The De Simone Formulation Visbiome® contains the same formulation found in VSL#3®* produced before January 31, 2016 (the “De Simone Formulation”). In the early 1990s, Professor Claudio De Simone invented The De Simone Formulation, a high potency, eight strain probiotic product intended to aid individuals with gastrointestinal distress. Professor De Simone’s original partners – VSL Pharmaceuticals’ distributors – previously sold his extensively tested probiotic under the name VSL#3®*. In 2016, De Simone severed his relationship with VSL Pharmaceuticals. After June 2016 the VSL#3®* formulation was changed. However, the distributors continued to sell their new product under the name VSL#3®*, attempting to pass it off as the same as the original formula, while neglecting to tell customers or physicians about the change. In June 2019, a federal court issued a permanent injunction against the distributors of VSL#3®*, preventing them from linking their new formulation to the De Simone Formulation in certain ways and stopping any marketing claims that state or suggest a false continuity between the new VSL#3®* and the original De Simone Formulation. The De Simone Formulation, now found in Visbiome®, has been the subject of extensive clinical research that cannot be
attributed to other probiotics.