That too was rejected in December 2011 with eight human intervention studies, two human observational studies and three non-human studies failing to impress the EU’s central food science agency that the formulation could ease gastrointestinal discomfort.
Appealing this, Clasado questioned the ruling of EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) that only trials of four weeks or longer were sufficient in the gastro area.
The NDA said four weeks was needed due to the, “fluctuating nature of gastro-intestinal symptoms” and dismissed a two-week trial Clasado had submitted under the EU nutrition and health claims regulation (NHCR).
“EFSA considers that it is the responsibility of the applicant to ensure that the studies are performed according standards that are generally accepted by experts in the relevant field,” the NDA wrote in its response to the Clasado appeal.
The NDA also mentioned correction for multiple outcomes and backed its initial assessment that there had been inappropriate statistical analysis for cross-over design.
“It is noted in the Opinion that, in response to EFSA’s request for the full study report and a statistical re-analysis of the data which would be appropriate for cross-over designs, the applicant provided a brief summary report including limited information on a statistical analysis. The Panel considered that on the basis available to the Panel, the statistical analysis was inappropriate for the study design.”
For an intention-to-treat analysis, the NDA said it had not received any data that could sway its opinion during stop-the-clock procedures.
“EFSA would like to clarify that in its stop the clock letter of 20 July 2011 … EFSA requested the applicant to present a comprehensive analysis of the outcomes of this study, which would be considered to include an ITT analysis and other sensitivity analysis.”
“The comments received did not provide further evidence which would warrant a change in the conclusions of the NDA Panel on this study.”
Clasado was unavailable for comment at the time of publication.
