Essentials of European Medical Device Regulatory Affairs

Case 3 – EnteroMed Ltd.

Two ads for an oral gel, seen in February, March and June 2017: a. A web page, seen on www.enteromed.co.uk, describing the uses of Enterosgel, and related linked pages, stated, “ENTEROSGEL as an oral intestinal adsorbent has a capacity to adsorb harmful medium-weight substances such as pathogens, bacterial toxins or some allergens in the gut. Gut nasties are naturally expelled with the stool, helping towards treatment of diarrhoea, some allergies with gastrointestinal symptoms and IBS-D … ENTEROSGEL is an effective adjuvant in treatment of allergies with gastrointestinal symptoms in children and adults …

The Organisationfor Professionals inRegulatory Affairs

Case 3 – EnteroMed Ltd.

– Drug-free ENTEROSGEL is shown to help as a supportive treatment of diarrhoea dominant IBS. – Enterosgel has a positive effect, reducing abdominal pain severity and normalizing stool frequency in IBS-D patients, thus contributing to the harmonization of quality of life … – Enterosgel is developed to adsorb bacterial toxins and other harmful medium-weight molecular substances, including allergens … The unique ENTEROSGEL porous molecules are scientifically developed to adsorb harmful medium-weight substances in the stomach and gut, such as bacterial toxins, pathogens and allergens, not attaching to the good bacteria and vitamins”.

The Organisationfor Professionals inRegulatory Affairs