EFSA Rejects Kemin Article 13.5 Weight Loss Claim for Slendesta Product
Kemin has affirmed there is a significant body of evidence supporting that Slendesta® Potato Extract contributes to weight loss in overweight individuals. This is in contrast to the opinion issued by the European Food Safety Authority (EFSA) on February 13, 2013.
14 Feb 2013 --- In June 2012, Kemin submitted a dossier pursuant to the Article 13.5 of Regulation (EC) 1964/2006 based on proprietary data which included four unpublished pertinent human studies on weight loss, one unpublished meta-analysis and 12 supportive published and unpublished human intervention trials offered on the effects of Slendesta and potato extract on gastric emptying, postprandial blood glucose concentrations and increases in satiety measurements, and cholecystokinin (CCK) concentrations.
The core, pertinent weight loss “RTL” study was a multi-center, randomised, controlled clinical trial with 240 overweight and obese subjects. It was designed to show and did in fact show that Slendesta had a statistically significant placebo-adjusted reduction in weight loss over baseline after the end of the 12-week study intervention in the 30 mg treatment group (p = 0.0464). Moreover, when the RTL study results were analyzed according to weight changes in the proposed health claim target group of 135 overweight subjects only, the 30 mg dose of Slendesta resulted in a highly statistically significant placebo-subtracted reduction in body weight from baseline at eight weeks (p = 0.0146), at the end of the study (p = 0.0052), as well as a statistically significant effect over time (treatment x time interaction (p= 0.0457)) and a statistically significant treatment main effect (p = 0.0458).
Kemin’s end-of-study weight loss findings used similar statistical procedures to those considered to show a statistically significant effect on body weight loss in EFSA’s glucomannan opinion. Glucomannan is the only instance in which EFSA has found a cause and effect between an ingredient and weight loss to date. Kemin had also presented a meta-analysis showing statistically significant weight loss when the Slendesta clinical weight loss trials were pooled (p < .001). In the studies presented by Kemin, reliable science and analysis report that there was a weight loss effect that was statistically significant, the company notes. Accepted procedures such as subject randomization and data analysis were carried out using scientifically sound methods. The clinical trial data were analyzed by a qualified third party statistician, according to recognized statistical procedures. The Slendesta data has also been the subject of a review by two qualified experts in the fields of weight loss and satiety and found to confirm the statistically significant effects of the Slendesta treatment on body weight and satiety. Kemin maintains a strong belief and confidence in the positive results of the clinical studies presented.
Kemin disagrees with the recent opinion issued by EFSA that a cause and effect relationship has not been established between the consumption of Slendesta and reduction of body weight. Slendesta is marketed worldwide as a satiety and weight loss ingredient for use in food supplements and conventional foods. The active component in Slendesta, Proteinase Inhibitor II (PI2), is a naturally occurring, well-studied protein found in potato that works within the body to help dieters be successful in weight reduction by enhancing the body’s natural release of CCK, a factor used to signal the brain that food has been eaten, helping to create feelings of fullness satisfaction, and satiety. Notably, EFSA’s negative opinion only addresses the proposed health claims that can be made on labeling of finished products in Europe and does not impact the ingredient’s regulatory status. Slendesta retains its status as a lawful and non-novel food ingredient that can continue to be used by our customers in their food supplements and conventional foods, the company claims. Slendesta is a registered trademark of Kemin Industries, Inc.
