The need for human data: the role of clinical trials and postmarketing surveillance in the safety assessment of macronutrient substitutes.

It seems self-evident to me that macronutrient substitutes are important additions to the medical, dietetic, and individual armamentarium for maintenance and/or improvement of overall health status. This is particularly true given the enormous amount of obesity in our population. Regarding clinical trials and postmarketing surveillance, there are two basic principles that stand out to me: 1. Clinical trials are absolutely necessary for marketing, but the extent of such trials is a function of the specific food or ingredient under consideration. 2. Postmarketing surveillance may or may not be necessary or desirable, depending on the possibility of adverse effects after prolonged consumption.