If a manufacturer wishes to refer to data collected through clinical trials to make claims about a product’s effectiveness and safety, then the product it is selling must be the same product used in the clinical trials.
We, the undersigned, are medical doctors, scientists and experts in the field of gastrointestinal disorders.
Each of us recognizes the medical need for probiotic products properly studied, manufactured, and standardized for use in the dietary management of inflammatory bowel diseases and other conditions.
If the manufacturer wishes to refer to data collected through clinical trials to make claims about the product’s effectiveness and safety, then the product it is selling must be the same product used in the clinical trials.
When the product, especially in the case of a high concentration multistrain probiotic product, is intended to be part of the dietary management of individuals who may be immunosuppressed, safety of those individuals is of paramount importance and should have been extensively assessed previously.
