products by reference to whether or not they contain schedule 4 substances, schedule 10 substances or neither. Where the advertisements refer to products containing schedule 4 substances, each of s 42DLB(7) and (9) applies, whereas for the balance s 42DLB(9) alone applies. Accordingly, the impugned products can be divided into four categories, best summarised as follows: (1) Products claimed to contain both schedule 4 and schedule 10 substances. There are 25 products in this category, namely product numbers 1, 2, 3, 4, 5, 10, 11, 12, 18, 22, 25, 27, 31, 37, 39, 40, 41, 42, 50, 62, 63, 69, 91, 98 and 99; (2) Products claimed to contain schedule 10 substances. There are 11 products in this part, namely product numbers 8, 14, 15, 17, 19, 21, 23, 24, 30, 55 and 58; (3) Products claimed to contain schedule 4 substances. There are 45 products in this part, namely product numbers 6, 7, 9, 13, 16, 20, 26, 28, 32, 33, 34, 54, 61, 64, 65, 66, 67, 68, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 92, 93, 94, 95, 96 and 97; and (4) Products claimed to contain therapeutic goods not entered on the Register, but which did not claim to contain any scheduled substances. There are 16 products in this part, namely product numbers 29, 35, 36, 38, 43, 44, 45, 46, 47, 49, 51, 52, 53, 57, 59 and 60. Annexure A identifies the category into which each impugned product falls. Having regard to the evidence, I am satisfied that these categories are appropriate for the goods identified in them. 41 Each product listed in annexure A appears in schedule 2 and/or 4 to the statement of claim. 42 As summarised in the liability judgment at [31], between December 2018 and October 2019 a series of warning letters and responses were exchanged, and conversations were held, between representatives of the Secretary and Mr Keskin on behalf of Evolution. Evolution did not cease advertising the impugned products prior to the commencement of these proceedings, notwithstanding the terms of the s 42DV direction issued to Mr Keskin by the Secretary. 43 Of particular note are the following communications: (1) The first warning letter was sent from the TGA to Mr Keskin on 24 December 2018. From this date, the respondents were on notice of the Secretary's concerns regarding the impugned conduct and had been informed of what the respondents were required to do in order to comply with the TG Act. At no time did they make changes to the Website necessary to bring it into conformity with the respondents' obligations under the TG Act; (2) On 23 January 2019 Mr Keskin was issued with a notice given pursuant to s 42DV of the TG Act, which required him to cause Evolution to cease advertising and publishing references to therapeutic goods not entered on the Register and/or schedule 4 and/or schedule 10 substances within seven days of the notice (s 42DV direction). Mr Keskin failed to do so; (3) On 4 October 2019 the Secretary's solicitors wrote to Mr Keskin advising him that the advertising on the Website continued to contravene the TG Act and the s 42DV direction; (4) In early- to mid-October 2019 the respondents initially engaged with the Secretary's solicitors regarding the required removal of impugned products from the Website; (5) However, on 23 October 2019 the respondents sent an email to their email subscribers, stating that "SARMS are now only available online from 8pm to 4am". This was plainly a response to the Secretary's solicitor's contact with Mr Keskin in early- to mid-October 2019 and amounted in my view to a form of subterfuge engaged by Mr Keskin and Evolution in an attempt to avoid the scrutiny of the Department. 44 Prior to the commencement of the proceedings Evolution continued, in the face of the s 42DV direction issued to Mr Keskin, to maintain the Website and the After Hours Website. As noted in the liability judgment at [7], at the first case management hearing conducted on 3 April 2020, at a time when they were represented by solicitors and counsel, the respondents consented to the making of interim injunctions restraining their conduct. 45 Mr Keskin was at all relevant times the sole director of Evolution, and in a position to influence its conduct in relation to the alleged contraventions of the TG Act: liability judgment at [30]-[37]. He was aware that contraventions of the TG Act were occurring or would occur. The correspondence to which I have referred above outlines aspects of his involvement, and also his approach to the Secretary's warnings, which include his failure to comply with the s 42DV notice.

ASSESSMENT OF PENALTY 46 I accept the submissions advanced by the Secretary that there have been numerous breaches of Part 5-1 of the TG Act, as set out in annexure A to these reasons. 47 Section 42Y(1) of the TG Act provides that within 6 years of a contravention of a civil penalty provision the Secretary may apply on behalf of the Commonwealth to the Federal Court for an order that the wrongdoer pay the Commonwealth a pecuniary penalty. 48 Section 42Y(3) provides: In determining the pecuniary penalty, the Court must have regard to all relevant matters, including: (a) the nature and extent of the contravention; and (b) the nature and extent of any loss or damage suffered as a result of the contravention; and (c) the circumstances in which the contravention took place; and (d) whether the person has previously been found by the Court in proceedings under this Act to have engaged in any similar conduct. 49 Section 42DLB(1), s 42DX and s 54B(3) are civil penalty provisions: see s 42YA. 50 I accept the Secretary's submission that the maximum penalty for each contravention of s 42DLB(1) is $10,500,000 and the maximum penalty for each contravention of each of s 42DX and s 54B(3) is $1,050,000. 51 I also accept the submissions for the Secretary as follows. 52 A process of "instinctive synthesis" should be applied to the imposition of a penalty in a case such as the present: Markarian v The Queen [2005] HCA 25; 228 CLR 357 (Gleeson CJ, Gummow, Hayne and Callinan JJ) at [37] and, in the context of civil penalties, Australian Building and Construction Commissioner v Construction, Forestry, Mining and Energy Union [2017] FCAFC 113; 254 FCR 68 (ABCC v CFMEU) (Dowsett, Greenwood and Wigney JJ) at [100]. This involves assessment of the appropriate penalty based on all relevant factors including: (a) careful attention to the maximum penalties, first because the legislature has legislated them, secondly because they invite comparison between the worst possible case and the case before the court at the time, and thirdly because in that regard they provide, taken and balanced with all other relevant factors, a yardstick: Markarian at [30]-[31]; (b) it will rarely be appropriate to start with the maximum penalty and proceed by making a proportional deduction from that maximum: Markarian at [31]-[32]; (c) the court should not adopt a mathematical approach of increments or decrements from a predetermined range, or assign specific numerical or proportionate value to the relevant factors: Markarian at [37]; (d) it is not appropriate to determine the objective sentence and then adjust it by some mathematical value given to one or more factors such as a plea of guilty or assistance to authorities: Markarian at [37]; (e) the court may not add and subtract item by item from some apparently subliminally derived figure to determine the penalty to be imposed: Markarian at [39]; and (f) since the law strongly favours transparency, accessible reasoning is necessary in the interests of all: Markarian at [39]. 53 The objects of the TG Act set out in s 4 are relevant. They include providing for "the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia" and providing "a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia". 54 The Register is central to this national system of controls in relation to therapeutic goods in Australia. As Perram J explained in Secretary, Department of Health and Ageing v Export Corporation (Australia) Pty Ltd [2012] FCA 42; 288 ALR 702: [8] … In general terms, any medicine which contains potentially harmful ingredients can only be included in the Register by being registered. [9] In practice, the process necessary to obtain registration is a rigorous, complex, costly and quite often lengthy process for an applicant. Applications for the registration of a medicine are evaluated by the Secretary having regard to a range of matters including the quality, safety and efficacy of the goods, the presentation of the goods, whether the goods conform to any relevant standard and whether the goods have been manufactured in accordance with applicable requirements. For example, with respect to safety considerations the applicant for registration will usually be required to provide information to satisfy the secretary as to: the chemical analysis of the medicine; toxicological data for the medicine; and satisfactory results of proper clinical trials of the medicine in humans. 55 The TG Act proscribes the importation or supply of therapeutic goods which are neither listed nor registered on the Register by the sponsor of the goods: see s 19D. Section 42DLB(1), (7) and (9) in particular provide important support to the regulatory apparatus of the TG Act and the system of registration on the Register, by proscribing the advertisement of therapeutic goods not entered on the Register and that are prescribed by the TG Regulations for the purpose of s 42DLB(9). 56 Deterrence encompasses the need to deter repetition of the contravening conduct by the contravener (specific deterrence) and to deter others who might be tempted to engage in similar contraventions (general deterrence). This informs the assessment of the appropriate penalty: Australian Competition and Consumer Commission v TPG Internet Pty Ltd [2013] HCA 54; 250 CLR 640 at [65] (French CJ, Crennan, Bell and Keane JJ). The penalty must not be set at a level "such as to be regarded by that offender or others as an acceptable cost of doing business". Rather, "those engaged in trade or commerce must be deterred from the cynical calculation involved in weighing up the risk of penalty against the profits to be made from contravention": Singtel Optus Pty Ltd v Australian Competition and Consumer Commission [2012] FCAFC 20; 287 ALR 249 at [62]-[63] (Keane CJ, Finn and Gilmour JJ), cited with approval in TPG Internet at [66], ABCC v CFMEU at [98]). 57 The penalty should not be oppressive in the sense that it should be no higher than necessary to achieve the object of deterrence: Australian Competition and Consumer Commission v Leahy Petroleum Pty Ltd (No 2) [2005] FCA 254; 215 ALR 281 (Merkel J) at [9]. 58 The maximum penalty for a corporation, in this case being $10,500,000 for each contravention of s 42DLB(1), must be considered because it shows the penalty for the worst possible case and enables comparison with the case at hand: Markarian at [31]. The maximum penalty for an individual is $1,050,000 for each contravention of each of s 42DX and s 54B(3). The exercise, however, is not a mathematical one starting with the maximum penalty and adjusting by reference to mitigating and aggravating circumstances: ABCC v CFMEU at [166]. 59 A useful way of considering the number of contraventions is to look to the notion of continuing offence in criminal law. Where an offence is a continuing offence, a new contravention occurs each day. That is a question of statutory construction, requiring consideration of whether a contravention occurs "once and for all" or whether the contravention continues until the conduct ceases: see eg Leydon v Forrest (1980) 23 SASR 364 (King CJ) at 375. 60 The Secretary submits that each day on which an advertisement for one of the impugned products remained on the Website or After Hours Website amounts to a separate contravention of the Act, and further submits that the number of days for which an advertisement was published should be inferred from the first date on which it appears in the evidence to the last date on which it appears in the evidence. I accept these propositions: see also Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107 (Jagot J) at [12] and [43]. 61 The appropriate way of understanding how many times Evolution "advertised" on the Website and After Hours Website, and therefore understanding the number of contraventions of s 42DLB(1), lies in asking "on how many occasions was the information about the products in question sought to be made known to the public?". That occurred every day the advertisement remained published. I note that if the same product was advertised on both the Website and After Hours Website on the same date, there would be potential double counting of contraventions. However, in an aide memoire provided with his submissions the Secretary set out the dates on which each product was advertised on the Website and the After Hours Website. No product was advertised on both on the same date, and there is therefore no double counting of contraventions. 62 However, if one multiplies the number of days by the number of goods advertised to reach the total number of contraventions, and then applies the statutory maximum penalty, that yields the eye-watering conclusion that the total penalty for Evolution would exceed $137 billion. Applying the same sort of calculation to Mr Keskin the total would be over $795 million. Plainly, it is not appropriate to apply this approach literally in the present case. 63 As the Secretary submits, citing Construction, Forestry, Mining and Energy Union v Cahill [2010] FCAFC 39; 269 ALR 1 (Middleton and Gordon JJ) at [39], it is more suitable to consider the "course of conduct" principle which ensures that an offender is not punished multiple times for the same criminality. There, their Honours explained that "the principle recognises that where there is an interrelationship between the legal and factual elements of two or more offences, […] care must be taken to ensure that the offender is not punished twice for what is essentially the same criminality. That requires careful identification of what is "the same criminality", necessarily a fact-specific inquiry". Their Honours also explained that, even if contraventions are properly characterised as arising from a single course of conduct, a Court is not obliged to apply the principle if the resulting penalty fails to recognise the seriousness of the contravention: [40]-[41] (Middleton and Gordon JJ, with whom Moore J agreed at [2]). 64 I accept that Evolution's conduct can be described as involving eight courses of conduct as set out in section 3 above. This approach allows differentiation of the seriousness of the contraventions involved in the advertising of products claimed to contain schedule 4 and, even more so, schedule 10 substances, and the less serious offences involving advertising products that were not entered on the Register but which also did not contain any schedule 4 or schedule 10 substances. The broad differentiation between the conduct in advertising on the Website may logically be distinguished from the After Hours Website because the latter is coloured by the fact that it was implemented after the provision of the s 42DV declaration and apparently in an attempt to avoid detection of contravening behaviour. 65 Mr Keskin's contraventions arose from his failure to take reasonable steps to prevent Evolution's contraventions of s 42DLB(1) in contravention of s 54B(3), and to comply with the s 42DV direction in relation to each of the Website and the After Hours Website in contravention of s 42DX. I accept the submission advanced by the Secretary that he can sensibly be said to have engaged in two courses of conduct, and that the s 54B(3) contraventions persisted for 362 days, while the s 42DX contraventions continued for 396 days. 66 The "course of conduct" principle does not have paramountcy in the process of assessing the appropriate penalty and does not itself operate as a de facto limit on penalty. Rather, its application and utility must be tailored to the circumstances: Australian Competition and Consumer Commission v Hillside (Australia New Media) Pty Ltd trading as Bet365 (No 2) [2016] FCA 698 at [24]-[25] (Beach J), cited with approval by the Full Court in Australian Competition and Consumer Commission v Reckitt Benckiser (Australia) Pty Ltd [2016] FCAFC 181; 340 ALR 25 at [141] (Jagot, Yates and Bromwich JJ); Australian Competition and Consumer Commission v Cement Australia Pty Ltd [2017] FCAFC 159; 258 FCR 312 at [425]-[426] (Middleton, Beach and Moshinsky JJ); Australian Competition and Consumer Commission v Yazaki Corporation [2018] FCAFC 73; 2622 FCR 243 at [231] (Allsop CJ, Middleton and Robertson JJ). 67 The principle does not restrict the Court's discretion as to the amount of penalty to be imposed for a course of conduct. Specifically, the maximum penalty for a course of conduct is not restricted to the statutory maximum penalty for a single contravention: see eg Australian Competition and Consumer Commission v EDirect Pty Ltd (in liq) [2012] FCA 976; 206 FCR 160 at [74.10] (Reeves J); Yazaki Corporation at [227]-[230]. Thus in applying the course of conduct principle, it is not appropriate or permissible to treat multiple contraventions as just one contravention for the purposes of determining the maximum penalty: Yazaki Corporation at [227], [230]. Where a company engages in a multitude of contraventions (as here), there may be no meaningful maximum penalty (or limit) to guide the penalty discretion: Reckitt Benckiser at [157]. 68 Where multiple penalties are to be imposed on a particular wrongdoer, the totality principle ought to be considered. The result of its application is that the total penalty for related offences ought not to exceed what is proper for the entire contravening conduct involved: Trade Practices Commission v TNT Australia Pty Ltd [1995] FCA 13; ATPR ¶41-375 at 40,169 (Burchett J), see also Australian Competition and Consumer Commission v Baxter Healthcare Pty Ltd [2010] FCA 929 at [22] (Mansfield J). The totality principle operates as a "final check" to ensure that the penalties to be imposed on a wrongdoer, considered as a whole, are "just and appropriate": see eg Johnson v R [2004] HCA 15; 205 ALR 346 at [3]-[5] (Gleeson CJ), [18]-[35] (Gummow, Callinan and Heydon JJ), cited in Clean Energy Regulator v MT Solar Pty Ltd [2013] FCA 205 at [81] (Foster J). In determining whether final penalties are "just and appropriate", the correct approach is to start by ascertaining the penalty that would be appropriate for individual contraventions and then to adjust those amounts for reasons of totality: Clean Energy Regulator at [82]. 69 Finally, I note that the assessment of penalty by reference to penalties imposed in comparable circumstances should be approached with some caution. The authorities make plain that it is the consistent application of principle that is relevant to the assessment of penalty, rather than the range of penalties given in disparate circumstances that cannot be said to be analogous: Flight Centre Limited v Australian Competition and Consumer Commission (No 2) [2018] FCAFC 53; 260 FCR 68 (Allsop CJ, Davies and Wigney JJ) at [63]. However, it is not irrelevant to note that in Peptide Clinics the respondent advertised peptides, which were listed in schedule 4 to the then current Poisons Standard and presented a "completely unacceptable" risk to human health. The respondent found to have contravened s 42DLB(1) by publishing advertisements in circumstances where either subsections (2), (4) or (7) applied, and to have contravened 42DMA by publishing advertisements prohibited by the Therapeutic Goods Advertising Code 2015 (Cth). The contraventions occurred over a 12 month period, and although no loss or damage could be proved, the respondent claimed on its website that it had 50,000 satisfied patients and its only products were peptides. There was evidence that the respondent received $2,150,740 in income and made a gross profit of $889,961 between 1 July 2018 and 22 March 2019, and that as at 22 March 2019 it had retained earnings of $856,478. Justice Jagot found that there were 19,850 contraventions, which could be divided into nine courses of conduct, and imposed a total penalty of $10 million. 70 As to the nature and extent of the contraventions, in addition to taking into account the above propositions, the following more specific points may be made in relation to the assessment of penalty in respect of each of Evolution and Mr Keskin. 71 First, the breaches were very serious. Not one of the impugned products was entered on the Register, and 83% (81 of the 97 products) were promoted as containing schedule 4 or schedule 10 substances, or both. The advertising of such substances, which in the case of schedule 4 substances are prescription-only and in the case of schedule 10 substances are prohibited for any use, clearly falls at the most serious end of the spectrum of offences under s 42DLB of the TG Act. As set out in [40] above, annexure A demonstrates that there were 45 products containing schedule 4 substances, 11 containing schedule 10 substances and 25 containing both. 72 The seriousness is compounded by the fact that there were an extremely large number of contraventions over a sustained period of time, all of which took place after the Secretary had given clear notice that by advertising the impugned products Evolution was acting in breach of the terms of the TG Act, including by way of a s 42DV notice. 73 Secondly, the conduct of the respondents significantly undermined the operation of the TG Act and the controls it establishes in relation to the quality and safety of therapeutic goods and restrictions on the availability of poisons. 74 Thirdly, the dangers that such substances pose to human health and safety, particularly the schedule 4 and schedule 10 substances, have been illustrated through select examples at [30] to [34] above. It is relevant to note that, as the contraventions relate to advertising only, the Secretary has not sought to establish what the advertised products, if sold, contained. I take these matters into account in assessing penalty. 75 Fourthly, the contraventions formed part of a deliberate marketing strategy. The respondents intended to persuade customers to purchase the impugned products, and continued to do so despite the s 42DV direction that had been issued to Mr Keskin. The conduct only ceased immediately prior to the commencement of these proceedings, well after the respondents had been first notified that the Secretary intended to commence the proceedings. 76 Fifthly, the conduct associated with the advertising on the After Hours Website was contumelious. As described at [43(4)] above, after receiving correspondence from the Secretary's solicitors in October, the After Hours Website was put into operation. The respondents plainly knew that they ought not to be advertising the impugned products, and their advertising of those products on the After Hours Website shows the respondents were prepared to expand their advertising conduct. I infer that the use of the After Hours Website was an attempt on the part of Evolution and Mr Keskin to avoid detection by the Department of the respondents' continued contravening conduct. 77 Sixthly, the Secretary gave the respondents the opportunity to address concerns regarding advertising over a significant period of time, as noted above at [43], but they failed or refused to do so. 78 Seventhly, as summarised in the liability judgment at [7] to [9] the respondents did little to co-operate in the course of these proceedings. After an initial, short period of co-operation that included consent to an interim injunction (which I take into account), the respondents ceased to be involved. 79 Eighthly, the Secretary submits that an inference can be drawn that the scale of the first respondent's business was "substantial". He submits that Exhibit 2 shows that during the period between January and September 2019 a total of $473,508.37 was deposited into a Commonwealth Bank account in the name of Evolution. Mr Dimmock explained that this figure was reached after applying certain criteria to each transaction, for example by only including transactions which contained descriptions or financial figures likely to relate to the business of Evolution (as opposed to personal transactions within the same account), such as where the description included the words "vitamins" or "supps", or where the transaction was in an amount that suggested the purchase of a product. The total arrived at comprised 125 direct payments to the Commonwealth Bank account, together with deposits from payment-processors Zipmoney (201 payments) and Afterpay (261 payments). In addition, in the same period eWay processed 3,940 sales totalling $756,516.78 for Evolution, with a total "settlement amount" payable of $755,963.87. The Secretary submits that while he cannot prove that all of those revenues derived from the contraventions because the records produced by the various financial institutions and payment processors do not enable it to identify which individual products were purchased, it may be inferred that the scale of Evolution's business was substantial. 80 In my view the evidence is not sufficient for me to regard the sales figures as indicative of sales made of the impugned products or to reach a conclusion as to the substantiality of the business operations of Evolution. I do, however, infer from the conduct of Evolution that it advertised the impugned products for the purpose of advancing its own economic interests, and did so in circumstances where it elevated those interests above the safety of the public. 81 Ninthly, I take into account that the respondents have not previously been found by the Court to have engaged in any similar conduct. 82 Tenthly, I note that Evolution is currently the subject of a Notice of Proposed Deregistration initiated by the Australian Securities and Investments Commission (ASIC) pursuant to s 601AB(1) or s 601AB(1A) of the Corporations Act 2001 (Cth). It would appear that ASIC has not decided to deregister Evolution on the basis of any of the conduct impugned in these proceedings. Mr Sullivan gives evidence that the Secretary has requested that the deregistration of Evolution be deferred given that these proceedings remain on foot. ASIC has acceded to that request. I take this into account because it would seem that for Evolution the role of specific deterrence will be minimal. 83 Finally, whilst specific deterrence insofar as the conduct of Evolution is concerned is less relevant, it remains important for Mr Keskin, who has declined to be involved in these proceedings or offer an explanation for his conduct. General deterrence is relevant to the assessment of penalty for both of the respondents. In this regard it may be noted that the Secretary has not established the actual sale of any of the impugned products. Nor has he provided evidence of the contents of the impugned products and (more particularly) whether any included the substances referred to in the advertisements. Nevertheless it is relevant to general deterrence to note that the advertisements - and particularly those containing schedule 10 and schedule 4 substances - are examples of very serious contraventions. Other traders should be sent a very strong message that such conduct should not occur. 84 I consider that these matters are also to be taken into account when considering the appropriate penalty for Mr Keskin.

THE PENALTY AND DISPOSITION 85 Taking into account all of the matters to which I have referred above, I consider that the following penalties should be imposed upon Evolution by reference to the eight courses of conduct identified in [21] above: (1) Course of conduct 1 - $1 million; (2) Course of conduct 2 - $1 million; (3) Course of conduct 3 - $1.5 million; (4) Course of conduct 4 - $4 million; (5) Course of conduct 5 - $1 million; (6) Course of conduct 6 - $2 million (7) Course of conduct 7 - $1 million; (8) Course of conduct 8 - $2 million. 86 This amounts to $13.5 million. Having regard to the totality principle, I consider that a total penalty of $11 million is appropriate. 87 Taking into account the matters to which I have referred above, and noting that Mr Keskin engaged in a lower number of contraventions than Evolution, I consider that the following penalties should be imposed upon Mr Keskin by references to the two courses of conduct identified in [23] above: (1) Course of conduct 1 - $500,000; (2) Course of conduct 2 - $700,000. 88 This amounts to a total of $1.2 million. Having regard to the totality principle, I consider that a total penalty of $1 million is appropriate. 89 The Secretary also seeks his costs of and incidental to the proceedings. I consider that such an order is appropriate. I certify that the preceding eighty-nine (89) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Burley.

Associate: Dated: 29 July 2021 Annexure A Product Number Product Name 1 EVO Labs - TRANSFORM - 60 Capsules Ephedra extract (schedule 4) 2 EVO Labs - SHRED - 90 Capsules Stenabolic (SR9009) (schedule 4) 3 EVO Labs - RECOMP - 90 Capsules Ostarine (SARM) (schedule 4) Andarine (SARM) (schedule 4) 4 EVO Labs - KONG - 60 Capsules Ostarine and testolone (SARMs) (schedule 4) Ibutamoren (schedule 4) Ligandrol (SARM) (schedule 4) 5 300 LABZ - LEGACY RECOMPOSITION - 90 Capsules Stenabolic (SR9009) (schedule 4) Ostarine (SARM) (schedule 4) 6 AGGRESSIVE LABZ - MALEVOLENT - 90 Capsules Ligandrol (SARM) (schedule 4) 7 AGGRESSIVE LABZ - TANTALYZE - 60 Capsules Ostarine, S23, Testalone (SARMs) (schedule 4) Ligandrol (SARM) (schedule 4) 8 Enhanced Athlete - CARDARINE - 60 Capsules 9 Enhanced Athlete - Growth Hormone - 60 Capsules 10 Medfit RX - DYCARDROL DMHA - 30 powder servings DMHA (schedule 10) Ligandrol (SARM) (schedule 4) 11 EVO LABS - EXTREME SHRED - 120 Capsules Andarine (SARM) (schedule 4) Yohimbine (schedule 4) Stenabolic (SR9009) (schedule 4) 12 Olympus Labs - ENDURA SHRED - 90 Capsules Ostarine (SARM) (schedule 4) 13 EVO LABS - GH-ULTRA25 - 30ml dropper 14 EVO LABS - GW ULTRA20 - 60 Capsules 15 EVO LABS - GW-ULTRA20 - 20mg X 30ml dropper 16 EVO LABS - SWOLE - 60 Capsules Ibutamoren (schedule 4) 17 Focused Nutrition - GW501516 - 90 Capsules 18 Medfit RX - Black Magic - 60 Tablets Testolone (SARM) (schedule 4) Ligandrol (SARM) (schedule 4) Stenabolic (schedule 4) 19 Medfit RX - JACKED THE RIPPER - 30 powder servings Andarine (SARM) (schedule 4) 20 Medfit RX - KONG - 30 Tablets 21 Olympus Labs - CARDAR1NE - 90 Capsules 22 AGGRESSIVE LABZ - LOCKED IN - 60 Capsules Adrafinil (schedule 4) 23 Hydroxyelite 24 AGGRESSIVE LABZ - HADES - 60 Capsules 25 EVO LABS - CRUSH'D - 25 powder servings Yohimbine (schedule 4) 26 -EVO LABS - AMNES1A - 120 Capsules 27 AGGRESSIVE LABZ - LEATHERFAZE - 20 powder servings Yohimbine (schedule 4) Synephrine (schedule 4) 28 Enhanced Athlete - CODE RED FAT Yohimbine (schedule 4) 29 MEDFIT RX - HUMAN GROWTH HORMONE 30 300 LABZ - GLORY JUICE - 45 powder servings 31 AGGRESSIVE LABZ - Diamondbackz - 60 capsules Yohimbine (schedule 4) Ephedra (schedule 4) 32 AGGRESSIVE LABZ - OPHIDREX HARDCORE - 90 capsules Ephedra (schedule 4) 33 AlphaLab Technologies -XTREME MASS - 60 capsules 34 ANABOLIC TECHNOLOGIES - XTREME 35 BRAINPLUS IQ - 60 capsules 36 EDEN HEALTH ALPHA MALE - 60 capsules 37 EVO LABS - SUPER SHRED - 8 HOURS Yohimbine (schedule 4) Synephrine (schedule 4) 38 FOCUSED NUTRITION - CYCLE CARE - 60 capsules 39 Hi-Tech Pharmaceuticals - LIPODRENE Yohimbine (schedule 4) 40 Hi-Tech Pharmaceuticals - LIPODRENE Yohimbine (schedule 4) Ephedra extract (schedule 4) 41 Hi-Tech Pharmaceuticals - Stimrex Yohimbine (schedule 4) Ephedra extract (schedule 4) 42 Hi-Tech Pharmaceuticals - Stimrex ES - 90 tablets Yohimbine (schedule 4) Ephedra extract (schedule 4) Synephrine (schedule 4) 43 Life Extension - Vitamin D3 - 44 Life Extension - Optimized Ashwagandha 45 Liquid Zeolite Co.Inc - ULTRA 46 Muscle Gelz - AndroShred gel 47 Nature's Way - MSM 1000mg 48 - 49 NEW CHAPTER - MIND FORCE - 60 Capsules 50 NUTRA-PRO - OXY-V - 50 capsules Yohimbine (schedule 4) 51 Olympus Labs - SUP3R-7 - 60 capsules 52 Sunfood Superfoods OCEANS ALIVE 53 WellBetX - Berberine - 500mg 54 MEDFIT RX - TESTOSTERONE gel 55 AGGRESSIVE LABZ - JAKKED AF - 45 powder servings 56 - 57 Enhanced Athlete - GENIUS - 60 Capsules 58 EVO LABS - SHARP - 120 Capsules Yohimbine (schedule 4) 59 Neurella Labs - Neurella - 120 capsules 60 ONNIT - Alpha Brain - 30 Capsules 61 UNDERGROUND PHARMA MAXIMUS - 90 CAPSULES Dimethazine (AAS) (schedule 4) 62 300 LABZ - CLENAVAR - 90 CAPSULES Synephrine (schedule 4) Noopept (schedule 4) 63 300 LABZ - FIRE STACK - 45 CAPSULES Yohimbine (schedule 4) Noopept (schedule 4) 64 Aggressive Labz - MAXX DMZ - 60 Capsules Dimethazine (AAS) (schedule 4) 65 Enhanced Athlete - LIGAN-ELITE 66 Enhanced Athlete - S-23 VENOM - 60 Capsules 67 Enhanced Athlete - ACE-XT (ACP-105) - 60 Capsules 68 Enhanced Athlete - ANDARINE S4 - 60 Capsules 69 Enhanced Athlete - CENTAURUS - 60 Capsules Ligandrol (SARM) (schedule 4) 70 Enhanced Athlete - Yohimbine - 120 Capsules 71 EVO LABS - BEAST - 30ML dropper 72 EVO LABS - BEAST - 90 Capsules Stenabolic (SR9009) and Testolone (SARMs) (schedule 4) 73 EVO LABS - GH-ULTRA 25 - 60 Capsules 74 EVO LABS - LGD-ULTRA 10 - 30ml dropper 75 EVO LABS - LGD-ULTRA 10 - 60 Capsules 76 EVO LABS - LGD2226 - 30 ml dropper 77 EVO LABS - LGD33-ULTRA 15 - 30ml dropper 78 EVO LABS - LGD33-ULTRA 15 - 60 Capsules 79 EVO LABS - OSTA-ULTRA 50 - 30ml dropper 80 EVO LABS - OSTA-ULTRA 50 - 60 Capsules 81 EVO LABS - RAD ULTRA 10 - 60 Capsules 82 EVO LABS - RAD-ULTRA 10 - 30ml dropper 83 EVO LABS - RIPPED - 90 Capsules 84 EVO LABS - S23 - 25mg x 30mL dropper 85 EVO LABS - S23 ULTRA 25 - 60 Capsules 86 EVO LABS - S23-ULTRA 25 - 30ml dropper 87 EVO LABS - S4 ULTRA 50 - 90 Capsules 88 EVO LABS - S4-ULTRA 50 - 30ml dropper 89 EVO LABS - SR-ULTRA 20 - 30ml dropper 90 EVO LABS - SWOLE - 30ML dropper Ibutamoren (schedule 4) 91 Evo Labs - TRANSFORMER DETOX STACK Ephedra extract (schedule 4) 92 EVO LABS - ULTIMATE MASS - 30ml dropper YK-11, Testalone and Ostarine (SARMs) (schedule 4) Stenabolic (SR9009) (schedule 4) 93 EVO LABS - ULTIMATE MASS - 60 Capsules Stenabolic (SR9009) and Testolone (schedule 4) 94 EVO LABS - YK ULTRA 10 - 60 Capsules 95 EVO LABS - ZEUS - 60 Capsules Ibutamoren (schedule 4) Ligandrol (SARM) (schedule 4) 96 Olympus Labs - SUP3R-EPI ELITE 97 SUNDOWN NATURALS - MELATONIN 10 MG - 90 Capsules 98 THE KONG STACK Ostarine and Testolone (SARMs) (schedule 4) Ibutamoren (schedule 4) Ligandrol (SARM) (schedule 4) 99 ULTIMATE LEAN MASS STACK Ephedra extract (schedule 4) Stenabolic (SR9009) (schedule 4) Ostarine and Testolone (SARMs) (schedule 4) Impugned substances Product category No. of Website advertisement days No. of After Hours Website advertisement days DMAA (schedule 10) 1 199 272 Cardarine (schedule 10) 1 213 0 Cardarine (schedule 10) 1 213 50 Cardarine (schedule 10) 1 199 73 Cardarine (schedule 10) 1 157 0 Testalone (SARM) (schedule 4) 3 157 0 Ibutamoren (schedule 4) 3 157 0 Cardarine (schedule 10) 2 157 24 Ibutamoren (schedule 4) 3 171 33 Cardarine (schedule 10) 1 201 50 Cardarine (schedule 10) 1 201 1 Cardarine (schedule 10) 1 187 0 Ibutamoren (schedule 4) 3 171 24 Cardarine (schedule 10) 2 171 33 Cardarine (schedule 10) 2 171 0 Ligandrol (SARM) (schedule 4) 3 163 73 Cardarine (schedule 10) 2 157 0 Cardarine (schedule 10) 1 163 0 Cardarine (schedule 10) 2 163 73 No information is provided about the type and dose of ingredients other than it provides "5 SARMS" 3 157 0 Cardarine (schedule 10) 2 157 0 1, 5-Dimethylhexylamine (DMHA) (schedule 10) 1 154 24 DMAA (schedule 10) 2 144 24 DMAA (schedule 10) 2 144 74 DMAA (schedule 10) 1 154 73 Melatonin (schedule 4) 3 144 0 DMAA (schedule 10) 1 158 73 BURNING CREAM - 4 oz Aminophylline (schedule 4) 3 128 127 - 2019-05-16_11-18-44 gel 4 142 0 DMAA (schedule 10) 2 31 0 DMAA (schedule 10) 1 128 0 Yohimbine (schedule 4) 3 127 0 Methylstenbolone (an Anabolic/androgenic Steroidal Agent (AAS)) (schedule 4) 3 127 0 EPI DROL - 60 capsules Epistane and Halodrol (AAS) (schedule 4) 3 127 0 4 144 74 4 124 0 OF INSANE ENERGY - 90 capsules DMAA (schedule 10) 1 124 73 4 124 0 ELITE - 90 tablets DMAA (schedule 10) 1 124 0 HARDCORE - 90 tablets DMAA (schedule 10) 1 124 0 HARDCORE - 90 tablets DMAA (schedule 10) 1 138 73 DMAA (schedule 10) 1 138 73 7000IU - 60 Softgel Tablets 4 138 22 Extract - 60 capsules 4 138 74 - liquid Zeolite - 30 servings dropper 4 124 74 4 124 0 - Pure OptiMSM - 200 Tablets 4 124 127 - - - - 4 144 74 DMAA (schedule 10) 1 124 73 4 144 0 2.0 MARINE PHYTOPLANKTON - 30 servings dropper 4 124 74 - 60 Vegetarian Capsules 4 124 74 Testosterone (schedule 4) 3 31 0 DMHA (schedule 10) 2 31 0 - - - - 4 61 74 DMAA (schedule 10) 2 61 55 4 61 74 4 144 51 Methylstenbolone (AAS) (schedule 4) 3 0 56 DMAA (schedule 10) 1 0 56 DMAA (schedule 10) 1 0 56 Methylstenbolone (AAS) (schedule 4) 3 0 56 LDG-3303 - 60 Capsules LGD-3303 (SARM) (schedule 4) 3 1 56 S-23 (SARM) (schedule 4) 3 1 56 ACP-105 (SARM) (schedule 4) 3 1 33 Andarine (SARM) (schedule 4) 3 171 56 Cardarine (schedule 10) 1 1 56 Yohimbine (schedule 4) 3 0 56 YK-11, Stenabolic (SR9009) and Testalone (SARMs) (schedule 4) 3 0 56 YK-11 (SARM) (schedule 4) 3 1 56 Ibutamoren (schedule 4) 3 1 56 Ligandrol (SARM) (schedule 4) 3 0 56 Ligandrol (SARM) (schedule 4) 3 1 56 Ligandrol (SARM) (schedule 4) 3 1 33 Ligandrol (SARM) (schedule 4) 3 1 56 Ligandrol (SARM) (schedule 4) 3 1 56 Ostarine (SARM) (schedule 4) 3 1 56 Ostarine (SARM) (schedule 4) 3 1 56 Testolone (RAD140) (SARM) (schedule 4) 3 0 33 Testolone (SARM) (schedule 4) 3 1 55 Testolone (RAD140) (SARM) (schedule 4) 3 171 55 S23 (SARM) (schedule 4) 3 171 55 S23 (SARM) (schedule 4) 3 0 55 S23 (SARM) (schedule 4) 3 0 55 Andarine (S4) (SARM) (schedule 4) 3 1 55 Andarine (SARM) (schedule 4) 3 1 55 Stenabolic (SR9009) (SARM) (schedule 4) 3 171 55 Ligandrol (SARM) (schedule 4) 3 0 55 DMAA (schedule 10) 1 0 55 Ligandrol (SARM) (schedule 4) 3 1 32 Ligandrol (SARM) (schedule 4) 3 1 56 YK-11 (SARM) (schedule 4) 3 1 56 Ostarine, Testalone, S23 and LGD 3303 (SARMs) (schedule 4) 3 0 56 Epiandrosterone (Steroid Hormone) (schedule 4) 3 0 56 Melatonin (schedule 4) 3 0 109 Cardarine (schedule 10) 1 0 56 DMAA (schedule 10) 1 0 55

Corporations Act 2001(Cth)s 601AB(1), s

Crimes Act 1914(Cth)s 4AA

Evidence Act 1995(Cth)s 50, s

At a glance

Court

Decision date

Before

Source

Judgment (17 paragraphs)

Parties

Legislation Cited (5)

Cases Cited (22)

Cited By (2)