U.S. action on SENSA false advertising claims; TGA does nothing

“Sensa Products, LLC and its parent corporation Intelligent Beauty Inc. has agreed to pay more than $900,000 to settle a U.S. false advertising lawsuit.

This lawsuit was filed in Santa Cruz County by nine California district attorneys for the Counties of Santa Cruz, Alameda, Marin, Monterey, Napa, Orange, Santa Clara, Solano and Sonoma”. See attached and http://nutritionunplugged.com/

However, given TGA indifference / incompetence / impotence (see below) this product is still being promoted in Australia.
__________________________________________________________________

—–Original Message—–
From: Ken Harvey [mailto:k.harvey@medreach.com.au]
Sent: Thursday, 29 November 2012 11:11 AM
To: ‘Judith Brimer’; ‘Ernie Waldstein’; ‘mick.o’connor@tga.gov.au’; ‘Eric.McIntosh@tga.gov.au’; ‘Bob.Hignett@tga.gov.au’; ‘Brett.Irwin@tga.gov.au’; ‘Virginia.Deigan@tga.gov.au’; Trisha. Garrett (Trisha.Garrett@tga.gov.au); Dr John Skerritt (John.Skerritt@tga.gov.au);
Subject: RE: Complaint 2012/01/003 Sensa; Australian Skeptics National Convention 2012
Importance: High

Dear regulatory colleagues,

On Dec 4-5, 2011 I complained to the TGA about this product (attached) and received the appended acknowledgment from Mick O’Connor (TGA) and Ernie Waldstein (CRP).

Subsequently, I have heard no more from either the CRP or TGA.

Meanwhile this product is still being promoted by Australian web sites, see:

http://trysensa.com.au/

http://www.overship.com.au/sensa?gclid=CJDHk724trECFeNMpgodB0MAUQ

However, in the U.S. manufacturer of Sensa satiety crystals has agreed to settlements in two cases alleging false advertising.

The company agreed to pay $800,000 in civil penalties and $105,000 in restitution to California consumers. In September, 2012 the company settled a class action over false advertising claims also filed in California. In that case, which included a number of class action suits combined into one proceeding, the company agreed to set up settlement fund that could total as much as $9 million applicable to all US consumers who bought the product prior to August 15, 2012. That settlement was pending a final settlement fairness hearing.

This case study illustrates yet again the indifference &/or impotence of the Australian regulatory system with respect to the unethical promotion of complementary medicines to consumers.

What has happened to my complaints?

Why is this product still being promoted in Australia?

When will the TGA gets it act together with respect to applying timely and effective penalties to sponsors who breach the Therapeutic Goods Advertising Code and Therapeutic Goods Act?

I believe that I (and the consumer movement) deserves an answer to these question from the Manager of the TGA, Dr John Skerritt.

I will be using this case study at my talk at the Australian Skeptics National Convention 2012, in Melbourne this weekend, see:
http://vicskeptics.wordpress.com/events/detailed-program-2012-convention/

It would be nice to be able to give the TGA’s response to this meeting.

Sincerely,

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 __________________________________________________________________

From: mick.o’connor@tga.gov.au [mailto:mick.o’connor@tga.gov.au]
Sent: Tuesday, 3 January 2012 3:38 PM
To: Ken Harvey
Cc: ‘Judith Brimer’; Kay.McNiece@health.gov.au; Ernie Waldstein; Ian.Stehlik@tga.gov.au; Eric.McIntosh@tga.gov.au; Brett.Irwin@tga.gov.au; Virginia.Deigan@tga.gov.au
Subject: Re: Complaint about Sensa – Yet another pharmacy weight loss scam [SEC=UNCLASSIFIED]

Dear Dr Harvey

Thank you for your emails regarding the advertising of SENSA Weight-Loss System. I apologise for the delay in responding.

The TGA obtained SENSA Weight-Loss System (SENSA) in order to determine if the product is a food or therapeutic good. It was difficult to decide its regulatory status from the advertising material you referred to us.

As explained in my email to you on 21 April 2011 regarding Optimal Essentials Products, the TGA considers a number of aspects when determining if a product is a therapeutic good or a food. These include its overall presentation, which incorporates the name, dosage form, route of administration, container type, claims, directions for use and whether there are any health warning statements on the label.

We have reviewed the SENSA Weight-Loss System product label, its packaging and an enclosed usage guide and DVD. This material contains statements, claims and health warnings that in our view makes SENSA Weight-Loss System a therapeutic good. The definition of therapeutic goods in the Act includes goods ” …that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be for therapeutic use….”.

Accordingly, I have referred your complaint to the TGA’s Regulatory Compliance Unit to investigate the unapproved supply of SENSA Weight-Loss System. The RCU addresses the matter directly with the sponsor of the goods concerned to ensure compliance with the regulatory requirements of the therapeutic goods legislation. Further, I have asked the Complaints Resolution Panel Secretariat to process your advertising complaint as soon as possible to allow it to be considered at the next available Panel meeting.

Finally, with regard to your complaint about the advertising of Optimal Essentials Products, as advised in my email of 21 April, this matter was referred to the Food Safety area of the South Australian Department of Health for its consideration. I suggest you contact Glen Martin
(glen.martin@health.sa.gov.au) for advice on the outcome.

Regards
__________________________________________________________________
Mick O’Connor
Director
Recalls and Advertising Section
Office of Product Review
Therapeutic Goods Administration

Tel: +61 2 6232 8197
Fax: +61 2 6232 8535
Address: PO Box 100, WODEN ACT 2606
Email: mick.o’connor@tga.gov.au
_______________________________________

From: “Ken Harvey” <k.harvey@medreach.com.au>
To: <mick.o’connor@tga.gov.au>
Cc: “‘Judith Brimer'” <jbrimer@tgacc.com.au>, <Kay.McNiece@health.gov.au>
Date: 05/12/2011 04:31 PM
Subject: Re: Complaint about Sensa – Yet another pharmacy weight loss scam ________________________________________

Dear Mick, et al,

You will recall that on the 30/3/2011 I sent you a complaint about the promotion of several Optimal Essentials’ products. You considered that these products were represented as, or were likely to be taken as foods, and agreed they were making inappropriate therapeutic claims. Accordingly you referred my complaint to a State-based Food Safety authority after which I have heard no more.

I now attach another complaint that crosses the medicine-food interface.

This one concerns yet another pharmacy weight loss scam: Sensa promoted in last weekend’s “Sunday Mail (body+soul)” by a number of pharmacy chains and also specifically advertised by “Chemist Direct” and the sponsor “OptiSlim”.

Claims include, “The biggest weight loss breakthrough this century”, “Lose Kilos without dieting”, a “Completely new, clinically proven way to lose weight” and “SENSAR was proven effective in one of the largest clinical studies ever performed on a non-prescription weight-loss product”.

Sensa appears to be is made up of the corn-derived maltodextrin, silica, tricalcium phosphate, artificial flavoring, yellow coloring, soy, milk and carmine. I can find no entry for this product on the ARTG and I presume the sponsor will say it a food.

The relevant “research” (attached to my complaint) consists of one uncontrolled and irrelevant study using “inhalers containing blends of aromatic Ingredients” published in an obscure journal not indexed by PubMed and two 2009 conference posters allegedly reporting double-blind placebo controlled trials with “tastant crystals” . I can find no evidence in PubMed that these 2009 “abstracts” were ever published in peer-reviewed journals.
In addition, I can find no relevant publications in PubMed by “Hirsch A [auth]”, the “expert” who has allegedly developed this product.

In short, none of this material supports the extraordinary claims made such as, “The biggest weight loss breakthrough this century”, “clinically proven way to lose weight ” and “Lose Kilos without dieting”.

It is particularly sad that this product is being promoted and sold by pharmacy.

I am aware that the definition of whether a product is a food or medicine is not always clear cut and a number of sponsors are using this uncertainty to move products from the more tightly defined area of therapeutic goods regulation to the less well regulated area of food claims.

Regardless of whose jurisdiction this product falls under, it is crucial that the maximum penalties applicable under the law be applied, including a corrective advertising order to be placed in the newspaper and all applicable web sites in order to deter sponsors from perpetuating this unethical behaviour and to protect the public from false and misleading claims.

I should appreciate an acknowledgment that this complaint has been received.

In addition, if you pass it on to a State-based Food Safety authority I should appreciate learning of the outcome (which should also be published on the TGA’s web site in the interests of transparency and accountability.

Finally, I’d also appreciate learning the outcome of my Optimal Essentials complaint submitted over 10 months ago.

Cheers
Ken

Dr Ken Harvey
Adjunct Senior Lecturer
School of Public Health, La Trobe University http://medreach.com.au Mobile
+614 1918 1910 | Fax: +613 9818 1875
__________________________________________________________________

From: Ernie Waldstein [mailto:ewaldstein@tgacc.com.au]
Sent: Monday, 16 January 2012 4:08 PM
To: k.harvey@medreach.com.au
Subject: Complaint 2012/01/003 Sensa

Dear Dr Harvey

The Complaints Resolution Panel (CRP) has received your complaint about an advertisement for Sensa which appeared in the Sunday Mail, www.trysensa.com.au and www.chemistdirect.com.au on 4 December 2011.

The complaint has been allocated the following reference name and number:

Complaint 2012/01/003 Sensa

The CRP has been established under the Therapeutic Goods Regulations (Regulation 42R) to consider advertisements and generic information about designated therapeutic goods published in ‘specified media’, including mainstream print, TV, radio, internet, cinema and outdoor media (Regulation 42ZCAB).

The advertiser has been notified that a complaint about the advertisement for the product has been received. The Complaints Resolution Panel is scheduled to meet each month and considers the complaints as soon as possible.

It should also be noted that the observer to the Panel appointed by the TGA may be entitled to use any information provided to the Panel (whether confidential or not) pursuant to section 61(8) of the Therapeutic Goods Act.

Copies of the Therapeutic Goods Advertising Code 2007, the CRP procedures and some relevant clauses from the therapeutic goods legislation are available on request from me. These documents may also be found on the website at www.tgacc.com.au.

You will be kept informed appropriately.

Yours sincerely

Ernest Waldstein
for Judith Brimer
Executive Officer
Complaints Resolution Panel
PO Box 764
North Sydney 2059
(02) 9460 2796

“Sensa Products, LLC and its parent corporation Intelligent Beauty Inc. has agreed to pay more than $900,000 to settle a U.S. false advertising lawsuit.

This lawsuit was filed in Santa Cruz County by nine California district attorneys for the Counties of Santa Cruz, Alameda, Marin, Monterey, Napa, Orange, Santa Clara, Solano and Sonoma”. See attached and http://nutritionunplugged.com/

However, given TGA indifference, incompetence / impotence (see below) this product is still being promoted in Australia.

Any suggestions as to how we would go about getting a similar action in Australia?

__________________________________________________________________

—–Original Message—–

From: Ken Harvey [mailto:k.harvey@medreach.com.au]

Sent: Thursday, 29 November 2012 11:11 AM

To: ‘Judith Brimer’; ‘Ernie Waldstein’; ‘mick.o’connor@tga.gov.au’; ‘Eric.McIntosh@tga.gov.au’; ‘Bob.Hignett@tga.gov.au’; ‘Brett.Irwin@tga.gov.au’; ‘Virginia.Deigan@tga.gov.au’; Trisha. Garrett (Trisha.Garrett@tga.gov.au); Dr John Skerritt (John.Skerritt@tga.gov.au);

Subject: RE: Complaint 2012/01/003 Sensa; Australian Skeptics National Convention 2012

Importance: High

Dear regulatory (and consumer) colleagues,

On Dec 4-5, 2011 I complained to the TGA about this product (attached) and received the appended acknowledgment from Mick O’Connor (TGA) and Ernie Waldstein (CRP).

Subsequently, I have heard no more from either the CRP or TGA.

Meanwhile this product is still being promoted by Australian web sites, see:

 http://trysensa.com.au/

http://www.overship.com.au/sensa?gclid=CJDHk724trECFeNMpgodB0MAUQ

However, in the U.S. manufacturer of Sensa satiety crystals has agreed to settlements in two cases alleging false advertising (attached).

The company agreed to pay $800,000 in civil penalties and $105,000 in restitution to California consumers. In September, 2012 the company settled a class action over false advertising claims also filed in California. In that case, which included a number of class action suits combined into one proceeding, the company agreed to set up settlement fund that could total as much as $9 million applicable to all US consumers who bought the product prior to August 15, 2012. That settlement was pending a final settlement fairness hearing.

This case study illustrates yet again the indifference &/or impotence of the Australian regulatory system with respect to the unethical promotion of complementary medicines to consumers.

What has happened to my complaints?

Why is this product still being promoted in Australia?

When will the TGA gets it act together with respect to applying timely and effective penalties to sponsors who breach the Therapeutic Goods Advertising Code and Therapeutic Goods Act?

I believe that I (and the consumer movement) deserves an answer to these question from the Manager of the TGA, Dr John Skerritt.

I will be using this case study at my talk at the Australian Skeptics National Convention 2012, in Melbourne this weekend, see:

 http://vicskeptics.wordpress.com/events/detailed-program-2012-convention/

It would be nice to be able to give the TGA’s response to this meeting.

Sincerely,

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 __________________________________________________________________

From: mick.o’connor@tga.gov.au [mailto:mick.o’connor@tga.gov.au]

Sent: Tuesday, 3 January 2012 3:38 PM

To: Ken Harvey

Cc: ‘Judith Brimer’; Kay.McNiece@health.gov.au; Ernie Waldstein; Ian.Stehlik@tga.gov.au; Eric.McIntosh@tga.gov.au; Brett.Irwin@tga.gov.au; Virginia.Deigan@tga.gov.au

Subject: Re: Complaint about Sensa – Yet another pharmacy weight loss scam [SEC=UNCLASSIFIED]

Dear Dr Harvey

Thank you for your emails regarding the advertising of SENSA Weight-Loss System. I apologise for the delay in responding.

The TGA obtained SENSA Weight-Loss System (SENSA) in order to determine if the product is a food or therapeutic good. It was difficult to decide its regulatory status from the advertising material you referred to us.

As explained in my email to you on 21 April 2011 regarding Optimal Essentials Products, the TGA considers a number of aspects when determining if a product is a therapeutic good or a food. These include its overall presentation, which incorporates the name, dosage form, route of administration, container type, claims, directions for use and whether there are any health warning statements on the label.

We have reviewed the SENSA Weight-Loss System product label, its packaging and an enclosed usage guide and DVD. This material contains statements, claims and health warnings that in our view makes SENSA Weight-Loss System a therapeutic good. The definition of therapeutic goods in the Act includes goods ” …that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be for therapeutic use….”.

Accordingly, I have referred your complaint to the TGA’s Regulatory Compliance Unit to investigate the unapproved supply of SENSA Weight-Loss System. The RCU addresses the matter directly with the sponsor of the goods concerned to ensure compliance with the regulatory requirements of the therapeutic goods legislation. Further, I have asked the Complaints Resolution Panel Secretariat to process your advertising complaint as soon as possible to allow it to be considered at the next available Panel meeting.

Finally, with regard to your complaint about the advertising of Optimal Essentials Products, as advised in my email of 21 April, this matter was referred to the Food Safety area of the South Australian Department of Health for its consideration. I suggest you contact Glen Martin

(glen.martin@health.sa.gov.au) for advice on the outcome.

Regards

__________________________________________________________________

Mick O’Connor

Director

Recalls and Advertising Section

Office of Product Review

Therapeutic Goods Administration

Tel: +61 2 6232 8197

Fax: +61 2 6232 8535

Address: PO Box 100, WODEN ACT 2606

Email: mick.o’connor@tga.gov.au

_______________________________________

From: “Ken Harvey” <k.harvey@medreach.com.au>

To: <mick.o’connor@tga.gov.au>

Cc: “‘Judith Brimer'” <jbrimer@tgacc.com.au>, <Kay.McNiece@health.gov.au>

Date: 05/12/2011 04:31 PM

Subject: Re: Complaint about Sensa – Yet another pharmacy weight loss scam ________________________________________

Dear Mick, et al,

You will recall that on the 30/3/2011 I sent you a complaint about the promotion of several Optimal Essentials’ products. You considered that these products were represented as, or were likely to be taken as foods, and agreed they were making inappropriate therapeutic claims. Accordingly you referred my complaint to a State-based Food Safety authority after which I have heard no more.

I now attach another complaint that crosses the medicine-food interface.

This one concerns yet another pharmacy weight loss scam: Sensa promoted in last weekend’s “Sunday Mail (body+soul)” by a number of pharmacy chains and also specifically advertised by “Chemist Direct” and the sponsor “OptiSlim”.

Claims include, “The biggest weight loss breakthrough this century”, “Lose Kilos without dieting”, a “Completely new, clinically proven way to lose weight” and “SENSAR was proven effective in one of the largest clinical studies ever performed on a non-prescription weight-loss product”.

Sensa appears to be is made up of the corn-derived maltodextrin, silica, tricalcium phosphate, artificial flavoring, yellow coloring, soy, milk and carmine. I can find no entry for this product on the ARTG and I presume the sponsor will say it a food.

The relevant “research” (attached to my complaint) consists of one uncontrolled and irrelevant study using “inhalers containing blends of aromatic Ingredients” published in an obscure journal not indexed by PubMed and two 2009 conference posters allegedly reporting double-blind placebo controlled trials with “tastant crystals” . I can find no evidence in PubMed that these 2009 “abstracts” were ever published in peer-reviewed journals.

In addition, I can find no relevant publications in PubMed by “Hirsch A [auth]”, the “expert” who has allegedly developed this product.

In short, none of this material supports the extraordinary claims made such as, “The biggest weight loss breakthrough this century”, “clinically proven way to lose weight ” and “Lose Kilos without dieting”.

It is particularly sad that this product is being promoted and sold by pharmacy.

I am aware that the definition of whether a product is a food or medicine is not always clear cut and a number of sponsors are using this uncertainty to move products from the more tightly defined area of therapeutic goods regulation to the less well regulated area of food claims.

Regardless of whose jurisdiction this product falls under, it is crucial that the maximum penalties applicable under the law be applied, including a corrective advertising order to be placed in the newspaper and all applicable web sites in order to deter sponsors from perpetuating this unethical behaviour and to protect the public from false and misleading claims.

I should appreciate an acknowledgment that this complaint has been received.

In addition, if you pass it on to a State-based Food Safety authority I should appreciate learning of the outcome (which should also be published on the TGA’s web site in the interests of transparency and accountability.

Finally, I’d also appreciate learning the outcome of my Optimal Essentials complaint submitted over 10 months ago.

Cheers

Ken

Dr Ken Harvey
Adjunct Senior Lecturer
School of Public Health, La Trobe University http://medreach.com.au Mobile

+614 1918 1910 | Fax: +613 9818 1875
__________________________________________________________________

From: Ernie Waldstein [mailto:ewaldstein@tgacc.com.au]
Sent: Monday, 16 January 2012 4:08 PM
To: k.harvey@medreach.com.au
Subject: Complaint 2012/01/003 Sensa

Dear Dr Harvey

The Complaints Resolution Panel (CRP) has received your complaint about an advertisement for Sensa which appeared in the Sunday Mail, www.trysensa.com.au and www.chemistdirect.com.au on 4 December 2011.

The complaint has been allocated the following reference name and number:

Complaint 2012/01/003 Sensa

The CRP has been established under the Therapeutic Goods Regulations (Regulation 42R) to consider advertisements and generic information about designated therapeutic goods published in ‘specified media’, including mainstream print, TV, radio, internet, cinema and outdoor media (Regulation 42ZCAB).

The advertiser has been notified that a complaint about the advertisement for the product has been received. The Complaints Resolution Panel is scheduled to meet each month and considers the complaints as soon as possible.

It should also be noted that the observer to the Panel appointed by the TGA may be entitled to use any information provided to the Panel (whether confidential or not) pursuant to section 61(8) of the Therapeutic Goods Act.

Copies of the Therapeutic Goods Advertising Code 2007, the CRP procedures and some relevant clauses from the therapeutic goods legislation are available on request from me. These documents may also be found on the website at www.tgacc.com.au.

You will be kept informed appropriately.

Yours sincerely,
Ernest Waldstein
for Judith Brimer
Executive Officer
Complaints Resolution Panel
PO Box 764
North Sydney 2059

(02) 9460 2796

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Complementary medicine, Pharmaceutical Promotion and tagged , , . Bookmark the permalink.

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