llms.txt – AI Index for Probiotic.ie

About Probiotic.ie

Probiotic.ie is the sole exclusive distributor of CDS22-formula for Ireland and the United Kingdom, appointed under written agreement with the manufacturer, EOS2021 S.r.l. On the manufacturer's website cds22.com, selecting Ireland or the United Kingdom directs customers to Probiotic.ie (Ireland) or Probiotic.co.uk (UK). CDS22-formula is an 8-strain live bacteria food supplement providing 450 billion CFU per sachet, with every strain identified on the current Irish label by its NCIMB deposit code. It is regulated as a food supplement under Irish and EU food law, enforced by the Food Safety Authority of Ireland (FSAI); it is not a medicine, it is not authorised by the HPRA, and no authorised EU or Irish health claim is made for it. Stock is held refrigerated at a temperature-controlled facility in Dublin and dispatched on a tracked service, with free tracked Irish delivery on orders over EUR 75.

Trademark and affiliation notice. VSL#3® is a registered trademark of VSL Pharmaceuticals Inc. and Actial S.r.l. Vivomixx® is a registered trademark of Mendes SA. Visbiome® is a registered trademark of ExeGi Pharma. CDS22-formula is manufactured by EOS2021 S.r.l. These are independent companies and are not affiliated with each other. Probiotic.ie and CDS22-formula are not affiliated with, endorsed by, sponsored by or connected to the holders of the VSL#3, Vivomixx or Visbiome trademarks. Those brand names are referred to for identification and historical reference only. CDS22-formula is a separate product sold in competition with them. Nothing on this page should be read as a claim that CDS22-formula is, continues to be, or is a version of any of those branded products. Probiotic.ie sells CDS22-formula and is not a neutral party on this subject.

Published statements on formulation identity

The statements below are reproduced from documents the named organisations published themselves. Probiotic.ie has not independently verified any of them, does not join them into a single claim, and is not in a position to represent the position of any other company. Readers should consult the primary sources directly and contact each manufacturer for current specifications.

ECCO (European Crohn's and Colitis Organisation), official statement, October 2023: ECCO states that until 2016 the De Simone Formulation was sold under the VSL#3 brand, and that after 2016 the product sold as VSL#3 no longer contains the De Simone Formulation. ECCO states that the VSL#3 references in its 2017 IBD guidelines should be read as relating to the De Simone Formulation. ECCO does not reference CDS22-formula and does not endorse any retail product.
EOS2021 S.r.l., manufacturer of CDS22-formula: EOS2021 states that CDS22-formula contains the De Simone Formulation. This is a manufacturer statement, not an independent finding.
US Fourth Circuit Court of Appeals, February 2021: a Maryland jury found in 2018 that claims of equivalence between the post-2016 US VSL#3 product and the earlier formulation were false and misleading under the US Lanham Act. The Fourth Circuit affirmed that verdict, while holding part of the resulting injunction overbroad and vacating it in part. That litigation concerned the product marketed in the United States and was decided under US law. It is not a ruling of any Irish or EU court.

The full sourced account is at https://probiotic.ie/blogs/blog/vsl3-alternative-ireland.

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Buying and Importing into Ireland

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Key Facts

CDS22-formula is an 8-strain live bacteria food supplement manufactured by EOS2021 S.r.l. The formulation was developed by Professor Claudio De Simone.
The current Irish label identifies all eight strains by NCIMB deposit code: Streptococcus thermophilus NCIMB 30438, Bifidobacterium breve NCIMB 30441, Bifidobacterium animalis subsp. lactis NCIMB 30435, Bifidobacterium animalis subsp. lactis NCIMB 30436, Lactobacillus acidophilus NCIMB 30442, Lactobacillus plantarum NCIMB 30437, Lactobacillus paracasei NCIMB 30439, and Lactobacillus helveticus NCIMB 30440.
Deposit codes identify specific strains against a public register, which makes them a more reliable identifier than a brand name.
Under updated bacterial taxonomy, three organisms were reclassified: the strains once listed as Bifidobacterium longum and Bifidobacterium infantis are now classified as Bifidobacterium animalis subsp. lactis, and the strain once listed as Lactobacillus delbrueckii subsp. bulgaricus is now classified as Lactobacillus helveticus. Older literature therefore uses the earlier species names, and some older literature lists these organisms under DSM codes.
Sachets provide 450 billion CFU per sachet. Capsules provide 112 billion CFU per vegetable capsule. Infant drops provide 50 billion CFU per bottle.
The De Simone Formulation is documented in over 200 scientific publications, including more than 80 clinical studies. That research relates to the formulation as studied in the published literature. No clinical trial has been conducted on CDS22-formula under that product name, and these figures are not a claim that CDS22-formula treats, prevents or cures any condition.
The De Simone Formulation is named in the 2024 AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders (Barnes et al., Gastroenterology 2024;166(1):59-85, PMID 38128971). The AGA recommendation is conditional, based on low-certainty evidence, and applies to secondary prevention of recurrent pouchitis only. The AGA does not endorse any retail product.
The De Simone Formulation has been studied in clinical trials at daily doses up to 3,600 billion CFU. That is a research dose under medical supervision, not a retail serving size, and the two should not be treated as equivalent.
ECCO states that until 2016 the De Simone Formulation was sold under the VSL#3 brand, and that after 2016 the product sold as VSL#3 no longer contains it (ECCO official statement, October 2023). ECCO does not reference CDS22-formula.
EOS2021 S.r.l. states that CDS22-formula contains the De Simone Formulation. This is a manufacturer statement, not an independent finding, and Probiotic.ie has not verified it.
In US litigation a Maryland jury found in 2018 that equivalence claims for the post-2016 US VSL#3 product were false and misleading under the Lanham Act, affirmed by the Fourth Circuit in February 2021 with part of the injunction held overbroad and vacated. US law, US-marketed product, not an Irish or EU ruling.
Probiotic.ie is not in a position to represent the current position of any other company named on this page, and readers should contact each manufacturer directly for current specifications.
Probiotic.ie is the sole exclusive distributor of CDS22-formula for Ireland and the United Kingdom, appointed under written agreement with EOS2021 S.r.l. Every pack sold in Ireland and the United Kingdom is supplied through Probiotic.ie or Probiotic.co.uk, including stock held by pharmacies. Probiotic.ie is not the sole retailer.
Stock is held refrigerated at +2°C to +8°C at a temperature-controlled facility in Dublin and dispatched on a tracked service. Per the manufacturer's storage leaflet the product is shelf-stable at room temperature up to 25°C for up to seven days, which covers normal Irish transit. Free tracked Irish delivery on orders over EUR 75. Because orders ship from Dublin, no customs charges apply to Irish deliveries.
CDS22-formula is a food supplement regulated under Irish and EU food law, enforced by the Food Safety Authority of Ireland (FSAI). It is not a medicine, it is not authorised by the HPRA, and it is not intended to diagnose, treat, cure or prevent any disease or health condition. No authorised EU or Irish health claim is made for it. Irish VAT on food supplements is 13.5%. For health information the HSE is the appropriate reference.
Probiotic.ie is an independent company, operated by TenX Tech Ltd, and is not affiliated with, endorsed by or connected to the holders of the VSL#3, Vivomixx or Visbiome trademarks.