German firm, Dr. Niedermaier Pharma GmbH, submitted the article 13.5 dossier which suggested a blend of 17 fruits and vegetables fermented in five stages by five Lactobacillus strains could deliver “enhancement/modulation/improvement/regulation of the activity of the immune system”.
But EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said causality was not demonstrated in the dossier.
It noted the Lactobacillus probiotic bacteria-containing product in question, Regulat, was not sufficiently characterised as it was not clear just which strains were used in the one trial deemed relevant to the claim.
The rejection means no article 13.5 or article 14 probiotic health claim has yet drawn a positive opinion from the scientific assessor. Danone, the world’s largest probiotics player, has withdrawn three claims from the process but says it will resubmit them in the indefinite future.
Out of 13 article 13.5 claims published so far, only has been positive, relating tomato extract consumption and reduced blood aggregation. But this claim was only approved after NDA scientists reworded the claim so that it better reflected the available science.
Grounds for rejection
The NDA said only one proprietary, product-specific, randomised, double-blind, placebo-controlled 4-week study in 24 healthy men aged 20 to 48 years, was pertinent to the claim.
Some biomarkers registered changes, such as natural killer (NK) cell activity, oxidation status and Glutathione values in lymphocytes and monocytes, compared to placebo.
VCAM (Vascular cell adhesion molecule-1) and ICAM (intercellular adhesion molecule-1) levels were significantly reduced in the control group compared to placebo.
But the NDA said there was no demonstration of how this may have a positive health effect and said the trial was weakened by being conducted in the Autumn where about half of participants in both control and placebo had flu at one point or another.
“The Panel notes the weaknesses of the study which include the small sample size, absence of power calculations and inconsistent exclusions of subjects for the statistical analyses.”
It concluded: “In weighing the evidence the Panel took into account the lack of information to sufficiently characterise Regulat, the lack of evidence that the measured changes in the biomarkers of the activity of the immune system represent beneficial physiological effects, the weaknesses of the human intervention study, and the limited evidence provided by the in vitro and ex vivo studies to support the claimed effect.”
The in vitro and ex vivo studies involved fruit juices and vegetable juices but were deemed irrelevant as they did not utilise Regulat.
Dr. Niedermaier Pharma GmbH proposed the claim: “Regulat is a liquid concentrate for the regulation and modulation of the immune-system. It enhances the activity of the immune system by immune-stimulation, antioxidative and enzyme regulating effects and modulates the innate unspecific immune system improving the immune-cell function and immune system performance. Moreover, it down regulates cell adhesion molecules stabilizing cell/cell contacts and interactions.”
More than 4000 claims are due to be processed under the 2006 nutrition and health claims regulation by the end of January, 2010, although the European Commission has admitted it is unlikely this deadline will be met.
The opinion can be found here.