Essentials of European Medical Device Regulatory Affairs

Case 3 – EnteroMed Ltd.

• An FAQ page stated, “ENTEROSGEL can be used as a supportive treatment of gastroenteritis … IBS”. • A web page entitled “Enterosgel technology” stated, “Enterosgel works like a CLEVER SPONGE adsorbing only harmful medium- weight substances in the gut (bacterial endo and exo-toxins, pathogens, allergens)” • A web page entitled “Detoxification” stated “Exposure of the gastrointestinal tract to pathogens, toxins, allergens can result in development of gastrointestinal infections, intoxication and allergic reactions. Vital bodily functions are associated with the production of harmful and toxic metabolites. Part of them having reached the gut are usually eliminated from the body with faeces, but some of harmful substances may be reabsorbed into the bloodstream again and transported back to the liver, remaining in the enterohepatic circulation … Supportive detoxification is an important step towards achieving recovery, optimal health and longevity”.

The Organisationfor Professionals inRegulatory Affairs

Case 3 – EnteroMed Ltd

b. An advertorial seen in the national press stated, “The drug- free remedy for IBS” and made a number of efficacy claims for treatment of IBS and its symptoms. It also stated, “Enterosgel … acts like a clever sponge to selectively soak up harmful substances in your gut, such as bacterial toxins, pathogens and allergens, and expels them from your body naturally”.

The Organisationfor Professionals inRegulatory Affairs