EFSA said that the observed increase in plasma and urinary concentrations of isoprostanes and the increase in some markers of sub-clinical inflammation associated with CLA consumption, together with the limited data available on the effects of CLA on vascular function, could indicate a potential for “vascular damage in the longer term”.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) therefore rejected the joint BASF-Stepan application linking CLA and body fat mass reduction.
It wrote in its opinion: “The Panel considers that the information provided does not establish that a reduction in body fat mass, when accompanied by an increase in markers of lipid peroxidation and inflammation, is a beneficial physiological effect for the target population.”
Commenting on the decision, Dr Luca Bucchini, managing director at Hylobates Consulting in Rome, said this marked, “another bad day for fat-loss products”. He added that the way in which the claim had been rejected was relatively unprecedented i.e. something can’t be deemed beneficial if “suspicious effects” occur at the same time.
In a joint statement from the applicant firms, BASF Human Nutrition’s head of regulatory affairs Bernd Haber, and Stepan Lipid Nutrition’s head of regulatory and scientific affairs Jaap Kluifhooft said EFSA had not truly performed a scientific evaluation regarding the claimed effect of their products Tonalin and Clarinol on body fat reduction. They said this was shown by the omission of chapter three of the opinion, normally entitled: “Scientific substantiation of the claimed effect”.
Safety confusion
They said the safety of the proposed use of products for up to six months had been evaluated by EFSA in 2010 and 2012, and added, “it can be questioned from a procedural view whether mingling of safety and efficacy assessment is appropriate to the legal context (Novel Food Regulation and Health Claim Regulation)”.
EFSA had not concluded that the product may cause vascular damage in the long term, they noted, since such a cause and effect relationship cannot be established by this EFSA opinion.
Bucchini said it was confusing that EFSA had reaffirmed the safe use at six months even if possible negative effects were suspected during this same time frame.
“Because it is confusing, there may not be regulatory follow up other than denying the claim. Even for firms which want to provide appropriate label warnings, it is hard to see how to translate the opinion into information for consumers. This should make the use of CLA more challenging - unless of course EFSA's concerns are allayed by further evidence.”
The companies said they would be providing feedback to the opinion.
Is that a good thing?
BASF and Stepan questioned why EFSA had shed doubt on whether body fat reduction could be considered physiologically beneficial when its own guidance stated this was the case.
“The effect of Tonalin and Clarinol on body fat reduction was convincingly documented in our application and is crucially not even disputed by EFSA. It is surprising that the proven beneficial effect were mingled with indicative data on the markers of lipid peroxidation and inflammation.”
A fat backstory
Back in 2010 CLA firm Lipid Nutrition expressed frustration at the omission of a body fat claim from a dossier containing several CLA health claims, all of which were rejected.
CLA is most commonly used in food supplements and baked and dairy products.