EFSA panel admits errors in health claim opinion

However, the EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) stands by its negative opinion for the company’s Slimaluma weight management product, an ethanol-water extract of Caralluma fimbriata​.

The five article 13.5 dossiers had proposed claims on appetite control and reduction of body weight, body fat, waist circumference and caloric intake.

In all cases, EFSA’s NDA panel found that the publications submitted in support of the claims failed to establish a cause and effect relationship between the ingredient and the claimed benefit. Click here​ to read our coverage of the initial opinion.

Gencor immediately responded to the opinion with a vigorous defence of its science and formally requested the NDA to revisit the Slimaluma dossiers.

Cause celebre​​

Indeed, in an interview with NutraIngredients on Wednesday at the Vitafoods show in Geneva, Dr Paul Clayton, a clinical pharmacologist, said of the initial judgement: “EFSA are in breach of their own scientific principles because it has nothing to do with the dossier that was submitted.” ​Dr Clayton works as an advisor to Gencor Pacific, but is not an employee of the company and is not affiliated with their UK consultant, Herbal Sciences International.

“I think that there are many companies in the food and supplement industries who are interested in coming together and setting up a class action against EFSA. This is a ‘cause celebre’: This could be the watershed case because it appears from reading EFSA’s initial response that it is such an apparently clear breach of appropriate protocols, of their own SOPs [standard operating procedures], this could be the test case that everything else crystallises around,”​ said Dr Clayton.

To listen to the full interview, please click 'play' on the audio file here:

Back track​

In a letter from EFSA to the company’s UK-based consultant dated May 18th, EFSA, “acknowledges a mistake in the abstract in relation to the inclusion of a comment on body weight in an Opinion referring to the reduction in waist circumference”.​

“However, please note that the abstract of the Opinion only serves for publication purposes in the EFSA journal and does not form part of the Scientific Opinion. This mistake has been corrected in the new version of the Opinion (corrigenda) which will be published shortly on the EFSA’s website.”​

The letter continues: “EFSA acknowledges that a statistically significant reduction in waist circumference was observed in the intervention group compared to placebo in the study by Kuriyan et al. ​(Appetite​, 2007, Vol. 48, Pages 338-344)

“However, […] only a reduction in waist circumference leading to an improvement in the adverse effects of an excess abdominal fat, and particularly visceral fat, is considered a beneficial physiological effect by the Panel.”​

“In this context, no significant differences in body weight, body fat, blood glucose or lipid profiles were observed over time between the intervention and placebo groups in the study by Kuriyan, and therefore the reduction in waist circumference observed in the intervention group compared to placebo was not associated with a reduction in body fat and did not lead to an improvement in the adverse effects of an excess abdominal fat.”​

With regards to the hunger claim, EFSA has now stated that while it now acknowledges a significant reduction in hunger ratings, “no significant effect of the ethanol-water extract of ​Caralluma fimbriata on energy intake was observed when compared to a suitable control”​.

Invalid claims and contention ​

Mr R V Venkatesh, managing director of Gencor Pacific, told NutraIngredients that the company is responding to EFSA’s acknowledgements. Venkatesh said that company would respond to both the waist circumference and hunger issues.

“EFSA stated that a statistically significant reduction in waist circumference without a reduction in body fat is not acceptable to them and that they are talking about blood glucose and blood lipids level also needing to be reduced for the claim to be valid. We find that their claim and contention is not valid and does not have a scientific basis,”​ he said.

“The references to blood sugar and blood lipids levels make no sense in this discussion when one is discussing waist circumference and in our opinion they are not valid criteria for assessment of this claim. Our study was not about anti-diabetic or anti-cholesterol end point and our claims were also not related to those two conditions. ​

“It is also surprising and in our view unscientific for the panel to expect a statistically significant difference in multiple parameters in one single study for so many physiological functions, for which the study was not designed. That is not something feasible in any study for any product,”​ he added.

Mr Venkatesh also challenges the conclusion that waist circumference alone is not an acceptable health benefit, stating that this “contradicts published science which shows that general and abdominal adiposity are associated with the risk of death and that waist circumference alone or waist to hip circumference can be used as evidence to assess risks of death due to obesity”​.

These are the conclusions of a study published in the prestigious New England Journal of Medicine ​in November 2008, which involved 359,387 participants and lasted for just under 10 years.

“This is solid and undisputable evidence that reducing waist circumference does give a health benefit and that alone could be a criteria used for assessment for risks of mortality due to obesity,”​ said Venkatesh. No mention is made in the study to body fat content, blood glucose or blood lipid levels, he said.

“The length of this peer reviewed and published study coupled with the number of participants in the study provides evidence which completely and totally refutes the panel's conclusions about this health claim. ​

“We demand that the panel should revise it's opinions on this claim and confirm that reducing waist circumference alone is indeed a health benefit and confirm that our claim is acceptable and valid,”​ said Mr Venkatesh.

NutraIngredients will run more reaction to this next week.