The European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies has rejected an article 13.5 application submitted by Piimandusühistu E-Piim, the manufacturer of a probiotic cheese, claiming that its product “helps to maintain the cardio-vascular system/heart health through reduction of blood pressure.” The applicant evidently submitted 38 publications and four proprietary reports related to the maintenance of normal blood pressure and the Lactobacillus plantarum TENSIA™ bacteria found in its “semi-hard Edam-type” Harmony™ “heart cheese.”

EFSA ruled, however, that “none of these publications addressed the effects of L. plantarum,” while three of the four unpublished proprietary reports were uncontrolled and therefore inadmissible. The fourth study, according to EFSA, “was a randomised, double-blind, placebo-controlled, cross-over human intervention,” but ultimately failed “to show an effect of L. plantarum TENSIA™ on blood pressure.” The panel therefore concluded that “a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum TENSIA™ in the semi-hard Edam-type ‘heart cheese’ of Harmony™ and maintenance of normal blood pressure.”