Direction about advertisements: Pracmed Healthcare Pty Ltd

THERAPEUTIC GOODS ACT 1989

_____________________________

DIRECTION UNDER SECTION 42DV

ISSUED TO:

PRACMED HEALTHCARE PTY LTD
ACN 135 384 502

and

MR ROGER LEWIS
[REDACTED]

ON: 10 November 2023

ABOUT: Advertising indications and restricted representations without the relevant approvals

BY:   Gaelene Pyke
         Delegate of the Secretary of the Australian Department of Health and Aged Care
         Therapeutic Goods Administration
         PO Box 100
         Woden ACT 2606

Contact Officer Name: [REDACTED]
Telephone: 02 6289 4627 (Branch)
Email: complementary.medicines@health.gov.au

DIRECTION ABOUT AN ADVERTISEMENT

Made Under Section 42DV of the Therapeutic Goods Act 1989

TO:  PRACMED HEALTHCARE PTY LTD
       [REDACTED]

         And

        MR ROGER LEWIS
        [REDACTED]

By express post and email: [REDACTED]

I, Gaelene Pyke, delegate of the Secretary of the Australian Department of Health and Aged Care in the Therapeutic Goods Administration (TGA), being satisfied, that there has been a contravention of ss 21B(4)and 42DLB of the Therapeutic Goods Act 1989 (the TG Act) in relation to the advertising of vitamins or supplements, being therapeutic goods, by Pracmed Healthcare Pty Ltd (Pracmed Healthcare) as follows:

1. the advertising of vitamins or supplements, where these are therapeutic goods, for an indication that the vitamins or supplements have a specific therapeutic use for weight loss or bariatric surgery patients, where such an indication has not been accepted in relation to the inclusion of the goods in the Australian Register of Therapeutic Goods (ARTG);
2. the advertising of vitamins or supplements, where these are therapeutic goods, for an indication that the vitamins or supplements have a specific therapeutic use for improving cognitive functions, where such an indication has not been accepted in relation to the inclusion of the goods in the ARTG; 
3. the advertising of vitamins or supplements, where these are therapeutic goods, and the advertisement refers to therapeutic goods that are not entered in the ARTG and are prescribed by the Therapeutic Goods Regulations 1990 (the Regulations) for the purposes of s 42DLB(9) of the TG Act in circumstances where a relevant authorisation or requirement does not apply to the reference; and   
4. the advertising of vitamins or supplements, where these are therapeutic goods and where the advertisements contain a restricted representation (within the meaning of s 42DD of the TG Act) relating to morbid or severe obesity where no relevant approval (under s 42DF of the TG Act) or permission (under s 42DK of the TG Act) is in force in relation to the restricted representation

DIRECT Pracmed Health and Mr Roger Lewis (as the persons apparently responsible for

the advertising) to:

1. cease making all claims, references or representations made by advertisements referred to in the column entitled ‘claims/representations/references/statements’ of the table at Attachment A (see PDF); 
2. cease making all claims references or representations made by advertisements (including removing third party comments or customer reviews included in such advertisements)  about vitamins or supplements, where these are therapeutic goods, for an indication that the goods have a specific therapeutic use for improving cognitive functions or a specific therapeutic use for weight loss or bariatric surgery patients where those are not indications accepted in relation to the inclusion of the goods on the ARTG, on any website or social media platform (a relevant website) for which you are responsible (but only to the extent the relevant website is accessible by persons located in Australia);
3. cease making advertisements about vitamins or supplements, where these are therapeutic goods, and these advertisements refer to therapeutic goods that are not entered in the ARTG and are prescribed by the Regulations for the purposes of s 42DLB(9) of the TG Act, and no relevant authorisation or requirement  applies in relation to the reference. 
4. cease making all restricted representations relating to morbid or severe obesity in advertisements about vitamins or supplements, where these are therapeutic goods, where no relevant approval or permission is in force in relation to the restricted representation, on any relevant website for which you are responsible (but only to the extent the relevant website is accessible by persons located in Australia).

CONDITIONS

under subsection 42DV(3) of the TG Act

This Direction is subject to the following conditions:

1. Pracmed Healthcare and Mr Roger Lewis must: 
   1. do the things the subject of this Direction by 1 December 2023; and 
   2. following that day, continue to do those things for an indefinite period.    
2. Pracmed Healthcare and Mr Roger Lewis must email evidence of compliance with this Direction to the email address listed on the first page of this Direction by 8 December 2023, including a list of all relevant websites covered by this Direction in relation to claims or representations (including restricted representations) covered by this Direction. 
3. For the avoidance of doubt, the condition in 4(b) does not require Pracmed Healthcare or Mr Roger Lewis to email evidence of compliance with this Direction for the indefinite period following 8 December 2023. 

OTHER INFORMATION

The possible consequences of failing to comply with this Direction are explained in Attachment B (see PDF).

This is an initial decision and is reviewable. Your review rights are set out in Attachment C (see PDF). 

Please Note, as required under subsection 42DV(6) of the TG Act, the TGA will publish this Direction on its website. Publication is planned as soon as practicable after your submission due date of 20 November 2023 to any objections you may have in relation to the publication of information contained in the Direction.

DATED: 10 November 2023

(Signed electronically)

Gaelene Pyke

Assistant Secretary A/g
Medicines Regulation Division
Therapeutic Goods Administration
Delegate of the Secretary
Australian Department of Health and Aged Care