The firm was crushed by the rejection that arrived despite three ‘stop-the-clock’ exchanges of data with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA).
But the company’s research director, Florence Massiera PhD, told NutraIngredients that NDA guidance in weight management published after her firm’s submission was made, along with some learnings taken from the rejection, would inform a resubmission.
“We are obviously disappointed because in this first application, we focused on reduced fat storage by adipose cells, which we consider as a benefit per se,” she said.
One study showed this effect but the NDA said the reduction in fat storage did not necessarily transfer into a metabolic benefit and so rejected the dossier.
Nor did it accept, “the use of subcutaneous abdominal adipocyte size as a surrogate measure for changes in visceral adipose tissue,” Massiera noted.
With this in mind, and the NDA weight management guidance, she said, “We are also submitting a second application for health claim to EFSA in which we will emphasize the improvement of cardiometabolic risk by the KOT (hypo-caloric) diet.”
“We continue our work that consists in the validation of the efficiency of the KOT weight loss system with new ongoing clinical trials in the US and France (multicentric) in overweight and obese subjects.”
Of the lack of guidance at the time of submission she said, “it would have been helpful to guide us in the selection of pertinent markers within our scientific results in order to emphasize the claimed effects in the first place.”
In its original dossier, Ceprodi KOT submitted the claim: Hypo-caloric snacks (KOT) products contribute to reduce adipocyte size at the abdominal level in the context of a low-calorie diet.
She questioned the NDA reasoning by noting that, “visceral fat is impossible to extract in the context of a nutritional clinical trial if bariatric surgery is not involved. Moreover, subcutaneous adipose tissue is far the most studied in clinical data on overweight and obese subjects.”
Massiera said the rejection had not affected the company’s business.
“Our communication is based on the publication of our pre-clinical and clinical results in international congress and peer reviewed journals towards the scientific and medical community,” she said.
“For us it would be interesting to obtain health claims on the basis of scientific results in order to directly communicate to consumers but it is not our primary goal.”
The NDA opinion can be found here.