The article 13.5 application from Estonian dairy co-op E-piim was submitted earlier this year after the firm produced further evidence to support the link between Lactobacillus plantarum TENSIA consumed in an Edam-style cheese known as ‘Harmony’ and the maintenance of normal blood pressure. However, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) delivered a negative opinion – stating that “a cause and effect relationship has not been established.”
An initial application from E-piim was rejected in 2011 on the same basis.
In it’s latest rebuttal, the NDA panel noted that while the L. plantarum TENSIA strain was ‘sufficiently characterised’ and the that maintenance of normal blood pressure is a beneficial physiological effect, the evidence provided to substantiate a direct relationship between the two was insufficient.
“The applicant provided 47 references which did not address the effects of L. plantarum TENSIA on BP,” wrote the panel, adding that “no conclusions can be drawn from these references for the scientific substantiation of the claim.”
The EFSA opinion also noted that while two randomised, double-blind, placebo-controlled, intervention studies investigated the effect on BP of L. plantarum TENSIA, only one flawed study actually suggested a link.
“In weighing the evidence, the Panel took into account that only one human intervention study with important methodological limitations showed a BP-lowering effect of L. plantarum TENSIA consumed in the Edam-type “heart cheese” of Harmony when consumed daily for eight weeks, and that no evidence was provided for a mechanism by which L. plantarum TENSIA in the Edam-type “heart cheese” of Harmony could exert the claimed effect,” said the EFSA opinion.
Insufficient evidence
The NDA panel reiterated that it was unable to draw any conclusions for the substantiation of the health claim from 47 (27 human and 20 non-human) references - which included human intervention studies, guidelines, narrative reviews, and in vitro studies that did not address the effects of L. plantarum TENSIA on blood pressure (BP).
In addition, it noted that data from two randomised controlled trials was mixed – with only one actually showing a benefit on blood pressure.
“In weighing the evidence, the Panel took into account that only one human intervention study with important methodological limitations showed a BP-lowering effect of L. plantarum TENSIA consumed in the Edam-type “heart cheese” of Harmony when consumed daily for eight weeks, and that no evidence was provided for a mechanism by which L. plantarum TENSIA in the Edam-type “heart cheese” of Harmony could exert the claimed effect,” stated the opinion.