About
Lacticaseibacillus rhamnosus (formerly Lactobacillus rhamnosus) is a Gram-positive, non-motile, non-spore-forming, rod-shaped lactic acid bacterium originally isolated from the human gut, widely used as a probiotic in fermented dairy products, functional foods, and dietary supplements. It is added to food to support gut health and has a long history of safe use in fermented dairy products and infant formulas across multiple markets.
Safety summary
L. rhamnosus is broadly recognised as safe for healthy adults; multiple FDA GRAS notices and EFSA's Qualified Presumption of Safety (QPS) listing confirm this consensus. Adverse events are rare and have occurred almost exclusively in individuals with an underlying disease or compromised immune system. No virulence factors, toxigenicity genes, or clinically concerning antibiotic-resistance determinants have been identified in well-characterised strains, though intrinsic vancomycin resistance is common to the species and should be monitored.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| Health Canada (Canada) | Approved | L. rhamnosus is accepted for use in food products in Canada; specific probiotic health claims are subject to separate regulatory review by Health Canada.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | L. rhamnosus holds Qualified Presumption of Safety (QPS) status from EFSA for use in food and as a feed additive; EFSA recommends continued surveillance of the species. Antibiotic susceptibility to ampicillin, erythromycin, gentamicin, streptomycin, and tetracycline must be confirmed at strain level; intrinsic vancomycin resistance is considered non-transferable.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Lactobacillus spp. including L. rhamnosus are permitted as probiotics under the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. Probiotic properties must be substantiated; labelling must include genus, species, strain designation, viable count at end of shelf life, and recommended serving size. ICMR-DBT guidelines provide additional guidance.source |
| FDA (Food and Drug Administration) (United States) | Approved | Multiple strains (e.g., MP108, DSM 33156, ATCC PTA-126815, CBT LR5, CGMCC 21225) have received GRAS no-objection letters from FDA for use in beverages, cereals, dairy, grain products, confections, and foods for infants (excluding infant formula) at up to 1×10⁹ CFU/serving. |
Who should approach with care
Research citations
- 1FDA. GRAS Notice (GRN) 1240 Agency Response Letter – Lactobacillus rhamnosus ATCC PTA-126815. fda.gov
- 2EFSA. Safety and efficacy of Lactobacillus rhamnosus CNCM I-3698 and Lactobacillus farciminis CNCM I-3699 as a feed additive for all animal species. ncbi.nlm.nih.gov
- 3PubMed. Tolerance and safety of the potentially probiotic strain Lactobacillus rhamnosus PRSF-L477: a randomised, double-blind placebo-controlled trial in healthy volunteers. pubmed.ncbi.nlm.nih.gov
- 4PubMed. Adherence capability and safety assessment of an indigenous probiotic strain Lactobacillus rhamnosus MTCC-5897. pubmed.ncbi.nlm.nih.gov
- 5FDA. GRAS Notice 1084 – Lactobacillus rhamnosus CBT LR5, 2023. fda.gov
- 6FSSAI. FSS (Health Supplements, Nutraceuticals, FSDU, FSMP, Functional Food and Novel Food) Regulations Compendium, 2021, 2021. fssai.gov.in
