Five separate article 13.5 weight management claim rejections entered the EU lawbooks for Gencor’s Slimaluma product whose ingredients are sourced from ethanol-water extract of the aerial parts of Caralluma fimbriata.
The submission saw EFSA alter its initial opinion to acknowledge an overlooked a statistically significant reduction in weight circumference in one of trials referenced by Gencor, but EFSA’s health claims panel said the reduction was “small” and so saw no reason to alter its opinion that weight loss benefits could not be attributed to the supplement.
In appealing the EFSA opinion, Gencor managing director RV Venkatesh said, “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.”
But the Commission and member states did not back these protests at committee level.
Other rejected article 13.5 opinions to enter the register included a beta-glucan immunity claim from Leiber for a product called Yestimun and a dry skin claim from the L’Oreal-Nestle joint venture, Laboratoires Inneov
The May 4 edition of the Official Journal of the European Union can be found here.
The full register can be found here.