Health claim regulation of probiotics in the USA and the EU: Is there a middle way?
Abstract
In both the USA and Europe, supermarkets and pharmacies are brimming with probiotics - products containing live micro-organisms claiming they improve health. The availability of these products corresponds to a growing consumer demand for foods that improve or maintain health and wellness. The most persuasive include claims that consumption may confer health benefits. While some of these claims may have merit, others have not been substantiated. For a number of products, claims are based on insufficient research, underpowered studies, or mixed research results, yet individual consumers find that the product is of benefit to them. In attempting to regulate health claims, as distinct from safety, government entities may take positions which represent opposite ends of a philosophical spectrum. On one end of the spectrum they may take a limited approach to regulation relying primarily on the marketplace that respects individual autonomy and assumes a sophisticated consumer and honest sellers; alternatively they may choose substantial regulation based on a belief that consumers need protection from profit-seeking manufacturers. The USA and the European Union have taken two different approaches on this regulatory spectrum.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Cites
Potential Uses of Probiotics in Clinical Practice
Reid, G., Jaß, J., Sebulsky, M. T., & McCormick, J. K. (2003) · Clinical Microbiology Reviews · doi:10.1128/cmr.16.4.658-672.2003 · Cited by 918 · see citing works
Functional Foods: A Survey of Health Claims, Pros and Cons, and Current Legislation
Arvanitoyannis, I. S., & van Houwelingen-Koukaliaroglou, M. (2005) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408390590967667 · Cited by 208 · see citing works
Health Claims in Europe: Probiotics and Prebiotics as Case Examples
Loveren, H. V., Sanz, Y., & Salminen, S. (2012) · Annual Review of Food Science and Technology · doi:10.1146/annurev-food-022811-101206 · Cited by 91 · see citing works
Tobacco Control and Free Speech — An American Dilemma
Bayer, R., & Kelly, M. (2010) · New England Journal of Medicine · doi:10.1056/nejmp0909626 · Cited by 20 · see citing works
Regulating biotechnology: comparing EU and US approaches. European Policy Papers #8
Patterson, L. A., & Josling, T. E. (2002) · Archive of European Integration (AEI) (University of Pittsburgh) · Cited by 6 · see citing works
On Regularity and Regulation, Health Claims and Hype
Marks, J. H. (2011) · The Hastings Center Report · doi:10.1002/j.1552-146x.2011.tb00113.x · Cited by 5 · see citing works
Satine, L. A. (2008) · PubMed · Cited by 5 · see citing works
Commercial Speech in the United States and Europe
Gassy-Wright, O. V. (2005) · Digital Commons (University of Georgia School of Law) · Cited by 3 · see citing works
Aerni, P. (2006) · Repository for Publications and Research Data (ETH Zurich) · doi:10.3929/ethz-a-005388934 · Cited by 2 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Intestinal permeability – a new target for disease prevention and therapy
Bischoff, S. C., Barbara, G., Buurman, W., Ockhuizen, T., Schulzke, J.-D., Serino, M., Tilg, H., Watson, A., & Wells, J. M. (2014) · BMC Gastroenterology · doi:10.1186/s12876-014-0189-7 · Cited by 1,755 · see citing works
Probiotics: If It Does Not Help It Does Not Do Any Harm. Really?
Lerner, A., Shoenfeld, Y., & Matthias, T. (2019) · Microorganisms · doi:10.3390/microorganisms7040104 · Cited by 117 · see citing works
Žučko, J., Starčević, A., Diminić, J., Oros, D., Mortazavian, A. M., & Putnik, P. (2020) · Current Opinion in Food Science · doi:10.1016/j.cofs.2020.01.007 · Cited by 89 · see citing works
Technologies and Trends to Improve Table Olive Quality and Safety
Campus, M., Degirmencioğlu, N., & Comunian, R. (2018) · Frontiers in Microbiology · doi:10.3389/fmicb.2018.00617 · Cited by 70 · see citing works
Probiotics and their Beneficial Health Effects
Zaib, S., Hayat, A., & Khan, I. A. (2023) · Mini-Reviews in Medicinal Chemistry · doi:10.2174/1389557523666230608163823 · Cited by 59 · see citing works
Garg, V., Velumani, D., Lin, Y.-C., & Haye, A. (2024) · PharmaNutrition · doi:10.1016/j.phanu.2024.100423 · Cited by 44 · see citing works
Next Generation Probiotics for Neutralizing Obesogenic Effects: Taxa Culturing Searching Strategies
López‐Moreno, A., Acuña, I., Torres-Sánchez, A., Ruiz-Moreno, Á., Cerk, K., Rivas, A., Suárez, A., Monteoliva‐Sánchez, M., & Aguilera, J. (2021) · Nutrients · doi:10.3390/nu13051617 · Cited by 34 · 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
“In contrast to the EU regulatory framework, the United States generally does not require pre-market approval for health claims, particularly for structure/function claims [57,58].”
Stopping Deceptive Health Claims: The Need for a Private Right of Action Under Federal Law
Hoffmann, D. E., & Schwartz, J. (2016) · American Journal of Law & Medicine · doi:10.1177/0098858816644715 · Cited by 15 · see citing works
Self-citationProbiotic and enterohemorrhagic Escherichia coli: An effective strategy against a deadly enemy?
Cordonnier, C., Thévenot, J., Etienne‐Mesmin, L., Alric, M., Livrelli, V., & Blanquet‐Diot, S. (2016) · Critical Reviews in Microbiology · doi:10.1080/1040841x.2016.1185602 · Cited by 15 · see citing works
Venema, K. (2013) · Beneficial Microbes · doi:10.3920/bm2013.x001 · Cited by 12 · see citing works
Jagelavičiūtė, J., Bašinskienė, L., & Čižeikienė, D. (2025) · Fermentation · doi:10.3390/fermentation11080481 · Cited by 11 · see citing works
Cao, Y., Zhang, L., Xiong, F., Guo, X., Kan, X., Song, S., Liang, B., Liang, B., Li, Y., & Zheng, C. (2023) · Future Microbiology · doi:10.2217/fmb-2022-0234 · Cited by 8 · see citing works
Chikindas, M. L. (2014) · Probiotics and Antimicrobial Proteins · doi:10.1007/s12602-014-9161-7 · Cited by 7 · see citing works
Ng, J. Y., & Luong, M. (2020) · European Journal of Integrative Medicine · doi:10.1016/j.eujim.2020.101159 · Cited by 6 · see citing works
Oberhelman, R. A., Kosek, M. N., Yori, P. P., Olórtegui, M. P., & Connolly, E. (2014) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.13-0639 · Cited by 6 · see citing works
The coming of age of probiotics and the struggle for their regulation and refinement
Aziz, G., & Zaidi, A. (2025) · Food Bioscience · doi:10.1016/j.fbio.2025.106955 · Cited by 5 · see citing works
Meléndez-Illanes, L., Díaz, C. G., Chilet‐Rosell, E., & Álvarez‐Dardet, C. (2015) · Journal of Public Health · doi:10.1093/pubmed/fdv151 · Cited by 4 · see citing works
(2016) · CRC Press eBooks · doi:10.1201/9781315372129-16
- Authors
- Hoffmann, D. E.
- Affiliations
- University of Maryland, Baltimore (US)
- Corresponding author
- Hoffmann, D.E.
- ORCID
- Hoffmann, D.E.
- Venue
- Beneficial Microbes
- Publisher
- Walter de Gruyter GmbH
- Published
- 2013-03-01
- Volume
- 4
- Issue
- 1
- Pages
- 109-115
- ISSN
- 1876-2883 (ISSN-L)
- 1876-2891
- OpenAlex
- W2140499820
- Cited by
- 19
- References
- 10
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 2 · 2021: 1 · 2020: 2 · 2019: 1 · 2018: 1 · 2016: 3 · 2015: 2 · 2014: 3 · 2013: 1
- FWCI
- 1.85
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Beneficial Microbes (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Consumer Attitudes and Food Labeling
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- probiotics, health claims regulation, functional foods, United States regulation, European Union regulation, regulatory philosophy, consumer protection, individual autonomy, health claim substantiation
- MeSH terms
- European Union, Humans, United States, Drug Approval, Probiotics
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
