Abusing the FDA Approval Process

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

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. Then, the company presents their reasons why their product should be allowed in the public food supply based on their research. At the very least, the research reports are controversial, and rarely reviewed by independent researchers not related to the industry.

As with the case of aspartame approval, both the FDA Bureau of Foods and the Bureau of Drugs were involved in its approval because aspartame was first submitted for FDA approval as an ulcer drug. The FDA Bureau of Foods is never required to perform any clinical testing on submissions, but the Bureau of Drugs is required to test products submitted for drug approval. The Bureau of Drugs reviewed the clinical tests for aspartame and found them to be unacceptable. They then returned them to The Bureau of Foods with recommendations on how to request acceptable clinical tests from Monsanto.

The same thing happened with sucralose approval. The FDA review board did not accept the tests originally submitted by McNeil Nutritionals for sucralose, and sucralose was determined not to be conclusively safe for public approval. The unacceptable test studies were performed on rats, rabbits, and dogs at levels of three percent sucralose, and when re-submitted at a lower one percent dose, the tests passed the approval process.

The FDA determined an ADI (Acceptable Daily Intake) of 500-mg/kg bw/d as safe for sucralose consumption. But, the FDA does not have the power to rule on an individual's overuse of the product exceeding the ADI, nor on the combination of chemical sweeteners in sweetener blends. Technically their job is to determine the safe acceptable intake value of sucralose for proportional animal body weight.

So, what happens if you DO consume above the safe recommended daily allowance for sucralose? Do you ever keep track of exactly what that is for you or for your child? Do you know the ADI for aspartame and the other chemical sweeteners? Have you consumed too much by the end of the day? The FDA is technically required to consider this fact.

The best example of defects in the FDA approval system is the cancer warning falsely placed on saccharin. Beth Hubrich is a dietitian with the Atlanta-based Calorie Control Council, an advocacy group representing the makers of several artificial sweeteners. Hubrich states that the flaws in the early saccharin studies in which rats were fed huge doses of saccharin and cyclamate, are well documented, yet the results of more than thirty subsequent human studies found no cancer link.

According to Hubrich, these studies were industry sponsored because the FDA required the industry to do the research. So this puts the corporations on some sort of "honor system", trusting these mega-corporations and Big Pharma to be honest about research findings that could cost them billions of dollars in profits.

Aspartame's FDA Approval Process Shows Significant Flaws

Aspartame approval is an example of how data can be "skewed" by a corporation going through the FDA approval process. In October 1980, a Public Board of Inquiry (PBOI) was impaneled by the FDA to evaluate aspartame safety. The PBOI found that the chemical caused an unacceptable level of brain tumors in animal testing. Based on this fact, the PBOI ruled that aspartame should not be added to the food supply. One year later, it was surprisingly granted approval.

This ruling kicked-off over two decades of maneuvering, manipulating and dissembling of the truth behind aspartame dangers and Monsanto's monopoly of the American sweetener market. Selling this ulcer chemical as a sweet food additive to hundreds of millions of healthy people every day was much more profitable than limiting sales to the much smaller group of ulcer sufferers.

How could this 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. According to Jim Turner, Washington consumer attorney and author of The Chemical Feast: The Nadar Report on the Food and Drug Administration, Searle, a drug company with little experience in food regulations, began studies on aspartame to comply with the FDA approval process for drugs -- but they failed to get approval. 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 and DKP.

In 1974, however, in spite of the information in the 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, Washington University in St. Louis, as well as other research scientists throughout the world.

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 is 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 problem 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 about aspartame 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 the 1960s monkey seizure study.

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

  1. Their failure to properly report data
  2. But not the study's design or conduct

They 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. The U.S. Attorney, at that time, allowed the statute of limitations to run out, and along with two of his aides, joined Searle's law firm shortly after the investigation.

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, Ill, former White House Chief of Staff, and 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 FDA commissioner's job went to Dr. Arthur Hull Hayes.

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 advisors, 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 go to 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 visionHeadaches
  • Seizures

The complaints were more serious than the agency had ever received on any food additive. At the same time, scientists began looking more closely at this manufactured chemical sweetener, while the consumer complaints increased; complaints mirroring the research results on aspartame safety as early as the 1960s.

In 1985, the FDA asked the Centers for Disease Control (CDC) to review the first 650 complaints. 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 took no action based on their report. By 1992, there were over 10,000 registered complaints, but the FDA stopped filing aspartame complaints as specific to aspartame use, placing them in categories specific to the complaints, such as seizures and headaches, NOT as aspartame.

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. Monsanto 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 the company producing aspartame.

From 1985 to 1995, approximately 400 aspartame research studies were performed both by Searle/Monsanto researchers and independent scientists. Most interestingly, those studies finding no problems with aspartame were one hundred percent funded by G.D. Searle/Monsanto. 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 public consensus concludes that aspartame puts some, if not all, consumers at risk, it may be much too late. The point is to eat safely now. Remember: the brain you save may be your own.

Posted April 2008 | Permanent Link

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