The three different mushroom species used in AndoSan™ are all recognized as common food ingredients in the EU and USA. The fact that our special strain of Agaricus subrufescens (syn. Agaricus blazei Murill ) has been developed through extensive natural selective breeding – not GMO – for medicinal properties does not affect the regulatory situation, it is still classified as a food ingredient.
To establish absolute certainty around the regulatory situation in the EU, ImmunoPharma has submitted and received approval for a regulatory dossier on AndoSan™ as a food supplement in Belgium, one of the few EU countries that issues positive regulatory approvals. Due to EU open market regulations, this is positively securing regulatory access for AndoSan™ throughout the EU market.
As soon as new production facilities are established and technically well documented, ImmunoPharma will submit a SaGRAS with FDA to positively secure the regulatory status in the US.