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Considerations for determining safety of probiotics: A USP perspective
Open accessAbstract
A history of safe use is a backbone of safety assessments for many current probiotic species, however, there is no global harmonization regarding requirements for establishing probiotic safety for use in foods and supplements. As probiotic manufacturers are increasingly seeking to use new strains, novel species, and next-generation probiotics, justification based on a significant history of use may be challenged. There are efforts underway by a variety of stakeholders, including the United States Pharmacopeia (USP), to develop best practices guidelines for assessing the quality and safety of probiotics. A current initiative of the USP seeks to provide expert advice specific to safety considerations for probiotics. Toward this goal, this review provides a helpful summary guide to global regulatory guidelines. We question the suitability of traditional animal toxicology studies designed for testing chemicals for relevance in assessing probiotic safety. This includes discussion of the use of excessive dose levels, the length of repeated dose toxicity studies needed, and the most suitable animal species used in toxicology studies. In addition, the importance of proper manufacturing practices with regard to final product safety are also included. Thus, an outline of essential parameters of a comprehensive safety assessment for a probiotic are provided.
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“To exclude such risks, regulatory authorities (EFSA, FDA) and experts explicitly require strain characterization, phenotypic determination of minimum inhibitory concentration (MIC), and whole genome sequencing (WGS) annotated against carefully curated databases of antibiotic resistance/virulence genes (e.g., CARD, ARG-ANNOT, ResFinder) to determine whether resistance is innate or potentially trans”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [33]
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“This uneven safety assessment weakens the current evidence because probiotic safety cannot be inferred from beneficial functional traits alone and must be supported by strain-level safety evaluation, including assessment of transferable antimicrobial resistance, virulence-associated genes, mobile genetic elements, and toxicological evidence. 42”
From Comparative Genomic Insights into Pangenome Diversity and Functional Adaptation of Akkermansia and Faecalibacterium as Gut-Associated Next-Generation Probiotics: A Systematic Review (2026) · cites this paper as [42]
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Self-citation
Metadata
- Authors
- Roe, A. L., Boyte, M.-E., Elkins, C. A., Goldman, V. S., Heimbach, J., Madden, E., Oketch-Rabah, H., Sanders, M. E., Sirois, J., & Smith, A.
- Affiliations
- Procter & Gamble (United States) (US)
- United States Pharmacopeial Convention (US)
- Consumer Healthcare Products Association (US)
- Corresponding author
- Roe, Amy L.
- Venue
- Regulatory Toxicology and Pharmacology
- Publisher
- Elsevier BV
- Published
- 2022-12
- Volume
- 136
- Pages
- 105266
- ISSN
- 0273-2300 (ISSN-L)
- PMC
- PMC10292223
- OpenAlex
- W4300981179
- Cited by
- 136
- References
- 93
- Citations by year
- 2026: 53 · 2025: 45 · 2024: 23 · 2023: 15
- FWCI
- 1.90
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Regulatory Toxicology and Pharmacology (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion, cc-by-nc)
- Funders
- National Institutes of Health (CC999999)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Keywords
- probiotics, probiotic safety assessment, regulatory guidelines, United States Pharmacopoeia, veterinary toxicology, repeated-dose toxicity, dose levels, animal species selection, manufacturing practices, international harmonization
- MeSH terms
- Animals, Dietary Supplements, Probiotics
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