“The applicant provided 47 references which did not address the effects of L. plantarum TENSIA on BP."

EFSA issues fresh rejection for probiotic ‘heart cheese’ health claim

By Nathan Gray

- Last updated on GMT

The EFSA scientific opinion stated that the evidence provided failed to substantiate a cause and effect relationship.
The EFSA scientific opinion stated that the evidence provided failed to substantiate a cause and effect relationship.
The European Food Safety Authority (EFSA) has delivered a negative opinion on a second dossier suggesting that a link a probiotic cheese can benefit blood pressure.

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.

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