A comprehensive review of probiotic claims regulations: Updates from Asia-Pacific, United States, and Europe

Abstract

Background

Probiotics are defined, classified, and regulated differently across countries, which affects consumer protection and market access for manufacturers. This review examined the regulatory similarities and differences for probiotics in the APAC region, the U.S., and Europe to address these challenges.

Method

A detailed literature search was conducted on databases such as Google Scholar, PubMed, and open sources of relevant regulatory authorities. Relevant articles, guidelines, and recommendations related to probiotics in APAC, U.S. and Europe were screened and reviewed.

Results

Probiotics are categorized as "food" in U.S., Europe, Japan, Thailand, Malaysia, Singapore, and Indonesia, with Malaysia, Singapore, and Indonesia also classifying them as "health supplements." Other terms like “functional food," "novel food," and "health functional food" are used in various countries. Claims for probiotics also vary internationally. Countries such as China, Philippines, and Singapore have pre-approved claims, while the U.S., South Korea, Australia & New Zealand, and India do not have any pre-approved claim. Europe enforces the strictest rules and generally does not approve any probiotic health claims, whereas U.S. and APAC regions are more flexible. For instance, in Thailand, claim of “reducing disease risk” is permitted.

Conclusion

Harmonizing the regulations could benefit consumers and manufacturers by ensuring consistent standards and facilitating market entry. This would help industry stakeholders navigate the complex regulatory landscape and aid consumers in understanding the benefits of probiotic products.