A website has been established - http://www.gut-health.eu/ - calling on clinical gut scientists to sign up in support of their reform ambitions that include pre-claim submission meetings with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) and more detailed guidance about biomarkers, trial outcomes and trial design.
To date about 40 researchers, including Glenn Gibson from the University of Reading, Bruno Pot from the Lille Institut Pasteur in France and Robert Boyle from Imperial College in London, have signed their support of the campaign’s mission statement.
The action was taken after many researchers left an EFSA-hosted gut health and immunity workshop in Amsterdam on December 1 with greater concern than they arrived.
“During the … workshop, the NDA panel and industry stakeholders exchanged ideas on the Guidelines for assessment of health claims on pre- and probiotics,” the researchers write in their letter. “While the discussion was open, the outcome, from a scientific perspective, was very limited.”
Call for justice
They warned that Europe’s leading position in probiotic research could be jeopardised if the current approach by the NDA continued and had little sympathy for the NDA position that it too is learning about gut/immunity science and how to scrutinise it and the way dossiers are presented.
“The statement made during the workshop by the NDA panel that ‘this (i.e. the health claims assessment procedure) is a learning process for all of us’ does not do justice to the hundreds of top quality research papers related to health benefits of probiotics,” they write.
“For the evaluation of peer-reviewed published research papers which were the basis of rejected health claim dossiers, it would be helpful, if not crucial, to know which standards were and will be used in the evaluation.”
“If future research would be limited to those aspects that are considered by the current Regulation, we fear that a substantial number of promising health applications, using well-documented pre- and probiotic products, will not even be considered for proper assessment.”
The researchers note the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) called for more probiotic research since 2001 which has been met with more than 5700 papers published since 2002.
“As a consequence awareness of probiotic efficacy and mechanisms has increased tremendously, both in the public and in the scientific and medical community, and, most logically, applications for selected, well-documented strains have been proposed,” they wrote.
Scientific sense
They called for clinical endpoints such as diarrhoea to be considered by the regulation, before concluding: “As we have indicated above, the rigidity of the regulation may withhold the consumer products with benefits that could provide health advantages. Therefore we believe that for pre- and probiotics, we need an amendment within the regulation to bring these points back within the scope that can and will be considered by EFSA through a broader mandate.”
“We all agree, however, that in the end, any regulation, but certainly a Health Claim Regulation on pro- and prebiotics, as well as other food products, MUST make scientific sense.”
“We hope that politics will pay attention to these matters and ask the commission and DG Sanco to take appropriate measures.”