EFSA’s Panel on Nutrition, Allergies and Dietetic Products (NDA) rejected article 14 disease risk reduction flu, cold and sore throat claims submitted by Czech firm, SVUS Pharma, for its OTC product, ProteQuine, prompting CSFA vice president and SVUS business development manager, Vaclav Bazata to lament over the way nutrient science is being treated in the EU.
“What we are seeing is a higher standard being applied for some nutrients than others,” he said, highlighting plant sterols and stanols that had won positive NDA opinions as an example.
“EFSA wants platinum, not gold science,” he said, noting his company and others would be commenting in the 30-day window on the bovine lactoferrin opinion more as a matter of obligation than for any expected shift from EFSA.
“It’s a mess and the problem is that EFSA is not listening to industry, especially with the pharma industry behind the scene.”
He said members of the Czech Department of Health had expressed, “anger and frustration” at the ruling.
ProteQuine launched on the Czech market in 1999 and is available through OTC pharmacy distribution in Slovakia, Poland, the Ukraine and some Baltic states, with sales in the millions of euros.
It makes soft claims about immunity that include giving consumers bear-like strength.
“Some will look at this opinion and try to attack our claims,” Bazata said.
The rejected dossier contained published human studies, several unpublished reports on ProteQuine, and review papers on lactoferrin.
The NDA opinions can be found here.