Infant formula comments

FDA is reopening the comment period for a 1996 proposed rule that recommended changes to infant formula regulations regarding clinical studies and the presence of microorganisms in formula products, according to the July 31 Federal Register. The 1996 comment period first was reopened in May 2003 and several meetings have been held since, the agency notes. In addition, the Institute of Medicine issued a report in March 2004 entitled, "Infant Formula: Evaluating the Safety of New Ingredients," that discussed clinical trials. FDA asks in its current notice whether the agency should require a measure for body composition as an indicator of normal physical growth, and if so, at what measure. According to the FDA, some of the 2003 comments questioned FDA's authority to require a clinical study to measure physical growth. The IoM report, however, concluded that growth studies should "remain the centerpiece" of testing new infant formulas because "the inability of a formula to support growth represents a significant harm to infants"...