Table 5.

Summary of probiotics categorization and regulation frameworks worldwide.

Country	Category	Regulatory Framework	Claims	Reference
USA	Drugs, nutraceuticals	FDA	Health claims Nutrient claims Structure claims GRAS	[145,146]
	Dietary supplements	DSHEA	Probiotics considered as foods
	Biological product	FDA (BLA)	Probiotics as a reference product, biosimilar product, or an interchangeable product; solely to be used for medical therapeutic purpose
	Life biotherapeutic agent	FDA	Probiotics as a biological product that contains live organisms and is applicable to the prevention, treatment, or cure of a disease or condition; recombinant life biotherapeutic agent
	Medical Food	FDA/DSHA	Probiotics specially formulated to be intended for dietary management under supervision; medical foods are exempt from the labeling requirements for nutrient content and health claims
China	Functional foods	SFDA	Conventional foods mark (the presence of a specific ingredient in the label of regular foodstuffs) Healthy foods (the presence of health function)	[147]
Europe	Functional Food and nutraceuticals	EFSA (FUFOSE)	Health claims, nutrition claims QPS	[143,144,148]
	Life biotherapeutic products	EMA	Probiotics as medicinal products containing live microorganisms for human use
Japan	Functional foods and nutraceuticals	MHLW, FOSHU	Foods with functional claims Foods with nutrient functional claims	[149,150]
Canada	Natural health products	FDA (CFIA)	Nutrient content claims Health claims	[151]

EFSA: European Food Safety Agency; EMA: European Medicines Agency; FAO/WHO: Food and Agricultural Organization/World Health Organization; MHLW: Ministry of Health and Welfare; FOSHU: food for specified health use; FUFOSE: functional food science in Europe; SFDA: State Food and Drug Administration; DSHEA: Dietary Supplement Health and Education Act; BLA: biologic license application; CFIA: the Canadian Food Inspection Agency.