In a lengthy response to the NDA opinion, Cambridge said its scientists were “preparing for a confrontation with European regulators”, which could be construed as a euphemism for the submission of further data and tweaking of claim wording.
It said it would be employing the 30-day window it has under the terms of the 2006 nutrition and health claims regulation to resubmit its dossier.
EFSA says no
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found causality had not been demonstrated in Cambridge’s article 14 disease reduction submission because intervention studies used inappropriate atherosclerotic disease markers and studies used higher doses than in the product in question.
Other study shortcomings included small samples; short study length; lack of controls and the use of patients whose results could not be extrapolated into the general population.
It did not however question the bioavailability of lycopene.
The product in question is a branded food supplement called Ateronon, for which Cambridge sought to make the claim: “Lycopene-whey complex prevents oxidative damage of plasma lipoproteins, which reduces the build up of arterial plaques and reduces the risk of heart disease, stroke and other clinical complications of atherosclerosis.”
After a PubMed search, Cambridge identified 80 pertinent studies, including six intervention studies, 22 observational studies, 44 other human studies and eight reviews, but the selection failed to convince the NDA scientists.
The complex contained a 10 per cent lycopene extract.
Cambridge over troubled waters
In its statement Cambridge said while the NDA had acknowledged that its tomato-derived lycopene extract, “does indeed block the breakdown of fats known as lipids, circulating in the blood, they question whether this process is linked to atherosclerosis, or furring of the arteries by fatty deposits.”
“Their stance flies in the face of evidence for the break-down of cholesterol, produced by Nobel-prize winning scientists in the 1980s,” it said.
Cambridge chief executive, Gunter Schmidt, said: “We were astonished that the EFSA does not accept that oxidative damage of blood lipids is linked to atherosclerosis. There are literally tens of thousands of published studies showing it. As far as we are concerned, it is a scientific fact which has been established for very many years. It did not cross our minds they might dispute this assumption, so we are now looking at what secondary data we will need to offer them.”
The company said Ateronon could reduce rates of lipid oxidation to near zero, “within as little as eight weeks”, with the lycopene-whey combination improving bioavailability of the lycopene antioxidants.
Alf Lindberg, emeritus professor of clinical microbiology at Sweden’s Karolinska Institute, and former Nobel prize committee member, said he was “baffled by EFSA’s questioning of the link between lipid oxidation and atherosclerosis.”
Clasado Limited, another UK company that recently had three prebiotic/gut health,immunity and traveller's diarrhoea article 13.5 and article 14 claims rejected, has also vowed to fight the opinions – or rejig its dossiers to provide what it believes EFSA requires.
The NDA opinion can be found in full here.