The founder of the International Probiotics Association (IPA) has called on the Global Alliance for Probiotics (GAP) to work with it to develop the science and dossiers that can win health claims in Europe and elsewhere.
“The IPA is your home. Come home,” said Jarrow Rogovin, IPA founder, board member and founder of €80m Californian food supplements firm, Jarrow Formulas, to Harri Makivuokko, from Finnish GAP member, Valio.
"There are all kinds of things that need to be done and we can only do them together."
Rogovin said too many resources had been wasted and would continue to be wasted if the groups went forward working separately.
“Vast resources have been diverted from IPA to GAP which has an achievement gap,” Rogovin jibed, before issuing public invites to Valio and other GAP members like Danone to join IPA.
“Yes we would think about joining IPA,” Makivuokko responded. “We have to think about that.”
GAP was born in 2011 with the specific task of winning the first probiotic claim under the EU nutrition and health claims regulation (NHCR) and counts Valio, Lallemand, Yakult, Danone, Chr Hansen, DuPont-Danisco and Probi as members.
But its failure to make progress has frustrated not only GAP but other groups. A representative from the Brussels-based Yoghurt and Live Fermented Milks Association (YLFA) affirmed closer collaboration could be beneficial to all, even as the group pursues a generic descriptor probiotic labelling route as has been demonstrated successfully in Italy. YLFA has four members: Danone, Yakult, Chr Hansen and DuPont-Danisco.
In a presentation at Probiota 2014 in Amsterdam this morning, Makivuokko emphasised the strength of GAP’s probiotic strain cluster data, and reiterated the group’s urgent need for dialogue with the European Food Safety Authority (EFSA) before it submitted a dossier.
“It is 2.5 years since we began and we are still waiting for pre-submission dialogue with EFSA,” Makivuokko said. “Industry needs more dialogue at a technical level with EFSA. We need to get feedback and know what to put on the table to squeeze into a health claim.”
He added: “We still need [EFSA’s] NDA panel to define what a healthy person is before committing to a €1m trial. We have downsized our research team which is a bad sign.”
“If a systematic review is sufficient we will submit a dossier but we need EFSA's feedback first. We won't submit a dossier until we have EFSA's input.”
Celia Martin, PhD, France-based global regulatory affairs manager at IPA and GAP member, Lallemand Health Solutions, said her company and all the groups needed to continue to push for greater dialogue with EFSA.
"It was dialogue with Health Canada that enabled us to win five probiotic health claims there. We can't proceed in Europe until EFSA and the NDA are willing to sit down and talk with us."
There are no approved probiotic or prebiotic health claims in the European Union despite more than 300 applications under various articles of the NHCR.
That situation provoked professor Gregor Reid, from the University of Western Ontario and the Lawson Health Research Institute in Canada to call for more direct protest against NDA panelists and EU politicians and further engage consumers to drive regulatory change.
Other speakers at the event like Peter Wennstrom, president and founder of the Healthy Marketing Team, said companies need to innovate and focus less on the limits imposed by the NHCR.