Despite formal challenges to the article 13.5 opinion from the Estonian applicant, Piimandusühistu E-Piim, along with the University of Tartu and the Bio-Competence Centre of Healthy Dairy Products LCC, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) stood by its original findings.
NDA said its initial discounting of trial data due lack of adequate controls was correct.
“It is noted in the Opinion that the study in question (Mikelsaar et al., 2009b unpublished) does not show an effect of cheese containing L. plantarum TENSIA(compared to control cheese) on blood pressure in humans. The Panel considered that the sub-group analyses were not pre-planned, and chance findings could not be excluded,” NDA wrote.
“The comments received did not provide further evidence which would warrant a re-evaluation of the study.”
The NDA addressed comments that it should have accepted findings in two non-randomised, pilot trials and one acute, open-label, one arm, uncontrolled human intervention study.
However the NDA affirmed that, “these two studies are effectively uncontrolled, both by design (i.e., the order of administration of the test and control cheeses is not randomised, so that factors of, e.g., biological, technical or behavioural nature, other than the intervention and which could have an effect on blood pressure are not controlled for in the study design) and by the nature of the statistical analyses applied (i.e., control period effectively not taken into account in the data analysis for the test period).”
For the one-arm study the NDA said, “the study was not controlled for factors other than the test cheese that might have had an effect on blood pressure.”
Piimandusühistu E-Piim’s dossier contained 38 publications and proposed the claim: “Regular consumption (at least 3 weeks) of 50 g/day Südamejuust (Heart cheese) of Harmony brand comprising probiotic Lactobacillus plantarum TENSIA helps to maintain the cardio-vascular system/heart health through reduction of blood pressure.”
The original NDA opinion can be found here.