Probiotic safety—No guarantees
Open accessAbstract
For centuries, people have consumed live bacteria in many foods, such as yogurt, cheese, kimchi, and sauerkraut. The mass-marketing of isolated live bacteria for their purported beneficial or “probiotic” properties, however, is a relatively recent phenomenon. The World Health Organization defines probiotics as “live microorganisms which when administered in adequate amounts confer a health benefit on the host.” Yet to be sold as a probiotic supplement in the United States, a live microorganism does not require evidence of efficacy or even safety.
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Accurate data on the incidence of infections associated with probiotic use remain unknown.
“Despite the large number of clinical observations regarding the use of probiotics, accurate data on the incidence of infections associated with their use remain unknown [77].”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [77]
The presence of such ARGs and VFs may have clinical relevance, particularly in immunocompromised individuals or those with disrupted gut barriers, where opportunities for opportunistic infection or horizontal gene transfer may be increased.
“The presence of such ARGs and VFs may have clinical relevance, particularly in immunocompromised individuals or those with disrupted gut barriers, where opportunities for opportunistic infection or horizontal gene transfer may be increased.22,29-35”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [30]
Products like Tufpro, Ecogro, and Progermila bambini have contained opportunistic pathogens such as Bacillus cereus, Acinetobacter spp., and Pseudomonas spp.
“Products like Tufpro, Ecogro, and Progermila bambini have contained opportunistic pathogens such as Bacillus cereus, Acinetobacter spp., and Pseudomonas spp.30”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [30]
Probiotic-borne AR genes could be transferred to resident potential pathogens, other microbes harbored by the host, and/or environmental microbes, thereby increasing the ecological pool of antimicrobial resistance genes.
“one concern is the theoretical situation in which probiotic-borne AR genes could be transferred to resident potential pathogens, other microbes harbored by the host, and/or environmental microbes, thereby increasing the ecological pool of antimicrobial resistance genes.15–17”
From Emerging issues in probiotic safety: 2023 perspectives (2023) · cites this paper as [15]
In general, high quality, safe probiotic products are produced under dietary supplement and food regulations, although there have been incidences of noncompliance documented for supplements and calls for improved product quality.
“In general, high quality, safe probiotic products are produced under dietary supplement and food regulations, although there have been incidences of noncompliance documented for supplements15 and calls for improved product quality.135”
From Emerging issues in probiotic safety: 2023 perspectives (2023) · cites this paper as [15]
Cites
Safety assessment of probiotics for human use
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Safety of probiotics used to reduce risk and prevent or treat disease.
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A review of probiotic supplementation in healthy adults: helpful or hype?
Khalesi, S., Bellissimo, N., Vandelanotte, C., Williams, S., Stanley, D., & Irwin, C. (2019) · European Journal of Clinical Nutrition · doi:10.1038/s41430-018-0135-9 · Cited by 242 · see citing works
Bafeta, A., Koh, M., Riveros, C., & Ravaud, P. (2018) · Annals of Internal Medicine · doi:10.7326/m18-0343 · Cited by 162 · see citing works
Probiotics and gastrointestinal conditions: An overview of evidence from the Cochrane Collaboration
Parker, E. A. D., Roy, T., D’Adamo, C. R., & Wieland, L. S. (2017) · Nutrition · doi:10.1016/j.nut.2017.06.024 · Cited by 148 · see citing works
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Prevalence of probiotic use among inpatients: A descriptive study of 145 U.S. hospitals
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Emerging issues in probiotic safety: 2023 perspectives
Merenstein, D., Pot, B., Leyer, G., Ouwehand, A. C., Preidis, G. A., Elkins, C. A., Hill, C., Lewis, Z. T., Shane, A. L., Zmora, N., et al. (2023) · Gut Microbes · doi:10.1080/19490976.2023.2185034 · Cited by 481 · see citing works
Potential Pharmaceutical and Food Applications of Postbiotics: A Review
Rad, A. H., Abbasi, A., Kafil, H. S., & Ganbarov, K. (2020) · Current Pharmaceutical Biotechnology · doi:10.2174/1389201021666200516154833 · Cited by 113 · see citing works
Cui, Y., Wang, S., Ding, S., Shen, J., & Zhu, K. (2020) · Journal of Hazardous Materials · doi:10.1016/j.jhazmat.2019.121266 · Cited by 64 · see citing works
Current Concepts in Probiotic Safety and Efficacy
Churin, A. A., Sokolyanskaya, L. O., Lukina, A. P., & Karnachuk, O. V. (2026) · Nutrients · doi:10.3390/nu18040696 · Cited by 31 · see citing works
“Despite the large number of clinical observations regarding the use of probiotics, accurate data on the incidence of infections associated with their use remain unknown [77].”
Madhumathi, I., Ramesh, V., Rathakrishnan, B., Abirami, B., Gunasekaran, K., Kumar, T. S., Jeyasankar, P., Raja, G., Selvam, K., Rajendran, S., et al. (2026) · Gut microbes reports · doi:10.1080/29933935.2026.2668863
“30,44”
- Authors
- Cohen, P. A.
- Affiliations
- Cambridge Health Alliance (US)
- Corresponding author
- Cohen, Pieter A.
- ORCID
- Cohen, Pieter A.
- Venue
- JAMA Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2018-12-01
- Volume
- 178
- Issue
- 12
- Pages
- 1577
- ISSN
- 2168-6106 (ISSN-L)
- OpenAlex
- W2892079098
- Cited by
- 113
- References
- 10
- Citations by year
- 2026: 6 · 2025: 13 · 2024: 17 · 2023: 14 · 2022: 17 · 2021: 14 · 2020: 12 · 2019: 15 · 2018: 4 · 2017: 1
- FWCI
- 10.55
- Type
- journal article
- Language
- en
- Open access
- green
- nrs.harvard.edu
- Licence
- cc-by
- Locations
- JAMA Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Consumer Attitudes and Food Labeling
- Keywords
- probiotics, probiotic safety, probiotic supplements, live microorganisms, dietary supplements, regulatory oversight, health claims
- MeSH terms
- Humans, Risk Assessment, Probiotics
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