Against all odds: How aspartame was approved by FDA

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The story of Aspartame- from banned to approved

In December 1965, James Schlatter, who was a chemist at G.D. Searle, accidentally discovered aspartame, a white odorless substance that is 200 times sweeter than sugar but has no calories. Shortly after the discovery, G.D. Searle started safety tests on aspartame that are necessary before applying for FDA approval of food additives.

On behave of G.D. Searle Company, Dr. Harold Waisman, a biochemist at the University of Wisconsin, ran safety tests on infant monkeys to see if aspartame is safe enough for human consumption. There were seven monkeys included in the research and all were fed with the mixture of aspartame and milk. At the end of the research, one monkey died and five others had grand mal seizures (a serious form of epilepsy with muscle spasms and prolonged loss of consciousness). G.D. Searle never submitted the test results to the FDA.

Neuroscientist Dr. John Olney (responsible for removing monosodium glutamate from foods for babies) informed the G.D. Searle Company that his studies on aspartame showed rather disturbing results, that is, that aspartic acid (one of the ingredients of aspartame) caused holes in the brains of infant mice. But even then the G.D. Searle Company applied for FDA approval and submitted over 100 studies to support aspartame’s safety.

A study showed that Aspartic acid causes holes in the brain of infant mice.

FDA scientists said that the information provided by G.D. Searle Company was inadequate and that further clinical tests were needed in order to make the final decision, but only one month later FDA approved the usage of aspartame in dry foods.

Couple of months later, Jim Turner (consumer advocate who was crucial in getting cyclamate off the market) and Dr. John Olney filed the objections against aspartame’s approval. Their petition led to an FDA investigation that found G.D. Searle’s testing procedures full of inaccuracies and manipulated data and they requested a criminal investigation. This was the first time in the history of FDA that they requested a criminal investigation of a manufacturer.

They found that 98 of 196 animals died during one of G.D. Searle’s studies and were not autopsied long after their death, in some cases more than one year after death. A mass, a uterine polyp, and ovarian neoplasms were found in animals but not reported in G.D. Searle’s reports.

In 1981, after Ronald Reagan was elected for a new President of the United States, Donald Rumsfeld, CEO of G. D. Searle Company, became a member of Regan’s team and decided that Dr. Arthur Hull Hayes Jr. should be the new FDA Commissioner.

Aspartame is also known as NutraSweet, Canderel and Amino Sweet

Even though, three of six FDA scientists (Dr. Robert Condon, Dr. Satya Dubey, and Dr. Douglas Park), advised against approval of Aspartame, saying that the G.D. Searle tests were unreliable to determine the safety of aspartame, Dr. Arthur Hayes Jr., the new FDA commissioner, ignored the Public Board of Inquiry and the recommendations of his own internal FDA team and approved NutraSweet (Aspartame) for dry products.

Furthermore, in 1983, the National Soft Drink Association (NSDA) advised the FDA to delay approval of aspartame in carbonated beverages because it is very unstable in liquid form and it breaks down into DKP (diketopiperazine) and formaldehyde, both known as toxins when stored in temperatures above 85 degrees Fahrenheit (30 degrees Celsius). Even so, FDA approved the use of aspartame in carbonated beverages and syrup bases.

The first carbonated beverages containing aspartame were sold for public consumption in the Fall of 1983.

100% of the research funded by the G.D. Searle company confirmed aspartame’s safety but 92% of the independently funded research found consuming aspartame dangerous. Six of the seven non-industry funded studies that confirmed aspartame’s safety were from the FDA.

G.D. Searle was formed by a young druggist named Gideon Daniel Searle and, in 1985, became the pharmaceutical unit of Monsanto.

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