How Aspartame Became Legal?
November 9, 2012 in Health
January 10, 1977– The FDA formally requests the U.S. Attorney’s office to begin grand jury proceedings to investigate whether indictments should be filed against Searle for knowingly misrepresenting findings and “concealing material facts and making false statements” in aspartame safety tests. This is the first time in the FDA’s history that they request a criminal investigation of a manufacturer.
January 26, 1977– While the grand jury probe is underway, Sidley & Austin, the law firm representing Searle, begins job negotiations with the U.S. Attorney in charge of the investigation, Samuel Skinner.
March 8, 1977– G. D. Searle hires prominent Washington insider Donald Rumsfeld as the new CEO to try to turn the beleaguered company around. A former Member of Congress and Secretary of Defense in the Ford Administration, Rumsfeld brings in several of his Washington cronies as top management.
July 1, 1977– Samuel Skinner leaves the U.S. Attorney’s office and takes a job with Searle’s law firm. (see Jan. 26th)
August 1, 1977– The Bressler Report, compiled by FDA investigators and headed by Jerome Bressler, is released. The report finds that 98 of the 196 animals died during one of Searle’s studies and weren’t autopsied until later dates, in some cases over one year after death. Many other errors and inconsistencies are noted. For example, a rat was reported alive, then dead, then alive, then dead again; a mass, a uterine polyp, and ovarian neoplasms were found in animals but not reported or diagnosed in Searle’s reports.
December 8, 1977– U.S. Attorney Skinner’s withdrawal and resignation stalls the Searle grand jury investigation for so long that the statue of limitations on the aspartame charges runs out. The grand jury investigation is dropped.
June 1, 1979– The FDA established a Public Board of Inquiry (PBOI) to rule on safety issues surrounding NutraSweet.
September 30, 1980– The Public Board of Inquiry concludes NutraSweet should not be approved pending further investigations of brain tumors in animals. The board states it “has not been presented with proof of reasonable certainty that aspartame is safe for use as a food additive.”
January 1981– Donald Rumsfeld, CEO of Searle, states in a sales meeting that he is going to make a big push to get aspartame approved within the year. Rumsfeld says he will use his political pull in Washington, rather than scientific means, to make sure it gets approved.