The five article 13.5 dossiers, submitted by Gencor Pacific, had proposed claims on appetite control and reduction of body weight, body fat, waist circumference and caloric intake.
However, in all cases, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found that the publications submitted in support of the claims failed to establish a cause and effect relationship between the ingredient and the claimed benefit.
Gencor’s claims submissions related to its branded Slimaluma product. The active ingredients in Slimaluma are sourced from ethanol-water extract of the aerial parts of Caralluma fimbriata.
The publications submitted in support of the claims included in vitro studies, human 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.
Not all of the publications submitted were always found to be pertinent to the proposed claims, so were discounted by the NDA panel.
In some cases, EFSA acknowledged “statistically significant weight loss” in the intervention group, but said there is no indication as to whether this difference lies between the experimental and placebo group or between different time points for the experimental group.
The panel also raised concerns with the measurement methods of energy intake in one of the human studies, which was self-reported rather than measured directly within the laboratory. The validity of this method or measurement, said EFSA, was “questionable”.
In another trial, the panel noted that the impact of the intervention on the waist circumference of participants in the placebo group was not reported. It was also not reported whether the reductions in waist circumference observed in the experimental group reached statistical significance when compared to the placebo group.
The five negative opinions, published this week, were adopted on April 30.