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USA/India - Regulatory Aspects Relevant to Probiotic Products


Jun 13, 2023

Probiotics, which are defined as living bacteria benefitting the host by modulating immune system and thereby preventing infections when ingested in appropriate amounts, is one of the fastest growing areas of nutritional supplements. Recognising this, several safety concerns must be addressed during its administration. Due to high consumer demand, numerous probiotic products in the market and ongoing research on functional foods have led to improvisation and introduction of the stringent policies for probiotic manufacturers. This will safeguard the interest of consumers from ambiguous label claims. The current worldwide categorisation of probiotics and their regulations are relatively broad, creating legal ambiguity and misunderstandings. While designing polices or regulations for probiotics, it must be taken into consideration that it varies according to its intended use (drug vs. nutritional supplement or food). Besides this, introduction of a uniform nomenclature for probiotic commodities is a necessity in order to guarantee efficient regulatory control over probiotic-related problems. This article discusses the parameters for probiotic strain safety evaluation as well as the precise specifications for manufacturing, labelling, and safe distribution. The FDA’s proposed regulatory requirements (for probiotics marketing globally) and the FSSAI’s proposed regulatory requirements (for producing and selling probiotics in India) are also highlighted in the article, along with the approved list of probiotic cultures, brand licencing, and futuristic approach.

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