Why the Sellers of VSL#3® Were Found Liable For False Advertising

Following four years of litigation against imitators, Visbiome has emerged victorious and its inventor, Professor Claudio De Simone, has been vindicated for his tireless efforts and ingenuity.    

The timeline:

• 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 and its distributors – previously sold his extensively tested probiotic under the name VSL#3*.

• In 2016, De Simone severed his relationship with VSL Pharmaceuticals. The company then began selling an imitation of the probiotic, instead.

• VSL continued to sell its 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 November 2018, a U.S. Federal Court unanimously found VSL liable for false advertising.

• The distributors of VSL#3 filed multiple motions for retrial. All were denied.

• In June 2019, the Court filed a permanent injunction against the distributors of VSL#3, preventing them from linking their imitation to the De Simone Formulation in other ways, such as citing clinical trials that had only been performed on the De Simone Formulation itself.

*VSL#3 is a registered trademark of VSL Pharmaceuticals Inc.  

Trust Only the Original and Genuine Formulation

VSL#3® and its distributors have continued to mislead consumers throughout the litigation process.

Ongoing False Representations by Alfasigma:

A federal jury has already unanimously found that Alfasigma has made false statements to patients and healthcare professionals. As of the date of this letter their efforts to mislead consumers continues:

Alfasigma Claims:

The Facts

Studies performed on the original probiotic formulation sold under the name “VSL#3”, “…can be relied on to show efficacy and safety of the Italian-made product.”9

-   To date, not one bridging study has been published on the new VSL#3.

-   The sole study Alfasigma relies on to establish equivalence only evaluated the genetics of the two products and not the clinical activity.10

-   The authors of that study had to issue a correction because they could not be sure that the tested product actually was commercial VSL#3.11

That genetic similarity alone is sufficient to establish the equivalence of original formulation and the new knock off VSL#3

-   Genetic similarity of live probiotic organisms is not sufficient to establish clinical equivalence.12

-   The Alfasigma position ignores the basic biological concept of “nature vs nurture.”

Regarding the recent litigation “...the verdict contained no specific findings concerning the quality, production, efficacy or safety of VSL#3.”

-   There was so much evidence presented at trial which questioned the quality, production, efficacy and safety of the new VSL#3 that the Jury could not possibly rule on every specific scientific finding.

-   The Jury looked at the totality of the of evidence and ruled unanimously that Alfasigma was falsely advertising.

New VSL#3 contains the same 8 strains as the original.9

-   At trial, significant evidence was presented to show that new VSL#3 actually only contained 7 strains as of the time of the trial.

Alfasigma claims their new product is the same as the original because the strains are genetically similar.

-   Changes in the production and fermentation methods of probiotics can result in performance changes (even when the genetics is the same).13,14,15,16

-   New VSL#3 is not fermented with the necessary dairy ingredients, which are critical to the health and vitality of these yogurt bacteria.

Alfasigma attempts to link the new VSL#3 back to the original by pointing to a few early studies performed on prototypes of the product made prior to 2000.9

-   Alfasigma fails to acknowledge that these early prototypes were created under the direction of the product inventor using his proprietary Know-How and with dairy based fermentation methods. 

-   New VSL#3 is made without dairy and without the inventor’s proprietary formula.

Alfasigma endeavors to provide scientific support for its product by citing a genetic characterization study performed by Douillard, et al.9,10

-   The study in question does not establish the clinical or genetic equivalence of the original formulation vs the new VSL#3.

- The study was performed only on individual strains given to the investigators by the company and not on commercial VSL#3 product.

- The authors of the study had to publish a correction to the original publication conceding that they had not tested commercial VSL#3 product11

- Supplementary Table 3 (Genome sequencing statistics S3 Table) of the analysis indicates that of two of the reported strains genetically correspond to the same strain, suggesting that there were only 7 strains in the VSL#3 formulation at the time of the study (Bifidobacterium_animalis_lactis_Bi_07_uid163693/NC_017867.gbk)

There is Only One De Simone Formulation – and Visbiome® Has It