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

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 reduce caloric intake”. Slimaluma^® is an ethanol-water extract of Caralluma fimbriata standardised by its content in pregnane glycosides that is sufficiently characterised. A decrease in energy intake might be a beneficial physiological effect. A double blind, placebo controlled, randomised trial in humans investigating the effects of Slimaluma^® on energy intake was considered as being pertinent to the claim. 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 decreased energy intake.