There is only ONE De Simone Formulation
Now known under the name CDS22-formula, the De Simone Formulation (DSF) is the same probiotic blend that was previously marketed as VSL#3®* by VSL Pharmaceuticals Inc. and Actial S.r.l.
However, since February 2016, the product sold under the name VSL#3®* no longer contains the original formulation known as the De Simone Formulation.
In 2019, the distributors of VSL#3®* were found liable in the United States for false advertising and ordered to pay $18 million in damages, along with a permanent injunction against further misleading communications.
Following this, the European Crohn’s and Colitis Organisation (ECCO) updated its guidelines to clarify that all scientific references prior to 2016 mentioning VSL#3®* refer exclusively to the De Simone Formulation (DSF) (ECCO, ECCO News, 2023). Supporting this, in 2024, the European Society for Clinical Nutrition and Metabolism (ESPEN) published an article titled “Clarifying Correct Attributions in Scientific Literature: The Case of the De Simone Formulation and VSL#3®”, reinforcing the need to distinguish clearly between DSF and the later formulations sold under the VSL#3®* brand.
In 2025, a federal class action lawsuit was admitted in the United States alleging fraud: consumers claim that distributors continued to sell VSL#3®* as if it contained the original formulation by Prof. Claudio De Simone, despite knowing that the composition had been changed in 2016 and lacked evidence of efficacy.
*VSL#3® is a registered trademark of VSL Pharmaceuticals Inc. and Actial S.r.l., independent companies unrelated to EOS2021 S.r.l.
The original De Simone Formulation is now available under:
- Visbiome® (ExeGi Pharma LLC) in the United States and Canada
- De Simone Formulation® (Hecto Healthcare Co. Ltd.) in the Republic of Korea
Now available in the EU & UK under the brand CDS22-formula.
