As the inventor of the probiotic formulation which was formerly sold under the name VSL#3, I feel that it is important to make consumers aware of major recent events concerning a product currently sold under the brand name “VSL#3®*”.
- On November 20, 2018: a Federal jury unanimously found that the sellers of VSL#3 misled the public by engaging in false and misleading advertising. Follow this link to the recent announcement of the U.S. Jury Verdict
- On November 15th 2018: it was announced that the VSL#3 product in Canada has been discontinued and is no longer available in Canada.
- In early January 2019: major retailers such as Amazon and Costco, and the wholesale distributors McKesson and Cardinal, all blocked ended the sale of VSL#3 branded products in the U.S.
- In late January 2019:the first major international treatment guideline dropped the use of the brand name “VSL#3.” The European Society for Clinical Nutrition and Metabolism issued a formal amendment to the ESPEN guideline: Clinical Nutrition in Inflammatory Bowel Disease, which changes the guideline listing name for this formulation from the trademark “VSL#3” to the generic name “De Simone Formulation.” https://bit.ly/2RrWmOg
In the early 1990s, I invented the 8-strain high potency probiotic which was ultimately studied and sold with the brand name “VSL#3®” from 2002 to 2016. This product was previously distributed under a commercial agreement between VSL Pharmaceuticals, Inc. and myself. For more than two decades, I have protected the secret formula required to produce this probiotic (also known as the “De Simone Formulation”) to ensure that patients can receive a dependable, high quality product.
When I terminated my business relationship with the VSL company, my former partners attempted to create a “knock-off” version of my formulation. This issue became the subject of recent litigation in U.S. Federal Court. During the course of the trial, extensive scientific data were presented to show that this new “VSL#3” formulation was qualitatively and quantitatively different than my original invention. On November 20, 2018, a federal jury unanimously found that the sellers of VSL#3 were liable for false and misleading advertising when selling the new VSL#3 to the public.
Now, my original formulation is available in the U.S. and Canada only under the brand name Visbiome, and is distributed by ExeGi Pharma LLC.
It is my commitment to you that we will continue to distribute these products in their original form, with the highest quality manufacturing processes available, and to ensure that patients and healthcare practitioners can rely on this formulation for decades to come.
I ask that you share this information with anyone who you think should be made aware of these recent developments.
Sincerely,
Professor Claudio De Simone
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Recent list of published research related to this matter:
- Cinque et al. 2016 – Production Conditions Affect the In Vitro Anti-Tumoral Effects of a High Concentration Multi-Strain Probiotic Preparation. https://bit.ly/2rmw318
- Cinque et al. 2017 – VSL#3 probiotic differently influences IEC‐6 intestinal epithelial cell status and function. https://bit.ly/2Edoqmb
- Trinshieri et al. 2017 – Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing. https://bit.ly/2AOGkrd
- Biagioli et al. 2017 – Metabolic Variability of a Multispecies Probiotic Preparation Impacts on the Anti-inflammatory Activity. https://bit.ly/2UgzVye