The reports of systemic dye absorption, its toxic implications, and its lack of sensitivity for the detection of pulmonary aspiration bring attention to the need for further investigation and regulation of the technique. It is evident that safety standards derived from healthy humans or animals cannot be translated to critically ill patients. For instance, the patients reported herein were estimated to have received approximately 1 mg/kg/d of FD&C Blue No. 1, well below the limit set by the US Food and Drug Administration (ie, 12 mg/kg/d), and both patients exhibited profound metabolic derangements prior to death. As such, it remains unclear what level of absorption, if any, can be considered safe, particularly in patients with underlying metabolic derangements or impaired GI barrier function, such as occurs during sepsis. Thus, new dosing safety standards must now be developed. Furthermore, rather than relying on changes in skin coloration, a development commonly associated with profound toxicity, more sensitive screening techniques such as quantitative spectrophotometric analysis of body fluids, including serum and urine, are needed if the use of food dyes is to be used for the detection of aspiration in critically ill patients.