The Unregulated Probiotic Market
Open accessAbstract
BACKGROUND & AIMS: This narrative review provides an overview of the current regulation of probiotics, with a focus on those used for the dietary management of medical conditions (Medical Foods). FINDINGS: The probiotic market has grown rapidly, both for foods and supplements intended to enhance wellness in healthy individuals, and for preparations for the dietary management of disease. Regulation of probiotics varies between regions. Unless they make specific disease-related health claims, probiotics are regulated as food supplements and regulation is focused on the legitimacy of any claims, rather than efficacy, safety and quality. Many properties of probiotics are strain-specific, and safety and efficacy findings associated to specific formulations should not be generalized to other probiotic products. Manufacturing processes, conditions and ingredients are important determinants of product characteristics and changes to manufacturing are likely to give rise to a product not identical to the "original" in efficacy and safety if proper measures and controls are not taken. Current trademark law and the lack of stringent regulation of probiotic manufacturing mean that the trademark owner can commercialize any formulation under the same brand, even if significantly different from the original. These regulatory deficits may have serious consequences for patients where probiotics are used as part of clinical guideline-recommended management of serious conditions such as inflammatory bowel diseases, and may make doctors liable for prescribing a formulation not previously tested for safety and efficacy. CONCLUSIONS: Current regulation of probiotics is inadequate to protect consumers and doctors, especially when probiotics are aimed at the dietary management of serious conditions.
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Globally, regulatory inconsistency prevails.
“Globally, regulatory inconsistency prevails.38”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [38]
Well-studied probiotic species include Bifidobacterium (ssp. adolescentis, animalis, bifidum, breve, and longum) and Lactobacillus (ssp. acidophilus, casei, fermentum, gasseri, johnsonii, reuteri, paracasei, plantarum, rhamnosus, and salivarius).
“well-studied probiotic species include Bifidobacterium (ssp. adolescentis, animalis, bifidum, breve, and longum) and Lactobacillus (ssp. acidophilus, casei, fermentum, gasseri, johnsonii, reuteri, paracasei, plantarum, rhamnosus, and salivarius) [211].”
From International Society of Sports Nutrition Position Stand: Probiotics (2019) · cites this paper as [211]
Probiotics have been studied in vulnerable groups including infants, patients with severe acute pancreatitis, inflammatory bowel diseases, liver diseases, HIV, and other conditions, with greater cause for concern for products containing high concentrations up to 450-900 billion live bacteria per dose.
“Further, probiotics have been studied in vulnerable groups, including infants, patients with severe acute pancreatitis, inflammatory bowel diseases, liver diseases, HIV, and other conditions [213, 216–218] with even greater cause for concern with the small number of products that contain high concentrations of up to 450–900 billion live bacteria per dose [211].”
From International Society of Sports Nutrition Position Stand: Probiotics (2019) · cites this paper as [211]
All common probiotic species are considered safe for the general population by EFSA.
“All common probiotic species are considered safe for the general population by the European Food Safety Authority (EFSA), although this definition does not provide guidance on the increasing use of probiotics in people with medical conditions.”
From International Society of Sports Nutrition Position Stand: Probiotics (2019) · cites this paper as [211]
The benefits of probiotics are not validated by EFSA, jeopardizing the use of the term probiotic without an approved claim, with some exceptions such as Italy, Czech Republic, and Bulgaria.
“Moreover the benefits of probiotics are not validated by EFSA, jeopardizing the use of the term probiotic without an approved claim with some exceptions such as in Italy, Czech Republic, and Bulgaria [211].”
From International Society of Sports Nutrition Position Stand: Probiotics (2019) · cites this paper as [211]
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“38 The European Union lacks dedicated probiotic legislation, though health claims are regulated.”
- Authors
- de Simone, C.
- Venue
- Clinical Gastroenterology and Hepatology
- Publisher
- Elsevier BV
- Published
- 2019-04
- Volume
- 17
- Issue
- 5
- Pages
- 809-817
- ISSN
- 1542-3565 (ISSN-L)
- OpenAlex
- W2787854015
- Cited by
- 317
- References
- 25
- Citations by year
- 2026: 30 · 2025: 37 · 2024: 43 · 2023: 42 · 2022: 53 · 2021: 52 · 2020: 30 · 2019: 24 · 2018: 6
- FWCI
- 26.22
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Gastroenterology and Hepatology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- INFM-OAR (INFN Catania) (submittedVersion, cc-by-nc-nd)
- Funders
- Università degli Studi dell'Aquila
- 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 › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- probiotics, probiotic regulation, medical foods, dietary supplements, health claims, trademark law, inflammatory bowel disease, consumer protection, physician liability
- MeSH terms
- Diet Therapy, Drug and Narcotic Control, Health Policy, Humans, Dietary Supplements, Probiotics
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