“The questions refer to the totality of evidence,” IPA director general, Ioannis Misopoulos told us. The probiotics sector has been hit by the strict EU nutrition and health claims regulation (NHCR), with no claims as yet being backed by EFSA’s NDA panel.
Animal and in vitro data has often been rejected or discounted and even clinical trials that have passed peer review in the scientific literature have failed to impress the NDA en route to the panel issuing 100s of probiotic health claim rejections.
The questions were compiled by the IPA’s Regulatory Affairs Committee after a review of the sector, the science that exists within it and the way that science is viewed by regulators and science agencies like EFSA.
“The team performed an in-depth scientific assessment based on EFSA’s previous guidance and previously submitted dossiers and asked for further clarification and a request for a face-to-face meeting,” Misopoulos said.
No meeting has yet been established between EFSA and the group that has more than 60 members and counts most major players among them, but Misopoulos said EFSA acknowledged reception of the IPA document.
“It is great that EFSA has been very transparent and allowed us to have this rare opportunity for dialogue,” Misopoulos continued.
“We hope that we will get the chance to meet with them formally very soon. We truly appreciate EFSA’s willingness to create a dialogue with IPA.”
Swiss bliss
While no probiotic health claims have been approved in the EU, a factor in analyst reports of flat to negative market growth for the sector in most member states, non-EU Switzerland in March approved Danone Activia spoonable yoghurt to benefit digestive health.
The IPA said its Regulatory Affairs Committee was working across many fronts, “to support regulatory initiatives globally and is actively working on projects with the United States Food and Drug Administration (FDA), the US Pharmacopeial Convention (USP), EFSA and other regulatory and standards setting organizations worldwide to ensure fair, scientifically sound, international standards for the probiotic industry.”
IPA Regulatory Affairs Committee members include DuPont, Chr Hansen, Lallemand and Procter and Gamble.