In a letter sent last week to the European Commission’s head of Food Law, Nutrition and Labelling, Basil Mathioudakis, Gencor managing director RV Venkatesh, accused EFSA’s health claims panel of misrepresenting the studies it reviewed in the rejected dossiers for its weight loss ingredient, Slimaluma.
Venkatesh said EFSA’s Dietetic Products, Nutrition and Allergies (NDA) panel had twice changed its interpretation of a gold standard, clinical trial that showed a statistically significant reduction in waist circumference.
In the letter to Mathioudakis, Venkatesh pointed out that the NDA had stated in its initial opinion published in May this year that there was no statistical reduction in waistline circumference.
When Gencor pointed out that the trial showed there was, the NDA acknowledged its error and published an amended version of its opinion without changing its verdict that Slimaluma did not demonstrate weight loss.
Small reduction
In its latest statement published as a response to opinion feedback, NDA unit head, Dr Juliane Kleiner described the effect as “a small reduction”, something Venkatesh took issue with.
“It is not proper for EFSA to comment about big or small reduction as it is a statistically significant reduction,” he wrote.
“A statistically significant reduction in waist circumference is just that, a statistically significant trend between active and placebo as per bio-statistical analysis, with a high confidence interval of over 99.9% as seen in a double blind, randomised, placebo controlled study. It is not proper for EFSA to comment about big or small reduction as it is a statistically significant reduction.”
According to Venkatesh, the comments were, “clearly in conflict with each other and two of them, including this latest one, do not represent the study report fairly and objectively, as required by a scientific committee.”
Body water v abdominal fat
He also took issue with the NDA’s assertion that the decrease in waist circumference, small or otherwise, could have been caused by a reduction in body water and not necessarily abdominal fat.
He said a search of the academic literature revealed little to substantiate the link between reduced body water and waist circumference.
“There seems to be no published reference for this assertion,” he wrote.
In response to the NDA’s assertion that the “small reduction” in waist size had not improved metabolic effects such as reduced blood glucose and blood lipid levels, Venkatesh stated that the trials did not do this because they were not designed to test such parameters.
“We have also pointed out to EFSA that the blood sugar and lipid levels were normal for the study population at the beginning and at the end of the study,” he wrote.
“So expecting them to significantly reduce would be akin to wanting an adverse effect on the trial population. Why EFSA continue to keep stating these same points which have been rebutted earlier is a mystery to us.”
The letter also reaffirms earlier criticisms of the NDA for failing to acknowledge a statistically significant reduction in hunger and energy intake.
He called on the EC to, “overturn EFSA’s opinions.”
The active ingredients in Slimaluma are sourced from ethanol-water extract of the aerial parts of Caralluma fimbriata.
The publications submitted in support of the claims included in vitro studies, human intervention studies and reviews on the reliability and validity of Visual Analogue Scales for the assessment of appetite, the central control of body weight and appetite, the link between leptin and obesity, the impact of soluble fibres or multivitamin and mineral supplements on body weight and mitotic clonal expansion.
Click here to read our coverage of the initial opinions and here to read how it came to be that EFSA admitted making an error in those initial opinions.