Overview of Regulatory Oversight and Evaluation of Probiotics in the United States, and India

Author: Shaik Najma and Koushik Yetukuri

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Abstract

Live microorganisms known as "probiotics" are marketed with the promise that, when taken orally, they will improve or restore the gut microbiota's health. The first probiotic was named Lactobacillus bulgaricus, a bacillus strain discovered in Bulgarian yogurt. Bulgarian physician and microbiologist Stamen Grigorov discovered the finding in 1905. The contemporary notion is typically credited to Russian Nobel winner Élie Metchnikoff, who proposed in 1907 that Bulgarian peasants who consumed yogurt lived longer. The U.S. Food and Drug Administration (FDA) may regulate a probiotic product as a dietary supplement, a component of food, or a medication, depending on its intended purpose. Several probiotics are offered as dietary supplements that can be marketed without first receiving FDA approval. When probiotics first became popular in India, no rules existed. Hence, the Indian Council of Medical Research (ICMR) in conjunction with the Department of Biotechnology (DBT) formed a task force to create the regulatory rules for probiotic manufacturing in India to assess the safety and prevent the popularisation of probiotic products with misleading claims. Regulation, health claims, research and evidence, consumer awareness, and education are issues in the United States as a result of the usage of probiotics, whereas quality control, a lack of regulatory framework, low awareness, and accessibility are challenges in India. The fundamental purpose of this project is to compare the regulations and registration requirements required for probiotic approval in the US and India. The research was conducted to gather information from numerous marketing websites and official websites like the FDA, FSSAI, ICMR-DBT, and CDSCO. My research revealed that many people nowadays mostly depend on controlling their dietary habits to maintain their health, such as by including probiotics in their diet. Hence, there is an increase in the number of probiotic product regulations and approvals globally to maintain safety.

Keywords

Probiotic, Lactobacillus bulgaricus, Dietary supplement, Regulations, Indian Council of Medical Research (ICMR), Department of Biotechnology (DBT)

Conclusion

Probiotics are products containing live microorganisms and are marketed with the promise that, when taken, they would improve or restore the health of the gut microbiota. The regulation and evaluation of probiotics in India and the US are different in several ways, The Food Safety and Standards Authority of India (FSSAI), which oversees establishing standards for food and food products, oversees regulating probiotics in India. Probiotics are functional food components, and the FSSAI has established rules for their usage in food products. According to the FSSAI's regulations, probiotics must be beneficial to health, safe, and effective. On the other hand, in the US, the regulation of probiotics falls under the jurisdiction of the Food and Drug Administration (FDA). The FDA classifies probiotics as dietary supplements, which means that they are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). According to the DSHEA, dietary supplements are considered safe until proven otherwise, and manufacturers are responsible for ensuring the safety and labeling of their products. In terms of evaluation, in India, probiotics are evaluated based on the safety and efficacy of the strain used and its potential health benefits. The evaluation process in India involves testing the probiotic strain in vitro and in vivo before it is approved for use in food products. In the US, probiotics are evaluated based on the safety and efficacy of the product. The evaluation process in the US involves testing the finished product for purity, potency, and effectiveness and ensuring that the product is properly labelled. Overall, while both India and the US have regulations and evaluation processes for probiotics, the specific guidelines and procedures differ between the two countries.

References

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How to cite this article

Shaik Najma and Koushik Yetukuri (2023). Overview of Regulatory Oversight and Evaluation of Probiotics in the United States, and India. Biological Forum – An International Journal, 15(5): 45-55.