Writing to Basil Mathioudakis, the EC’s Unit Head of Food Law, Nutrition and Labelling, on November 17, Yakult’s European branch emphasised its need for further dialogue with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA).
“We respectfully request that the EC, before proceeding further with this opinion, consider allowing us, the applicant, to provide EFSA with additional information and to engage in further discussions.”
The company raised many questions at the NDA’s recent gut and immune health workshop in Amsterdam, to which some clarification had been provided, but many questions remained.
- why the NDA discounted peer-reviewed and validated upper respiratory tract infection (URTI) measures such as rhinitis; runny noses; sore throat, cough and fever
- the interpretation of drop-out rates
- the lack of a plausible biological mechanism
In regard to the last point, Yakult wrote: “Whilst the biological mechanism is not fully understood, this should not be reason for the negative opinion for the claim. To our opinion, this is a ‘point of principle’, which needs further clarification and dialogue.”
Another key point it sought dialogue with the NDA about was the panel’s approach to biomarkers. “We assert that the key issue here is that signs and symptoms are sufficient to assess health maintenance, not their link to URTI.”
Yakult also questioned why the NDA panel had discounted questionnaires; discounted lower powered trials and why trials demonstrating modulation of immune parameters had been discounted.
The opinion can be found here.
Yakult’s submitted emerging science, article 13.5 dossier sought to link consumption of its Lactobacillus casei Shirota (LcS) strain and maintenance of defenses against URTIs via a boosted immune system. It contained 15 studies, 12 of which were peer-reviewed, and ten of which were human intervention trials.
In addition to Yakult’s own scientific and regulatory team, several academics also sent letters to Mathioudakis in support of Yakult’s submission, its Shirota strain and the probiotic immunity science body of work in the 30-day window after the claim was rejected.
Continuing negative attitude
Twenty-year probiotics researcher, Professor Glenn Gibson, Head of Food Microbial Sciences Unit at Reading University in the UK, said the panel had taken an, “extreme stance”.
“The criticisms of these studies are not scientifically justified…” Professor Gibson wrote.
“The continuing negative attitude of EFSA toward probiotics and prebiotics affects consumers, industry and academic researchers. This is preventing the differentiation of poor quality probiotic and prebiotic products...”
He called the opinion and the so-far mass rejection of pre- and probiotic claims an, “assault on the peer review process generally”.
But at the meeting in Amsterdam NDA chief, Professor Albert Flynn, said the NDA was not devaluing the peer review process because the parameters it was working within were very different to those of the peer review scientific process.
Other academics to write to Mathioudakis were Professor Ronald Eccles, director of the Common Cold Centre and Healthcare Clinical Trials at the Cardiff University School of Biosciences; Professor Michael Gleeson from the School of Sport, Exercise and Health Sciences at Loughborough University; and three academics from the University of Antwerp.
The Antwerp researchers noted that the International Classification of Health Problems in Primary Care had defined URTIs as an illness with, “evidence of acute inflammationof the nasal or pharyngeal mucosa and the absence of other specifically defined respiratory conditions, for example streptococcal tonsillitis, laryngitis, bronchitis, pneumonia, asthma and hay fever.
They also noted a 2010 Cochrane review that said URTI’s had symptoms including “rhinitis (but not hay fever or allergic rhinitis); sore throat (not streptococcal tonsillitis); with or without fever, cough, and/or productive sputum/purulent sputum.” (Arroll & Kenealy, 2010)