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”.
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 caloric intake”. The target population is overweight adults (i.e., > 18 years of age). The Panel considers that a decrease in energy intake might be a beneficial physiological effect.
Thirteen 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 relationship between waist circumference and cardiovascular events, 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 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Among the publications submitted, two published human intervention studies, an unpublished animal study and an unpublished in vitro study investigated the effects of ethanol-water extract of Caralluma fimbriata.
The human study which reported on energy intake 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. Significant reductions in energy intake were only observed in the experimental group compared to baseline. No statistically significant differences in energy intake between the experimental and placebo groups were reported at day 60. The Panel notes that measurement of energy intake was via self-reported methods (rather than being measured directly within the laboratory), the validity of which is questionable.
The Panel considers that the results from the animal study and the in vitro study do not predict an effect of the ethanol-water extract of Caralluma fimbriata Slimaluma® on the reduction of energy intake in humans.
In weighing the evidence, the Panel took into account that in the one human study assessing changes in energy intake no significant effect of the ethanol-water extract of Caralluma fimbriata on energy intake 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 the ethanol-water extract of Caralluma fimbriata Slimaluma® and a decreased energy intake.