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.


Issue 550

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.