Lactobacilli: Legal Regulation and Prospects for New Generation Drugs.

Area of Science:

• Microbiology
• Food Science
• Pharmacology
• Regulatory Science

Background:

• The global probiotics industry is rapidly evolving, driven by advancements in omics technologies, particularly metagenomics.
• Metagenomic studies of human and animal microbiomes are transforming approaches to probiotic discovery and application.
• The efficacy, safety, and market success of probiotic-based products are significantly influenced by regulatory landscapes.

Purpose of the Study:

• To review the legal and technical regulatory aspects of probiotics and postbiotics in Russia, the European Union, and the United States.
• To compare the advantages and disadvantages of probiotics and postbiotics.
• To highlight the significance of the lactobacilli family in probiotic research and development.

Main Methods:

• Literature review of scientific publications on probiotics, postbiotics, and microbiome research.
• Analysis of legal and regulatory frameworks governing probiotics and postbiotics in key global regions.
• Comparative assessment of probiotic and postbiotic characteristics.

Main Results:

• Postbiotics are emerging as a promising alternative to traditional live probiotic cultures, offering distinct advantages.
• The lactobacilli family remains a dominant group in probiotic research, with numerous studied strains.
• Russia has proactively implemented legislation, such as Federal Law No. 492-FZ on biosecurity, to regulate microbiota and promote its preservation.

Conclusions:

• Postbiotics present a compelling alternative to probiotics, with potential benefits for health and industry.
• Regulatory harmonization and clear guidelines are crucial for the safe and effective development and marketing of probiotics and postbiotics.
• Emerging fields like microbiome nutrigenomics offer new avenues for preserving and manipulating the microbiota for health benefits.