USA/India - Safety Concerns, Regulatory Guidelines, Current Market Trends, and Future Directions toward the Use of Probiotics in Gut-Brain-Skin Axis
USA
Nov 28, 2021
The concept of “gut-brain skin axis” is a newly emerging and important avenue of investigation for researchers to treat emotional state (stress, anxiety) and various skin diseases influenced by alteration in normal intestinal microflora. The role of probiotics and correlation between the gut, emotional state, and skin microflora was explored. Before using probiotics as a drug, the parametric assessment in terms of risk versus benefits must carefully be made. Depending on the intended use of a probiotic (drug vs. dietary supplement or food), regulatory requirements differ. However, the position of the regulatory system for probiotics is quite vague and unclear even within the existing categories in the international market which leads to legal uncertainty and confusion. The current market trend like R&D in innovative product development, product launches, brand mergers, or acquisitions for probiotics related to gut-skin and gut-brain axis is studied. It requires more in-depth research for existing and exploring newer potential probiotic strains for varied applications and provides a future direction for probiotic research for routine healthcare practice. This article focuses on safety assessment parameters of probiotic strain, and specific requirements for manufacturing, labeling, and safe delivery, proposed regulatory guidelines by the FDA (for marketing probiotics in a global context) and FSSAI for manufacturing and selling probiotics in an Indian market, approved list of probiotic cultures and licensing of brands, current market trends, and future directions are mentioned.
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