tim's journal

More on the FDA approval of aspartame

I found a brief case study on the approval of aspartame in Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies: Workshop Summary from the Institute of Medicine [1]. In this account, the approval process is framed with considerably less hype and with very thorough references, e.g., FDA documents.

In 1973, midst the controversies surrounding the use of cyclamate and saccharin, G.D. Searle & Co. submitted a food additive petition for aspartame. This was approved certain "dry" uses, i.e., as a tabletop sweetener and in cold breakfast cereals, powdered beverages, desserts, dessert toppings and chewing gum, but with a caveat. Labels of products containing the sugar substitute were to include the statement "Phenylketonurics: Contains Phenylalanine" as a warning to those with a rare genetic defect preventing the metabolism of phenylalanine, a chemical component of aspartame. Thus, the impression that I and some others may have made that aspartame had been actively rejected by the FDA until Commissioner Hayes is incorrect.

Following the FDA's approval, a number of individuals filed objections and requested a hearing. In conjunction with data discrepancies by a contract laboratory in the toxicological testing of other substances, the agency decided to stay the approval's effective date pending a hearing. Four years later, the FDA convened a three-member Public Board of Inquiry to conduct the hearing. This was quite unusual. Under most circumstances, such a hearing is conducted by an Administrative Law Judge. In this case, the objectors agreed to a modified procedure in which the objectors submitted a list of names from which Board members were then selected.

The Board, while agreeing with the FDA's assessment that aspartame posed no risk to causing brain damage or neuroendocrine function, nevertheless recommended against approval due to unresolved questions regarding brain tumors discovered in rodent studies. This was rejected by the Commissioner who affirmed the original ruling in 1981. It should be mentioned that the case study fails to mention that the Commissioner had been freshly appointed by the Reagan administration. In his decision, the Commissioner commented that "[few] compounds have withstood such detailed testing and close scrutiny". One year later, as a floor amendment to a bill amending the Orphan Drug Act, Searle was granted a patent term extention "to restore some of the time lost during the lengthy delays in securing final FDA approval". This amendment was proposed by Hon. Henry Waxman, who explained it simply as "the Senate amendment extends the patent for a food additive".

In 1982, Searle petioned to have the ruling amended to allow the use of aspartame in carbonated beverages. This was approved the following year. Though several persons filed objections requesting an immediate stay and a public hearing, these were rejected without hearing. In 1985, Community Nutrition Inst., a consumer group, brought a judicial challenge to approval for use in carbonated beverages. The court affirmed the FDA ruling, finding that "the FDA properly denied a hearing after finding that petitioners have raised no material issue regarding the safety of the wet use of aspartame".

Subsequently, the FDA continued to approve additional uses, each time rejecting objections and denying hearing requests, finally approving a petition that aspartame be permitted for use as a general purpose sweetener in 1996.

References
[1] Institute of Medicine . Food Forum, Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary, Washington, D.C.: National Academy Press, 1999.