The authenticity of probiotic foods and dietary supplements: facts and reflections from a court case

ABSTRACT There are numerous excellent papers on probiotics and food supplements’ authenticity and safety, but this article is unique compared to the others. It summarizes judicial events regarding the authenticity of a probiotic formulation (the De Simone Formulation (DSF)) commercially available under the trademark VSL#3® until 2016. In 2019, the U.S. District Court found the distributors of the “new” VSL#3® liable for having sold an untested “copy product” different from the DSF. The jury required one of the distributors to pay the owner of the DSF $15 million dollars, and the District Court entered judgment in this amount. The District Court’s monetary judgment was affirmed by the U.S. Court of Appeals in 2021. This article arises from this judicial affair to examine the rules and regulations protecting patients and doctors from misrepresentations and the potential role of class actions brought by consumers to dissuade companies from taking advantage of regulatory deficiencies.