Limosilactobacillus reuteri
Limosilactobacillus reuteri, named Lactobacillus reuteri until 2020, is a heterofermentative lactic acid bacterium. Commercial strains are grown by fermentation, harvested, mixed with cryoprotectants and freeze-dried. Besides capsule and powder grades, it is often sold in oil-suspension drops and chewable tablets, so the delivery format is part of the specification. Brands usually buy a named strain at a stated CFU per gram.
Suppliers sell different products under the same name. Specify the one you need.
Pure L. reuteri powder at a high count stated in billions of CFU per gram, sold for dilution or blending by the buyer.
Concentrate diluted with a carrier such as maltodextrin, microcrystalline cellulose or potato starch to a fixed lower count, which is easier to dose in capsules, sachets and powders.
A specific strain identified by a culture-collection deposit number or a trade designation, sold with that strain's own documentation; the strain designation belongs on the specification.
Freeze-dried culture suspended in a vegetable oil such as sunflower or medium-chain triglyceride oil for drops, with the count stated per drop or per gram.
Culture coated with lipids, polysaccharides or other wall materials, or supplied in enteric or acid-resistant capsules, to limit exposure to moisture, oxygen and acid during processing and storage.
Compare each result with your own specification when the lot arrives.
Freeze-dried concentrates are usually kept frozen (around -18 °C or colder) or refrigerated, sealed in foil or other moisture- and oxygen-barrier packs, often with desiccant or a nitrogen flush. Let a cold pack reach room temperature before opening so moisture does not condense on the powder, and reseal partly used packs at once. Shelf life is set by the supplier from real-time stability counts at a stated temperature, and aged stock is retested for viable count before use.
Record the actual CFU/g on each lot's COA, since counts vary between lots and set the amount needed per batch, along with the strain designation and carrier. Rotate stock FEFO and build in the overage your stability data calls for so the finished product still meets its label count at the end of shelf life.
Facts from regulators and standards bodies, each linked to its source.
Health Canada's Probiotics monograph for natural health products lists Limosilactobacillus reuteri (formerly Lactobacillus reuteri) as a medicinal ingredient, and the licence application and label must give the strain designation.
Source: webprod.hc-sc.gc.ca (opens in a new tab)FDA's GRAS Notice Inventory lists GRN 254 for Lactobacillus reuteri strain DSM 17938, notified by BioGaia AB; it closed on November 18, 2008 with FDA having no questions. The notice covers that notifier's strain and intended use only.
Source: hfpappexternal.fda.gov (opens in a new tab)FDA's draft guidance on dietary supplements containing live microbials states its intent to exercise enforcement discretion so that firms may declare live microbial quantity in colony forming units (CFUs), in addition to the weight declaration required by regulation.
Source: fda.gov (opens in a new tab)This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.
Manufacturers and distributors whose own websites say they sell it.
Manufacturer · Lyngby, Denmark
Danish biosolutions company formed from Novozymes and Chr. Hansen that supplies probiotic strains, HMOs, dairy cultures and enzymes to supplement, infant formula and food makers.
Suppliers are in alphabetical order and none pays to appear. Each claim is checked against the supplier’s own website on the date shown. Ask for the specification sheet and a recent COA before you order, and confirm details with the supplier.
Common forms include freeze-dried concentrate, standardized dilution, named strain, oil suspension and microencapsulated or coated. Ask each supplier for the specification sheet of the exact grade they quote.
Expect viable count (CFU/g), identity, water activity, contaminant microbiology, heavy metals and allergen statement, each with its method, specification and result for that lot.
Freeze-dried concentrates are usually kept frozen (around -18 °C or colder) or refrigerated, sealed in foil or other moisture- and oxygen-barrier packs, often with desiccant or a nitrogen flush. Let a cold pack reach room temperature before opening so moisture does not condense on the powder, and reseal partly used packs at once. Shelf life is set by the supplier from real-time stability counts at a stated temperature, and aged stock is retested for viable count before use.
Health Canada's Probiotics monograph for natural health products lists Limosilactobacillus reuteri (formerly Lactobacillus reuteri) as a medicinal ingredient, and the licence application and label must give the strain designation. FDA's GRAS Notice Inventory lists GRN 254 for Lactobacillus reuteri strain DSM 17938, notified by BioGaia AB; it closed on November 18, 2008 with FDA having no questions. The notice covers that notifier's strain and intended use only. FDA's draft guidance on dietary supplements containing live microbials states its intent to exercise enforcement discretion so that firms may declare live microbial quantity in colony forming units (CFUs), in addition to the weight declaration required by regulation.
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