Kemin Disputes EFSA Health Claims Rejection for Weight Loss Ingredient Slendesta

February 20, 2013

In its February 12–published opinion, EFSA said that none of the studies Kemin submitted as evidence show an effect of Slendesta on reduced body weight.

In response to a February EFSA opinion that a cause-and-effect relationship has not been established between reduction of body weight and weight-loss ingredient Slendesta, the ingredient’s supplier, Kemin (Lisbon, Portugal), is arguing that there is a significant body of evidence supporting Slendesta’s weight-loss efficacy.

Slendesta is a potato protein extract said to instill feelings of satiety and to result in weight loss by enhancing the body’s natural release of cholecystokinin (CCK).

In its February 12–published opinion, EFSA said that none of the studies Kemin submitted as evidence show an effect of Slendesta on reduced body weight.“There was no effect of Slendesta Potato Extract on reduction of body weight in any of these studies,” it said. Also, EFSA said, regarding a meta-analysis of four studies, “The Panel notes that the purpose of the meta-analysis as claimed by the applicant does not address the conditions of use proposed for the claim (i.e. the dietary and lifestyle conditions in which Slendesta should be consumed in order to achieve the claimed effect are not specified).”

However, Kemin argues that the studies it submitted do show significant support. The company had submitted “four unpublished pertinent human studies on weight loss, one unpublished meta-analysis, and 12 supportive published and unpublished human intervention trials on the effects of Slendesta and potato extract on gastric emptying, postprandial blood glucose concentrations and increases in satiety measurements, and cholecystokinin (CCK) concentrations.”

Specifically, Kemin says, the core, pertinent weight-loss study it submitted was a multicenter, randomized, controlled clinical trial with 240 overweight and obese subjects. The company says the study 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.

The company also points out that its 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-the only opinion for which EFSA found a cause and effect between an ingredient and weight loss to date.

“In the studies presented by Kemin, reliable science and analysis report that there was a weight loss effect that was statistically significant,” the company says. It points out that it used scientifically sound methods and study procedures, and that clinical trial data were analyzed by a qualified third-party statistician.

“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,” it says.