A general postlaunch monitoring framework for functional foods tested with the phytosterol/-stanol case

The regulations and/or directives in force for functional foods primarily focus on the warrant of safety before the particular foods reach the consumer. Aspects that come into the picture after marketing are not structurally and/or regulatory dealt with at this moment. This absence of clear guidelines about responsibility, timing and contents of a postlaunch monitoring (PLM) system hamper the establishment of an internationally standardized and stakeholder-adopted framework. The current paper describes a proposal for PLM and is illustrated with a case study on phytosterols/-stanols.