“Stunned” Lipid Nutrition’s global Group marketing manager, John Kurstjens, said his company would likely submit a dossier by year’s end that would include at least one new double-blind, placebo-controlled, randomised demonstrating body fat reduction.
Along with its chief CLA rival Cognis, Kurstjens questioned why ‘body fat reduction’ had not featured in the rejections issued by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) last week, despite its presence in the dossier in the form of a suggested claim and backing data.
“We are really surprised by this and we don’t know the reasons why body fat has not been mentioned in the opinions,” he said.
The NDA turned down CLA (conjugated linoleic acid) for body weight, lean body mass, insulin sensitivity, and DNA protection, but not fat reduction.
Kurstjens said the article 13.5 process would give the company greater control of the dossier as it would be the only submitter whereas the previous article 13.1 dossier had other input, including that of Cognis.
“This process gives us more control over the claims and information flow,” he said. “If EFSA has questions they know who to contact.”
Invitation to resubmit
His colleague Jaap Kluifhooft, the director of regulatory affairs at Lipid, added in a statement: “We consider the fact that EFSA did not evaluate the scientific opinion on the relation between CLA and reduction of body fat, as an invitation to Lipid Nutrition to present this specific benefit and health claims in a specific article 13.5 dossier,” says Lipid Nutrition. “We have learned from the process and are very confident to receive a positive opinion via article 13.5”
Both Lipid and Cognis highlighted the existence of gold standard trials backing the body fat reduction claim.
Dr Arne Ptock, global product line manager for Cognis’s branded version of CLA – Tonalin, said last week. “This is why we will review the opinion in detail and raise our concerns with the European Commission to clarify whether our claims will be evaluated in a later batch.”