A comprehensive review of probiotic claims regulations: Updates from Asia-Pacific, United States, and Europe
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Europe has the strictest regulations and generally discourages any health claims made about probiotics.
“Notably, Europe has the strictest regulations and generally discourages any health claims made about probiotics (Table 3) [39].”
From Current Concepts in Probiotic Safety and Efficacy (2026) · cites this paper as [39]
Cites
Hill (2014) · doi:10.1038/nrgastro.2014.66 · Cited by 9,592 · see citing works
Guarner, F. (1998) · International Journal of Food Microbiology · doi:10.1016/s0168-1605(97)00136-0 · Cited by 638 · see citing works
The Genus Enterococcus: Between Probiotic Potential and Safety Concerns—An Update
Hanchi, H., Mottawea, W., Sebei, K., & Hammami, R. (2018) · Frontiers in Microbiology · doi:10.3389/fmicb.2018.01791 · Cited by 569 · see citing works
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
Safety assessment of dairy microorganisms: The Enterococcus genus
Ogier, J.-C., & Serror, P. (2007) · International Journal of Food Microbiology · doi:10.1016/j.ijfoodmicro.2007.08.017 · Cited by 404 · see citing works
A systematic review of the safety of probiotics
Didari, T., Solki, S., Mozaffari, S., Nikfar, S., & Abdollahi, M. (2014) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2014.872627 · Cited by 367 · see citing works
The Unregulated Probiotic Market
de Simone, C. (2019) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2018.01.018 · Cited by 317 · see citing works
Díaz, L. D., Fernández‐Ruiz, V., & Cámara, M. (2020) · Journal of Functional Foods · doi:10.1016/j.jff.2020.103896 · Cited by 289 · see citing works
Kolaček, S., Hojsak, I., Berni Canani, R., Guarino, A., Indrio, F., Orel, R., Pot, B., Shamir, R., Szajewska, H., Vandenplas, Y., et al. (2017) · Journal of Pediatric Gastroenterology and Nutrition · doi:10.1097/mpg.0000000000001603 · Cited by 224 · see citing works
Bacterial composition of commercial probiotic products as evaluated by PCR-DGGE analysis
Fasoli, S., Marzotto, M., Rizzotti, L., Rossi, F., Dellaglio, F., & Torriani, S. (2003) · International Journal of Food Microbiology · doi:10.1016/s0168-1605(02)00259-3 · Cited by 217 · see citing works
Food health claims – what consumers understand
Nocella, G., & Kennedy, O. (2012) · Food Policy · doi:10.1016/j.foodpol.2012.06.001 · Cited by 170 · see citing works
Are Probiotic Really Safe for Humans?
ZAWISTOWSKA-ROJEK, A., & TYSKI, S. (2018) · Polish Journal of Microbiology · doi:10.21307/pjm-2018-044 · Cited by 153 · see citing works
Safety of Probiotics: Functional Fruit Beverages and Nutraceuticals
Žuntar, I., Petrić, Z., Kovačević, D. B., & Putnik, P. (2020) · Foods · doi:10.3390/foods9070947 · Cited by 142 · see citing works
Spacova, I., Binda, S., ter Haar, J. A., Henoud, S., Legrain-Raspaud, S., Dekker, J., Espadaler-Mazo, J., Langella, P., Martín, R., Pane, M., et al. (2023) · Frontiers in Microbiology · doi:10.3389/fmicb.2023.1272754 · Cited by 129 · see citing works
Arora, M., & Baldi, A. (2015) · Indian Journal of Medical Microbiology · doi:10.4103/0255-0857.150868 · Cited by 110 · see citing works
Thomas, M. B., Vaidyanathan, M., Radhakrishnan, K., & Raichur, A. M. (2014) · Journal of Food Engineering · doi:10.1016/j.jfoodeng.2014.03.015 · Cited by 70 · see citing works
Potential pitfalls of health claims from a public health nutrition perspective.
Mariotti, F., Kalonji, E., Huneau, J., & Margaritis, I. (2010) · Nutrition reviews · doi:10.1111/j.1753-4887.2010.00322.x · Cited by 68 · see citing works
van den Nieuwboer, M., van de Burgwal, L., & Claassen, E. (2015) · PharmaNutrition · doi:10.1016/j.phanu.2015.09.003 · Cited by 67 · see citing works
Dietary Supplements—Regulatory Issues and Implications for Public Health
Denham, B. E. (2011) · JAMA · doi:10.1001/jama.2011.982 · Cited by 64 · see citing works
Lalor, F., & Wall, P. G. (2011) · British Food Journal · doi:10.1108/00070701111105358 · Cited by 62 · see citing works
Probiotics: achieving a better regulatory fit.
Hoffmann, D. E., Fraser, C. M., Palumbo, F., Ravel, J., Rowthorn, V., & Schwartz, J. (2014) · PubMed · Cited by 46 · see citing works
Sato, K., Kodama, K., & Sengoku, S. (2023) · Nutrients · doi:10.3390/nu15020476 · Cited by 31 · see citing works
Composition and Laboratory Correlation of Commercial Probiotics in India
Kesavelu, D., Rohit, A., Karunasagar, I., & Karunasagar, I. (2020) · Cureus · doi:10.7759/cureus.11334 · Cited by 30 · see citing works
Biological Warfare of the Spiny Plant
Halpern, M., Waissler, A., Dror, A., & Lev‐Yadun, S. (2011) · Advances in applied microbiology · doi:10.1016/b978-0-12-387022-3.00008-2 · Cited by 26 · see citing works
Patients’ Understanding of the Regulation of Dietary Supplements
Ashar, B. H., Miller, R. G., Pichard, C. P., Levine, R. B., & Wright, S. M. (2007) · Journal of Community Health · doi:10.1007/s10900-007-9063-7 · Cited by 24 · see citing works
Health claim regulation of probiotics in the USA and the EU: Is there a middle way?
Hoffmann, D. E. (2013) · Beneficial Microbes · doi:10.3920/bm2012.0033 · Cited by 19 · see citing works
Probiotics - What They Are, Their Benefits and Challenges
Thantsha, M. S., Mamvura, C. I., & Booyens, J. (2012) · InTech eBooks · doi:10.5772/32889 · Cited by 18 · see citing works
Online Information on Probiotics: Does It Match Scientific Evidence?
Neunez, M., Goldman, M., & Ghezzi, P. (2020) · Frontiers in Medicine · doi:10.3389/fmed.2019.00296 · Cited by 17 · see citing works
Status of probiotic regulations in Southeast Asia countries
Southeast Asia Probiotics Scientific & Regulatory Experts Network, Tee, E. S., Nutrition Society of Malaysia, Hardinsyah, Southeast Asia Probiotics Scientific & Regulatory Experts Network, Sum, C. A. S., & Southeast Asia Probiotics Scientific & Regulatory Experts Network (2021) · Malaysian Journal of Nutrition · doi:10.31246/mjn-2021-27-3-probiotic-regulations-review · Cited by 14 · see citing works
Regulation of Probiotic and Other Live Biologic Products
Schmelz, R. M. (2020) · doi:10.1002/9781119593058.ch18 · Cited by 6 · see citing works
Arora, M., Kaur, N., Arora, M., & Bansal, P. (2018) · Applied Clinical Research Clinical Trials and Regulatory Affairs · doi:10.2174/2213476x05666181011144420 · Cited by 5 · see citing works
Probiotics Regulation in Asian and Australasian Countries
Au, C., Lin, S., Shao, W., Jin, S., Wen, Y., Singh, J., Basuki, V., Tanaka, H., Ji, G. E., Tee, E. S., et al. (2019) · CRC Press eBooks · doi:10.1201/9780429057465-38 · Cited by 4 · see citing works
Antibiotic Resistance and Safety Assessment of Enterococcus faecium CKDB003 for Using as Probiotics
Kim, H., & Kang, S. A. (2020) · The Korean Journal of Food And Nutrition · doi:10.9799/ksfan.2020.33.3.223 · Cited by 2 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Probiotic Development Strategy Centered on Stability and Regulatory Considerations
Kim, H., Haque, M. A., Razzak, M. A., Jang, M. J., Song, S., & Ku, S. (2026) · Comprehensive Reviews in Food Science and Food Safety · doi:10.1111/1541-4337.70320 · Cited by 43 · see citing works
Kamath, S., Ariaee, A., Abdelhafez, A., Asif, Z., Chan, N. S. L., Collins, K., Hunter, A., & Joyce, P. (2025) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2025.115720 · Cited by 36 · see citing works
Refaat, S. S., Erdem, Z. A., Kasapoğlu, M. Z., Ortakcı, F., & Dertli̇, E. (2025) · Food Science & Nutrition · doi:10.1002/fsn3.70740 · Cited by 30 · 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
“This restriction leads to cautious labeling and limited marketing [39,60].”
InfluentialSin, P. Y., Tan, S. H., Asras, M. F. F., Lee, C., Lee, T. C., Karim, M. R., & Ling, N. (2025) · Discover Food · doi:10.1007/s44187-025-00540-1 · Cited by 19 · see citing works
Bhuiyan, M. N. I., Saha, B. K., & Satter, M. A. (2026) · Advanced Gut & Microbiome Research · doi:10.1155/agm3/5517462 · Cited by 15 · see citing works
El‐Saadony, M. T., Saad, A. M., Sitohy, M. Z., Alkafaas, S. S., Dladla, M., Ghosh, S., Mohammed, D. M., Ibrahim, E. H., Fahmy, M. A., Elkelish, A., et al. (2026) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1713426 · Cited by 13 · see citing works
Mafe, A. N., Nkene, I. H., Ali, A. B. M., Edo, G. I., Akpoghelie, P. O., Yousif, E. A., Isoje, E. F., Igbuku, U. A., Ismael, S. A., Essaghah, A. E. A., et al. (2025) · Probiotics and Antimicrobial Proteins · doi:10.1007/s12602-025-10569-4 · Cited by 14 · see citing works
Jagelavičiūtė, J., Bašinskienė, L., & Čižeikienė, D. (2025) · Fermentation · doi:10.3390/fermentation11080481 · Cited by 11 · see citing works
Ankiel, M., Halagarda, M., Piekara, A., Sady, S., Żmijowska, P., Popek, S., Pachołek, B., Jefmański, B., Kucia, M., & Krzywonos, M. (2025) · Sustainability · doi:10.3390/su17188398 · Cited by 11 · see citing works
Biohacking the human gut microbiome for precision health and therapeutic innovation
Bautista, J., & López‐Cortés, A. (2026) · Frontiers in Microbiology · doi:10.3389/fmicb.2026.1776983 · Cited by 14 · see citing works
Mafe, A. N., Obumneme, O. S., Edo, G. I., Akpoghelie, P. O., Gaaz, T. S., Yousif, E., Isoje, E. F., Igbuku, U. A., Ismael, S. A., Essaghah, A. E. A., et al. (2025) · Probiotics and Antimicrobial Proteins · doi:10.1007/s12602-025-10756-3 · Cited by 9 · see citing works
Exploring regional variations in probiotics: Implications for efficacy and application
Abavisani, M., Khoshroo, N., Tafti, P., Moghadam, M. A., Kesharwani, P., & Sahebkar, A. (2025) · Microbial Pathogenesis · doi:10.1016/j.micpath.2025.107963 · Cited by 8 · see citing works
Conventional versus emerging techniques in probiotic enumeration: a comprehensive review
Sun, X., Zhang, J., Chen, J., Yang, L., Pang, X., Fan, Y., Chen, X., Chen, K., Liu, C., Li, X., et al. (2025) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408398.2025.2527355 · Cited by 6 · see citing works
Postbiotics of Marine Origin and Their Therapeutic Application
Cerezo, I. M., Pérez‐Gómez, O., Rohra-Benítez, S., Domínguez‐Maqueda, M., García‐Márquez, J., & Arijo, S. (2025) · Marine Drugs · doi:10.3390/md23090335 · Cited by 6 · see citing works
Martín-Miguélez, J. M., Peromingo, B., Castaño, C., Córdoba, J. J., Delgado, J., & Martín, I. (2025) · Foods · doi:10.3390/foods14244332 · Cited by 6 · see citing works
Allahverdi, M., & Dadmehr, M. (2026) · Journal of Food Composition and Analysis · doi:10.1016/j.jfca.2026.108917 · Cited by 4 · see citing works
Allen, K., Ahlborn, G. J., Wangsgard, J., & Pang, S. (2025) · Analytical Methods · doi:10.1039/d5ay00931f · Cited by 4 · see citing works
Guarnieri, A., Falcone, M., Brancazio, N., Mukhtar, F., Worku, A. T., Cutuli, M. A., Iacovino, V. P., Ganassi, S., Cristofaro, A. D., Marco, R. D., et al. (2025) · Frontiers in Cellular and Infection Microbiology · doi:10.3389/fcimb.2025.1681687 · Cited by 4 · see citing works
Nurchalisah Rustan, M., Wahyuni, S., Nafilawati, W. O., Sadimantara, M. S., & Pagala, F. (2026) · Nutrition Research · doi:10.1016/j.nutres.2026.05.008 · Cited by 4 · see citing works
Regulation of Food Supplements and Pharmacists’ Responsibility in Professional Practice: A Review
Niculas, C., Sonia Bianca, B. L. A. J., Cherecheș, M. C., Miron, R., Valea, D. C., & Muntean, D.-L. (2026) · Pharmacy · doi:10.3390/pharmacy14010025 · Cited by 3 · see citing works
Zang, J., Xiao, L., Zhao, X., Shi, Y., Ma, K., Zhang, C., Geng, S., Rui, X., Lin, T., & Li, W. (2026) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408398.2026.2631641 · Cited by 3 · see citing works
de Souza, H. F., Filho, J. G. A. C., Teixeira, R. D., Silva, F. V., Teixeira, F. D., Bell, J. M. L. N. D. M., Rocha, R. S., da Cruz, A. G., Brandi, I. V., & Kamimura, E. S. (2026) · Food Research International · doi:10.1016/j.foodres.2026.118767 · Cited by 3 · see citing works
Probiotics and prebiotics in the Brazilian dairy sector: An integrative review
Prudêncio, E. S., Nali, G. D. S., Prestes, A. A., de Souza, C. K., do Carmo, M. R. S., Gomes, A. S. G., Pimentel, T. C., da Cruz, A. G., & Antunes, A. E. C. (2026) · International Journal of Dairy Technology · doi:10.1111/1471-0307.70129 · Cited by 3 · see citing works
Probiotics in integrative medicine: Bridging the gap between traditional and modern approaches
Bhavani, S., Chinnakannu, M., Saravanan, A., Agaram, S., & Chopra, S. (2025) · Scripta Medica · doi:10.5937/scriptamed56-53531 · Cited by 2 · see citing works
Zou, J., Liu, W., Dai, J., & Dong, G. (2025) · BMC Genomics · doi:10.1186/s12864-025-12009-7 · Cited by 2 · see citing works
Live biotherapeutics: Emerging trends and future directions in microbial therapy
Kandiyal, B., Gupta, M., & Das, B. (2025) · Progress in molecular biology and translational science · doi:10.1016/bs.pmbts.2025.12.001 · Cited by 2 · see citing works
Bai, S., Chen, Q., & Zhang, X. (2026) · Food Bioscience · doi:10.1016/j.fbio.2026.108820 · Cited by 2 · see citing works
Zalila‐Kolsi, I., & Al-Barazie, R. (2026) · Biology · doi:10.3390/biology15090665 · Cited by 2 · see citing works
Cheong, K., Pan, T., Wang, M., Wang, D., & Zhong, S. (2026) · Pediatric Research · doi:10.1038/s41390-026-04983-9 · Cited by 2 · see citing works
Chong, S. Y., Raja‐Razali, R. B., Ismail, N. H., Ushidee-Radzi, M. A., Zahia-Azizan, N. A., Manickam, M., Norhisham, D. ‘., Ilham, Z., Reale, A., Nazzaro, S., et al. (2026) · Foods · doi:10.3390/foods15122079 · Cited by 2 · see citing works
Utaida, T., Fitriati, A., Itsaranuwat, P., & Moongngarm, A. (2025) · Journal of Functional Foods · doi:10.1016/j.jff.2025.107124 · Cited by 1 · see citing works
How “pro” are probiotics for wildlife species? Novel data, lack of evidence, and future directions
Bornbusch, S. L., Thacher, P., Francisque, M., DeCandia, A. L., Bortner, R., Garelle, D., Kendrick, E. L., Maslanka, M., & Muletz‐Wolz, C. R. (2026) · ISME Communications · doi:10.1093/ismeco/ycag036 · Cited by 1 · see citing works
Functional foods and nutraceuticals as neuroprotectors
Ferreira, C., Vieira, P. G. S., Rincón, E. O., Reis, F., & Viana, S. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-33841-0.00014-2
dos Santos, A. B. C. D. O., da Silva, K. S. C., dos Santos, F. S., Garcia, M. D. F. D. M., Farias, J. Q., Felipe, K. H., Sousa, C. A. G. D., Araújo, S. F. D., Pontes, P. H. D. S., Lima, M. A. D. S., et al. (2026) · Revista Sociedade Científica · doi:10.61411/rsc2026128919
Probiotics in the Prevention and Management of Antibiotic-Resistant Infections
Marzi, M., & Tunç, A. K. (2026) · Fenerbahçe Üniversitesi Sağlık Bilimleri Dergisi · doi:10.56061/fbujohs.1817657
Chen, J., Chou, C.-H. P., & Liu, Y. (2026) · Microorganisms · doi:10.3390/microorganisms14061306
Hằng, Đ. T. T., Dau, D. T., Nguyen, T. P., Nguyen, T. T. H., Trịnh, Q. V., Thanh, N. V., Ho, X. T., Huong, P. T., & Anh, P. T. V. (2026) · Current Microbiology · doi:10.1007/s00284-026-05021-x
Tian, J., Tang, C., Ji, F., Wang, Q., Chunqin, X., Fan, J., Hu, X., & Cao, M. (2026) · Food Reviews International · doi:10.1080/87559129.2026.2698085
Probiotics unveiled: bridging general health benefits to the era of precision medicine
Ullah, M., Rizwan, M., Waheed, M. I., Alam, M. S., Jan, S. U., Raza, A., Shahid, M. F., Andoh, V., & Chen, Y. (2026) · World Journal of Microbiology and Biotechnology · doi:10.1007/s11274-026-05143-1
Probiotics from Marine Actinobacteria and Applications in Aquaculture
Chauhan, M. R., Prajapati, H., Raval, S. V., Galiana, C. L. P., Martínez‐Espinosa, R. M., & Raval, V. H. (2026) · Springer eBooks · doi:10.1007/978-981-95-9849-6_9
Bifidobacterium-Driven Microbiome Regulation of Neonatal Bilirubin Metabolism
Lin, C., Lin, Y., Liang, M., Li, Y., Chen, W., & Wang, G. (2026) · Journal of Future Foods · doi:10.1016/j.jfutfo.2026.08.022
Self-citationAshraf, W., Fei, T., Kang, J., Lin, X., & Wang, L. (2026) · Food Chemistry · doi:10.1016/j.foodchem.2026.151141
Time to rethink prevention of neonatal group B streptococcal disease
Teuscher, J. L., Lohrmann, F., Herting, E., Sugihara, F., Henneke, P., & Härtel, C. (2026) · Seminars in Immunopathology · doi:10.1007/s00281-026-01080-1
Probiotics: A Scientific Approach to Gut Health and Immunomodulation
Iqbal, R., Afzaal, M., Liaqat, A., Chughtai, M. F. J., Saeed, F., & Rehman, S. (2026) · IntechOpen eBooks · doi:10.5772/intechopen.1016423
The potential impact of probiotics on human health
Mishra, S., Dagariya, S., Tiwari, S., & Dakal, T. C. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-45154-6.00034-9
Jaglan, P., Buttar, H. S., & Sobti, R. C. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-45154-6.00022-2
- Authors
- Garg, V., Velumani, D., Lin, Y.-C., & Haye, A.
- Corresponding author
- Garg, Vandana
- ORCID
- Garg, Vandana
- Venue
- PharmaNutrition
- Publisher
- Elsevier BV
- Published
- 2024-12
- Volume
- 30
- Pages
- 100423
- ISSN
- 2213-4344 (ISSN-L)
- OpenAlex
- W4404794093
- Cited by
- 44
- References
- 33
- Citations by year
- 2026: 27 · 2025: 17
- FWCI
- 9.48
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- PharmaNutrition (publishedVersion)
- 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, health claims, functional foods, novel foods, dietary supplements, regulatory harmonization, Asia-Pacific region, United States, Europe, consumer protection, market access
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review