Responding to objections submitted by the Natural Resources Defense Council (NRDC), the U.S. Food and Drug Administration (FDA) has confirmed its decision to allow the use of advantame as a non-nutritive sweetener and flavor enhancer in foods intended for human consumption. FDA apparently received 12 responses to its May 21, 2014, final rule on advantame, but only NRDC’s submission met the requirements for agency consideration. In particular, NRDC cited five animal studies allegedly showing that aspartame affects the hypothalamus, arguing that aspartame and advantame are “structurally related.”
But FDA disagreed with this reasoning, noting that although advantame is structurally related to aspartame, the two substances are “chemically different and metabolized differently in the human body.” As a result, the agency did not consider the health effects of aspartame when reviewing the toxicological data for advantame. As the agency concluded, “NRDC’s objection to the advantame final rule does not provide any new evidence or identify any evidence that we overlooked in our evaluation that would call into question FDA’s determination of safety for advantame… Therefore, this objection does not provide a basis for us to reconsider our decision to issue the final rule on advantame.” Additional details about the European Food Safety Authority’s safety assessment of advantame appear in Issue 492 of this Update. See Federal Register, December 24, 2014.