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 body fat”.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.
The food constituent that is the subject of the health claim is an ethanol-water extract of Caralluma fimbriata (Slimaluma®). The ethanol-water extract of the aerial parts of Caralluma fimbriata is the source of the ingredients in Slimaluma® claimed as “active” by the applicant. The specific extraction and subsequent manufacturing processes are specified for the content of pregnane glycosides (at least 25 % by weight), which are claimed by the applicant to be the active ingredients for appetite control, of saponin glycosides (at least 10 % by weight) and of bitters (at least 3 % by weight). The Panel considers that the food constituent, ethanol-water extract of Caralluma fimbriata (Slimaluma®), which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “helps to reduce body fat”. The target population is overweight adults (i.e., > 18 years of age). The Panel considers that a reduction in body fat mass might be a beneficial physiological effect.
Ten publications were identified by the applicant as being pertinent to the claim. The references provided included in vitro studies, 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. The Panel considers that no scientific conclusions can be drawn from these references for the substantiation of the claimed effect.
Among the publications submitted, two published human intervention studies, an unpublished animal study and an unpublished in vitro study investigated the effects of ethanol-water extract of Caralluma fimbriata. Only one of the human intervention studies reported on measures of body fat and as such was considered pertinent to the claim.
The human study was a double blind, placebo controlled, randomised intervention in 62 healthy overweight and obese volunteers. The experimental group received 1 g of ethanol-water extract of Caralluma fimbriata per day for 60 days whilst the placebo group received maltodextrin capsules. At day 60, significant reductions in body fat were only observed in the experimental group compared to baseline. No significant changes in the estimated percentage of body fat were observed between the two groups over the duration of the study.
The Panel considers that the results from the animal study and the one in vitro study do not predict an effect of the ethanol-water extract of Caralluma fimbriata in Slimaluma® on the reduction of body fat in humans.
In weighing the evidence, the Panel took into account that in the one human study assessing changes in body fat no significant effect of the ethanol-water extract of Caralluma fimbriata on body fat mass was observed when compared to a suitable control.
The Panel concludes that a cause and effect relationship has not been established between the consumption of ethanol-water extract of Caralluma fimbriata Slimaluma® and the reduction in body fat.