On December 3, 2009, FDA issued a warning letter to Nestle HealthCare Nutrition, Minnetonka, Minnesota, regarding their product BOOST Kid Essentials Nutritionally Complete Drink, promoted on their website as a "medical food" for the medical condition of "failure to thrive".
Q: In the December 3, 2009 warning letter to Nestle, is FDA expressing regulatory positions on the condition "failure to thrive" or the use of medical foods for "failure to thrive"?
A: No. The warning letter represents Agency action that pertains to Nestle's use of the term "failure to thrive". FDA is not taking an Agency position on the condition of "failure to thrive," nor is the Agency ruling out the possibility that there may be a medical food appropriate for a specific subset of patients that is justified and consistent with FDA's statutory definition.