The U.S. Food and Drug Administration (FDA) has denied two citizen petitions asking the agency to prohibit the use of aspartame as a non-caloric sweetener. Dated July 16, 2002, the first petition argued that the Public Health Security and Bioterrorism Preparedness Response Act authorizes FDA to recall dangerous chemicals without manufacturer approval. Citing studies conducted by the European Ramazzini Foundation (ERF), the second petition urged FDA to revoke approval for the sweetener under the Delaney Clause in section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act, which provides that “no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.”
Responding to these claims, FDA reasoned that the first petition and subsequent comments contained “no substantive scientific evidence demonstrating that aspartame’s use presents a public health risk or that this sweetener is adulterated or misbranded.” The agency also found that the second petition failed to include adequate data from the ERF studies or demonstrate that consumer exposure to aspartame exceeds the acceptable daily intake.
As the agency concluded, “The safety of aspartame has been reviewed repeatedly, not only by FDA, but by other regulatory authorities, including those of Canada, the United Kingdom, Australia, Europe, and Japan. All these authorities agree that aspartame is safe for the general population except for individuals with phenylketonuria.”