Safety and Regulation of Probiotic Foods and Supplements

Abstract

Probiotics safety has received a lot of attention recently due to some serious issues including bacterial translocation causing sepsis and horizontal transfer of acquired antibiotic resistance gene. To resolve these concerns, manufacturers have to demonstrate safety of probiotics on a strain-by-strain basis because not all probiotics are the same. Also, to prevent the outbreak of pathogenic bacteria with antibiotic resistance, probiotics harboring acquired antibiotic resistance genes such as tetW should not be used since recent research cannot rule out the possibility of gene transfer even if the gene is on chromosomal DNA. Furthermore, high hygienic standard to prevent contamination by pathogenic bacteria or allergen during the production of probiotics is another requirement to assure the safety of probiotics. Meanwhile, health claims for probiotics are regulated in Japan, called the Food for Special Health Uses (FOSHU) system. Both proven effectiveness and safety are required for approval as an FOSHU.