Aspartame / NutraSweet
of the Aspartame Controversy
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December 1965 -While working on an ulcer
drug, James Schlatter, a chemist at G.D. Searle, accidentally discovers
aspartame, a substance that is 180 times sweeter than sugar yet has no
Spring 1967 -Searle begins the safety
tests on aspartame that are necessary for applying for FDA approval of
Fall 1967 -Dr. Harold Waisman, a biochemist
at the University of Wisconsin, conducts aspartame safety tests on infant
monkeys on behalf of the Searle Company. Of the seven monkeys that were
being fed aspartame mixed with milk, one dies and five others have grand
November 1970 -Cyclamate, the reigning
low-calorie artificial sweetener is pulled off the market after some scientists
associate it with cancer. Questions are also raised about safety of saccharin,
the only other artificial sweetener on the market, leaving the field wide
open for aspartame.
December 18, 1970 -Searle Company executives
lay out a "food and Drug Sweetener Strategy' that they feel will put the
FDA into a positive frame of mind about aspartame. An internal policy memo
describes psychological tactics the company should use to bring the FDA
into a subconscious spirit of participation" with them on aspartame and
get FDA regulators into the "habit of saying, "Yes"."
Spring 1971 -Neuroscientist Dr. John
Olney (whose pioneering work with monosodium glutamate was responsible
for having it removed from baby foods) informs Searle that his studies
show that aspartic acid (one of the ingredients of aspartame) caused holes
in the brains of infant mice. One of Searle's own researchers confirmed
Dr. Olney's findings in a similar study.
February 1973 -After spending tens of
millions of dollars conducting safety tests, the G.D. Searle Company applies
for FDA approval and submits over 100 studies they claim support aspartame's
March 5, 1973 -One of the first FDA
scientists to review the aspartame safety data states that "the information
provided (by Searle) is inadequate to permit an evaluation of the potential
toxicity of aspartame". She says in her report that in order to be certain
that aspartame is safe, further clinical tests are needed.
May 1974 -Attorney, Jim Turner (consumer
advocate who was instrumental in getting cyclamate taken off the market)
meets with Searle representatives to discuss Dr. Olney's 1971 study which
showed that aspartic acid caused holes in the brains of infant mice.
July 26, 1974 -The FDA grants aspartame
its first approval for restricted use in dry foods.
August 1974 -Jim Turner and Dr. John
Olney file the first objections against aspartame's approval.
March 24, 1976 -Turner and Olney's petition
triggers an FDA investigation of the laboratory practices of aspartame's
manufacturer, G.D. Searle. The investigation finds Searle's testing procedures
shoddy, full of inaccuracies and "manipulated" test data. The investigators
report they "had never seen anything as bad as Searle's testing."
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,
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
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
January 21, 1981 -Ronald Reagan is sworn
in as President of the United States. Reagan's transition team, which includes
Donald Rumsfeld, CEO of G. D. Searle, hand picks Dr. Arthur Hull Hayes
Jr. to be the new FDA Commissioner.
March, 1981 -An FDA commissioner's panel
is established to review issues raised by the Public Board of Inquiry.
May 19, 1981 -Three of six in-house
FDA scientists who were responsible for reviewing the brain tumor issues,
Dr. Robert Condon, Dr. Satya Dubey, and Dr. Douglas Park, advise against
approval of NutraSweet, stating on the record that the Searle tests are
unreliable and not adequate to determine the safety of aspartame.
July 15, 1981 -In one of his first official
acts, Dr. Arthur Hayes Jr., the new FDA commissioner, overrules the Public
Board of Inquiry, ignores the recommendations of his own internal FDA team
and approves NutraSweet for dry products. Hayes says that aspartame has
been shown to be safe for its' proposed uses and says few compounds have
withstood such detailed testing and repeated close scrutiny.
October 15, 1982 -The FDA announces
that Searle has filed a petition that aspartame be approved as a sweetener
in carbonated beverages and other liquids.
July 1, 1983 -The National Soft Drink
Association (NSDA) urges the FDA to delay approval of aspartame for carbonated
beverages pending further testing because aspartame is very unstable in
liquid form. When liquid aspartame is stored in temperatures above 85 degrees
Fahrenheit, it breaks down into DKP and formaldehyde, both of which are
July 8, 1983 -The National Soft Drink
Association drafts an objection to the final ruling which permits the use
of aspartame in carbonated beverages and syrup bases and requests a hearing
on the objections. The association says that Searle has not provided responsible
certainty that aspartame and its' degradation products are safe for use
in soft drinks.
August 8, 1983 -Consumer Attorney, Jim
Turner of the Community Nutrition Institute and Dr. Woodrow Monte, Arizona
State University's Director of Food Science and Nutritional Laboratories,
file suit with the FDA objecting to aspartame approval based on unresolved
September, 1983 -FDA Commissioner Hayes
resigns under a cloud of controversy about his taking unauthorized rides
aboard a General Foods jet. (General foods is a major customer of NutraSweet)
Burson-Marsteller, Searle's public relation firm (which also represented
several of NutraSweet's major users), immediately hires Hayes as senior
Fall 1983 -The first carbonated beverages
containing aspartame are sold for public consumption.
November 1984 -Center for Disease Control
(CDC) "Evaluation of consumer complaints related to aspartame use." (summary
by B. Mullarkey)
November 3, 1987 - U.S. hearing, "NutraSweet:
Health and Safety Concerns," Committee on Labor and Human Resources, Senator
Howard Metzenbaum, chairman.
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