About
What it is and where it shows up.
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host (FAO/WHO definition); common genera include Lactobacillus, Bifidobacterium, and Saccharomyces. They are used in fermented dairy products, functional foods, and dietary supplements to support gut health, immune function, and general well-being.
Safety summary
The regulatory and scientific consensus.
Probiotics are broadly considered safe for healthy adults, with numerous strains holding GRAS status in the United States; however, the FDA has raised serious concerns about their use in pre-term infants, citing documented cases of probiotic sepsis. Immunocompromised and critically ill patients are at elevated risk of bacteremia or fungemia from probiotic supplementation. An emerging regulatory and scientific concern is the potential transfer of antibiotic resistance genes from probiotic strains to pathogenic bacteria.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Restricted | Since Regulation (EC) 1924/2006 on nutrition and health claims entered into force, the term 'probiotic' is treated as an unauthorized health claim and cannot appear on food labels in the EU. Of 355 probiotic health claims assessed by EFSA, only one has been scientifically accepted: 'live cultures in yoghurt or fermented milk improve lactose digestion in individuals who have difficulty digesting lactose.' Probiotic microorganism species may still be used in food and feed products subject to EFSA's Qualified Presumption of Safety (QPS) assessment framework, which was implemented in 2007.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Probiotics are regulated under the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016, gazetted on 23 December 2016, with enforcement from 01 January 2018. 'Probiotic food' is defined as food containing live micro-organisms beneficial to human health that confer specified health benefits when ingested in adequate numbers. ICMR-DBT guidelines provide additional evaluation criteria for safety, efficacy, and product labeling. Products must not be used by pregnant/lactating women, infants, or children under 5 years without advisory statements.source |
| FDA (Food and Drug Administration) (United States) | Approved | Probiotics are not defined as a single regulatory product category under the FD&C Act; depending on intended use claims, they may be regulated as foods, dietary supplements, or drugs. Many individual strains (e.g., multiple Bifidobacterium and Lactobacillus species) are GRAS-affirmed or self-affirmed GRAS for use in conventional foods. Use of live microorganisms in foods for pre-term infants is explicitly NOT GRAS and is considered an unsafe food additive per FDA memorandum (October 2023). |
Who should approach with care
Whose guidance would steer them away.
Infants — FDA (October 2023) has determined that the use of live microorganisms in foods for pre-term infants is not GRAS and is associated with serious adverse events including probiotic sepsis; the American Academy of Pediatrics does not endorse routine use in pre-term neonates.
Children — FSSAI regulations require that probiotic products carry advisory labels stating they are not to be used by infants or children under 5 years without medical guidance.
Other — Immunocompromised and critically ill patients (e.g., those with central venous catheters or receiving enteral nutrition) are at elevated risk of Saccharomyces fungemia or bacteremia from probiotic supplementation, as documented in peer-reviewed literature and regulatory safety reviews.
Ibd — Patients with active inflammatory bowel disease and compromised gut mucosal integrity may face altered translocation risk from live probiotic organisms; physician guidance is recommended before use.
Pregnancy — FSSAI probiotic food regulations explicitly require advisory labeling that products should not be used by pregnant and lactating women without medical advice.
Research citations
The sources behind this verdict.
- 1FDA. Microorganisms & Microbial-Derived Ingredients Used in Food (Partial List). fda.gov
- 2FDA. Regulatory Status of Live Microorganisms When Used or Intended for Use in Foods Intended for Pre-Term Infants, 2023. fda.gov
- 3PubMed. Considerations for Determining Safety of Probiotics: A USP Perspective, 2023. pmc.ncbi.nlm.nih.gov
- 4FSSAI. Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food) Regulations, 2016, 2016. fssai.gov.in
- 5PubMed. Why the European Food Safety Authority Was Right to Reject Health Claims for Probiotics, 2012. pubmed.ncbi.nlm.nih.gov
- 6PubMed. Regulatory Oversight and Safety of Probiotic Use, 2012. pmc.ncbi.nlm.nih.gov
Independently researched8 citations