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of L. plantarum,” while three of the four unpublished proprietary reports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.”

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For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.