Regulatory categories of probiotics across the globe: A review representing existing and recommended categorization
Open accessAbstract
Probiotics are friendly live microorganisms (in most cases, bacteria) that are similar to beneficial micro-organisms found in the human gut, whenever consumed, have potential to confer benefit to the health of consumers by maintaining, or improving their intestinal microbial flora and are available to consumers mainly in the form of dietary supplements and foods. All-time high interest in the field of probiotics is due to emerging probiotic industry. Probiotics are available in foods and dietary supplements, even as pharmaceutical formulations (capsules, tablets and powders) and in some other forms as well, but their claims of health benefits may challenge the traditional border between food and medicine. A number of probiotic products have been already introduced into the international market as food supplements, dietary supplements, natural health products, functional foods and many more other categories; as a result, the position of regulatory system for probiotics within existing categories become vague and quite unclear. Common terminology for probiotic products has become a necessity to achieve adequate regulatory control for discussion of probiotic-related issues among government, producers and consumers. The lack of a consistent terminology across the globe leads to legal uncertainty and confusion instead of being a direct obstacle for development of a mature market. This article will explain differences in regulatory categorizations across the globe; discuss the terms like food and drugs with a close relationship to probiotics, the problems associated with unsatisfactorily approached categorization as well as suggestive consolidations for the new categorization which will demarcate probiotics into categories explaining their nutritive claims, health claims or both.
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In Brazil, probiotics are considered functional foods, different from food, and legislation requires safety and efficacy demonstration, so all products must be registered and approved by ANVISA.
“In Brazil, probiotics are considered as functional foods, and considered to be different from food. But legislation asks for safety and efficacy demonstration of food products and hence all these products must be registered and approved by a health authority called National Health Surveillance Agency Brazil (ANVISA) [230].”
From International Society of Sports Nutrition Position Stand: Probiotics (2019) · cites this paper as [230]
Japan is viewed by many to be a global market leader given that probiotics are available as both foods and drugs, and was the first global jurisdiction to implement a regulatory system for functional foods and nutraceuticals in 1991.
“Japan is viewed by many to be a global market leader given that probiotics are available as both foods and drugs [230], and was the first global jurisdiction to implement a regulatory system for functional foods and nutraceuticals in 1991.”
From International Society of Sports Nutrition Position Stand: Probiotics (2019) · cites this paper as [230]
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- Authors
- Arora, M., & Baldi, A.
- Affiliations
- Indo Soviet Friendship College of Pharmacy (IN)
- Corresponding author
- Baldi, A
- Venue
- Indian Journal of Medical Microbiology
- Publisher
- Elsevier BV
- Published
- 2015-02
- Volume
- 33
- Pages
- S2-S10
- ISSN
- 0255-0857 (ISSN-L)
- OpenAlex
- W2082400706
- Cited by
- 110
- References
- 27
- Citations by year
- 2026: 9 · 2025: 17 · 2024: 12 · 2023: 13 · 2022: 8 · 2021: 10 · 2020: 5 · 2019: 8 · 2018: 14 · 2017: 9 · 2016: 3 · 2015: 2
- FWCI
- 1.16
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Indian Journal of Medical Microbiology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- University of the Punjab
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Consumer Attitudes and Food Labeling
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Keywords
- probiotics, probiotic regulation, probiotic products, functional foods, dietary supplements, natural health products, health claims
- MeSH terms
- Humans, Public Health, Global Health, Dietary Supplements, Probiotics
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