This arbitration result is an OCR result of a scanned copy from the original fax of the arbitration report from 2005. I have tried my best to ensure that no mistakes have crept in.
The expert who substantiated the product for Ultima was Brent Murphy, now a director of Solal.
The arbitrator was Prof Tessa v.d. Merwe, a world expert on obesity.
What is significant of this arbitration result is that Prof Tessa v.d. Merwe:
- completely dismisses Mr Murphy’s use of proof from animal models to extrapolate proof to effect in humans
- points out that there is no proof that any of the ingredients, even those tested in humans, have any significant effect
ARBITRATION IN TERMS OF CLAUSE IS OF THE PROCEDURAL GUIDE OF THE CODE OF ADVERTISING PRACTICE
IN THE MATTER BETWEEN ADVANCED HEALTH FOODS CC AND DR. H-A-STEINMAN
ARBITRATOR: Prof- M-T van der Merwe
REFERENCE: ULTIMA FAT AWAY / DR HA STEINMAN / 1783
ULTIMA ARBITRATION FOR ADVERTISING STANDARDS AUTHORITY INDEX
1. Covering letter to Mr Leon Grobler: Consultant, Dispute Resolution- The Advertising Standards Authority, South Africa.
2. Overview of Obesity 4
3. Introduction 5
4. Outlining product credentials and claims 7
5 Addressing the comments of Mr. Brent Murphy B. Pharm (Rhodes), MPS, Consulting Pharmacist 8
6. Addressing the; comments of Dr. Harris A Steinman 11
7. Final conclusion 11
8. Recommendation to the Advertising Standards Authority of South Africa 12
9. Bibliography and References 13, 17
2. OVERVIEW OF OBESITY
Approximately 1.2 billion people world-wide are afflicted with the disease of overweight and obesity of which 500 million will be at a body mass index > 30. Clearly obesity and overweight has become a disease or pandemic proportions and it was therefore given chronic disease status in 1997 by the WHO. A classification for obesity was introduced based on the body mass index (BMI), i.e. weight divided by height squared.1‘3 The patient is regarded as being overweight at a BMI between 25 – 30 and as obese at a BMI of 30 and above, with various categories ranging up to the category of morbid obesity. It is a very complex and multifactorial disease involving the ventro-medial hypothalamus in terms of satiety and appetite regulation, the nucleus tractus solitarius for relaying important neurological information between brain and periphery, the hypo-thalamic-adrenal stress axis, as well. as various incretints, cytokines and polypeptides secreted in the gastro-intestinal tract.4, 3 At any given time, more than 20 neuropeptides and hormones may be involved in regulating satiety, energy expenditure and metabolism on a minute to minute basis.4, 7 In addition to that, numerous biological factors throughout lifespan as well as genetic inheritance patterns will have to be considered in treating and counseling the obese patient. This is no longer a disease that can be contained world-wide by a simple approach of energy intake vs energy output. Nor can it be managed on an over the counter basis as has so often been the case in the past and present. Obese patients very often have multiple comorbid diseases that are life-threatening4‘7, (Table 1) and creating the perception that these diseases can be managed on an ad hoc basis by unskilled staff, is creating an environment of irresponsibility within the. lay community.
Worldwide both governmental-and nongovernmental organizations have been urged by the WHO, IASO, IDF (International Diabetes Federation) and the Global Alliance to act in a responsible manner concerning regulation, so as not to financially exploit the innocent that may not have the necessary scientific skills to judge the veracity of products, package inserts and labeling of various products promoted as weight loss agents.
A document has been put forward to the Advertising Standards authority of South Africa (from now onwards referred to as ASA) concerning the claims made around a product registered as Ultima Fat Away from the company ‘Advanced Health Foods cc* , P.O. Box 30043, Tokai, 7966, and represented by Ms Margarta Preece. A consultant was approached by Advanced Health Foods cc, namely Mr Brent Murphy, to forward professional comments on the claims and substantiations on the above mentioned products, to the ASA (October 27, 2004). This was in response to a complaint lodged by Dr. Harris Steinman on the 10th October 2004, with respect to the validity of the claims made on the product label as well as on their website. www,ultima.bz. ASA ruled in favour of the product during a Directorate meeting held on the 11th November 2004, and stated that the advertising material of the mentioned product does not contravene Clause 4.1 of the Section II of the Code on Advertising7, An appeal to the ruling of the ASA Directorate was launched by Dr. Steinman on the 29th November 2004 after he provided additional evidence and review of the literature. A second meeting of the Directorate of the ASA was scheduled for the 25th January 2005, and a ruling was made by the Directorate to postpone the hearing in order to give the parties the opportunity to attend a scheduled meeting on the afternoon of the 29th March 2005. It would appear that a letter dated the 18th March 2005, indicated that Dr, Harris Steinman did not have the financial resources to fly to Johannesburg to attend the meeting. He provided additional information regarding the validity of the claims of the abovementioned product. At the same time on the 11th March 2005, the Advanced Health Company -notified the ASA that they would also not be able to attend the scheduled meeting on the 29th March 2005. My office was approached on the 10th of June 2005 for the first time to act as an independent arbitrator since it would appear that a deadlock in the negotiations had been reached. By the 1st of August 2005, both Advanced Health Foods and Dr. Steinman were informed that documentation was being prepared for delivery to my office. On the 19th of September 2005, I was given the official go-ahead to start the evaluation of the official documentation and based on the scheduling of personal time I proceeded with this in the first week of November 2005.
• Contained in the documentation that I received in my office was the original complaint lodged by Dr. Steinman
• Colour copies of the packaging
• The initial response to complaint of Advanced Health Foods (This included a 9-page document by Mr. Brent Murphy)
• Response from the advertiser to ASA
• The ASA directorate ruling of the 23rd November 2005
• The complainants objection to the ASA formal ruling
• The complainant’s formal appeal against the ASA directorate ruling (This included a 7 page document by Dr. Steinman)
• The advertisers response to the appeal
• Additional submissions from the advertiser
• Australian Government Department of Health and Ageing Therapeutic Goods Administration (Substances that may be used as active ingredients in ‘Listed’ medicines in Australia)
• Advertising standards committee ruling dated 16th February 2005
May it be noted for the record that an extensive literature search was performed by my office in the field of alternative medicine, food supplements, and herbal preparations that may be related to the claims of this particular product. The review of the ASA document by this Office therefore incorporates both scientific and para-scientific (alternative medicine) updates in this field.
4. OUTLINING PRODUCT CREDENTIALS AND CLAIMS
Product: Ultima Fat-Away
Fast acting fat eliminator.
A powerful multi-action formula
Effectively blocks fat absorption;
Helps eliminate existing body fat
Energizes and boosts metabolic rate
Lose weight and still enjoy the foods you love
Temptation is no longer your enemy and guilt is a thing of the past
Potent yet gentle ingredients
Can safely bind over 12 times its own weight of the fat and on content of your meal
The potent FAT AWAY ingredients can. quickly and effectively help to strip away your body fat
Contains powerful energizers and B-vitamins that can increase your energy levels
It turns wistful thinking into reality
Providing a revolutionary fast acting weight loss formula that requires minimum effort but gives you maximum reward
Regular use of the FAT AWAY will bind much of the fat you eat, lowering the number of kilojoules you absorb
It allows you the flexibility to choose foods that are more tasty and appealing
Recommended dosage: 3 – 4 tablets with each meal. The higher the fat content of your meal, the more tablets you will need.
Maximum dosage: 6 tablets per meal, 18 tablets per day
Each single dose of 6 tablets (the maximum recommended dose that appears on the packaging)
Hydroxycitric acid (HCA) (brindleberry extract) 107mg
Capsicum (also known as capsaicin) 120mg
5. ADDRESSING THE COMMENTS OF MR. BRENT MURPHY B. PHARM (RHODES), MPS. CONSULTING PHARMACIST
Document 1. Dated Wednesday October 27th 2004
a. Refer page 5, point 18.104.22.168
No data claims should be extrapolated from animal work, and as such 5 of the animal studies quoted, have no relevance.
b. Refer page 5, point 22.214.171.124
Again the study refers to a rat model, and has no relevance in humans.
a Refer page 6, point 4-1.1.5
This indicates a placebo controlled fecal fat excretion of 3 – 4gm per day. Given that most obese patients will consume an average of 70gm of fat/day or more (commonly around 100gm fat per day), 3 – 4gm would indicate approximately a half percent loss of fecal fat on total fat intake, per day. In weight loss terms this is a neglible amount. Given that the patient needs to create a 500cal deficit per day for 7 consecutive days in order to lose half kilogram of weight— it is quite clear that this amount of fat excretion is certainly not going to promote weight loss, let alone in a rapid fashion.
d. Refer page 6, point 126.96.36.199
The statement that 501gm of food daily is approximately 160gm of food per meal in (dry weight) is merely an assumption, and the remainder of the calculation is based on this assumption- This carries no validity in terms of the remainder of the calculation of 2.8gm of fat blocked per day. Even assuming that this calculation may be correct, this amount of fat blocked per day, as explained before, is so negligible that it will have no impact on a daily weight loss programme,
e. Refer page 7. point 4.1.4,2
Hypoglycaemic and hypolipidaemic effects of chitosan in diabetic mice cannot be extrapolated to the human model.
f. Refer page 8, point 188.8.131.52
Chitosan’s nutrient digestibility and plasma lipid concentrations in broiler chickens cannot be extrapolated to the human model.
g. Refer page 9, point 184.108.40.206
This point indicates, a decrease in calorie consumption of 30-40 kcal / day. This one and only human study shows no clinical relevance in daily practice. As explained previously, a minimum 500 kcal deficit per day would be regarded as clinically significant in a weight loss programme. 30 kcal would equate a third of a slice of bread per day.
h. Refer pages 9,10,11, 12
The above pages refer to the metabolic effects of caffeine, of which FAT AWAY supplies 480mg/dose (the maximum dose per day would be 1 440mg).
– Caffeine is known to induce thermogenesis and elevate the basal metabolic rate, but in isolation, has never been shown to consistently induce a long term significant weight loss. Most of the recent studies conducted were in the presence of ephedra or ephedrine and were also short term studies. The weight loss appears to be small and minimal in comparison to tho new prescription drugs that have been available since 1998. Since the WHO has now declared obesity a chronic disease, claims to its treatment should incIude the following principles:
– It should be managed as a chronic disease on a long term basis
– Drugs should be safe and show minimal side effects in the long run
– It should have no addictive properties
Placebo controlled trials should indicate an effective weight loss of > 5% sustained over more than 52 weeks
– There should be no rebound effect and weight maintenance should be demonstrated over the long term
In view of the following, the caffeine / ephedrine combination has lost its popularity since 1990 (most of the references referred to by Mr. Brent Murphy is outdated and have no relevance In the modem context of the management of obesity), To support this notion, over the counter (OTC’s) have now been banned in most parts of the USA (FDA regulation) and as a whole in Europe.
- Caffeine is also know to increase fat oxidation and will lead to an elevation of FFA concentration in the bloodstream. In obese patients this FFA concentration is known to already be high and is in fact one of the mechanisms whereby hypertriglyceridaemia develops. Hyper-triglyceridaemia is very strongly associated with the development of diabetes. According to the recommended dose on the package display of the FAT AWAY product, patients may consume as much as 1440 grams of caffeine per day, which is equivalent to 24 cups of coffee per day (the average cup of coffee contains around 6Ograms of caffeine/ 100-120mls). At this dose, the following side effects can be expected:
- Tremors, agitation, nausea, headaches/ migraines, scotoma, addiction, tachycardia, hypertension, ischaemic heart disease, dyslipidaemia, uncontrolled diabetes, severe gastro-intestinal reflux, spastic colon syndrome, insomnia, nightmares and a loss of concentration. (For comparison, a schedule 7 drug such as Stopayne, would only contain 48mg of caffeine per tablet),
- I do not think it is appropriate for me to comment on whether Mr. Brent Murphy is regarded as independent, credible or expert in his field. This is for the Board of the Directors to determine. However, I do not believe that anyone with a vested financial interest should be consulted regarding this matter,
- I do not believes that any of the original product claims that were addressed as controversial by Dr. Steinman, can be .seen either as individual points or addressed outside the boundaries of the company trying to promote a holistic weight loss product. (Refer page 66). It is quite clear that this product is primarily being sold as a weight loss preparation and that the fat binding effect of chitosan is of secondary importance, it is therefore important for the board of directors to Judge this product not in terms of correctness of mechanistic claims solely, but whether its claims to being a rapid onset weight loss product is correct.
* Refer Bibliography
- The remainder of the references that I did not specifically address in my comments above, regarding chitosan or caffeine, were all methodologically flawed and not based on evidence-based scientific studies.
6. ADDRESSING THE COMMENTS OF DR. HARRIS A STEINMAN
Refer page 21, point no 2 & 3: No credible research to support Ultima’s claims.
Comment. On extensive review of the literature as it pertains credibility within the scientific community for evidence based placebo-controlled studies. I could not find anything to support and independent, significant weight loss over and above placebo for the following compounds:
- Chromium picolinate
Information pertaining to the effect of caffeine and ephedrine on weight loss has already been discussed under the previous section and will not be alluded to again.
Additional comment, page 75.
The claim that any of the above ingredients is purely there to ‘help’ or ‘assist’ weight loss is incorrect, and should not be allowed by any advertising bureau as it is misleading to the public in general,
7. FINAL CONCLUSION
- Obesity is a chronic disease and should be managed with products that includes the following profiling:
- A documented and unchallenged safety profile over many years.
- Significant efficacy based on evidence based, randomized, placebo-controlled trials,
- It must have an effect over and above lifestyle modification or placebo
- Significant weight loss according to the WHO definition would imply a weight loss of 5% or more sustained over a minimum period of 52 weeks.
- Known, scientifically described and proven mode of action that is accepted by the scientific community and experts In the field,
- A single-compound therapeutic tool whereby the weight loss can be ascribed, independently, to that particular compound as such.
8. RECOMMENDATION TO THE STANDARDS ADVERTISING AUTHORITY
An extensive literature review could-find no evidence that any of the above criteria could be applied to the product under investigation; neither could any of the claims be substantiated based on scientific studies.
It is therefore my considered opinion and recommendation to the Advertising Standards Authority of South Africa, to rule against, the advertising claims of’ Ultima-Fat-Away marketed by Advanced Health Foods cc.
Should the South African Standards Authority require any additional support for the above recommendation, the International Association for the Study of Obesity (IASO) based in London can be approached through my office for the relevant information.
(available on request)