Aspartame's FDA Approval Process Shows Significant Flaws

Aspartame's FDA Approval Process Shows Significant Flaws
By Dr. Janet Starr Hull
Illustrations by Lynn Townsend Dealey

All too often I hear people excuse the negative health effects of diet sweeteners because the products are "FDA approved."   Well, FDA approval may not be something the American consumer can actually depend upon anymore, like in days past. The FDA rules and regulations for the approval of food additives is a standard procedure for every applicant, but it has some serious flaws that need to be addressed. ¹

Basically, all the FDA is responsible for is reviewing the summaries of research conducted by the company applying for approval, typically from scientific studies the applicant has pay-rolled and performed in-house.   Then, the same company presents their explanation why their product should be allowed in the public food supply based on their research. At the very least, these research reports are debatable, yet rarely reviewed by independent researchers independent of the industry. ²

Interestingly, as with the case of aspartame approval, the FDA Bureau of Foods does not perform its own clinical testing, but the Bureau of Drugs does. The Bureau of Drugs reviewed the clinical tests for aspartame and found them to be unacceptable.   They then returned the test results to The Bureau of Foods with recommendations on how to conduct acceptable clinical tests.

Aspartame's FDA Approval Process Shows Significant Flaws: Aspartame's approval is a perfect example of what can be skewed and go wrong in the FDA approval process.

Let me rewind the history tapes for a moment.   In 1965, Jim Schlatter, a chemist at G.D. Searle & Company was working on a project to discover new treatments for gastric ulcers . He accidentally spilled some of the heated chemical on his hand. Later he licked his finger as he reached for a piece of paper, and noticed the sweet taste. He and a friend decided to test some in coffee and both agreed the chemical had a sweet taste. The result: aspartame - two amino acids bonded by free methanol. The manufacturer (G.D. Searle) merely changed the paperwork submitted to the FDA from drug to food additive, but did not change the substance itself. But, the FDA did not go for it.

By March 1973, G.D. Searle submitted their final research on aspartame, along with the first petition to the FDA for aspartame approval in foods.   In 1974, the FDA approved aspartame for use in carbonated beverages and in dry products.   But in December 1975, the FDA task force concluded that some of Searle's studies were questionable and the FDA withdrew the 1973 aspartame approval. But G.D. Searle continued to push for re-approval of aspartame as a sweetener, not a drug.

In October 1980 after great controversy and corporate pressure to re-approve aspartame, a Public Board of Inquiry (PBOI) was impaneled by the FDA to evaluate aspartame safety. The Board found that aspartame caused an unacceptable level of brain tumors in animals tested.   Based on this fact, the PBOI ruled that aspartame should not be added to the food supply. One year later, aspartame was shockingly granted approval.

This debatable re-approval kicked-off over two decades of maneuvering, manipulating and dissembling of the truth behind aspartame's dangers and G.D. Searle 's (NutraSweet's) monopoly of the American sweetener market. Selling this "ulcer medication" as a food additive to hundreds of millions of healthy people every day meant many more dollars than limited sales to the much smaller group of ulcer sufferers. And, new medications were created to combat the side effects caused from aspartame use - side-effects such as migraine headaches, PMS, sexual dysfunction, sleep apnea, hair loss, and hyperactivity.

How could all this really happen? Well, there were apparently some questionable decisions behind the FDA approval of aspartame, no doubt, and it appears aspartame approval was not for the benefit of the consumer. Here's why, according to Jim Turner, Washington consumer attorney and author of The Chemical Feast: The Nadar Report on the Food and Drug Administration. Turner has actively opposed aspartame's approval since the 1970s.

"Searle, a drug company with little experience in food regulations, began studies on aspartame to comply with the FDA approval process -- but they failed to do so," states Turner. The early tests of the chemical additive showed it produced microscopic holes and tumors in the brains of experimental mice, epileptic seizures in monkeys, and was converted by animals into dangerous substances, including formaldehyde.

In 1974, however, in spite of the information in its files, the FDA approved aspartame as a dry-foods additive. But the agency also made public, for the first time, the data supporting the food-additive decision. This data was then reviewed by renowned brain researcher Dr. John Olney from Washington University in St. Louis, as well as other research scientists.

Dr. Olney discovered two studies showing brain tumors in rats and petitioned the FDA for a public hearing. Consumer Action for Improved Foods and Drugs, represented by Mr. Turner, also petitioned for a public hearing based on "the approval process having been founded on 'sloppy' science", and on the reports showing aspartame caused epileptic seizures in monkeys and damage to the human eye.

Dr. Olney had already demonstrated in laboratory studies that aspartic acid (forty percent aspartame) caused microscopic holes to form in the brains of rats after each feeding. Aspartame also includes fifty percent phenylalanine, which is proven to harm children with PKU, and methyl (wood) alcohol, which is a carcinogen and extremely neurotoxic in large amounts.

Faced with this array of possible health dangers, the FDA granted the hearing requests. In lieu of withdrawing its aspartame approval, the agency requested that Searle refrain from marketing the sweetener until after completion of the hearing. It then proposed that a Public Board of Inquiry (PBOI) review the matter.

In July of 1975, as the FDA prepared for the PBOI review - an FDA inspector conducted a routine inspection of Searle's Skokie, Ill. testing facilities, and found many "deviations" from proper procedure protocols.   This report led the FDA commissioner, at the time, to empanel a Special Commissioner's Task Force to review Searle's laboratories.

In December of 1975, the Task force reported serious problems with Searle's research on a wide range of products, including aspartame.   It found eleven other pivotal studies conducted in a manner so flawed that it raised more doubts concerning aspartame's safety, and created the possibility of serious criminal liability for G.D. Searle.

The FDA then delayed aspartame's approval.   It also contracted, over serious internal objection from several FDA representatives, a group of university pathologists (curiously at Searle's expense) to review most of the studies, and a task force was eventually set up to review three selected studies. The U.S. Attorney for Chicago requested a grand jury review of a 1960s monkey seizure study.

The pathologists paid by Searle only reviewed one part of Searle's laboratory protocols:

1. Searle's failure to properly report data

They did not re-open the study's design or conduct protocols.

The Searle-funded pathologists found no serious problems.   The FDA task force, on the other hand, found Searle's key tumor safety study unreliable, but their recommendations were ignored. FDA Chief Counsel Richard Merrill submitted a thirty-three-page letter to U.S. attorney Samuel Skinner recommending a grand jury investigation into G.D. Searle "for concealing material facts and making false statements in reports of animal studies to establish the safety of aspartame." Two specific studies of concern were cited. No action was taken, and Skinner allowed the statue of limitations to run out. Along with two of his aides, Skinner joined Searle's law firm shortly after that.

During the time period these committees met, the FDA organized the PBOI.   G.D. Searle and the FDA Bureau of Foods each nominated three members for the board, and the FDA commissioner selected one member from each list they submitted.   In October 1980, based on its limited review, the board blocked aspartame marketing until the tumor studies could be explained. Unless the FDA commissioner overruled the board, the matter was closed.

The next month in November 1980, Ronald Reagan was elected U.S. President. Donald Rumsfeld (former congressman from Skokie, Illinois, former White House Chief of Staff, and twice former Secretary of Defense) had been President of G.D. Searle since January 1977. He left Searle and joined the Reagan transition team.   A full court press began against the FDA's board decision to suspend aspartame approval.

In meetings a few months later in January 1981, Rumsfeld told a corporate sales meeting attendee that he would call in his chips and get aspartame approved by the end of the year. On January 25th, the day President Reagan took office, the previous FDA commissioner's authority was suspended, and the next month, the appointed commissioner's job went to Dr. Arthur Hull Hayes.

According to Turner, transition records do not show why the administration chose Dr. Hayes, a professor and Defense Department contract researcher.   In July of that year, Dr. Hayes, defying the FDA aspartame, approved aspartame for dry foods - his first major decision in office. In November 1983, the FDA approved aspartame for soft drinks - Hayes' last decision.

By November 1983, Hayes was under fire for accepting corporate gifts, and left the agency to work at Searle's public-relations firm as senior medical advisor. Shortly after the FDA soft-drink approval, Searle began test marketing, and complaints began to arrive at the FDA's doorstep, such as:

• Dizziness
• Blurred vision
• Headaches
• Seizures

The complaints were more serious than the agency had ever received on any food additive. At the same time, independent research scientists began looking more closely at the dangers of this manufactured chemical sweetener.

In 1985, the FDA asked the Centers for Disease Control (CDC) to review the first 650 complaints on aspartame (there were over 10,000 registered complaints as early as 1991).   The CDC realized that the symptoms in approximately twenty-five percent of the complainants stopped and then restarted, either purposely or by accident, when aspartame use was stopped and then restarted. The FDA discounted their report.

Time progressed and aspartame use increased, and according to data released by 1995, human brain tumors, like those in the animal studies, had risen ten percent, and previously benign tumors grew forcefully.   Searle and the FDA deputy commissioner defended that the data posed no problem. Two years later, this FDA deputy commissioner became vice president of clinical research for Searle. ³

From 1985 to 1995, approximately 400 aspartame research studies were performed both by Searle researchers and independent scientists. Most interestingly, those studies finding no problems with aspartame were one hundred percent funded by G.D. Searle. All studies funded by non-industry sources raised very serious questions and doubts concerning aspartame's safety in the public food supply.

"Given this record, it is little wonder that many health-conscious people believe avoiding NutraSweet improves their quality of life," states Turner, "If and when a scientific consensus concludes that aspartame puts some, if not all , of its consumers at risk, it will be much too late. The point is to eat safely now. Remember: the brain you save may be your own."

¹ Hull, JS. Sweet Poison: How The World's Most Popular Artificial Sweetener Is Killing Us-My Story. New Horizon Press, 1997.

² http://www.cfsan.fda.gov/~lrd/foodaddi.html

³ Hull, JS. Sweet Poison: How The World's Most Popular Artificial Sweetener Is Killing Us-My Story. New Horizon Press, 1997.

Posted on April 28, 2006 in FDA | Link

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