Essentials of European Medical Device Regulatory Affairs

Case 3 – EnteroMed Ltd Complaint to ASA

Johnson and Johnson Ltd and two members of the public challenged whether the following claims were misleading and could be substantiated, that Enterosgel could: 1. adsorb “toxins”, including pathogens and bacterial toxins, and remove them from the body, thus resulting in health benefits such as the prevention and treatment of gastrointestinal infections; and 2. treat irritable bowel syndrome (IBS). Johnson and Johnson Ltd challenged whether the following claims were misleading and could be substantiated, that Enterosgel could treat:

– 3. allergies; and – 4. gastroenteritis.

The Organisationfor Professionals inRegulatory Affairs

Case 3 – EnteroMed Ltd

• https://www.asa.org.uk/rulings/enteromed-ltd- a17-379661.html

The Organisationfor Professionals inRegulatory Affairs