Souvenaid update

A recent NPS review is relevant:

http://www.nps.org.au/health-professionals/health-news-evidence/2014/souvenaid

Also, I understand that the subsidy of Souvenaid was considered at a recent meeting of the Repatriation Pharmaceutical Reference Committee (RPRC). I have yet to be informed of the outcome.

Finally, I am still waiting for the outcome of a complaint about the promotion of this product submitted in May 2013 to the TGACRP and handballed to the NSW Food Authority. Correspondence appended.

From: Ken Harvey [mailto:k.harvey@medreach.com.au]
Sent: Monday, 13 May 2013 7:01 AM
To: Judith Brimer (jbrimer@tgacc.com.au); Mick O’Connor (mick.o’connor@tga.gov.au)
Subject: Re: CRP / TGA Complaint Souvenaid

Dear Judith and Mick,

I’ve attached a complaint about Souvenaid, currently being heavily promoted to consumers (and health professionals):

  • “For the treatment of mild Alzheimer’s disease”,
  • “A new approach in the early stages of Alzheimer’s Disease”,
  • “Nutritionally supports memory function in the early stages of Alzheimer’s disease” and
  • “Clinically proven”.

I submit that the claims made, the defined ingredients and the dose (1 bottle a day) satisfy the definition of a therapeutic good contained in the Therapeutic Goods Act 1989. As such the promotion of this product breaches Section 22(5); 42C(1) and 42DL(1)(c) of the Act and at least Section 4(1)(a), 5 and 6(b)(iv) of the Therapeutic Goods Advertising Code 2007.

Alternatively, these claims breach Section 7 of Standard 1.2.7 (Nutrition, Health and Related Claims) under section 92 of the Food Standards Australia New Zealand Act 1991 &/or Section 3 of Standard 1.1A.2 as amended operating as a transitional alternative standard to Standard 1.2.7.

I would prefer that the CRP &/or the TGA investigate this complaint because, when complaints about products that bridge the medicine – food divide are declared a food and are sent to State Health Departments nothing happens. The CRP at least provides accountability if not redress!

Please acknowledge receipt of this complaint (and the appended references) and let me know how you intend to handle it.

Cheers
Ken

Dr Ken Harvey
Adjunct Associate Professor
School of Public Health,
La Trobe University
http://medreach.com.au
VOIP (03) 90293697 | Mobile +614 1918 1910 | Fax: +613 9818 1875

—–Original Message—–
From: Judith Brimer [mailto:jbrimer@tgacc.com.au]
Sent: Tuesday, 14 May 2013 1:21 AM
To: Ken Harvey
Cc: Janine Curll
Subject: RE: CRP / TGA Complaint Souvenaid

Dear Ken,

I have referred this complaint (our reference Complaint 2013/05/007 Souvenaid) to the NSW Food Authority as it is a food for special medical purposes that is regulated by Standard 2.9.5.

As you can see, I have copied Janine Curll, NSW Food Authority, on this email so that this matter can be followed through with you directly.

Kind regards,

Judith Brimer
Executive Officer
Therapeutic Goods Advertising Code Council and Complaints Resolution Panel
Tel: 02 9460 2796 | Fax: 02 9460 2798

—–Original Message—–
From: Janine Curll [mailto:Janine.Curll@foodauthority.nsw.gov.au]
Sent: Tuesday, 14 May 2013 1:53 AM
To: Ken Harvey
Cc: ‘Judith Brimer’; Ian Beer; Greg Vakaci
Subject: RE: CRP / TGA Complaint Souvenaid

Dear Dr Harvey

Thank you for the complaint regarding this Food for Special Medical Purposes. I encourage you to refer complaints regarding compliance with this standard and other food compliance matters to the Authority.

I will be reviewing your complaint and will provide a considered response shortly.

I welcome you to the food regulatory space and thank you for your efforts in the health products space past, present and into the future. I am the primary regulatory enforcement officer in NSW responsible for implementing standard 1.2.7 and enforcing the relevant laws relating to claims on food generally. Please do not hesitate to contact me on my direct line at any time.

Kind regards
Janine

Janine Curll BSc LLB
NSW Food Authority
6 Avenue of the Americas Newington NSW 2127 | PO Box 6682 Silverwater NSW 1811 Switch +61 2 9741 4777 | Helpline 1300 552 406 | www.foodauthority.nsw.gov.au Direct line 9741 4728 | Fax +61 2 9741 4888 | Mob 0427 427 785 janine.curll@foodauthority.nsw.gov.au

 

 

 

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About Dr Ken Harvey

Public Health Physician, Medical activitist
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