EFSA health claims chief shares common dossier failures
170 delegates turned up last week to the European Food Safety Authority (EFSA) HQ in Parma, Italy, for the day-long technical meeting on human studies backing health claims with the stated aim of improving submissions.
They represented the global food, supplements, pharma and cosmetics industries, academia and research institutions as well as other regulators.
In his presentation, Panel on Dietetic Products, Nutrition and Allergies (NDA) chief professor Martin scanned through some of the key stats since the EU nutrition and health claims regulation (NHCR) kicked into life in late 2007 before defining dossier dilemmas.
Dossier dilemmas
Other study problems included subject selection, enrolment, randomisation and retention.
Among intervention studies Dr Martin said inadequate protocols and blinding, insufficient size and controls, along with treatment of multiple outcomes were often causes of rejection or discounting of study findings by the NDA.
In meta-analyses, problems included transparency issues like incomplete reporting of studies, inappropriate inclusion/exclusion criteria, primary/secondary analyses, pre-planned comparisons/sensitivity analyses, and restricted searching.
Under article 13.5 and 14, Dr Martin said there had been 412 applications received since August 2007, 39% of which had been withdrawn. About 40 (11%) remained under evaluation, while 76% of those assessed had been rejected.
Other presentations about meta-analysis composition were criticised as lacking authority in the European context.
Commenting on the day, Italy based consultant, Luca Bucchini, backed the role EFSA was performing.
"Scientists on EFSA panels want to see better nutrition science, better articles and better studies, and are proud to place EFSA at the epicentre of this transparency movement," he said. "Applicants are less concerned about advancing science in general, and would like more concrete answers. Hence some unhappiness."
"There is perhaps a tension between EFSA's role as a promoter of exciting new, ever better science, and that of being a predictable but boring regulator. I think that the relevant EFSA staff is managing this tension well, and are going to have an increasing role in ensuring consistency and predictability - even if panelists may have a little less exciting work on their hands."
A list of attendees can be found here.
