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Probiotics 101

Probiotics Regulation in the U.S. and other countries


According to the NIH website (, depending on the intended use, probiotics are regulated as a dietary supplement, a food ingredient, or a drug.

Many probiotics are sold as a dietary supplement either online or offline. In this case, probiotics product doesn’t require FDA approval and at the same time, they are not allowed to make health claim such as lowering your risk of getting disease without FDA’s consent. In 2023, the FDA warned health care providers that premature infants who are given probiotics are at risk of severe, potentially fatal infections caused by the microorganisms in the products. 

For other countries outside of United States, in most countries, probiotics are sold either under food or drug regulations.

Very few countries have developed specific regulations for probiotics within a specific category dedicated for supplements which outlines clear expectations on characterization, safety, efficacy and quality. Probiotic Food and Probiotic dietary supplement generally fall under food law, with or without a specific framework such as “Foods with probiotics” (Argentina), “Food products with additions” (Saudi Arabia, Mexico, Morocco), “Foods with function claims” (Japan), “Health functional food” (South Korea), or “Dietary supplements” (USA). 



#Probiotics, #Regulation, #FDA

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