Live Biotherapeutic Products
What the US FDA means by a live biotherapeutic product, how it differs from a probiotic supplement, and which examples are approved or still in trials.
Content last updated . This page has not been medically reviewed.
The definition
In its guidance for trial sponsors (June 2016), FDA defines a live biotherapeutic product (LBP) as a biological product that contains live organisms such as bacteria, is applicable to preventing, treating or curing a disease or condition in people, and is not a vaccine. [1] The guidance says LBPs are not filterable viruses, oncolytic bacteria or gene therapy agents and, as a general matter, are not given by injection. [1] This is a US regulatory definition read 2026-10-22; other countries use their own terms.Why the word matters
The label depends on the claim, not the organism. FDA's guidance says it covers LBPs including those lawfully marketed as foods such as conventional foods and dietary supplements when they are proposed for clinical uses regulated as biologics. [2] In other words, the same kind of organism can be a food or supplement in one setting and an investigational medicine in another. The label of a probiotic supplement is not a sign that it was tested as a medicine. NCCIH notes probiotics can be found in yogurt and other fermented foods, dietary supplements and beauty products, and that most of the time it is unknown which probiotics help. [3] Ingredient guides stay in Supplements: see Probiotic Supplements Explained and Probiotic Strains and Labels.What the guidance covers
The guidance is about chemistry, manufacturing and control information for early clinical trials, in a sponsor's investigational new drug application. It applies whether the trial is commercial or academic. [2] It is a document for developers, not a consumer safety statement.Examples and their status
Evidence labels: approved medicine, promising but limited, insufficient evidence.| Example | What it is | Status from sources read |
|---|---|---|
| REBYOTA | Product made from donor stool microbes | US FDA-approved to prevent recurrent C. difficile infection in adults [4] |
| VOWST | Product made from purified donor stool spores | Same type of indication in adults [5] |
| VE303 | Defined mix of 8 Clostridia strains | Phase 2 trial; larger phase 3 needed [6] |
| Pasteurized Akkermansia | Single-species product | One small exploratory trial [7] |
An integrated safety analysis calls REBYOTA the first microbiota-based live biotherapeutic product approved by FDA. [8] Whether other regulators use the same category was not verified; the EDQM pages that describe a European standard for these products could not be read (HTTP 403), so no European claim is made.
How to evaluate claims
- "Clinically studied" on a supplement does not mean it was studied as a medicine for the claimed use.
- A trial registration proves nothing about effectiveness.
- Check whether a regulator approved the exact product and indication.
Related guides
Defined Microbial Products, Fecal Microbiota-Based Therapies and Probiotics vs Microbiota-Based Medicines.Frequently asked questions
What is a live biotherapeutic product?
A biological product with live organisms, aimed at preventing, treating or curing a disease, and not a vaccine, per FDA's guidance. [1]
Is a probiotic supplement an LBP?
Not automatically. It depends on whether it is proposed for a clinical use regulated as a biologic. [2]
Which LBPs are approved?
In the US, FDA lists REBYOTA and VOWST for preventing recurrent C. difficile infection. [4][5]
Can LBPs be injected?
FDA's guidance says as a general matter they are not given by injection. [1]
Do LBPs treat gut conditions in general?
No. Approval is for a named indication only.
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
Safety
Live organisms can cause infection, particularly in very ill people or those with weakened immunity; NCCIH says risk of harmful effects from probiotics is greater in people with severe illnesses or compromised immune systems. [3] Product-specific safety comes from trials, for example the five-trial REBYOTA analysis, which found no infection traced to the product. [8] Clinicians, not product labels, should guide use. See Probiotic Safety.
References
- US FDA, Early Clinical Trials With Live Biotherapeutic Products: CMC Information (guidance PDF, June 2016). Read 2026-10-22.
- US FDA, Early Clinical Trials With Live Biotherapeutic Products: CMC Information (guidance page). Read 2026-10-22.
- NCCIH, Probiotics: Usefulness and Safety. Read 2026-10-22.
- US FDA, REBYOTA product page. Read 2026-10-22.
- US FDA, VOWST product page. Read 2026-10-22.
- VE303, a defined bacterial consortium, for prevention of recurrent C. difficile infection: randomized clinical trial. JAMA 2023. PubMed 37060545. Read 2026-10-22.
- Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: proof-of-concept exploratory study. Nat Med 2019. PubMed 31263284. Read 2026-10-22.
- Safety of fecal microbiota, live-jslm (REBYOTA) in recurrent C. difficile infection: five prospective trials. Ther Adv Gastroenterol 2023. PubMed 37333464. Read 2026-10-22.
Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.