Scientific Opinion on the substantiation of a health claim related to ethanol-water extract ofCaralluma fimbriata(Slimaluma®) and helps to reduce caloric intake pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Abstract

Following an application from Gencor Pacific Inc. submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma®) and “helps to control hunger/appetite”. Slimaluma® is an ethanol-water extract of Caralluma fimbriata standardised by its content in pregnane glycosides that is sufficiently characterised. A reduction of appetite leading to a reduction in subsequent energy intake might be beneficial physiological effect. A double blind, placebo controlled, randomised trial in humans investigating the effects of Slimaluma® on appetite ratings and subsequent energy intake was considered as being pertinent to the claim. The mean hunger level of the experimental group was found to be significantly lower than that of the placebo group. No statistically significant differences in energy intake between the experimental and placebo groups were reported. The Panel concludes that a cause and effect relationship has not been established between the consumption of the ethanol-water extract of Caralluma fimbriata Slimaluma® and a reduction of appetite leading to a reduction in subsequent energy intake.