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USA/EU - Global overview for probiotics: Trends, markets, and harmonization


Sep 26, 2022

Probiotics are one of the more intensely researched dietary ingredient categories, and their benefits have been supported in translational science. However, current diverging global regulations present challenges to ensuring consumer access to safe probiotic products of quality, highlighting the need for clear, harmonized regulations and claims to facilitate delivery of foods and dietary supplements with probiotics to consumers worldwide.
In 2001 and 2002, the UN Food and Agriculture Organization (FAO) and World Health Organization (WHO) published two joint reports with guidelines and recommendations for governments around the globe for the evaluation of the safety and nutritional aspects of probiotics.1 These recommendations are widely respected and have been extremely helpful to governments, shaping regulations for probiotics internationally. The regulations set a baseline for the probiotic industry but have been interpreted independently, creating gaps as governments developed different requirements at the national levels.
These guidelines and the definition shaped the future trajectory of the industry and the global probiotics market is now dynamic and diverse. Continued growth, coupled with increasing consumer demand over the years, offers many opportunities for food, beverage, and dietary supplement organizations. The guidelines and FAO-WHO definition have resulted in a complex mosaic of diverse global regulatory frameworks, which presents challenges when commercializing probiotic products but may also be seen as opportunities.

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