Essentials of European Medical Device Regulatory Affairs

ASA – Examples of cases taken

Pro Bono Bio - TV ad and website for a healthcare company, Pro Bono Bio, promoting a topically applied gel: a. The TV ad featured a voice-over that stated, "Joint pain and stiffness? Use new drug-free Flexiseq Gel. Flexiseq helps lubricate worn and damaged cartilage and is proven to be as effective as a prescription pain-killer ... Flexiseq drug free lubrication and effective pain relief for your joints." At the beginning and end of the ad was on-screen text, that stated "NEW DRUG FREE".

The Organisationfor Professionals inRegulatory Affairs

ASA – Examples of cases taken

b. The website www.flexiseq.com featured text that stated, "What is FLEXISEQ®? FLEXISEQ is a gel containing nanostructures called Sequessome™ vesicles, which are able to cross the skin and target sites of pain ... FLEXISEQ is a pain relieving gel FLEXISEQ is a topically applied gel. FLEXISEQ is specially formulated to combat joint pain associated with osteoarthritis ... FLEXISEQ ingredients have an excellent safety profile FLEXISEQ does not contain any pharmaceutical drug, and consequently FLEXISEQ benefits from an excellent safety profile avoiding the documented risks that may be associated with many common pain medicines ...

The Organisationfor Professionals inRegulatory Affairs