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Healthy Skepticism International News

March 2009

Advertising of therapeutic goods in Australia – a case study of FatMagnet

2 Mar 2009
Senator Jan McLucas
Parliamentary Secretary to the Minister for Health and Ageing
Parliament House
Canberra, ACT, 2600

Dear Senator McLucas,

Re: Failure of the “integrated three-tier system of controls” for the advertising of therapeutic goods in Australia – a case study of FatMagnet (ARTG: 145959, Cat Media Pty. Ltd.) .

The TGACRP web site states, “There is an integrated three-tier system of controls for the advertising of therapeutic goods in Australia….. The TGA has overall responsibility for the successful operation of the co and self-regulatory systems and for achieving compliance with outcomes of determinations”. See: http://www.tgacrp.com.au/ It also says, “Send any complaint about an advertisement for a therapeutic product to: PO Box 764 North Sydney NSW 2059….. It will be forwarded immediately to the appropriate complaints committee for consideration and determination.” On August 6, 2008 I complained about the promotion of FatMagnet, a complementary medicine weight loss product sponsored by Cat Media Pty Ltd (trading as Naturopathica) whom I understand may now be owned by PharmaCare Laboratories Pty Ltd. The promotion of products sponsored by Cat Media has resulted in over 15 successful complaints over the the last 3 years. The products involved include FatMagnet, Fatblaster, FatblasterMax, Xantrax, Diuret and Horney Goat Weed. My complaint about FatMagnet specifically:

-Noted the numerous previously proven breaches of the Therapeutic Advertising Code by this company;
-Asked that, if the CRP agreed that the FatMagnet promotion also breached the Code, they pass this matter on to the TGA so that effective sanctions could be applied under Section 42DM of the Therapeutic Goods Act 1989;
-Documented a number of Internet pharmacy sites that contained promotional material for FatMagnet that I believed were also in breach of the Code;
-Asked the CRP to ask the TGA to disallow misleading product and pack names such as, “FatMagnet”, “Fat Blaster”, “Fat Blaster Max”, “Xantrax (High Potency Weight Loss Formula)”, “Weight Loss Accelerate”, “Slim Me”, etc;
-Noted that the workload of both complainants and the CRP would be greatly reduced (and consumer protection enhanced) if the TGA declared a list of complementary weight loss ingredients “off-limits” for this indication and pointed out that there are numerous scientific reviews of these ingredients that would support such an approach. On Sept 18, 2008 the CRP determined that a number of the representations in the Cat Media advertisements breached sections 4(1)(b), 4(2)(a), 4(2)(c) and 4(2)(d) of the Code. The Panel also noted, without making any formal finding, that the references to “cheat[ing]” appeared likely to breach section 7(3) of the Code.

The Panel requested Cat Media to withdraw these representations and also advise other parties, such as retailers or website publishers, that these representations should be withdrawn from their own promotional material. See: http://www.tgacrp.com.au/index.cfm?pageID=13&special=complaint_single&complaintID=1140

I now draw your attention (and that of the Central Complaints Mail Box, the CRP, CRC and the TGA) to the ongoing promotion of this product, both on several Cat Media web sites and on numerous Internet pharmacy sites, which blatantly ignore the determinations of the CRP . The details are contained in Appendix I. I have also provided an updated summary of evidence about the key promoted ingredient (Chitosan) in Appendix II.

This case study is just the latest of many in which sponsors of complementary medicine have ignored the determinations of the CRP and the TGA has also failed to follow-up or take any action in these matters. Despite my request to the CRP, I have received no notification that these matters were referred to the TGA (including the issue of misleading and deceptive product names and packs) as I requested.

In conclusion, I draw the attention of all the parties involved to the TGA’s 2009, “Draft Guideline for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims for Weight Loss”http://web.archive.org/web/20110218204920/http://www.tga.gov.au/cm/consult/drweightloss.htm. If there is no change to the current laissez faire attitude towards proven breaches of the Therapeutic Goods Advertising Code by all parties involved in the co-regulatory system then clearly these new Guidelines will be as equally useless as the TGA’s 2001, “Guidelines for Levels and Kinds of Evidence to Support Indications and Claims For Non-Registerable Medicines, including Complementary Medicines, and other Listable Medicines”. I should like you (and/or TGA officers) to explain why these matters remain unresolved at my next meeting with you in Parliament House, Canberra, scheduled for 3:30 pm, March 10, 2009.

 

Yours sincerely,

Dr. Ken Harvey
Adjunct Senior Research Fellow
School of Public Health, La Trobe University
http://www.medreach.com.au
VOIP: 03 9029 0634; Mobile 04 1918 1910
cc
Complaint Resolution Panel (CRP)
Complaint Resolution Committee (CRC)
The Office of Complementary Medicines & the Advertising and Export Section, TGA

Appendix I - Current promotion of FatMagnet (ARTG: 145959)

-http://www.naturopathica.com.au/news.php
In addition, the video whose story board is outlined below continues to be available at several of the sponsor’s web site:
-http://www.fatblaster.com.au/tvc.php?tvc_id=20
-http://www.naturopathica.com.au/news.php
Furthermore, the Internet pharmacies originally complained about (and many more) also have failed to alter material that the CRP agreed breached the Therapeutic Goods Advertising Code, 2007, see:
-http://www.discountnaturalhealth.com/prod23.htm
-http://www.epharmacy.com.au/product.asp?id=52781&pname=Fatmagnet+Tablets+60
-http://web.archive.org/web/20090210021614/http://vitaminme.com.au/site/page.cfm?u=7&s=shopProductInfo&t=shopProductInfo&productId=12195
-http://www.cincottachemist.com.au/product_detail.php?crk=956627
-http://www.anatomyzone.com.au/products/FAT_MAGNET-53-0.html
-http://www.emedical.com.au/default.asp?pageID=56&itemID=17118&purchaseTypeID=1
-http://web.archive.org/web/20090604084457/http://www.pharmacyonline.com.au/naturopathica-blaster-magnet-p-11880.html

FatMagnet Video Story Board      

                                 

  Video     Voice over  
    Now you can prevent your body absorbing the fat you eat naturally  
    So when you start a healthy diet and exercise plan FatMagnet can help you reduce calories by helping your body absorb less fat  
    Fat magnet binds to some of the fat you eat and then passes right out of your body  
    This is oil in a glass of water  
    Watch how Fat Magnet attracts the oil, binds to it  
    then takes it away  
    Now there really is an easier, natural way to help support a healthier life style  
    Fat Magnet!  
    Absorb less fat! Lose more weight!  

Internet Sites (only a few of many are illustrated)




-http://www.discountnaturalhealth.com/prod23.htm





-http://www.epharmacy.com.au/product.asp?id=52781&pname=Fatmagnet+Tablets+60





-http://www.vitaminme.com.au/site/page.cfm? u=7&s=shopProductInfo&t=shopProductInfo&productId=12195





-http://www.cincottachemist.c om.au/product_detail.php?crk=956627





-http://www.anatomyzone.com.a u/products/FAT_MAGNET-53-0.html
 

Appendix II – Scientific reviews


From the Cochrane Database of Systematic Reviews 2009

http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD003892/frame.html

There is some evidence that chitosan is more effective than placebo in the short-term treatment of overweight and obesity. However, many trials to date have been of poor quality and results have been variable. Results obtained from high quality trials indicate that the effect of chitosan on body weight is minimal and unlikely to be of clinical significance.

From the NPS recommended Natural & Alternative Treatments Database

https://healthlibrary.epnet.com
Chitosan has also been proposed as a weight loss treatment on the same principle.2,3 However, despite some mildly positive results, the current balance of evidence suggests chitosan does not in fact significantly aid weight loss 4,5,37,41,44,46,49,50

From the NPS recommended Natural Medicines Comprehensive Database
http://www.naturaldatabase.com

Weight loss. There is conflicting evidence about the effectiveness of chitosan for weight loss. Some research suggests that combining chitosan with a calorie-restricted diet might result in modest weight loss (9610,http://www.naturaldatabase.com="">10020,11045,14314). Many studies on chitosan have significant methodological flaws, which limits the reliability of these findings. A meta-analysis of chitosan studies suggests that chitosan might modestly reduce weight compared to placebo; however, when only higher quality, larger studies are analyzed the effect of chitosan on weight loss is minimal, about 0.5 kg when taken for 1-6 months (13171). This may not be clinically significant. More evidence is needed to rate chitosan for these uses.

 

 

HS Int News index

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