Federal Court of Australia

Secretary, Department of Health and Aged Care v CDA Clinics QLD Pty Ltd trading as CDA Express [2026] FCA 1623

ORDERS

THE COURT DECLARES THAT:

Prohibited representations

1.    Between 27 April 2021 and 30 July 2021, the First Respondent contravened s 42DLB(1) of the Therapeutic Goods Act 1989 (Cth) (TG Act):

(a)    in relation to each of the advertisements identified in Column B of Items 1 to 14, 16, 17 and 21 of Annexure A to these Orders;

(b)    for each such advertisement, on each day during the period identified in Column C of Annexure A to these Orders,

in circumstances where s 42DLB(2) applied by advertising or causing to be advertised:

(c)    the products identified in Items 1 to 14 of Annexure A to these Orders on the website at www.cdaexpress.com.au (Website); and

(d)    cannabidiol (CBD) in the blog posts on the Website (Blog Posts) identified in Items 16, 17 and 21 of Annexure A to these Orders,

in advertisements containing representations regarding the treatment, cure or prevention of:

(e)    cancer (a neoplastic disease);

(f)    gonorrhoea (a sexually transmitted disease);

(g)    depression (a mental illness);

(h)    anxiety (a mental illness); and/or

(i)    post-traumatic stress disorder (a mental illness),

being diseases specified under reg 6B(1)(b) of the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) and s 30 of the Therapeutic Goods Advertising Code (No 2) 2018 (Cth) (Advertising Code), in circumstances where:

(j)    those representations were each prohibited representations within the meaning and for the purposes of s 42DJ(1) of the TG Act; and

(k)    no permission under s 42DK(3) of the TG Act was in force in relation to those representations.

2.    Between 27 April 2021 and 30 July 2021, the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the TG Act referred to in paragraph 1 and was therefore involved in those contraventions within the meaning and for the purposes of s 42YC of the TG Act.

Restricted representations

3.    Between 27 April 2021 and 30 July 2021, the First Respondent contravened s 42DLB(1) of the TG Act:

(a)    in relation to each of the advertisements identified in Column B of Items 1 to 14, 16, 17 and 19 of Annexure A to these Orders; and

(b)    for each such advertisement, on each day during the period identified in Column C of Annexure A to these Orders,

in circumstances where s 42DLB(4) applied by advertising or causing to be advertised:

(c)    the products identified in Items 1 to 14 of Annexure A to these Orders on the Website; and

(d)    CBD in the Blog Posts identified in Items 16, 17 and 19 of Annexure A to these Orders,

in advertisements containing representations that referred to one or more of:

(e)    fibromyalgia;

(f)    epilepsy;

(g)    autoimmune conditions;

(h)    chronic pain;

(i)    seizures;

(j)    meningitis; and/or

(k)    autism, and

which were each a serious form of disease, condition or ailment within the meaning of s 28 of the Advertising Code, in circumstances where:

(l)    these representations were each restricted representations within the meaning and for the purposes of s 42DD of the TG Act; and

(m)    there was no approval under s 42DF(1) or permission under s 42DK(1) of the TG Act in force in relation to those representations.

4.    Between 27 April 2021 and 30 July 2021, the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the TG Act in paragraph 3 and was therefore involved in those contraventions within the meaning and for the purposes of s 42YC of the TG Act.

Advertising substances or goods containing substances in Schedule 3, 4 or 8 to the Poisons Standard February 2021 and Poisons Standard June 2021 (as applicable and, together, the Poisons Standard)

5.    Between 20 April 2021 and 30 July 2021, the First Respondent contravened s 42DLB(1) of the TG Act:

(a)    in relation to each of the advertisements identified in Column B of Items 1 to 22 of Annexure A to these Orders; and

(b)    for each such advertisement, on each day during the period identified in Column C of Annexure A to these Orders,

in circumstances where s 42DLB(7) applied by advertising or causing to be advertised:

(c)    the products identified in Items 1 to 15 of Annexure A to these Orders on the Website;

(d)    CBD in the Blog Posts identified in Items 16 to 21 of Annexure A to these Orders;

(e)    CBD in the Facebook posts made on the First Respondent’s Facebook page at www.facebook.com/cdaexpressau identified in Item 22 of Annexure A to these Orders (Facebook Posts), in circumstances where:

(f)    those advertisements referred to CBD substances, or goods containing CBD substances, that:

(i)    were included in Schedule 3, 4 or 8 to the Poisons Standard; but

(ii)    were not included in Appendix H of the Poisons Standard; and

(g)    the references described in paragraph 5(f) above were not authorised or required by a government or government authority.

6.    Between 27 April 2021 and 30 July 2021, the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the TG Act referred to in paragraph 5 insofar as they relate to:

(a)    each of the advertisements identified in Column B of Items 1 to 21 of Annexure A to these Orders; and

(b)    for each such advertisement, on each day during the period identified in Column C of Annexure A to these Orders and was therefore involved in those contraventions within the meaning and for the purposes of s 42YC of the TG Act.

Advertising goods not included in the Australian Register of Therapeutic Goods

7.    Between 27 April 2021 and 30 July 2021, the First Respondent contravened s 42DLB(1) of the TG Act:

(a)    in relation to each of the advertisements identified in Column B of Items 1 to 15 of Annexure A to these Orders; and

(b)    for each such advertisement, on each day during the period identified in Column C of Annexure A to these Orders,

in circumstances where s 42DLB(9) applied by advertising or causing to be advertised on the Website the products identified in Items 1 to 15 of Annexure A to these Orders, in circumstances where:

(c)    those products were not included in the Australian Register of Therapeutic Goods; and

(d)    those products:

(i)    were the subject of an approval or authority under s 19 of the TG Act and therefore were therapeutic goods prescribed by reg 7(a) of the TG Regulations; or

(ii)    alternatively, were neither the subject of an exemption, approval or authority under the TG Act nor an exemption, approval or authority under the TG Regulations, and therefore were therapeutic goods prescribed by reg 7(i) of the TG Regulations; and

(e)    the references to those products contained in the advertisements described in paragraph 7(a) above were not authorised or required by a government or government authority.

8.    Between 27 April 2021 and 30 July 2021, the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the TG Act in paragraph 7 and was therefore involved in those contraventions within the meaning and for the purposes of s 42YC of the TG Act.

THE COURT ORDERS THAT:

9.    Pursuant to s 42Y of the TG Act, the First Respondent pay to the Commonwealth of Australia (Commonwealth) a pecuniary penalty in the total sum of $6,500,000 in respect of the conduct described in paragraphs 1, 3, 5 and 7 of these Orders.

10.    Pursuant to s 42Y of the TG Act, the Second Respondent pay to the Commonwealth a pecuniary penalty in the total sum of $450,000 within 180 days of the date of these Orders.

11.    The First Respondent pay the Applicant’s costs of and incidental to the proceeding, as they relate to the claims against the First Respondent, such costs to be taxed if not otherwise agreed.

12.    The Second Respondent pay the Applicant’s costs of the proceeding as they relate to the claims against the Second Respondent in the lump sum of $20,000, within 180 days of the date of this order.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

ANNEXURE A

REASONS FOR JUDGMENT

COLLIER ACJ:

1    Before the Court is an Originating Application filed by the applicant, the Secretary of the Department of Health and Aged Care (Secretary) on 1 December 2023, seeking declarations pursuant to s 21 of the Federal Court of Australia Act 1976 (Cth) (FCA Act), pecuniary penalties pursuant to s 42Y of the Therapeutic Goods Act 1989 (Cth) (TG Act) and costs pursuant to s 43 of the FCA Act.

2    In summary, the relief sought relates to alleged contraventions by the first respondent, CDA CLINICS QLD PTY LTD, trading as CDA Express (CDA), of s 42DLB(1) of the TG Act. The alleged contraventions concern advertisements made by CDA between 20 April 2021 and 30 July 2021 (Relevant Period) on its Website (www.cdaexpress.com.au) and Facebook Page (www.facebook.com/cdaexpressau) concerning cannabidiol (CBD) products (Relevant Advertisements). The Secretary has alleged that the Relevant Advertisements made prohibited or restricted therapeutic claims in respect of a range of serious diseases and conditions, advertised prescription-only CBD substances and products, and advertised therapeutic goods that were not entered on the Australian Register of Therapeutic Goods (TG Register).

3    The Secretary has also sought relief against the second respondent, Dr Benjamin David Ngahuia Jansen, alleging that Dr Jansen was “involved” in CDA’s contraventions of s 42DLB(1) of the TG Act within the meaning of s 42YC of the TG Act. Dr Jansen has admitted to the alleged contraventions, as set out in a Statement of Agreed Facts and Joint Submissions filed jointly by the Secretary and Dr Jansen on 9 February 2026 (Agreed Facts and Submissions).

4    Before turning to the parties’ submissions, it is convenient to set out the background of the proceeding in some detail.

BACKGROUND

5    On 1 December 2023, the Secretary filed the Originating Application seeking the following detailed orders:

Declarations

Prohibited representations

1.    Declarations under s 21 of the Federal Court Act that:

(a)     in relation to each of the advertisements identified in Column B of Items 1 to 14, 16, 17 and 21 of Annexure A to this Originating Application; and

(b)     for each such advertisement, on each day during the period identified in Column C of Annexure A to this Originating Application,

the First Respondent contravened s 42DLB(1) of the Therapeutic Goods Act in circumstances where s 42DLB(2) applied by advertising or causing to be advertised:

(c)     the Products identified in Items 1 to 14 of Annexure A to this Originating Application on the website at www.cdaexpress.com.au (Website); and

(d)     CBD in the blog posts on the Website (Blog Posts) identified in Items 16, 17 and 21 of Annexure A to this Originating Application,

in advertisements containing representations regarding the treatment, cure or prevention of:

(e)     cancer (a neoplastic disease);

(f)     gonorrhoea (a sexually transmitted disease);

(g)     depression (a mental illness);

(h)     anxiety (a mental illness);

(i)     post-traumatic stress disorder (a mental illness); and/or

(j)     autism (a mental illness),

being diseases specified under reg 6B(1)(b) of the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) and s 30 of the Therapeutic Goods Advertising Code (No 2) 2018 (Cth) (Advertising Code), in circumstances where:

(k)     those representations were each prohibited representations within the meaning and for the purposes of s 42DJ(1) of the Therapeutic Goods Act; and

(l)     no permission under s 42DK(3) of the Therapeutic Goods Act was in force in relation to those representations.

2.     Declarations under s 21 of the Federal Court Act that the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the Therapeutic Goods Act referred to in paragraph 1 above and was therefore involved in those contraventions within the meaning and for the purposes of s 42YC of the Therapeutic Goods Act.

Restricted representations

3.     Further to paragraph 1 of this application, and in the alternative to that paragraph insofar as it applies to representations regarding the treatment, cure or prevention of autism, declarations under s 21 of the Federal Court Act that:

(a)     in relation to each of the advertisements identified in Column B of Items 1 to 14, 16, 17 and 19 of Annexure A to this Originating Application; and

(b)     for each such advertisement, on each day during the period identified in Column C of Annexure A to this Originating Application,

the First Respondent contravened s 42DLB(1) of the Therapeutic Goods Act in circumstances where s 42DLB(4) applied by advertising or causing to be advertised:

(c)     the Products identified in Items 1 to 14 of Annexure A to this Originating Application on its Website; and

(d)     CBD in the Blog Posts identified in Items 16, 17 and 19 of Annexure A to this Originating Application,

in advertisements containing representations that referred to:

(e)     fibromyalgia;

(f)     epilepsy;

(g)     autoimmune conditions;

(h)     chronic pain;

(i)     seizures;

(j)     meningitis; and/or

(k)     autism, and

which were each a serious form of disease, condition or ailment within the meaning of s 28 of the Advertising Code, in circumstances where:

(l)    these representations were each restricted representations within the meaning and for the purposes of s 42DD of the Therapeutic Goods Act; and

(m)     there was no approval under s 42DF(1) or permission under s 42DK(1) of the Therapeutic Goods Act in force in relation to those representations.

4.     Declarations under s 21 of the Federal Court Act that the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the Therapeutic Goods Act referred to in paragraph 3 above and was therefore involved in those contraventions within the meaning and for the purposes of s 42YC of the Therapeutic Goods Act.

Advertising substances or goods containing substances in Schedules 3, 4 or 8 to the Poisons Standard

5.     Declarations under s 21 of the Federal Court Act that:

(a)     in relation to each of the advertisements identified in Column B of Items 1 to 22 of Annexure A to this Originating Application; and

(b)     for each such advertisement, on each day during the period identified in Column C of Annexure A to this Originating Application,

the First Respondent contravened s 42DLB(1) of the Therapeutic Goods Act in circumstances where s 42DLB(7) applied by advertising or causing to be advertised:

(c)     the Products identified in Items 1 to 15 of Annexure A on its Website to this Originating Application;

(d)     CBD in the Blog Posts identified in Items 16 to 21 of Annexure A to this Originating Application; and

(e)     CBD in posts on the Facebook page identified in Item 22 of Annexure A to this Originating Application (Facebook Posts Conduct),

in circumstances where:

(f)     those advertisements referred to CBD substances, or goods containing CBD substances, that:

(i)     were included in Schedules 3, 4 or 8 to the Poisons Standard February 2021 and Poisons Standard June 2021 (as applicable and, together, the Poisons Standard); but

(ii)     were not included Appendix H of the Poisons Standard; and

(g)     the references described in paragraph 5(f) above were not authorised or required by a government or government authority.

6.     Declarations under s 21 of the Federal Court Act that the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the Therapeutic Goods Act referred to in paragraph 5 above, other than the Facebook Posts Conduct, and was therefore involved in those contraventions within the meaning and for the purposes of s 42YC of the Therapeutic Goods Act.

Advertising goods not included in the Australian Register of Therapeutic Goods

7.    Declarations under s 21 of the Federal Court Act that:

(a)     in relation to each of the advertisements identified in Column B of Items 1 to 15 of Annexure A to this Originating Application; and

(b)     for each such advertisement, on each day during the period identified in Column C of Annexure A to this Originating Application,

the First Respondent contravened s 42DLB(1) of the Therapeutic Goods Act in circumstances where s 42DLB(9) applied by advertising or causing to be advertised the Products at Items 1 to 15 listed in Annexure A on its Website in circumstances where:

(c)     those Products were not included in the Australian Register of Therapeutic Goods; and

(d)     those Products:

(i)     were the subject of an approval of authority under s 19 of the Therapeutic Goods Act and therefore were therapeutic goods prescribed by reg 7(a) of the TG Regulations; or

(ii)     alternatively, were neither the subject of an exemption, approval or authority under the Therapeutic Goods Act nor an exemption, approval or authority under the TG Regulations, and therefore were therapeutic goods prescribed by reg 7(i) of the TG Regulations; and

(e)     the references to those Products contained in the advertisements described in paragraph 7(a) above were not authorised or required by a government or government authority.

8.     Declarations under s 21 of the Federal Court Act that the Second Respondent aided, abetted, counselled or procured the First Respondent’s contraventions of s 42DLB(1) of the Therapeutic Goods Act referred to in paragraph 7 above and was therefore involved in those contraventions within the meaning and for the purposes of s 42YC of the Therapeutic Goods Act.

Pecuniary penalties (s 42Y of the Therapeutic Goods Act)

9.    Orders pursuant to s 42Y of the Therapeutic Goods Act that, within 30 days of the date of the order, each of the Respondents pay to the Commonwealth of Australia such pecuniary penalties as the Court determines appropriate in respect of the contraventions of s 42DLB(1) of the Therapeutic Goods Act referred to in paragraphs 1 to 8 above.

Other orders

10.     An order that the Respondents pay the Applicant’s costs of and incidental to these proceedings.

11.     Such further order or orders as the Court sees fit.

6    On 1 December 2023, the Secretary filed a Concise Statement setting out the Secretary’s allegations that, between April and July 2021, CDA advertised CBD products (Products) on the Website and Facebook Page in contravention of s 42DLB(1) of the TG Act. Specifically, the Secretary alleged that the Relevant Advertisements included Products Advertisements, Blog Posts, and Facebook Posts, as particularised at [5.1]-[5.3] of the Concise Statement:

5.1.     Advertisements for the sale of the products listed in rows 1 to 15 of Schedule 1 (Products), which were products that each contained CBD. The Products were available for online purchase and delivery to any address in Australia;

5.2.     Advertisements for CBD products contained in the Blog Posts listed in rows 16 to 21 of Schedule 1; and

5.3.     Advertisements promoting the use of CBD and containing hyperlinks to the Website in the Facebook Posts particularised in row 22 of Schedule 1.

Schedule 1 to the Concise Statement provided further information about the Relevant Advertisements but remained consistent with Annexure A to the Originating Application.

7    The Relevant Advertisements were allegedly made without the required approvals or permissions and:

    promoted the Products as treatments for a range of serious diseases and conditions, including anxiety, depression, PTSD, autism, cancer, gonorrhoea, epilepsy, chronic pain and other ailments;

    contained prohibited and restricted representations;

    referred to Schedule 3, 4 or 8 substances (for the purposes of the Poisons Standard February 2021 and the Poisons Standard June 2021 (as applicable and, together, the Poisons Standard); and

    advertised therapeutic goods that were not entered on the TG Register.

8    The Secretary further alleged that:

    each advertisement constituted a separate contravention for each day it was available to consumers; and

    Dr Jansen, who was the sole director of CDA during the Relevant Period and had oversight of the Website’s content, was involved in the contraventions by causing or permitting the Relevant Advertisements to be published.

9    On 4 June 2024, CDA filed a Concise Statement in Response which denied that pt 5-1 of the TG Act applied to the Relevant Advertisements as:

    the Products Advertisements were provided as part of a doctor-supervised patient assessment and treatment process, falling within the exclusionary provision contained in s 42AA(4) of the TG Act; and

    the Blog Posts and Facebook Posts contained factual, modest and balanced information, rather than promotional material.

10    On 14 June 2024, Dr Jansen filed a Concise Statement in Response which admitted many of the underlying factual matters. Nonetheless, regarding Dr Jansen’s involvement in the Website, Dr Jansen stated that he was unable to admit the allegations because he had not been a director of CDA since 5 July 2022 and had not had access to CDA’s books and records since that time. Like CDA, Dr Jansen denied that pt 5-1 of the TG Act applied to the Relevant Advertisements.

11    The Secretary filed a Concise Statement in Reply on 5 July 2024, and the parties filed substantial evidence over the course of 2024.

12    On 13 January 2025, CDA’s sole shareholder, CDA Health Pty Ltd, passed a resolution to voluntarily wind up CDA under s 491(1) of the Corporations Act 2001 (Cth) (Corporations Act).

13    On 15 January 2025, the lawyers for the Secretary sent a letter to Mr Neil McLean and Mr Brodie Hilet, the appointed Joint and Several Liquidators of CDA, advising that the Secretary intended to seek the Court’s leave to proceed against CDA, pursuant to s 500(2) of the Corporations Act.

14    On 24 February 2025, Mr McLean sent a letter to the lawyers for the Secretary confirming that the Joint and Several Liquidators of CDA did not consent to, oppose, or intend to contest, the Secretary seeking leave to proceed against CDA.

15    On 25 February 2025, the Secretary lodged for filing an Interlocutory Application seeking leave, pursuant to s 500(2) of the Corporations Act, to proceed against CDA, notwithstanding that CDA was in liquidation.

16    On 9 May 2025, I ordered by consent that the Interlocutory Application be determined on the papers, noting that Dr Jansen consented to the orders sought by the Secretary and did not wish to be heard further in that regard.

17    On 9 February 2026, the Secretary and Dr Jansen jointly filed the Agreed Facts and Submissions in which:

    Dr Jansen admitted that CDA had contravened s 42DLB(1) of the TG Act, as described in the Secretary’s Originating Application and Concise Statement (at [6], [58]-[79]);

    Dr Jansen admitted that, as the sole director of CDA during the Relevant Period, he aided, abetted, counselled or procured CDA’s contraventions of s 42DLB(1) of the TG Act, and was therefore “involved” in those contraventions within the meaning and for the purposes of s 42YC of the TG Act (at [6], [14]-[15], [58]-[79]);

    the parties agreed that the exclusionary provision contained in s 42AA(4) of the TG Act did not apply to the Relevant Advertisements (at [77]-[79]); and

    the Secretary and Dr Jansen jointly sought, by consent, declarations reflecting the admitted contraventions, a pecuniary penalty of $450,000 payable by Dr Jansen to the Commonwealth within 180 days, and costs of $20,000 against Dr Jansen (at [7], [89], [133]-[134]).

18    On 23 February 2026, I determined the Interlocutory Application and ordered that leave be granted to the Secretary to continue the proceedings against CDA, pursuant to s 500(2) of the Corporations Act. It was relevant to that determination that the Secretary had offered an undertaking to the Court not to enforce any costs order imposed on CDA without leave.

CDA’S ABSENCE

19    Unlike the position between the Secretary and Dr Jansen, the Secretary and CDA have not agreed on a statement of agreed facts or joint submissions. Beyond the Concise Statement in Response filed on 4 June 2024, CDA has made no further submissions and has not otherwise participated in the proceeding following the commencement of its liquidation. The Joint and Several Liquidators of CDA were not present at the hearing on 22 April 2026.

20    Rule 30.21(1)(b)(i) of the Federal Court Rules 2011 (Cth) (FCR) allows a party to apply for an order that, where a respondent is absent when a proceeding is called on for trial, the hearing proceed generally or in relation to a particular aspect of the application.

21    On 12 February 2026, the lawyers for the Secretary sought orders (with the consent of Dr Jansen) that the trial against CDA and Dr Jansen be set down for 22 April 2026. The Joint and Several Liquidators of CDA were copied into that email.

22    On 23 February 2026, I made consent orders listing the proceedings against Dr Jansen and CDA for a hearing on liability and remedies on 22 April 2026. The lawyers for the Secretary, Dr Jansen and the Joint and Several Liquidators of CDA were notified of those orders by email the same day.

23    In light of those communications and having regard to CDA’s lack of engagement in the proceeding, on 22 April 2026 I considered it appropriate, notwithstanding the absence of CDA, to proceed with the trial. I accept the Secretary’s submission at [12] of their written submissions filed on 15 April 2026 (Secretary’s Submissions) that CDA was given adequate notice of the trial and that the hearing could properly proceed and judgment be delivered in CDA’s absence.

24    As raised at [13] of the Secretary’s Submissions, in AA Shi Pty Ltd v Avbar Pty Ltd (No 5) [2010] FCA 971 at [12] I identified the following principles as relevant when a respondent is absent when a proceeding is called on for trial:

In such circumstances:

•    Because the Court is proceeding with the trial generally, the Court must investigate the merits of the matter: Applicant A184 of 2003 v Minister for Immigration and Multicultural and Indigenous Affairs (2004) 210 ALR 543 at [89].

•    The respondents/cross-claimants must prove their case on the balance of probabilities in the usual way: TVBO Production v Australia Sky Net Pty Ltd [2009] FCA 1132 at [15].

•    The Court should restrict the relief to that claimed in the pleadings: Stone v. Smith (1887) 35 ChD 188; Kingdon v. Kirk (1888) 37 ChD 141; Barker v. Furlong (1891) 2 Ch 172 at 178-179.

•    The Court may allow evidence to be tendered on behalf of the party which is present: Scoway Pty Ltd v Faxon Pty Ltd [2004] FCA 249 at [7]-[9].

25    With those principles in mind, I consider it appropriate to address at the outset the weight to be given to the Agreed Facts and Submissions in determining whether the Secretary has established the alleged contraventions against CDA.

26    In the Secretary’s Submissions, the Secretary relied extensively upon the Agreed Facts and Submissions where Dr Jansen:

    agreed various facts pursuant to s 191 of the Evidence Act 1995 (Cth) (Evidence Act); and

    made admissions concerning contraventions of s 42DLB(1) of the TG Act by CDA and, by operation of s 42YC, his involvement in those contraventions.

27    It is well established that facts agreed pursuant to s 191 of the Evidence Act, such as those agreed in the Agreed Facts and Submissions, are evidence before the Court, although it remains for the Court to determine whether those facts should be accepted and what weight should be attributed to them: ASIC v BHF Solutions Pty Ltd [2022] FCAFC 108; (2022) 293 FCR 330 at [24]. Furthermore, having been admitted as evidence in the proceeding, the Agreed Facts and Submissions may generally be used for any legitimate forensic purpose, including against CDA, unless excluded by the operation of the Evidence Act, a surviving common law exclusionary rule, or an exercise of the Court’s statutory discretion: McNamara v The King [2023] HCA 36; (2023) 280 CLR 201 at [67]-[69], [81], citing ASIC v Vines [2003] NSWSC 995; (2003) 48 ACSR 282 at [22].

28    I also accept the Secretary’s Submissions that, although the Agreed Facts and Submissions are not themselves an “admission” for the purposes of the Evidence Act (ACCC v Pratt (No 3) [2009] FCA 407; (2009) 175 FCR 558 at [83]-[84]), they may nevertheless support an inference as to the truth of the facts asserted, particularly where parties have chosen not to dispute those facts and no contradictory evidence has been adduced: Capic v Ford Motor Company of Australia Pty Ltd [2021] FCA 715; (2021) 154 ACSR 235 at [815]-[817].

29    I accept that the circumstances of the present case make those principles particularly apposite. As set out at [13]-[15] of the Agreed Facts and Submissions, Dr Jansen was the sole director of CDA during the Relevant Period. Dr Jansen has admitted that he was responsible for the day-to-day management of the company during that period. Although Dr Jansen was no longer a director when CDA filed its Concise Statement in Response and when the Agreed Facts and Submissions were executed, the agreed facts concern conduct occurring during the period in which he alone directed and managed CDA’s affairs.

30    In Fair Work Ombudsman v Blue Sky Kids Land Pty Ltd (in liq) (No 3) [2024] FCA 785 at [9] the Court recognised that admissions made by former directors after a company had entered liquidation could not formally bind the company. Nonetheless, the admissions were treated as relevant evidence where those directors had been intimately involved in the management and operations of the corporations during the relevant period. Similarly, in Clean Energy Regulator v E Connect Solar & Electrical Pty Ltd [2023] FCA 1082; (2023) 171 ACSR 216, the Court relied on admissions made by directors concerning conduct undertaken in their capacities as directors and agents when determining the liability of the corporate respondent, notwithstanding that the corporate respondent was not a party to the Statement of Agreed Facts and Admissions.

31    In my view, a similar approach is appropriate here. Dr Jansen was not merely a participant in the affairs of CDA. On the evidence and as agreed by Dr Jansen in the Agreed Facts and Submissions, Dr Jansen was CDA’s sole director and the person responsible for its day-to-day operations throughout the Relevant Period. The facts agreed by him in the Agreed Facts and Submissions concern matters squarely within his personal knowledge and involvement. In the absence of any evidence contradicting those agreed facts, I consider the Agreed Facts and Submissions to be persuasive evidence of the conduct of CDA and of the circumstances in which that conduct occurred.

32    Accordingly, while the Agreed Facts and Submissions do not themselves determine CDA’s liability, and while I must independently be satisfied that the Secretary has established the alleged contraventions, I accept the Secretary’s Submissions (at [21]) that the Agreed Facts and Submissions may properly be taken into account in assessing whether CDA contravened the relevant provisions of the TG Act.

33    I will now turn to consider the submissions made by the Secretary and Dr Jansen.

SUBMISSIONS OF THE PARTIES

The Secretary’s Submissions

34    The Secretary’s Submissions, filed on 15 April 2026, are extensive, comprising 55 pages of written submissions and an additional 23 pages of annexures. In light of the Agreed Facts and Submissions, the Secretary’s Submissions largely focus on CDA’s alleged contraventions and “only refer to Dr Jansen as necessary” (at [7]).

35    The Secretary’s Submissions can be summarised as follows:

    CDA contravened ss 42DLB(2), (4), (7) and (9) of the TG Act during the period 20 April 2021 to 30 July 2021 by advertising the Products and CBD generally on the Website and the Facebook Page.

    Part 5-1 of the TG Act is directed toward protecting public health through regulating the advertising of therapeutic goods and supporting the national regulatory system for therapeutic goods.

    A person contravenes s 42DLB(1) if that person publishes, or causes to be published, an advertisement for therapeutic goods in any of the circumstances described in subsections (2) to (9) of s 42DLB.

    The four relevant subsections of s 42DLB in the present proceedings are (2), (4), (7) and (9), which relate to advertisements containing prohibited representations, restricted representations, references to Schedule 3, 4 or 8 substances, and references to prescribed therapeutic goods not on the TG Register.

    The proceeding concerns the Products, namely fifteen CBD products listed in Annexure A of the Secretary’s Submissions, and CBD generally.

    CBD is a cannabinoid derived from cannabis and appears within Schedules 3, 4 and 8 of the Poisons Standard February 2021 and the Poisons Standard June 2021.

    CDA admitted in its Concise Statement in Response that the Products and CBD products generally:

•    could constitute therapeutic goods;

•    referred to substances included in Schedule 3, 4 or 8 but not Appendix H of the Poisons Standard February 2021 and the Poisons Standard June 2021;

•    were not entered on the TG Register; and

•    with the exception of one product, were the subject of an approval pursuant to ss 19(1) or 19(5) of the TG Act.

    The better view is that the Products fall within Schedule 4 of the Poisons Standard February 2021 and the Poisons Standard June 2021 because the Products were not entered on the TG Register.

    Although CBD is generally considered safe at low doses, medicinal cannabis products carry risks including delayed evidence-based treatment, adverse drug interactions and the absence of regulatory quality assessment and testing where products are not entered on the TG Register.

    CDA operated the Website between approximately 27 April 2021 and 30 July 2021 and controlled the publication of the website advertisements (being the Products Advertisements) and Blog Posts appearing on it.

    Prospective customers were required to create an account and complete a “Virtual Consult” questionnaire (Questionnaire) before becoming eligible to access the password-protected or “back end” section of the Website (Restricted Section).

    Prior to about 31 May 2021, eligible customers could access, review, order and pay for the Products before a CDA doctor had reviewed the Questionnaire responses.

    After about 31 May 2021, access to the Products was subject to review and approval by a CDA doctor, but customers who obtained access could still self-select the Products without product-specific medical approval.

    CDA doctors only reviewed orders after customers had ordered and paid for the Products and before the Products were shipped.

    The Website’s terms and conditions were publicly available between 27 April 2021 and 30 July 2021 (without the requirement of the user completing the Questionnaire). The terms and conditions included various disclaimers regarding the provision of medical advice and stated that the information on the Website was for informational purposes only, and not intended to diagnose, treat, cure or prevent disease.

    The Facebook Page (accessible at URL www.facebook.com/cdaexpressau) was operated by CDA, which published various Facebook posts between 20 April 2021 and 18 June 2021, promoting “plant-powered medicine”, “Medical CBD” and access to alternative treatments through CDA (the Facebook Posts).

    The contravening conduct related to three categories of the Relevant Advertisements, as identifiable by the terms previously used in these reasons, being the Products Advertisements, the Blog Posts, and the Facebook Posts. The Products Advertisements included various features such as product names, prices, therapeutic descriptions, conditions allegedly assisted by the Products, efficacy indicators, dosage guides and purchasing functions. The Blog Posts referred to the benefits of CBD generally and in relation to conditions including anxiety, chronic pain and cancer. The Facebook Posts promoted the Website and CDA’s services, referring for example to CDA giving “patients across Australia access to plant-powered medicine, including Medical CBD”.

    Each of the Products Advertisements, the Blog Posts, and the Facebook Posts constituted advertising because they were intended, directly or indirectly, to promote the use or supply of the Products and CDA’s services. Specifically:

•    The Products Advertisements “clearly promote[d] the use or supply of the Products and CBD more generally” because they included features such as product descriptions, therapeutic claims and mechanisms through which the Products could be purchased.

•    The Blog Posts, to the extent that they do not “expressly promote and encourage the use of CBD … do not appear on the CDAX Website in a vacuum”. It can be inferred that the Blog Posts were intended to induce viewers to engage with CDA’s services and promote the use of CBD.

•    The Facebook Posts promoted the use of CBD and induced viewers to engage with CDA’s services.

    The Products and CBD products generally were represented to be for a therapeutic use because the Relevant Advertisements referred to reducing pain, treating symptoms, improving health conditions, influencing physiological processes and providing treatment options.

    The Products Advertisements and Blog Posts contained prohibited representations concerning anxiety, depression, post-traumatic stress disorder (PTSD), cancer and gonorrhoea. Anxiety, depression and PTSD are mental illnesses, cancer is a neoplastic disease, and gonorrhoea is a sexually transmitted disease. CDA admitted that it did not hold any permission under s 42DK of the TG Act permitting the use of those prohibited representations, and therefore contravened s 42DLB(1) of the TG Act by reason of s 42DLB(2).

    The Products Advertisements and Blog Posts contained restricted representations concerning autism, fibromyalgia, epilepsy, autoimmune conditions, chronic pain, seizures and meningitis, which are all conditions constituting a “serious form” of disease, condition or ailment within the meaning of s 28 of the Therapeutic Goods Advertising Code (No 2) 2018 (Cth) (Advertising Code). CDA admitted it did not possess any approval under s 42DF of the TG Act or permission under s 42DK of the TG Act authorising those restricted representations, and therefore contravened s 42DLB(1) of the TG Act by reason of s 42DLB(4).

    All 22 of the Relevant Advertisements (in Annexure A) referred to CBD substances or products containing CBD substances included in Schedule 3, 4 or 8 and not listed in Appendix H of the Poisons Standard February 2021 and the Poisons Standard June 2021. Those references were not authorised or required by a government or government authority, and CDA therefore contravened s 42DLB(1) of the TG Act through the operation of s 42DLB(7).

    The Products relevant to the Products Advertisements were not entered on the TG Register and were prescribed therapeutic goods for the purposes of reg 7(a) or, alternatively, reg 7(i) of the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations). Accordingly, CDA contravened s 42DLB(1) of the TG Act by reason of s 42DLB(9).

    Section 42AA(4) of the TG Act did not apply to the Products Advertisements because the material on the Website was not advice or information given directly to a patient by a health practitioner in the course of treatment. The Website’s terms and conditions made it clear that no doctor/patient relationship was intended to be established. Professor Charlotte Hespe’s evidence demonstrated that the Questionnaire was not sufficient to establish a doctor-patient relationship, did not ensure informed consent and instead treated customers as participants in a transactional relationship. This aligns with the approach taken by the Court in Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107; (2019) 137 ACSR 494.

    The declarations sought by the Secretary are appropriate because they would record the Court’s disapproval of the conduct, assist the Secretary in administering the TG Act, clarify the law and deter other potential contraveners.

    Depending on the method used to count contraventions, CDA committed between approximately 1,949 and 12,381 contraventions of s 42DLB(1) of the TG Act.

    In accordance with the decisions in Peptide Clinics; Secretary, Department of Health v Evolution Supplements Australia Pty Ltd (No 2) [2021] FCA 872; Secretary, Department of Health v Oxymed Australia Pty Ltd [2021] FCA 1518; (2021) 397 ALR 241 and Secretary, Department of Health and Aged Care v Vapor Kings Pty Ltd [2023] FCA 1297, the appropriate approach is to group the conduct into the following “three courses of conduct”:

•    the Products Advertisements that contained one or more of the following: restricted representations, prohibited representations, representations to which s 42DLB(7) of the TG Act applied and representations to which s 42DLB(9) of the TG Act applied;

•    the Blog Posts that contained one or more of the following: restricted representations, prohibited representations and representations to which s 42DLB(7) of the TG Act applied; and

•    the Facebook Posts.

    Several specific points indicate that CDA’s conduct was serious, including that the conduct involved a very large number of contraventions and that the Products were not entered on the TG Register.

    The processes used on the Website gave rise to concerns regarding consumer safety and can be likened to some of the concerns raised by the Secretary, and accepted by the Court, in Peptide Clinics.

    The contraventions involving prohibited and restricted representations were particularly serious because no approvals or permissions were ever sought or obtained by CDA.

    The Relevant Advertisements undermined the integrity of the therapeutic goods regulatory framework and promoted self-selection of prescription-only medicines.

    The Relevant Advertisements carried significant public health risks because users of the Products could delay or avoid conventional treatments, could suffer adverse drug interactions, and could use products whose quality, safety and efficacy had not undergone full regulatory assessment. The risks were particularly acute where the Relevant Advertisements related to serious conditions including cancer, depression and epilepsy. During the Relevant Period, CDA sold 1,082 units of the Products to 676 customers at a price ranging from $49 to $439, meaning that some consumers incurred financial expense with respect to a Product that provided no benefit.

    While CDA has not previously been found by the Court to have engaged in similar conduct, Dr Jansen and CDA should have been aware of the TG Act advertising restrictions before the Website was launched on 27 April 2021, through prior correspondence with the Therapeutic Goods Administration (TGA) and TGA educational material.

    Despite receiving a cease-and-desist letter from the TGA on 2 July 2021, the conduct continued until the Website was taken down on 30 July 2021.

    The Relevant Advertisements formed part of a deliberate marketing strategy designed to promote the use and sale of the Products and CDA’s services.

    Although CDA may not have deliberately set out to breach the TG Act, its conduct was at the very least reckless as to compliance.

    Throughout the Relevant Period, Dr Jansen was the sole director of CDA, and was responsible for managing day-to-day operations, including suggesting, directing and approving changes to the Website, testing certain features of the Website and editing text on the Website. The involvement of senior management increases the seriousness of the contraventions.

    No discount for cooperation should be allowed. While CDA made some admissions, it actively defended the proceeding until entering liquidation and required the Secretary to prepare extensive evidence and submissions. CDA also continued its conduct after receiving the cease-and-desist letter and therefore did not demonstrate genuine contrition or a substantive culture of compliance.

    After allowing a 20% discount for totality, the appropriate overall penalty range is between $5 million and $8 million, comprising between $3 million to $4 million for the Products Advertisements, $1.5 million to $3 million for the Blog Posts and $0.5 to $1 million for the Facebook Posts.

    A penalty of $6.5 million is the appropriate penalty to order against CDA. Such a penalty is reasonable when considering the penalties in Peptide Clinics, Evolution Supplements, Oxymed and Vapor Kings, as well as the penalty against Dr Jansen proposed in the Agreed Facts and Submissions.

    CDA should pay the Secretary’s costs of and incidental to the proceeding, to be fixed by a registrar if not agreed.

36    At the hearing on 22 April 2026 the Secretary tendered a large amount of material (in the Tender Bundle) and sought to file draft proposed orders and an Aide Memoire outlining the references to risk of harm in the report of Professor Edward Ogden dated 25 September 2024 (Ogden Report). At my direction, the Aide Memoire and Ogden Report were filed on 22 April 2026.

37    The Secretary also made the following further oral submissions at the hearing on 22 April 2026, in response to written submissions provided by Dr Jansen at the hearing:

MR WHITE: Very, very briefly, your Honour. To the extent that what is submitted is an attempt to establish a fact, clearly it cannot do so because no evidence has been called in respect of the purported fact. And to the extent it is inconsistent with an agreed fact, as your Honour is aware, section 191, subsection (2), paragraph (b), of the Evidence Act provides that leave must be obtained where one attempts to lead a fact other than – sorry, which seeks to contradict or qualify an agreed fact. In our respectful submission, your Honour, without going through this in detail, we would submit that whilst we have not been able to find any authority which says that a party cannot depart from an agreed submission, leaving aside an agreed fact, assuming that a party can depart from an agreed submission, it becomes, therefore, relevant to see to what extent, if any, there are submissions in this document which are inconsistent with the agreed submissions, as opposed to, for example, an attempt to rely on unproven facts or inconsistent facts with agreed facts.

We would submit that your Honour would be reluctant to accept any submission made in this document which contradicts or seeks to qualify an agreed submission. I haven’t really had the time to pass through every line of this document, but it seems to me at the end of the day none of what is contained within it could in any way justify a change, and certainly not a diminution, in the agreed penalty which the parties have put before you, being $450,000 payable over a period of 180 days, and, in addition, costs in the sum of $20,000.

(transcript QUD533/2023 22 April 2026 p 12 lines 15-35)

Dr Jansen’s Submissions

38    Dr Jansen did not seek to file any written submissions prior to the hearing on 22 April 2026. Nonetheless, at the hearing, Dr Jansen provided three pages of written submissions (Dr Jansen’s Submissions), which were filed at my direction on 22 April 2026. Dr Jansen’s Submissions can be summarised as follows:

    It was never the intention of either CDA or Dr Jansen to commit any offence under the TG Act or “to break any rules”.

    The proceeding imposed a substantial personal and financial burden, including the prospect of a significant penalty, potential exposure to a substantial proportion of the TGA’s costs, approximately $500,000 in defence costs, and an “emotional toll”.

    Three principal issues remained contentious between the parties, namely the proposed penalty, the application of s 42AA(4)(b) of the TG Act, and the question of intention.

    The proposed penalty is “immense”, will likely take “a decade to pay off, if not more” and ought to have been more closely aligned with penalties imposed in cases such as Vapor Kings.

    Section 42AA(4)(b) of the TG Act was said to apply because the relevant material constituted advice or information given directly to patients by health practitioners “in the course of treatment”.

    Once a patient approved the consent form and a doctor approved the patient, a doctor-patient relationship was formed and “the course of treatment had commenced”. The course of treatment included a structured intake and screening process requiring photo identification, informed consent, extensive screening and consent questions, and identification of the patient’s general practitioner. Patients were required to complete more than 60 screening and consent questions, provide government-issued identification, and nominate an active general practitioner whose details were verified through “Medical-Objects, a secure eHealth messaging platform”. Each patient’s general practitioner was contacted following completed consultations, at a standard “far above gold standard”.

    Access to the cited content on the Website during the Relevant Period required completion of the intake and consent process and was contained within the Restricted Section, behind a secure, password-protected firewall. The content was unavailable to the general public and was accessible only to registered patients and authorised clinical staff as part of the private course of clinical consultation between a doctor and patient.

    It was accepted by the Secretary that there was no deliberate intention to break the law, as supported by correspondence from Stones Group Lawyers.

    Confusion existed following a 2021 TGA webinar concerning medicinal cannabis advertising which indicated that terms such as “Medicinal Cannabis”, “Medicinal Cannabis consulting”, “clinic”, “consult”, “appointment” and “prescribing” could be used in advertising.

    Confusion continues to exist within the industry because:

•    Pharmaceutical products such as “MS Contin (Morphine)” and “Nutraceuticals” called “Stress & Anxiety” and their prices can be displayed publicly online by pharmacies such as Chemist Warehouse.

•    Other online clinics (such as “Regenmed”) permit individuals to submit medical information online, view products and obtain prescription products without speaking directly to a doctor.

    The conduct occurred during the COVID-19 pandemic, a period characterised by lockdowns, travel restrictions, vaccine mandates and the expansion of telehealth services.

39    At the hearing on 22 April 2026, Dr Jansen also made the following oral submissions:

DR JANSEN: The relevant extracts that they are referring to here are quite selective. So if you do read through the whole report, you will see that there is actually positives to CBD, potentially, and also a very low rate of toxicity, extremely low. With regard to what we have had – had on the – the – on through the process and on the website was mention of these – some of these conditions, which we were either treating within that platform or referring to our other platform, which is a longer and more thorough consultation with the patients. And so some of the evidence that we have – have for these conditions is clinical and learnt from our experience and some is from other studies out there.

To take selective opinion of a few studies doesn’t take into the clinical aspect and the clinical learnings of effectiveness. And there is a couple in there which I think – meningitis, which we never claimed we would treat, and gonorrhoea, which was simply referenced to lab studies that had been done without claims of therapeutic benefit to people. That’s all, your Honour.

(transcript QUD533/2023 22 April 2026 p 11 lines 23-37)

…

DR JANSEN: If I may, your Honour. I believe in our joint submission there is an – an agreement or an agreed statement on the intent, and that it wasn’t the intent of myself nor the company to contravene the Act, your Honour. So I don’t believe that’s a – a departure.

(transcript QUD533/2023 22 April 2026 p 12 lines 43-46)

…

DR JANSEN: I – I think – sorry, I think so, your Honour. I think it’s justice will prevail, you will see.

(transcript QUD533/2023 22 April 2026 p 13 lines 18-19)

Consideration

Relevant Legislative Framework

40    On the basis of the alleged contraventions of s 42DLB(1) of the TG Act, the Secretary has sought, against CDA and Dr Jansen, declarations pursuant to s 21 of the FCA Act, pecuniary penalties pursuant to s 42Y of the TG Act and costs pursuant to s 43 of the FCA Act.

41    Given the complexity of the regulatory framework relevant to therapeutic goods, it is useful to first set out the principles relevant to the application of ss 42DLB and 42Y of the TG Act, as well as ss 21 and 43 of the FCA Act. For the purposes of the Secretary’s Originating Application, which alleged contraventions during the Relevant Period (20 April 2021 to 30 July 2021), the following versions of legislation and instruments applied:

    the TG Act, as amended and in force from 19 April 2021 to 31 August 2021 (Compilation No. 80);

    the TG Regulations, as amended and in force from 19 April 2021 to 30 June 2021 (Compilation No. 100), as further amended and in force from 1 July 2021 to 27 July 2021 (Compilation No. 101), and as further amended and in force from 28 July 2021 until 28 October 2021 (Compilation No. 102);

    the Advertising Code, as amended and in force from 30 July 2019 to 4 June 2021 (Compilation No. 1), as further amended and in force from 5 June 2021 to 9 July 2021 (Compilation No. 2), as further amended and in force from 10 July 2021 to 27 July 2021 (Compilation No. 3), and as further amended and in force from 28 July 2021 to 23 August 2021 (Compilation No. 4); and

    the Poisons Standard February 2021, as amended in force from 1 February 2021 to 31 May 2021, and the Poisons Standard June 2021, as in force from 1 June 2021 to 10 September 2021 (together the Poisons Standard, noting that there are no relevant differences between the standards for the purpose of these proceedings).

TG Act

42    Part 5-1 of the TG Act contains provisions regulating the advertising of therapeutic goods. Relevant to this case is s 42DLB of the TG Act, which prohibits the advertisement of therapeutic goods where the advertisement contains certain prohibited content or otherwise fails to comply with the TG Act’s advertising requirements. Section 42DLB relevantly provides:

(1)     A person contravenes this subsection if:

(a)     the person:

(i)     advertises, by any means, therapeutic goods; or

(ii)     causes the advertising, by any means, of therapeutic goods; and

(b)     subsection (2), (3), (4), (5), (6), (7), (8) or (9) applies to the advertisement.

Maximum civil penalty:

(a)     for an individual—5,000 penalty units; and

(b)     for a body corporate—50,000 penalty units.

Contravening provisions

(2)     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:

(a)     no permission under section 42DK is in force in relation to the prohibited representation;

(b)     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.

…

(4)     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:

(a)     neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation;

(b)     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.

…

(7)     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).

…

(9)     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).

Exception

(10)     Subsection (1) does not apply if:

(a)     the person is a broadcaster, a datacaster, the SBS or a person of a kind prescribed by the regulations for the purposes of this paragraph; and

(b)     as a result of steps taken by the person, it was reasonable for the person to assume that subsections (2) to (9) did not apply to the advertisement.

(11)     In this section:

broadcaster has the meaning given by clause 3 of Schedule 2 to the Broadcasting Services Act 1992.

datacaster means a person who holds a datacasting licence (within the meaning of the Broadcasting Services Act 1992).

SBS has the same meaning as in the Special Broadcasting Service Act 1991.

43    I note the following principles relevant to the application of s 42DLB of the TG Act (as in force during the Relevant Period):

    Section 42DLB is a civil penalty provision: s 42YA of the TG Act; Peptide Clinics at [23]-[24]; Oxymed at [20], [23]; Secretary, Department of Health, Disability and Ageing v AG Therapeutics Pty Ltd [2026] FCA 333 at [6].

    For the purposes of s 42DLB:

•    “Advertise” includes the making of any statement, pictorial representation or design that was intended, whether directly or indirectly, to promote the use or supply of the goods: s 3 of the TG Act; Peptide Clinics at [5].

•    “Therapeutic goods” includes goods that are represented to be, or likely to be taken to be, for “therapeutic use”: s 3 of the TG Act; Peptide Clinics at [5].

•    “Therapeutic use” includes use in connection with, inter alia, preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury, and/or influencing, inhibiting or modifying a physiological process, in persons: s 3 of the TG Act.

•    A “prohibited representation” includes, inter alia, a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre‑disposition to a neoplastic disease, sexually transmitted disease or mental illness: ss 42B and 42DJ(1) of the TG Act; reg 6B(1) and Schedule 2, pt 1 of the TG Regulations; s 30 of the Advertising Code; Oxymed at [29]-[31].

•    A “restricted representation” is a representation in an advertisement about therapeutic goods that refers to a “serious form” of a disease, condition, ailment or defect, namely where:

(a)    it is medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified health professional, except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or

(b)    there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self-administered test), which requires medical interpretation or follow-up …

but excluding, inter alia, a neoplastic disease, sexually transmitted disease or mental illness: ss 42DD of the TG Act; ss 28 and 30 of the Advertising Code; Oxymed at [32]-[35].

•    CBD is a substance included in Schedules 3, 4 and 8, but not Appendix H, of the Poisons Standard: Schedules 3, 4 and 8, and Appendix H, of the Poisons Standard.

•    Therapeutic goods prescribed by regulations for the purposes of s 42DLB(9) include, inter alia, therapeutic goods that were, at the relevant time:

•    the subject of an approval or authority under s 19 of the TG Act;

•    certain medicinal cannabis products manufactured in Australia under a licence granted under the TG Act; or

•    not the subject of an exemption, approval or authority under the TG Act or TG Regulations: reg 7 and Schedule 5A of the TG Regulations; Oxymed at [36]-[37].

    The TG Register is central to the regulatory framework established by the TG Act, with entry on the TG Register requiring a rigorous assessment of a product’s quality, safety and efficacy: Secretary, Department of Health and Ageing v Export Corporation (Australia) Pty Ltd [2012] FCA 42; 288 ALR 702 at [6]-[10]. Subsections 42DLB(1), (7) and (9) reinforce that framework by prohibiting the advertisement of certain therapeutic goods, including prescribed goods that are not entered on the TG Register.

    Previous decisions of the Court have found that, where a contravention of s 42DLB(1) continues over multiple days, a separate contravention is committed in respect of each day of the continuing conduct: Peptide Clinics at [12], [43]; Evolution Supplements at [60]-[61]; Vapor Kings at [20]. This approach is consistent with the concept of a continuous or continuing offence in criminal law: Oxymed at [162], citing R v Industrial Appeals Court; Ex parte Barelli’s Bakeries Pty Ltd [1965] VR 615 at 620. Nonetheless, in Oxymed at [171]-[172], Rofe J expressed reservations about construing s 42DLB as providing for a continuing offence, particularly in light of the absence at that time of any express statutory provision deeming a contravention to continue for each day that the conduct persisted.

    The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (Cth) inserted ss 42DLB(10A) and (10B) into the TG Act, with effect from 1 July 2024. Those provisions clarified that, from 1 July 2024 onwards (being after the Relevant Period):

•    a person who contravenes s 42DLB(1) commits a separate contravention in respect of each day during which the contravention continues; and

•    the maximum civil penalty for each day that a contravention of s 42DLB(1) continues is 10% of the maximum civil penalty otherwise applicable to that contravention.

44    Section 42AA of the TG Act limits the operation of Pt 5-1 in certain circumstances. In particular, s 42AA(4) provides that Pt 5-1, including s 42DLB, does not apply to advice or information given directly to a patient by specified healthcare practitioners in the course of treatment. Section 42AA of the TG Act relevantly provides as follows:

(1)    This Part does not apply to advertisements directed exclusively to:

(a)    medical practitioners, psychologists, dentists, pharmacists, optometrists, chiropractors, physiotherapists, nurses, midwives, dental hygienists, dental prosthetists, dental therapists or osteopaths; or

…

(c)    herbalists, homoeopathic practitioners, naturopaths, nutritionists, practitioners of traditional Chinese medicine or podiatrists registered under a law of a State or Territory; or

…

(2)    This Part does not apply to advertisements directed exclusively to persons who are members of an Australian branch (however described) of one of the bodies prescribed for the purposes of this subsection.

…

(4)    This Part does not apply to advice or information given directly to a patient by a person referred to in paragraph (1)(a) or (c) or subsection (2) in the course of treatment of that patient.

45    In Oxymed, the exclusionary provision contained within s 42AA(4) of the TG Act was held not to apply as the relevant website was available to the general public without restriction: Oxymed at [123], [125]. Relatedly, in Peptide Clinics at [21], Jagot J accepted the Secretary’s submissions that s 42AA(4) did not apply where:

    the relevant advertisements were publicly accessible;

    website customers were not “patients” for the purposes of s 42AA(4) as there was no direct contact between the customer and the medical practitioner, the customer did not know the identity of the medical practitioner, the medical practitioner had not consulted, clinically examined, treated the customer, nor advised the customer of the risks associated with using the Products; and

    the advice or information was not given “in the course of treatment” for the purposes of s 42AA(4), as the medical practitioner did not take a fully informed medical history, adequately advise customers of the risks and benefits of, and alternatives to, treatment, or appropriately follow up the management of the customer’s condition, and otherwise fell well short of the minimum standards expected of a medical practitioner treating a patient.

46    The effect of s 42YC of the TG Act is that a person who aids, abets, counsels, procures, induces or conspires in a contravention of s 42DLB of the TG Act, is taken to have contravened s 42DLB. Section 42YC of the TG Act relevantly states as follows:

(1)    A person must not:

(a)     aid, abet, counsel or procure a contravention of a civil penalty provision; or

(b)     induce (by threats, promises or otherwise) a contravention of a civil penalty provision; or

(c)     conspire to contravene a civil penalty provision.

(2)     This Act applies to a person who contravenes subsection (1) in relation to a civil penalty provision as if the person had contravened the civil penalty provision.

47    Liability under s 42YC of the TG Act arises where a person has knowledge of the essential facts constituting the corporate respondent’s contraventions of the relevant provisions of the TG Act: Secretary of the Department of Health, Disability and Ageing v Key Promotional Products Pty Ltd [2026] FCA 510 at [24], citing Productivity Partners Pty Ltd (trading as Captain Cook College) v Australian Competition and Consumer Commission [2024] HCA 27; (2024) 281 CLR 338 at [82], [148]-[149], [266] and [339].

48    Section 42YC(1) is expressed in terms substantially similar to s 550(2) of the Fair Work Act 2009 (Cth), in respect of which Katzmann J observed in Blue Sky Kids:

797.    The terms and expressions aiding, abetting, counselling, procuring and knowingly concerned are drawn from the criminal law. The words “aiding” and “abetting” are synonyms. They both mean helping, assisting or encouraging: Australian Securities and Investments Commission v Somerville (2009) 77 NSWLR 110 at [41] (Windeyer AJ). A person “counsels” the commission of a contravention if the person urges or advises its commission: see Stuart v The Queen (1974) 134 CLR 426 at 445 (Gibbs J, with whom Mason J agreed); MKP Management Pty Ltd v Shire of Kalamunda [2020] WASCA 130; 56 WAR 56; 285 A Crim R 1; 245 LGERA 85 at [91] (Buss P, Mazza and Vaughan JJA) and the other cases referred to there. “Procuring” means taking action to bring about the result: Somerville at [41]. Thus, a person “procures” a contravention if the person causes the contravention to be committed, persuades the principal to commit the contravention, or brings about its commission: Western Australia v Burke (No 3) [2010] WASC 110 at [19] (Murray J).

798.    To participate in a contravention and therefore be concerned in it, the person must have engaged in conduct which implicates or involves her or him in the contravention or “assents to or concurs in the conduct which constitutes the contravention”, so that there is a “practical connection” between the person and the contravention: Qantas Airways Ltd v Transports Workers’ Union of Australia [2011] FCA 470; 280 ALR 503; 211 IR 1 at [324]–[325] (Moore J), Leighton Contractors Pty Ltd v Construction, Forestry, Mining and Energy Union [2006] WASC 144; 154 IR 228 at [29] (Le Miere J). See also Construction, Forestry, Mining and Energy Union v Clarke [2007] FCAFC 87; 164 IR 299 at [26] (Tamberlin, Gyles and Gilmour JJ). It is unnecessary, however, that the person physically do anything to bring about the contravention if, by their statements and with their agreement what they said and agreed to do became associated with the conduct constituting the contravention: Leighton Contractors at [29] citing R v Tannous (1987) 10 NSWLR 303 at 308 (Lee J, Street CJ and Finlay J agreeing at 304 and 310).

799.    To be liable, whether by aiding, abetting, counselling or procuring, a putative accessory must intentionally participate in the contravention, which means that the person must know “the essential matters” that go to make up the events: Yorke v Lucas (1984) 158 CLR 661 at 667 (Mason ACJ, Wilson, Deane and Dawson JJ); 676 (Brennan J).

800.    To be knowingly concerned in a statutory contravention, the person must have been an intentional participant with knowledge, at the time of contravention, of the essential elements constituting it: Yorke v Lucas at 670 (Mason ACJ, Wilson, Deane and Dawson JJ). But the person need not know that the elements amount to a contravention: Yorke v Lucas at 667. A person may be an accessory without knowing that the conduct in which they are involved is unlawful: Australian Competition and Consumer Commission v Giraffe World Australia Pty Ltd (No 2) (1999) 95 FCR 302 at [186] (Lindgren J); Devine Marine at [176] (White J); Gore v Australian Securities and Investments Commission (2017) 249 FCR 167 at [15], [38] (Dowsett and Gleeson JJ); at [165] (Rares J). As Dowsett and Gleeson JJ observed in Gore at [15] and [38]:

[I]t is settled that in general, it is not necessary to prove knowledge of the law, or knowledge that a particular fact situation attracts legal consequences. That proposition applies to the proof of both principal and accessorial liability. …

[N]either Giorgianni [v The Queen (1985) 156 CLR 473] nor Yorke v Lucas required that it be proven that an alleged accessory knew of the relevant legal provisions which rendered the principal contravener’s conduct unlawful. Those decisions establish only that it must be proven that the alleged accessory knew the relevant factual matters leading to illegality. … To require more would be inconsistent with the long-established proposition that ignorance of the law is no defence.

(as recently affirmed by McElwaine J in Gussen v Commonwealth of Australia as represented by the Tertiary Education Quality and Standards Agency [2026] FCA 1088 at [36]).

49    Contraventions of ss 42DLB and 42YC of the TG Act are enforceable through s 42Y of the TG Act, which empowers the Court to order the payment of a pecuniary penalty to the Commonwealth in respect of a contravention of a civil penalty provision. Specifically, s 42Y of the TG Act provides:

Application for order

(1)     Within 6 years of a person (the wrongdoer) contravening 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.

Court may order wrongdoer to pay pecuniary penalty

(2)     If the Court is satisfied that the wrongdoer has contravened a civil penalty provision, the Court may order the wrongdoer to pay to the Commonwealth for each contravention the pecuniary penalty that the Court determines is appropriate (but not more than the maximum amount specified for the provision).

Determining amount of pecuniary penalty

(3)     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.

Civil evidence and procedure rules apply

(4)     The Court must apply the rules of evidence and procedure for civil matters when hearing and determining an application for an order under this section.

Note:     The standard of proof in civil proceedings is the balance of probabilities: see section 140 of the Evidence Act 1995.

Conduct contravening more than one civil penalty provision

(5)    If conduct constitutes a contravention of 2 or more civil penalty provisions, proceedings may be instituted under this Act against a person in relation to the contravention of any one or more of those provisions. However, the person is not liable to more than one pecuniary penalty under this section in respect of the same conduct.

50    In considering the application of s 42Y of the TG Act, I adopt the observations of Abraham J in Vapor Kings:

12.    It is appropriate to observe at the outset that the objects of the TG Act 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”: s 4 of the TG Act; Peptide Clinics at [28].

…

14.    The purpose of a civil penalty is primarily protective, in promoting the public interest in compliance by deterring further contravening conduct: Australian Building and Construction Commissioner v Pattinson [2022] HCA 13; (2022) 274 CLR 450 (Pattinson) at [15]-[16], [43] and [45]. A penalty of appropriate deterrent effect “must be fixed with a view to ensuring that the penalty is not such as to be regarded by [the] offender or others as an acceptable cost of doing business”: Pattinson at [17] citing Singtel Optus Pty Ltd v Australian Competition and Consumer Commission [2012] FCAFC 20; (2012) 287 ALR 249 at [62].

15.    Section 42Y(3) requires the Court, in determining a pecuniary penalty, to have regard to “all relevant factors” including: the nature and extent of the contravention; the nature and extent of any loss or damage suffered as a result of the contravention; the circumstances in which the contravention took place; and whether the person has previously been found by the Court in proceedings under the TG Act to have engaged in any similar conduct.

16.    In addition, there are a number of factors identified in the authorities, relevant to this task. For example, the assessment of a penalty of appropriate deterrent value will have regard to: (1) the nature and extent of the contravening conduct; (2) the amount of loss or damage caused; (3) the circumstances in which the conduct took place; (4) the size of the contravening company; (5) the degree of power it has, as evidenced by its market share and ease of entry into the market; (6) the deliberateness of the contravention and the period over which it extended; (7) whether the contravention arose out of the conduct of senior management or at a lower level; (8) whether the company has a corporate culture conducive to compliance, as evidenced by educational programs or other corrective measures in response to an acknowledged contravention; and (9) whether the company has shown a disposition to co-operate with the authorities responsible for the enforcement of the Act in relation to contravention: Pattinson at [18]. These are not to be considered as a rigid list of factors to be ticked off: Pattinson at [19]. Rather, they are to inform a multifactorial investigation that leads to a result arrived at by a process of “instinctive synthesis” addressing the relevant considerations: Australian Competition and Consumer Commission v Reckitt Benckiser (Australia) Pty Ltd [2016] FCAFC 181; (2016) 340 ALR 25 (Reckitt Benckiser) at [44].

17.    The maximum penalty is also one of the relevant factors. The maximum penalty for a contravention of s 42DLB by a body corporate (Vapor Kings) is 50,000 penalty units, and by an individual (Mr Kandakji) is 5,000 penalty units …

18.    In respect to the maximum penalty, the majority in Markarian v The Queen [2005] HCA 25; (2005) 228 CLR 357 observed at [31]:

… careful attention to maximum penalties will almost always be required, first because the legislature has legislated for 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 do provide, taken and balanced with all of the other relevant factors, a yardstick.

19.    In a civil penalty context, the relevance of a prescribed maximum penalty as a yardstick was explained by the Full Court of the Federal Court in Reckitt Benckiser at [155]-[156], a passage recently cited with approval in Pattinson at [53].

20.    Each day on which an advertisement for one of the Products remained on the Websites amounts to a separate contravention of the TG Act: Peptide Clinics at [12] and [43].

21.    Ordinarily, separate contraventions arising from separate acts should attract separate penalties. However, where separate acts give rise to separate contraventions which are inextricably interrelated, they may be regarded as a “course of conduct” for penalty purposes: Australian Competition and Consumer Commission v Yazaki Corporation [2018] FCAFC 73; (2018) 262 FCR 243 (Yazaki) at [234]. This avoids double punishment for those parts of the legally distinct contraventions that involve overlap in wrongdoing: see for example, Construction, Forestry, Mining and Energy Union v Cahill [2010] FCAFC 39; (2010) 269 ALR 1 at [39] and [41]. However, “[i]t is not appropriate or permissible to treat multiple contraventions as just one contravention for the purposes of determining the maximum limit dictated by the relevant legislation”: Yazaki at [227]. “It cannot of itself operate as a de facto limit on the penalty to be imposed for contraventions”: Reckitt Benckiser at [141] quoting Australian Competition and Consumer Commission v Hillside (Australia New Media) Pty Ltd (t/as Bet365) (No 2) [2016] FCA 698 at [24]-[25].

22.    The principle of totality requires the Court to make a “final check” of the penalties to be imposed on a wrongdoer, considered as a whole, to ensure that the total penalty does not exceed what is proper for the entire contravening conduct: Australian Competition and Consumer Commission v Australian Safeway Stores Pty Ltd [1997] FCA 450; (1997) 145 ALR 36 at 53, citing Mill v The Queen [1988] HCA 70; (1988) 166 CLR 59.

23.    An appropriate penalty is therefore one that is fashioned by reference to the facts of the particular case before the Court, in order to arrive at a penalty that is sufficient to deter the conduct in question, without being overly oppressive: Pattinson at [46].

24.    The principles to be applied in considering a jointly proposed penalty were addressed in Commonwealth v Director, Fair Work Building Industry Inspectorate [2015] HCA 46; (2015) 258 CLR 482 (DFWBII), where the majority observed at [46]:

[T]here is an important public policy involved in promoting predictability of outcome in civil penalty proceedings and that the practice of receiving and, if appropriate, accepting agreed penalty submissions increases the predictability of outcome for regulators and wrongdoers. As was recognised in Allied Mills and authoritatively determined in NW Frozen Foods, such predictability of outcome encourages corporations to acknowledge contraventions, which, in turn, assists in avoiding lengthy and complex litigation and thus tends to free the courts to deal with other matters and to free investigating officers to turn to other areas of investigation that await their attention.

25.    Further, their Honours said at [58] (emphasis added):

... Subject to the court being sufficiently persuaded of the accuracy of the parties’ agreement as to facts and consequences, and that the penalty which the parties propose is an appropriate remedy in the circumstances thus revealed, it is consistent with principle and ... highly desirable in practice for the court to accept the parties’ proposal and therefore impose the proposed penalty.

26.    Those observations about the desirability of acting upon agreed penalty submissions were made in the context of a broader recognition that as a civil litigant in civil proceedings, civil penalties are but one of numerous forms of relief which regulators can pursue, and it is entirely orthodox for regulators to make submissions as to that relief: see DFWBII at [24], [57]-[59], [63], [103], [107]. Those principles were more recently considered in Volkswagen Aktiengesellschaft v Australian Competition and Consumer Commission [2021] FCAFC 49; (2021) 284 FCR 24 (Volkswagen) at [124]-[131], referring to DFWBII, NW Frozen Foods Pty Ltd v Australian Competition and Consumer Commission [1996] FCA 1134; (1996) 71 FCR 285 and Minister for Industry, Tourism and Resources v Mobil Oil Australia Pty Ltd [2004] FCAFC 72; (2004) ATPR 41-993. A number of points were highlighted in Volkswagen, including: first, the Court must be satisfied that the penalty proposed by the parties is appropriate: at [125]; second, if persuaded of the accuracy of the parties’ agreement as to facts and that the proposed penalty is an appropriate remedy, it is highly desirable for the Court to accept the proposal: at [126]; third, in considering whether the proposed penalty is appropriate, it is necessary to bear in mind that there is no single appropriate penalty, but rather a permissible range, and that the proposed penalty may be “an” appropriate penalty if it falls within that range: at [127]; fourth, the Court should generally recognise that the proposed penalty was most likely a result of compromise and pragmatism on the part of the regulator, and while the regulator must estimate the penalty necessary to achieve deterrence, the Court must assess the proposed penalty on its merits, being wary of the possibility that the regulator may have been too pragmatic: at [129]; fifth, the Court’s task is not limited to simply determining whether the jointly proposed penalty is within the permissible range, though that might be expected to be a highly relevant and perhaps determinative consideration: at [131].

27.    The overriding statutory directive is for the Court to impose a penalty that is determined to be appropriate having regard to all relevant matters: Volkswagen at [131].

51    Similarly, in Evolution Supplements, Burley J made the following comments:

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].

52    As noted in Evolution Supplements at [69] and Oxymed at [135], caution must be exercised when comparing penalties imposed in other cases: Flight Centre Limited v Australian Competition and Consumer Commission (No 2) [2018] FCAFC 53; (2018) 260 FCR 68 at [63]. The task is not to identify a permissible range by reference to outcomes reached in different factual circumstances, but rather to ensure that the relevant principles are applied consistently in determining an appropriate penalty.

53    Therefore, in accordance with the principles set out in the above authorities, the assessment of a penalty under s 42Y of the TG Act involves a multifactorial assessment directed towards achieving appropriate deterrence, informed by all relevant circumstances of the contravening conduct, the statutory maximum penalties, and the principles of course of conduct and totality.

Court’s powers to grant declaratory relief and costs orders

54    Section 21 of the FCA Act states that:

(1)     The Court may, in civil proceedings in relation to a matter in which it has original jurisdiction, make binding declarations of right, whether or not any consequential relief is or could be claimed.

(2)     A suit is not open to objection on the ground that a declaratory order only is sought.

55    The principles relevant to the grant of declaratory relief pursuant to s 21 of the FCA Act were conveniently summarised by Abraham J in Vapor Kings, including by reference to the High Court’s decision in Forster v Jododex Australia Pty Ltd [1972] HCA 61; (1972) 127 CLR 421:

28.    The power to grant declaratory relief pursuant to s 21 of the Federal Court of Australia Act 1976 (Cth) “is a very wide one” and the court is “limited only by its discretion”: Seven Network Ltd v News Ltd [2009] FCAFC 166; (2009) 182 FCR 160 at [1016], citing Forster v Jododex Australia Pty Ltd [1972] HCA 61; (1972) 127 CLR 421 (Forster) at 435. Three requirements need to be satisfied before making declarations: (1) the question must be a real and not a hypothetical or theoretical one; (2) the applicant must have a real interest in raising it; and (3) there must be a proper contradictor: Forster at 437-438. That a party has chosen not to oppose a grant of particular declaratory relief is not an impediment to such relief being granted by the Court: Australian Competition and Consumer Commission v MSY Technology Pty Ltd [2012] FCAFC 56; (2012) 201 FCR 378 at [14], [30]-[33]. Other factors relevant to the exercise of the discretion include: whether the declaration will have any utility; whether the proceeding involves a matter of public interest; and whether the circumstances call for the marking of the Court’s disapproval of the contravening conduct: ASIC v Pegasus Leveraged Options Group Pty Ltd [2002] NSWSC 310; (2002) 41 ACSR 561 at 571; Australian Securities and Investments Commission v Monarch FX Group Pty Ltd, in the matter of Monarch FX Group Pty Ltd [2014] FCA 1387; (2014) 103 ACSR 453 at [63]; Australian Securities & Investments Commission v Stone Assets Management Pty Ltd [2012] FCA 630; (2012) 205 FCR 120 at [42].

29.    Even where there is agreement between the parties in respect of proposed declarations, it remains for the Court to decide whether declaratory relief is appropriate: Australian Securities and Investments Commission v MLC Nominees Pty Ltd [2020] FCA 1306; (2020) 147 ACSR 266 at [109].

(see also, the comments of Burley J in Evolution Supplements at [40]-[41]).

56    Section 43 of the FCA Act confers a broad discretion on the Court to award costs in proceedings before it and to determine the manner in which those costs are to be borne. Section 43 of the FCA Act relevantly provides that:

(1)    The Court or a Judge has jurisdiction to award costs in all proceedings before the Court (including proceedings dismissed for want of jurisdiction) other than proceedings in respect of which this or any other Act provides that costs must not be awarded.

…

(2)    Except as provided by any other Act, the award of costs is in the discretion of the Court or Judge.

(3)    …

57    In relation to the Court’s discretion to order costs pursuant to s 43 of the FCA Act, the Full Court in Commissioner of Taxation v Bosanac (No 2) [2022] FCAFC 5 at [11], citing Ruddock v Vadarlis (No 2) [2001] FCA 1865; (2001) 115 FCR 229 at [9]-[10], relevantly said:

11.    The disposition of costs is in the Court’s discretion; and of course that discretion must be exercised judicially, having regard to the applicable principles and the justice of the case in all the circumstances: s 43 of the Federal Court of Australia Act 1976 (Cth) (‘the Act’), discussed in Ruddock v Vadarlis (No 2) at [9]-[10]. As Black CJ and French J said in that case at [11]:

Within the general discretion of the courts to award costs it is accepted by decisions in both Australian and English jurisdictions that:

•    Ordinarily costs follow the event and a successful litigant receives costs in the absence of special circumstances justifying some other order.

•    Where a litigant has succeeded only upon a portion of the claim, the circumstances may make it reasonable that the litigant bear the expense of litigating that portion upon which he or she has failed.

•    A successful party who has failed on certain issues may not only be deprived of the costs of those issues but may be ordered as well to pay the other parties’ costs of them. In this sense “issue” does not mean a precise issue in the technical pleading sense but any disputed question of fact or law.

In support of these propositions their Honours referred to Hughes v Western Australian Cricket at 48,136.

58    With the relevant legislative framework and principles in mind, I will first turn to CDA’s liability and any applicable penalties, before turning to that of Dr Jansen.

CDA

Liability

59    Having regard to the evidence before the Court, I am satisfied that the Secretary has established, on the balance of probabilities, the contraventions alleged against CDA. That conclusion is supported by:

    the documentary evidence tendered by the Secretary in the Tender Bundle;

    the admissions made by CDA in its Concise Statement in Response; and

    the Agreed Facts and Submissions signed by Dr Jansen, who was CDA’s sole director throughout the Relevant Period and was responsible for the day-to-day management of CDA’s affairs. In particular, Dr Jansen admitted that CDA contravened s 42DLB(1) of the TG Act in the manner alleged by the Secretary and that he was involved in those contraventions within the meaning of s 42YC of the TG Act.

60    As I explained earlier in these reasons, the Agreed Facts and Submissions do not of themselves determine CDA’s liability. However, consistently with BHF Solutions and McNamara, the agreed facts constitute evidence before the Court and may be relied upon for legitimate forensic purposes. In circumstances where Dr Jansen was the sole director of CDA during the Relevant Period and the agreed facts concern matters falling squarely within his own knowledge and involvement, I consider those admissions to be supportive evidence of CDA’s conduct.

The Website, Products Advertisements, Blog Posts and Facebook Posts

61    I am satisfied that CDA operated the Website at www.cdaexpress.com.au during the Relevant Period and controlled the publication of the Products Advertisements and Blog Posts appearing on it. The Secretary relied upon a substantial body of documentary evidence, including screen captures of the Website and the website of Slick Designs Pty Ltd, who designed and developed the Website (see for example, Tabs 1-4 of Exhibit TJD-1 to the affidavit of Mr Tristan Dimmock affirmed on 15 October 2024; Tabs 4-6, 8-12, 14 and 16 of Exhibit AJT-1 and Tabs 1-2 of Exhibit AJT-2 to the affidavit of Ms Alicia Tan affirmed on 18 October 2024 (Tan Affidavit); Tabs 1-2 of Exhibit EPM-1 to the affidavit of Mr Eric McIntosh affirmed on 17 October 2024 (McIntosh Affidavit)). The Secretary also relied on various correspondence between TGA and Slick Designs, as well as TGA and CDA (see for example, Tabs 19-33 of Exhibit AJT-1 to the Tan Affidavit).

62    Additionally, the existence of the Website and the publication of the Blog Posts were admitted by CDA in its Concise Statement in Response (at [7]) and by Dr Jansen in the Agreed Facts and Submissions (at [21]-[24], [130] and Annexure A). While CDA’s Concise Statement in Response did not expressly admit to the publication of the Products Advertisements, I am satisfied that the publication and content of those advertisements were established by the documentary evidence tendered by the Secretary, including the screen captures of the Website, as further supported by Dr Jansen’s admissions concerning his responsibility for the operation of the Website and the content published on it (Agreed Facts and Submissions at [14]-[15] and [21]-[24]). Accordingly, having regard to the extensive evidence before me and in the absence of any evidence to the contrary, I am satisfied that the Website was operational between approximately 27 April 2021 and 30 July 2021, and that the Products Advertisements and Blog Posts were accessible on the Website at the times particularised in column C of Annexure A to the Originating Application. I will return later in these reasons to CDA’s contention that the Products Advertisements and Blog Posts were not publicly accessible and therefore fell outside the operation of pt 5‑1 of the TG Act (by way of s 42AA of the TG Act).

63    I am also satisfied that CDA operated the Facebook Page identified in Item 22 of Annexure A to the Originating Application and published the Facebook Posts particularised in row 22 of Schedule 1 of the Concise Statement between 20 April 2021 and at least 18 June 2021. The Facebook Posts included, inter alia, references to “Medical CBD”, “plant-powered medicine” and links directing viewers to the Website. These findings are supported by extensive documentary evidence, including the affidavit of Ms Jody Marshall affirmed on 18 October 2024 at [4]-[5], correspondence between CDA and TGA contained at Tabs 3 and 36 of the Tender Bundle and various screen captures of the Facebook Page (see for example, Tabs 1, 7, 15, 17 of Exhibit AJT-1 to the Tan Affidavit). Additionally, while CDA could not confirm the exact details or times of the Facebook Posts, CDA nevertheless admitted that the Facebook Page included the Facebook Posts particularised in row 22 of Schedule 1 of the Concise Statement (CDA’s Concise Statement in Response at [13]).

Whether CDA breached s 42DLB of the TG Act

64    Having established that the Relevant Advertisements existed, the next issue is whether, by publishing the Products Advertisements, Blog Posts and Facebook Posts, CDA “advertised” or caused “the advertising” of “therapeutic goods” within the meaning of s 42DLB of the TG Act. As discussed earlier in these reasons, the term “advertise” is defined broadly, and includes statements or material intended, whether directly or indirectly, to promote the use or supply of “therapeutic goods” (which are goods that are represented to be, or likely to be taken to be, for “therapeutic use”).

65    Considering this definition and the evidence before me, I accept the Secretary’s Submissions (at [75]-[81]) that the Relevant Advertisements constituted advertisements for the purposes of ss 3 and 42DLB of the TG Act. The Products Advertisements plainly promoted the supply and use of the Products by displaying product names, prices, dosage information, therapeutic descriptions, efficacy indicators and purchasing functionality. Customers who accessed the Restricted Section were able to review the Products and purchase them through the Website. The Products Advertisements also identified conditions in respect of which the Products were said to be beneficial, including anxiety, epilepsy, chronic pain and inflammation (I will address the exception in s 42AA of the TG Act later in these reasons).

66    I am also satisfied that the Blog Posts were advertisements, notwithstanding CDA’s argument that the Blog Posts and Facebook Posts contained factual information rather than promotional material (CDA’s Concise Statement in Response at [14]-[15], [22(b)]). I accept the Secretary’s Submissions that, even where the Blog Posts did not explicitly promote the sale of the Products and CBD products generally, the Blog Posts appeared on the same Website through which the Products could be obtained and repeatedly referred to the therapeutic benefits of CBD in connection with specific diseases and conditions. Similar to the finding in Peptide Clinics at [36], in my view the Blog Posts formed part of CDA’s broader strategy of encouraging consumers to engage with its services and obtain access to the Products and CBD products generally. Likewise, I accept that the Facebook Posts promoted CDA’s services and encouraged consumers to access the Website. References to “Medical CBD”, “plant-powered medicine” and online consultation services, coupled with hyperlinks directing users to the Website, appear plainly intended to promote the supply and use of CBD products.

67    I am further satisfied that the Products and CBD products generally were represented to be for “therapeutic use” within the meaning of s 3 of the TG Act. The Relevant Advertisements repeatedly referred to symptom control, treatment options, management of disease, pain reduction and health improvements. Such representations would readily convey to an ordinary consumer that the Products were intended for use in connection with, inter alia, preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury, and/or influencing, inhibiting or modifying a physiological process. It follows that CDA’s publication of the Relevant Advertisements satisfied the requirement in s 42DLB(1)(a) of the TG Act.

68    The remaining question is whether s 42DLB(1)(b) is also satisfied. This requires consideration of whether any of ss 42DLB(2), (4), (7) or (9) apply to CDA’s publication of the Relevant Advertisements.

69    In relation to s 42DLB(2) of the TG Act and whether the Products Advertisements or the Blog Posts (specifically those in Items 1 to 14, 16, 17 and 21 of Annexure A to the Originating Application) contained prohibited representations, I accept the expert evidence of Professor Ogden contained in the Ogden Report. Professor Ogden expressed the opinion that anxiety, depression and PTSD are mental illnesses, cancer is a neoplastic disease, and gonorrhoea is a sexually transmitted disease (Ogden Report at [134], [138], [140], [143] and [146]). Those opinions were not challenged by CDA. The Products Advertisements and Blog Posts identified in Items 1 to 14, 16, 17 and 21 of Annexure A to the Originating Application referred to the use of the Products or CBD generally in connection with one or more of those conditions. I am satisfied that those references constituted representations regarding the treatment, cure, prevention or monitoring of a mental illness, neoplastic disease or sexually transmitted disease for the purposes of reg 6B of the TG Regulations and s 30 of the Advertising Code. CDA admitted that it held no permission under s 42DK authorising those representations (CDA’s Concise Statement in Response at [19]). Accordingly, I am satisfied that CDA contravened s 42DLB(1) by operation of s 42DLB(2).

70    In relation to s 42DLB(4) of the TG Act and whether the Products Advertisements or the Blog Posts (specifically those in Items 1 to 14, 16, 17 and 19 of Annexure A to the Originating Application) contained restricted representations, I again accept Professor Ogden’s evidence. Professor Ogden opined that autism, autoimmune conditions, chronic pain, epilepsy, fibromyalgia, meningitis and seizures are all diseases or conditions requiring professional diagnosis, treatment and supervision (Ogden Report at [64]-[68], [69]-[73], [78]-[82], [88]-[96], [101]-[105] and [125]-[129]). Accordingly, in the absence of evidence to the contrary, I am satisfied that autism, autoimmune conditions, chronic pain, epilepsy, fibromyalgia, meningitis and seizures are all identified by the Advertising Code as a “serious form” of a disease or condition (and are not a neoplastic disease, sexually transmitted disease or mental illness).

71    The Relevant Advertisements identified in Items 1 to 14, 16, 17 and 19 of Annexure A to the Originating Application referred to those conditions. Pursuant to s 42DD of the TG Act, I am satisfied that those references constituted restricted representations for the purpose of s 42DLB(4) of the TG Act. CDA admitted that it possessed neither an approval under s 42DF nor permission under s 42DK authorising those representations (CDA’s Concise Statement in Response at [19]). Accordingly, I am satisfied that CDA contravened s 42DLB(1) by operation of s 42DLB(4).

72    Furthermore, I am satisfied that all 22 of the Relevant Advertisements referred to CBD substances, or goods containing CBD substances, included in Schedule 3, 4 or 8 and not Appendix H of the Poisons Standard. As noted earlier in these reasons, CBD is a substance plainly included in Schedules 3, 4 and 8, but not Appendix H, of the Poisons Standard. Professor Ogden addressed the scheduling status of CBD at [37] and [48]-[50] of the Ogden Report and expressed the opinion that the Products were properly characterised as Schedule 4 substances, on the basis that they fell within Category 1 of the TGA’s medicinal cannabis product classifications, being products containing more than 98% CBD. CDA admitted that the Relevant Advertisements referred to CBD substances, or goods containing CBD substances, included in Schedule 3, 4 or 8 and not Appendix H of the Poisons Standard (CDA’s Concise Statement in Response at [27]). CDA also admitted that it did not have the “various ‘advertising’ permissions, approvals, authorisations, requirements or exemptions” (CDA’s Concise Statement in Response at [19]). There is no other evidence to suggest that the references within the Relevant Advertisements were authorised or required by a government or government authority. Consequently, I am satisfied that by publishing the Relevant Advertisements, CDA contravened s 42DLB(1) by operation of s 42DLB(7).

73    Finally, as admitted by CDA (at [28] of the Concise Statement in Response), I am satisfied that the Products advertised on the Website through the Products Advertisements:

    were not entered on the TG Register; and

    were prescribed by reg 7 of the TG Regulations for the purposes of s 42DLB(9) of the TG Act (on the basis that the Products were either the subject of an approval under s 19 of the TG Act or were not the subject of an exemption, approval or authority under the TG Act or TG Regulations).

74    Once again, there is no evidence that the references in the Products Advertisements to the Products (that were not entered on the TG Register but were prescribed) were authorised or required by a government or government authority. Accordingly, I am satisfied that by publishing the Products Advertisements, CDA contravened s 42DLB(1) by operation of s 42DLB(9).

Whether s 42AA(4) of the TG Act is applicable

75    The principal defence originally advanced by CDA was that the Website fell within the exclusion contained in s 42AA(4) of the TG Act (CDA’s Concise Statement in Response at [22]). As previously noted, s 42AA(4) of the TG Act provides that Pt 5-1, including s 42DLB, does not apply to advice or information given directly to a patient by specified healthcare practitioners in the course of treatment.

76    On this issue I place significant weight on the expert report of Professor Hespe, which is Annexure CMH1 to the affidavit of Professor Hespe affirmed on 17 October 2024 (Hespe Report). Professor Hespe was asked to review the CDA process, including the Restricted Section, and express opinions concerning doctor-patient relationships, informed consent and prescribing standards.

77    Dr Jansen’s Submissions rely on an extract from the Hespe Report (at [1]-[2]) setting out Professor Hespe’s opinion as to when a person becomes a “patient” of a medical practitioner. However, I do not accept that the Hespe Report supports the proposition that a therapeutic relationship or an ongoing course of treatment existed. On the contrary, Professor Hespe concluded (at [84]-[110] of the Hespe Report) that:

    the Questionnaire was “by its very nature, superficial” and ultimately insufficient to establish a therapeutic relationship, adequately assess medication interactions or properly evaluate patient circumstances;

    the CDA process was “transactional” in nature rather than a “genuine” course of treatment;

    the CDA model did not satisfy accepted standards concerning clinical assessment, informed consent and prescribing practices; and

    the CDA model did not establish a genuine doctor-patient relationship and “[a]t best … looks like a relationship between an online pharmacist overseeing the dispensing of previously prescribed medication.”

78    In circumstances where Professor Hespe’s relevant expertise is not disputed, and where the Hespe Report is carefully reasoned, based upon a detailed review of the Website and supporting documentation, and not materially contradicted by any competing expert evidence, I accept Professor Hespe’s evidence.

79    Professor Hespe’s conclusions are also strongly supported by the contemporaneous evidence concerning the operation of the Website and the “Patient Treatment Protocol”. Importantly, many of the factual matters on which Professor Hespe relied are either common ground or supported by documentary evidence before the Court. While Dr Jansen ultimately admitted a number of those facts in the Agreed Facts and Submissions, I do not proceed on the basis that those admissions are binding upon CDA. Rather, I am satisfied that the documentary evidence independently supports Professor Hespe’s conclusions.

80    In its Concise Statement in Response, CDA pleaded that the Website formed part of a doctor-supervised assessment and treatment process. In particular, CDA alleged that patients had access to the Products Advertisements in the context of being treated through a “Patient Treatment Protocol” involving the taking of health information and/or patient history, clinical examination, investigations where necessary, diagnosis and the implementation of a management plan. CDA further contended that, aside from “a short initial period where there was an administrative / technical issue”, access to the Products Advertisements occurred only after approval by a CDA doctor.

81    For the following reasons, I am not persuaded that the evidence supports CDA’s characterisation of the Website, or that the Products Advertisements constituted advice or information given directly to patients by medical practitioners in the course of treatment for the purposes of s 42AA(4) of the TG Act.

82    First, the evidence establishes that prospective customers were required to create an account and complete the Questionnaire before becoming eligible to access the Restricted Section (Concise Statement in Response at [8(a)-(c)] and [22(a)(i)]; Agreed Facts and Submissions at [28]-[30]). However, the completion of the Questionnaire did not itself involve any direct consultation between the customer and a medical practitioner. Rather, it involved the electronic provision of information through a standardised online process. CDA pleaded that the Patient Treatment Protocol involved the taking of a patient history, clinical examination, investigations where necessary, diagnosis and implementation of a management plan (Concise Statement in Response at [22(a)(ii)]). However, I accept Professor Hespe’s evidence that the Questionnaire was incapable of adequately replicating many matters ordinarily examined during a clinical consultation, including assessment of the reliability of the patient’s history, the broader clinical context, potential contraindications and drug interactions (Hespe Report at [84]-[97]).

83    Second, the evidence concerning the operation of the Website supports Professor Hespe’s conclusion that the process was largely transactional in nature. The Secretary alleged that, prior to approximately 31 May 2021, eligible customers could access, review, order and pay for Products before any CDA doctor had reviewed their questionnaire responses (Secretary’s Submissions at [60.4]). Although CDA did not expressly admit that allegation (aside from the acknowledgment that the process differed for “a short initial period”), CDA also did not plead any positive case to the contrary. Rather, CDA’s response focused on the proposition that the Website formed part of a broader treatment protocol and that consumers only obtained access to Product information after becoming “patients” (Concise Statement in Response at [22(a)]). Significantly, Dr Jansen subsequently agreed that, prior to approximately 31 May 2021, eligible customers could access, review, order and pay for Products before their Questionnaire responses had been reviewed by a CDA doctor (Agreed Facts and Submissions at [30]). While that agreement is not binding on CDA, it is consistent with the documentary and affidavit evidence before the Court and supports the Secretary’s characterisation of the process.

84    Furthermore, even after modifications were introduced to the Website from approximately late May 2021, the evidence indicates that customers who obtained access to the Restricted Section were able to review information concerning all available Products and self-select Products for purchase, with CDA doctors ordinarily reviewing orders only after they had been placed and paid for (Agreed Facts and Submissions at [31]-[32]). Again, while I do not treat those agreed facts as dispositive against CDA, they accord with the extensive affidavit evidence concerning the operation of the Website referred to in the Secretary’s Submissions. In substance, the customer selected the Product and a medical practitioner subsequently determined whether the order would be approved. That sequence of events is difficult to reconcile with CDA’s pleaded contention (at [22](a) of the Concise Statement in Response) that the relevant information contained within the Products Advertisements was provided as part of an established course of treatment.

85    Third, the Website’s terms and conditions expressly stated that CDA did not provide medical advice except through a booked consultation, that information appearing on the Website was provided for informational and educational purposes only, and that it was not intended to diagnose, treat, cure or prevent disease. Those statements were relied upon by the Secretary, agreed to by Dr Jansen (Agreed Facts and Submissions at [34]), supported by the screen captures contained in Tab 2 of Exhibit EPM-1 to the McIntosh Affidavit and were not disputed by CDA in its Concise Statement in Response. In my view, those statements are fundamentally inconsistent with the proposition that the Website content itself constituted advice or information given directly to a patient in the course of treatment. Indeed, if CDA’s characterisation of the Website were correct, one would expect the Website to describe the information in those terms. Instead, the terms and conditions expressly disclaim that characterisation.

86    Viewed collectively, these matters strongly support Professor Hespe’s ultimate opinion that the CDA model did not establish a genuine therapeutic relationship, and fell short of accepted standards concerning clinical assessment, informed consent and prescribing practices (Hespe Report at [84]-[110]). As outlined above, the evidence demonstrates that customers were able to obtain information concerning, and in some cases select and purchase, the Products before any product-specific prescribing decision had been made. In those circumstances, I am not persuaded by CDA’s submission that access to the Website occurred “in the course of treatment” simply because a customer had completed a Questionnaire and been approved for access to the Restricted Section. Rather, the Website functioned primarily as a mechanism through which consumers could obtain information about, and seek access to, the Products and CBD products generally, which is distinct from a practitioner providing advice directly to a patient in the course of clinical treatment.

87    The conclusion I have reached is consistent both with the position adopted by Dr Jansen in the Agreed Facts and Submissions (at [77]-[79]) and with the authorities concerning s 42AA(4) of the TG Act discussed earlier in these reasons. While the Website was not publicly accessible in the same manner as the website considered in Oxymed (see Oxymed at [123], [125]), that factual distinction is not determinative. The critical question remains whether the relevant information was provided directly to a patient by a health practitioner in the course of treatment. I am satisfied that the present circumstances are more closely analogous to those considered in Peptide Clinics (at [21]) than to a conventional therapeutic relationship contemplated by s 42AA(4) of the TG Act. Although the CDA process involved registration, completion of the Questionnaire and some level of medical review, the evidence demonstrates that customers could obtain information concerning the Products, and in some cases select and order the Products, before any product-specific consultation had occurred.

88    The exclusionary provision in s 42AA(4) of the TG Act has no application in the present case.

89    It follows that the Secretary has established each category of contravention alleged against CDA.

Declarations

90    The Secretary seeks declarations substantially in the form set out in the proposed orders filed on 22 April 2026 (Proposed Orders). Those declarations correspond with the four categories of contraventions alleged in the Originating Application, namely contraventions involving prohibited representations, restricted representations, references to substances contained within Schedule 3, 4 or 8 of the Poisons Standard, and references to therapeutic goods not entered on the TG Register. Orders 1, 3, 5 and 7 of the Proposed Orders relate to CDA.

91    For the reasons outlined earlier in these reasons, I am satisfied that the requirements for the grant of declaratory relief under s 21 of the FCA Act are met. There is a real controversy concerning the operation of pt 5-1 of the TG Act, the Secretary plainly has a genuine interest in obtaining the relief sought in administering the legislative regime, and there is utility in making declarations notwithstanding the liquidation of CDA. Consistently with the authorities cited in Vapor Kings at [28], the declarations will record the Court’s findings, mark the Court’s disapproval of the conduct and promote compliance with the TG Act.

92    I am first satisfied that declarations should be made in relation to the prohibited representations identified in order 1 of the Proposed Orders. As I have already found, the Relevant Advertisements identified in Items 1 to 14, 16, 17 and 21 of Schedule 2 to the Proposed Orders (which reflects Annexure A to the Originating Application) contained representations regarding the treatment, cure or prevention of cancer, gonorrhoea, depression, anxiety and PTSD. Those conditions constitute a neoplastic disease, sexually transmitted disease or mental illness for the purposes of reg 6B of the TG Regulations and s 30 of the Advertising Code. I have further found that those representations were prohibited representations within the meaning of s 42DJ(1) of the TG Act and that no permission under s 42DK of the TG Act was in force. I am therefore satisfied that CDA contravened s 42DLB(1) by operation of s 42DLB(2) in the manner particularised in order 1 of the Proposed Orders.

93    Second, I am satisfied that declarations should be made in the terms sought by order 3 of the Proposed Orders concerning restricted representations. I have found that the Relevant Advertisements identified in Items 1 to 14, 16, 17 and 19 of Schedule 2 to the Proposed Orders referred to fibromyalgia, epilepsy, autoimmune conditions, chronic pain, seizures, meningitis and/or autism. I accept Professor Ogden’s evidence that those conditions constitute serious forms of disease, condition or ailment within the meaning of s 28 of the Advertising Code. The evidence further establishes, and CDA admitted, that no approval under s 42DF of the TG Act and no permission under s 42DK of the TG Act existed in relation to those representations. I am therefore satisfied that CDA contravened s 42DLB(1) by operation of s 42DLB(4) in the manner particularised in order 3 of the Proposed Orders.

94    Third, I am satisfied that declarations should be made in the terms sought by order 5 of the Proposed Orders concerning references to substances contained in Schedule 3, 4 or 8 of the Poisons Standard. The evidence establishes that all 22 advertisements identified in Schedule 2 of the Proposed Orders referred to CBD substances, or goods containing CBD substances, included in Schedule 3, 4 or 8, but not included in Appendix H, of the applicable Poisons Standard. I have also found that none of those references were authorised or required by a government or government authority. I note that order 5 of the Proposed Orders covers a broader period than the earlier declarations, extending to the Facebook Posts which were published from 20 April 2021. That distinction reflects the pleaded case and the evidence and, in my view, accurately captures the extent of the proven contraventions.

95    I am satisfied that CDA contravened s 42DLB(1) by operation of s 42DLB(7) in the manner particularised in order 5 of the Proposed Orders.

96    Finally, I am satisfied that declarations should be made in the terms sought by order 7 of the Proposed Orders concerning therapeutic goods not entered on the TG Register. As I have already found, the Products identified in Items 1 to 15 of Schedule 2 to the Proposed Orders were not entered on the TG Register during the Relevant Period. The evidence further establishes that those Products were either the subject of approvals or authorities under s 19 of the TG Act, and therefore prescribed under reg 7(a) of the TG Regulations, or alternatively were therapeutic goods falling within reg 7(i). The references to those Products were not authorised or required by a government or government authority. I am therefore satisfied that CDA contravened s 42DLB(1) by operation of s 42DLB(9) in the manner particularised in order 7 of the Proposed Orders.

97    I will therefore make the declarations sought by the Secretary against CDA in orders 1, 3, 5 and 7 of the Proposed Orders.

Pecuniary Penalty

98    By way of order 9 of the Proposed Orders, the Secretary seeks the imposition of a pecuniary penalty against CDA pursuant to s 42Y of the TG Act. The Secretary submits that, after application of the course of conduct and totality principles, an appropriate penalty is $6.5 million (Secretary’s Submissions at [195]).

99    As explained earlier in these reasons, the assessment of a penalty under s 42Y of the TG Act requires a multifactorial evaluation directed toward the achievement of appropriate deterrence (see particularly, Vapor Kings at [15]-[16]). The Court must have regard to the factors identified in s 42Y(3), together with the broader considerations discussed in authorities such as Australian Building and Construction Commissioner v Pattinson [2022] HCA 13; (2022) 274 CLR 450, Australian Competition and Consumer Commission v Reckitt Benckiser (Australia) Pty Ltd [2016] FCAFC 181; (2016) 340 ALR 25, Evolution Supplements, Oxymed and Vapor Kings. The ultimate task is to impose a penalty sufficient to achieve both specific and general deterrence, while avoiding a penalty that is greater than is reasonably necessary to achieve those objectives.

100    The starting point is the nature and extent of the contravening conduct. The conduct was extensive, involving multiple categories of advertising activity across the Website and Facebook Page. The conduct persisted throughout the Relevant Period and affected numerous advertisements appearing over extended periods of time. As the weight of authority demonstrates (see Peptide Clinics at [12], [43]; Evolution Supplements at [60]-[61]; Vapor Kings at [20]), each day on which one of the Relevant Advertisements remained available constituted a separate contravention. The Secretary’s Submissions referred (at [125]-[133], [143]-[150.3] and [191]-[194]) to the “course of conduct” principle, which was applied in authorities such as Oxymed at [174]-[179], [236], [266]-[269]; Peptide Clinics at [33] and [44]; Vapor Kings at [21] and [37]; Australian Competition and Consumer Commission v Yazaki Corporation [2018] FCAFC 73; (2018) 262 FCR 243 at [234]. However, even allowing for the application of the course of conduct principle, the scale of the offending remains significant.

101    I accept the Secretary’s Submissions (primarily at [145] and [150]) that the contravening conduct is appropriately viewed as comprising three courses of conduct, namely:

    Course of Conduct One: the Products Advertisements identified in Items 1 to 15 of Annexure A to the Originating Application (and particularised in rows 1 to 15 of Schedule 1 of the Concise Statement);

    Course of Conduct Two: the Blog Posts identified in Items 16 to 21 of Annexure A to the Originating Application (and particularised in rows 16 to 21 of Schedule 1 of the Concise Statement); and

    Course of Conduct Three: the Facebook Posts posted on the Facebook Page identified in row 22 of Annexure A to the Originating Application (and particularised in row 22 of Schedule 1 of the Concise Statement).

102    I accept the Secretary’s Submissions (for example, at [194]) that those categories reflect distinct but interrelated forms of conduct and provide an appropriate framework for assessing penalty. At the same time, it is necessary to bear in mind the observations of the Full Court in Yazaki at [227] that the course of conduct principle cannot operate to understate the true seriousness of extensive contravening conduct. I accept the Secretary’s Submissions (at [151]-[162]) and consider that several matters substantially aggravate the seriousness of the conduct.

103    First, the Relevant Advertisements concerned the Products, which were not entered on the TG Register. As Perram J observed in Export Corporation at [6]-[10], entry on the TG Register ordinarily reflects a rigorous assessment of quality, safety and efficacy. The promotion of products outside that framework undermines those statutory protections, and restrictions on advertising unregistered therapeutic goods therefore play an important role in preserving the integrity of the TG Act’s regulatory framework.

104    Second, the conduct involved both prohibited representations and restricted representations. The advertisements associated the Products and CBD products generally with a wide range of serious conditions, including anxiety, depression, PTSD, epilepsy, chronic pain, fibromyalgia, autism, meningitis and cancer. The legislation clearly singles out such representations for particular regulation because of the significant risk that vulnerable consumers may be influenced by therapeutic claims concerning serious diseases.

105    Third, I accept the Secretary’s Submissions (at [156] and [190]) that the conduct carried the potential for significant public harm. In that regard, I place considerable weight upon the evidence of Professor Ogden. Professor Ogden accepted that CBD may have therapeutic applications in some circumstances and that low-dose CBD generally has a relatively low toxicity profile when compared with many pharmaceutical products (Ogden Report at [42]-[47], [151]-[152]). However, Professor Ogden also identified several risks associated with the use of CBD products, particularly where those products are used without adequate medical supervision or in place of established treatments (Ogden Report at [153]-[165]). In particular, Professor Ogden explained that consumers may delay or avoid evidence-based treatment if persuaded that CBD products could appropriately address serious conditions such as cancer, epilepsy, depression or other mental illnesses (Ogden Report at [156], [246]-[273]). Professor Ogden identified risks arising from adverse drug interactions, including interactions resulting from CBD’s inhibition of metabolic enzymes and the consequent potential for increased toxicity or side effects from other medications (Ogden Report at [159]-[164]). Professor Ogden also identified risks associated with the use of products that had not undergone the level of regulatory assessment ordinarily associated with inclusion on the TG Register, including risks relating to product quality, consistency and contamination (Ogden Report at [165]). The significance of those risks should not be understated. As identified by the authorities discussed earlier in this decision, the TG Act is directed toward protecting public health. The statutory advertising restrictions are intended to prevent consumer decision-making of the kind that may occur when prescription-only products are promoted in connection with serious illnesses outside the regulatory framework contemplated by the TG Act.

106    Fourth, the advertisements formed part of a deliberate commercial strategy. I accept the Secretary’s Submissions that the Website, Blog Posts and Facebook Posts worked together to encourage consumer engagement with CDA’s services and to facilitate access to CBD products. The advertisements were neither inadvertent nor isolated but rather formed part of the manner in which CDA conducted its business.

107    Fifth, the conduct occurred with the involvement of the highest level of management within CDA. During the Relevant Period, Dr Jansen was CDA’s sole director and was responsible for the company’s day-to-day operations. The evidence demonstrates that he was involved in reviewing, editing and approving the Website, including the Blog Posts, Products Advertisements and changes to the Website’s functionality. As the authorities recognise, conduct occurring with the knowledge and involvement of senior management is more serious than conduct occurring at a lower organisational level (Vapor Kings at [16]).

108    Sixth, although I accept that CDA may not have deliberately set out to contravene the TG Act, I am satisfied that CDA’s approach to compliance with the statutory regime was nevertheless inadequate. In reaching that conclusion, I have regard to the evidence (as admitted by Dr Jansen in the Agreed Facts and Submissions at [119]) that prior to launch of the Website Dr Jansen attended a TGA webinar concerning medicinal cannabis advertising restrictions. I also have regard to the evidence that the TGA subsequently contacted CDA and, on 2 July 2021, issued correspondence requiring the removal of the advertising material (as admitted in CDA’s Concise Statement in Response at [11] and outlined in the Agreed Facts and Submissions at [127] and [130]). Notwithstanding that communication, I accept that, as confirmed in the Agreed Facts and Submissions at [130], the relevant conduct continued until 30 July 2021, before the Website was ultimately removed on 31 July 2021. Those matters distinguish the present case from one involving an isolated or genuinely accidental regulatory breach. At the very least, CDA proceeded in circumstances where the need for close compliance with the statutory advertising restrictions ought reasonably to have been apparent.

109    Despite the factors elevating the seriousness of CDA’s conduct, I accept that there are also matters operating in mitigation. There is no evidence that CDA has previously been found by the Court in proceedings under the TG Act to have engaged in similar conduct. That factor is expressly identified in s 42Y(3)(d) of the TG Act and weighs in CDA’s favour. I also accept that the Products involved CBD rather than products presenting an inherently high toxicity risk (as accepted in the Ogden Report at [42]-[47] and [151]-[152]). Furthermore, I accept that there is no evidence that CDA deliberately sought to deceive consumers or intentionally set out to defy the TG Act. However, that factor does not carry substantial weight as deliberate unlawfulness is not required before serious contraventions may arise.

110    CDA has not made any submissions and, as such, there is no suggestion from CDA that it should be entitled to a discount for cooperation. I therefore accept the Secretary’s Submissions (at [187]-[189]) that, although CDA made certain admissions in its Concise Statement in Response, it continued to defend the proceeding and did not ultimately participate in the resolution of the case in the manner later adopted by Dr Jansen. I acknowledge that the Secretary was required to prepare extensive evidence and substantial written submissions. In those circumstances, no significant allowance should be made for cooperation.

111    I have also considered CDA’s liquidation. While liquidation may reduce the practical operation of specific deterrence (Peptide Clinics at [35]), I accept the Secretary’s Submissions (at [190]) that it does not diminish the importance of general deterrence. The Court must continue to impose a penalty that adequately reflects the seriousness of the conduct and communicates the consequences of contravening the advertising provisions of the TG Act. To hold otherwise would risk undermining the general deterrent effect of civil penalties in cases involving insolvent corporations.

112    The maximum penalties available are extraordinarily large (amounting to at least $21.634 billion, as identified by the Secretary at [140]-[141] of the Secretary’s Submissions). Maximum penalties provide an important legislative yardstick (Vapor Kings at [18]-[19]). I accept the Secretary’s Submissions (at [142]) that, although the theoretical maximum penalties are of little practical utility as they are well beyond what would reasonably be imposed, the maximum penalties nonetheless demonstrate the seriousness with which the legislature views CDA’s conduct.

113    I have also considered, with caution (Flight Centre at [63]), the penalties imposed in Peptide Clinics, Evolution Supplements, Oxymed and Vapor Kings, which confirm that substantial penalties are appropriate where businesses promote therapeutic goods outside the limits imposed by the TG Act.

114    Having regard to all relevant matters, I consider that substantial penalties should be attributed to each of the three courses of conduct identified above. I also consider it necessary to apply the totality principle to ensure that the final penalty properly reflects the entirety of CDA’s offending without becoming crushing or disproportionate. After allowing for overlap between the various contraventions and applying the totality principle, I accept that the following ranges of penalties suggested by the Secretary for each course of conduct are appropriate having regard to the maximum penalty, the circumstances considered above and the need for deterrence:

    Course of Conduct One: $3 million to $4 million;

    Course of Conduct Two: $1.5 million to $3 million; and

    Course of Conduct Three: $0.5 million to $1 million.

115    In considering these ranges, I am satisfied that the pecuniary penalty sought by the Secretary, being $6.5 million, is appropriate and proportionate to CDA’s contravening conduct. In my view, that penalty appropriately reflects:

    the scale and duration of the contravening conduct;

    the large number of contraventions involved;

    the use of prohibited and restricted representations concerning serious diseases and conditions;

    the advertising of prescription-only CBD products and unregistered therapeutic goods;

    the risks to public health identified by Professor Ogden;

    the involvement of senior management;

    the continuation of the conduct following regulatory intervention;

    the absence of prior contraventions; and

    the overriding need for both specific and general deterrence.

116    Accordingly, pursuant to s 42Y of the TG Act, I will make the order sought in order 9 of the Proposed Orders.

117    In accordance with the ordinary rule that costs follow the event (Bosanac (No 2) at [11]), CDA should also pay the Secretary’s costs of and incidental to the proceeding insofar as those costs related to the proceeding against CDA, such costs to be taxed if not otherwise agreed.

Dr Jansen

Liability

118    Unlike CDA, Dr Jansen does not ultimately contest liability. In the Agreed Facts and Submissions filed on 9 February 2026, Dr Jansen admitted that CDA contravened s 42DLB(1) of the TG Act in the manner alleged by the Secretary and further admitted that he aided, abetted, counselled or procured those contraventions and was therefore involved in them within the meaning of s 42YC of the TG Act (Agreed Facts and Submissions at [58]-[79]).

119    As I observed earlier in these reasons, s 42YC of the TG Act applies where a person aids, abets, counsels or procures a contravention of a civil penalty provision and possesses knowledge of the essential facts constituting the contravention. In accordance with the authorities discussed previously, including Promotional Products, Productivity Partners and Blue Sky Kids, it is unnecessary that an accessory appreciate that the conduct is unlawful. Rather, it is sufficient that the person intentionally participated in the conduct with knowledge of the essential factual circumstances giving rise to the contravention.

120    I am satisfied that those requirements are established in the present case.

121    During the Relevant Period, Dr Jansen was the sole director of CDA and was responsible for the day-to-day management and operation of the company. As he admitted in the Agreed Facts and Submissions (at [87]), he exercised overall responsibility for CDA’s business operations, oversaw the operation of the Website, suggested and approved modifications to the Website’s content and functionality, tested aspects of the Website and edited content appearing on it.

122    Clearly, Dr Jansen was not a passive director removed from the conduct of the business. Rather, he was the individual principally responsible for the development and operation of the CDA model and the Website during the Relevant Period. The Website, including the Products Advertisements and Blog Posts, formed part of CDA’s core business activities. The evidence establishes that those activities occurred with Dr Jansen’s knowledge and involvement (as confirmed in the Agreed Facts and Submissions at [87.3]).

123    Furthermore, I am satisfied that Dr Jansen possessed knowledge of the essential facts constituting CDA’s contraventions. Dr Jansen was aware of:

    the content published on the Website;

    the nature of the Products being offered to consumers;

    the conditions and illnesses referred to throughout the Products Advertisements and Blog Posts; and

    consumers’ ability to access the Restricted Section of the Website and obtain the Products.

124    I am satisfied that those matters are sufficient to establish the requisite knowledge for the purposes of s 42YC. In the submissions he provided at the hearing, Dr Jansen submitted that there was confusion following TGA guidance and webinars concerning medicinal cannabis advertising, and that similar material could be observed elsewhere within the healthcare industry. Dr Jansen also contended that the Website content fell within the exclusion contained in s 42AA(4) of the TG Act because patients completed an extensive intake process and engaged in what he described as a course of treatment. Dr Jansen also reiterated on several occasions that he did not intend to contravene the TG Act.

125    Those submissions do not affect my conclusions concerning liability. First, as I have already found, the exclusion in s 42AA(4) of the TG Act does not apply having regard to the evidence concerning the operation of the Website and the opinions expressed by Professor Hespe. Second, the existence of uncertainty concerning aspects of the regulatory framework could not alter the objective facts constituting the contraventions. Third, Dr Jansen’s lack of intention to contravene the TG Act is not determinative. The relevant inquiry is whether he intentionally participated in the conduct with knowledge of the essential facts constituting the contraventions, which I am satisfied he did. Finally, Dr Jansen expressly agreed in the Agreed Facts and Submissions that s 42AA(4) did not apply to the Relevant Advertisements and that CDA committed the contraventions alleged by the Secretary. To the extent that the submissions made at the hearing sought to contradict or qualify facts agreed pursuant to s 191 of the Evidence Act, s 191(2)(b) of the Evidence Act provides that evidence contradicting or qualifying an agreed fact may not be adduced without leave.

126    In those circumstances, I am satisfied that Dr Jansen aided, abetted, counselled or procured CDA’s contraventions of s 42DLB(1) and was therefore involved in those contraventions within the meaning of s 42YC of the TG Act.

Declarations

127    By way of orders 2, 4, 6 and 8 of the Proposed Orders, the Secretary seeks declarations corresponding with the declarations sought against CDA and reflecting Dr Jansen’s involvement in CDA’s contraventions of s 42DLB(1) of the TG Act, by operation of ss 42DLB(2), (4), (7) and (9).

128    I am satisfied that the declaratory relief sought by the Secretary should be granted against Dr Jansen, particularly in light of the parties’ joint submission in the Agreed Facts and Submissions that such declarations be made. The evidence establishes that Dr Jansen aided, abetted, counselled or procured CDA’s contraventions concerning prohibited representations, restricted representations, references to substances included in Schedule 3, 4 or 8, but not in Appendix H, of the Poisons Standard and references to therapeutic goods not entered on the TG Register. The declarations sought by the Secretary accurately reflect the nature and extent of that involvement.

129    The declarations also have practical utility. Although Dr Jansen has admitted liability, it remains appropriate that the Court’s findings be formally recorded to mark the Court’s disapproval of Dr Jansen’s unlawful conduct (Vapor Kings at [28]). That is particularly so given that Dr Jansen’s contraventions concerned the advertising of prescription-only therapeutic goods and representations directed towards serious illnesses and conditions.

130    I am satisfied that declarations substantially in the form of orders 2, 4, 6 and 8 of the Proposed Orders should be made.

Pecuniary Penalty

131    The Secretary and Dr Jansen jointly submit that the Court should impose a pecuniary penalty of $450,000 on Dr Jansen pursuant to s 42Y of the TG Act, and order him to pay the Secretary’s costs in the fixed sum of $20,000.

132    As identified in Vapor Kings at [24]-[27], where parties jointly propose a pecuniary penalty, the Court is not bound to impose the proposed penalty. It remains necessary for the Court to be independently satisfied that the proposed penalty is appropriate. However, as the High Court explained in Commonwealth v Director, Fair Work Building Industry Inspectorate [2015] HCA 46; (2015) 258 CLR 482 (DFWBII) at [46] and [58], it is “highly desirable in practice for the court to accept the parties’ proposal”. On the basis of the authorities outlined in Vapor Kings (at [24]-[27]), I consider that significant weight should be given to agreed submissions where the Court is satisfied as to the accuracy of the agreed facts and the appropriateness of the proposed outcome.

133    In this case, I am satisfied that the agreed factual foundation is comprehensive and reliable. The Agreed Facts and Submissions extend to the nature of the contravening conduct, Dr Jansen’s role within CDA, the operation of the Website, the circumstances surrounding the contraventions and the matters said to bear upon penalty. There is no reason to doubt the accuracy of those agreed facts.

134    The contraventions in which Dr Jansen was involved were serious. For the reasons already discussed in relation to CDA, the conduct involved a substantial number of contraventions, representations concerning serious diseases and conditions, references to prescription-only CBD products and references to products not entered on the TG Register. The conduct occurred over an extended period, formed part of CDA’s business model and carried the potential for significant harm to consumers (as confirmed by the Ogden Report). Furthermore, the fact that Dr Jansen occupied the position of sole director substantially aggravates the seriousness of his involvement. The conduct did not arise from actions taken by junior staff or third parties. Rather, the evidence establishes that Dr Jansen occupied the highest level of management within CDA and exercised direct influence over the content and operation of the Website.

135    Nonetheless, I acknowledge that mitigating considerations are present. First, Dr Jansen ultimately cooperated with the Secretary. Although he initially defended the proceeding, he subsequently agreed to the Agreed Facts and Submissions, admitted liability, accepted the making of declarations and agreed to the imposition of a substantial pecuniary penalty. That cooperation avoided the need for a contested trial concerning his liability and materially reduced the issues requiring determination by the Court.

136    Second, I accept Dr Jansen’s Submissions that there is no evidence that Dr Jansen deliberately set out to breach the TG Act. Indeed, the Secretary accepted in the Agreed Facts and Submissions that neither CDA nor Dr Jansen intended to contravene the legislation. While that does not excuse the conduct, I consider it relevant to the assessment of the seriousness of his conduct and the level of specific deterrence required.

137    Third, I have taken into account the personal circumstances raised in Dr Jansen’s Submissions, including the substantial financial burden imposed by the proceeding and the broader “emotional toll” of the proceeding.

138    While those matters are relevant, they do not materially diminish the need for a penalty of substantial deterrent effect. As the High Court observed in Pattinson at [15]-[16], [43] and [45], the principal purpose of a civil penalty is deterrence. A penalty cannot be reduced to an amount that would undermine that objective.

139    I have also again considered Dr Jansen’s submission that confusion existed within the medicinal cannabis industry concerning permitted advertising practices. In particular, Dr Jansen referred to a TGA webinar conducted in 2021 and examples of other businesses which, he submitted, engaged in similar conduct. I accept that regulatory regimes involving emerging therapeutic products may present difficult questions of compliance. However, the evidence establishes that Dr Jansen was aware of the existence of the advertising restrictions and had attended a TGA webinar dealing with those restrictions shortly before the Website was launched (Agreed Facts and Submissions at [39], [119] and [129]). Further, the conduct continued under Dr Jansen’s control after CDA received direct correspondence from the TGA concerning the Website (Agreed Facts and Submissions at [127] and [130]). In those circumstances, any allegation of uncertainty on Dr Jansen’s part can be given only limited weight.

140    Additionally, I have considered the oral submissions made by Dr Jansen at the hearing concerning the relative safety of CBD and his contention that aspects of Professor Ogden’s report focused selectively upon potential harms. As previously noted, the evidence of Professor Ogden was that CBD possesses a relatively low toxicity profile and may have therapeutic benefits in certain circumstances. However, the contraventions in this proceeding do not arise because CBD lacks any therapeutic utility. Rather, the contraventions arise because the advertising of therapeutic goods is regulated by statute and because consumers were exposed to advertising representations that the legislature has determined require specific approvals or restrictions. Accordingly, those submissions do not materially affect my assessment of penalty.

141    Viewed as a whole, I am satisfied that the jointly proposed penalty appropriately reflects both the seriousness of the conduct and the mitigating factors arising from Dr Jansen’s cooperation and admissions. Importantly, the proposed penalty falls within the permissible range having regard to the statutory maximum and the extent of Dr Jansen’s admitted involvement.

142    In accordance with the authorities set out in this decision, particularly DFWBII, I am satisfied that the proposed penalty is an appropriate remedy in the circumstances revealed by the agreed facts and should be adopted.

143    Accordingly, I will make the order sought in order 10 of the Proposed Orders, namely that Dr Jansen pay to the Commonwealth a pecuniary penalty in the total sum of $450,000 within 180 days, pursuant to s 42Y of the TG Act.

144    I am also satisfied that the agreed costs order is appropriate. Dr Jansen should therefore pay the Secretary’s costs insofar as those costs concern the proceeding against Dr Jansen, such costs to be fixed in the amount of $20,000.

Conclusion

145    I am satisfied that the Secretary has established the contraventions alleged against CDA and Dr Jansen. The evidence demonstrates that, during the Relevant Period, CDA engaged in extensive advertising of CBD products in contravention of s 42DLB(1) of the TG Act, by operation of ss 42DLB(2), (4), (7) and (9) of the TG Act, and that Dr Jansen was involved in those contraventions within the meaning of s 42YC of the TG Act. In the circumstances, it is appropriate that declarations be made recording the contraventions, that CDA and Dr Jansen pay pecuniary penalties in the amounts of $6,500,000 and $450,000 respectively, and that costs be awarded as reflected in the orders accompanying these reasons.

Associate:

Dated:    30 October 2026