When was aspartame approved

Searle, along with hundreds of complaints filed to the Centers for Disease Control and the potential for brain damage found after consuming large amounts of aspartame, Metzenbaum strongly emphasized the need for adequate labeling. Unfortunately, after being sent to the Senate floor, the bill failed by a vote. When questioned about the backlash and complaints from users of aspartame, G. Searle responded that they actually expected more complaints than they received. Out of 70 million users, only six hundred consumers formally filed complaints.

In all interviews referencing the harmful side effects caused by aspartame, G. In , Dr. Sturtevant of G. Even without support from the FDA, skeptics of aspartame have continued to research its undesirable effects throughout the last few decades. In an article in the Star Tribune, the National Institutes of Environmental Health Sciences revealed that their scientists had requested grants to further investigate aspartame without the influence of the NutraSweet Company.

These requests were filed between and , but the FDA denied all four proposals because officials insisted the product was already proven safe and unless new scientific evidence was brought forward extra tests would be redundant. Rall and many other scientists agreed that updated testing on such a popular product was absolutely necessary to ensure safety. John Olney also continued his research and in published his results in the Journal of Neuropathology and Experimental Neurology.

Olney was convinced of the link between the two. Although a great deal of controversy continues to surround aspartame, health concerns have failed to hinder the success of G. Indeed, NutraSweet has become an international billion-dollar company. Their tactics have been wildly successful. In America, approximately 17,, pounds of aspartame were consumed in , and a majority of that intake was in the form of diet carbonated beverages. This contract guaranteed that NutraSweet would maintain their monopoly on aspartame production even after their patent expired.

According to Richard Nelson, a spokesperson for NutraSweet, by soft drinks were responsible for seventy-five percent of the aspartame consumed in the United States. A contract with the two largest soft drink companies solidified the prolonged success of NutraSweet. Although little legal action has been taken against aspartame recently, the growing popularity of the internet over the past twenty years has enabled consumers to become more aware of its possible harmful side effects.

In , an internet hoax was created to warn consumers of the dangers of aspartame. The website and emails were highly inaccurate and biased, but the email sparked conversation about possible symptoms related to the consumption of the substance.

If the reader can successfully navigate between the facts and embellishment, these websites can be useful resources. Janet Starr Hall, writer of Sweet Poison, has dedicated her life to warning the public about aspartame through her book and website. While her website is obviously anti-aspartame, she strives to utilize facts to validate her claims. Technology has exposed American society to an infinite number of daily dietary choices. With the plethora of opportunities and options, consumers must make educated decisions about what they put into their bodies.

This paper illustrates that although the government and the FDA is charged with keeping unsafe products off the market, some still slip through the cracks. No system is perfect and big business will continue to influence government decisions if citizens remain uninvolved and choose to look the other way. Unfortunately, just because a product is legal does not necessarily mean it is safe, especially in large quantities. By being aware of and educated about the food they eat, hopefully people can successfully eat healthier and limit the amount of unsafe chemicals in food.

As Michael F. She is majoring in history with a minor in psychology. Brody, Jane E. Burros, Marian. Chapman, Stephen. Cloninger, Marion R. Cockburn, Andrew. New York: Simon and Schuster, Federal Drug Administration. Recall Aspartame as a Neurotoxic Drug. By Mark D. FDA Docket 02P, Freeman, Martha M. Gordon, Greg. Government Accountability Office.

By David P. Washington, DC: U. Report to the Honorable Howard M. By Martin J. Washington DC: U. Hoffman, Eva and Margot Slade. A Competitor For Saccharin. Hollie, Pamela G. Hull, Janet S. Accessed February 20, La Pena, Carolyn D. Los Angeles Times. Soceity for Science and the Public. Merrill, Richard. Metcalfe, Ed. Monte, Woodrow. Chicago Tribune. July 29, , 8. Proquest Historical Newspapers Nill, Ashley. Noah, Lars. Accessed February, 16, Olney, John.

Puzo, Daniel P. Scott, Janny. Shribman, David. Smith, Jeffrey. Smyth, Todd R. Accessed February 17, Turner, James S. Swankin and Turner: Attorneys at Law. Accessed February 16, US Food and Drug Administration. The Story of the Laws Behind the Labels.

By Wallace Jannsen. Warner, Melanie. Yoshihara, Nancy. Websites such as www. Aspartame is a low-calorie sweetener that is much sweeter than sugar. Less aspartame is needed to provide a sweet taste so in the packet or bag it is commonly mixed with other ingredients to make it more convenient for consumers to substitute aspartame for a similar amount of sugar.

While table sugar is made of the two carbohydrates glucose and fructose, aspartame is composed of two amino acids, aspartic acid and phenylalanine, linked together. When the body breaks down aspartame the two amino acids are separated and a small amount of methanol is formed. These same compounds are also found in much larger amounts infrequently eaten foods including meat, milk, fruits, and vegetables. So, the amount you get from aspartame is minuscule compared with what you consume from other sources.

Whether they come from food or aspartame, the body uses the amino acids and methanol in exactly the same way and is unable to distinguish the original source.

With around-the-clock media coverage, the Internet and social media all competing for viewers, listeners, readers and clickers, sensational headlines abound.

Personal testimonials and misinterpreted studies about food and nutrition can create confusion and fear. Aspartame is no exception with unsubstantiated negative claims proliferating in the media and on the web contrary to substantial evidence supporting its safety and role in a healthful eating plan. Rather than believing every scary headline you see, consider the source, read other viewpoints and consult a reliable expert, like a registered dietitian or reputable sites like the Academy of Nutrition and Dietetics, American Heart Association, American Cancer Society, American Diabetes Association, U.

Department of Agriculture and Food and Drug Administration. The U. It is not. As an American who trusted the system we all created, as an American who worked for the system, it made me angry that public health has taken a backseat to greed.

Searle approached Dr. Kennedy Jr. Memorial Laboratory of Mental Retardation Research and a respected expert in phenylalanine toxicity, to conduct a study of the effects of aspartame on primates. The study was initiated on January 15, and was terminated on or about April 25, Waisman died unexpectedly in March, Seven infant monkeys were given aspartame with milk.

One died after days. Five others out of seven total had grad mal seizures. The actual results were hidden from the FDA when G. Searle submitted its initial applications. Searle denied knowledge of or involvement with the initiation, design or performance of the study. Yet, false results were submitted to the FDA like the rest of the G. Searle studies on aspartame and other products , bearing a Searle Pathology-Toxicology project number. Both Dr. Waisman and G. Searle were responsible for the study design.

A number of false statements were made by G. Searle including that the animals were unavailable for purchase for autopsy after the termination of the study. The FDA banned the sweetener cyclamate, Neuroscientist and researcher John W. Olney found that oral intake of glutamate, aspartate and cysteine, all excitotoxic amino acids, cause brain damage in mice Olney John W.

Olney informed G. Searle that aspartic acid caused holes in the brains of mice. Ann Reynolds, a researcher who was hired by G. Excitotoxic compounds like MSG, aspartate, cysteine seem to create hypothalamic lesions, particularly in young animals. The reason for the latter is likely the fact that the blood brain barrier closes most slowly if ever completely around structures like hypothalamus. The outcome for such animals rats was obesity,severe behavioral changes, etc.

None of the tests submitted by G. An internal G. Searle memo laid out the strategy for getting aspartame approved Helling :. We must create affirmative atmosphere in our dealing with them. It would help if we can get them or get their people involved to do us any such favors.

This would also help bring them into subconscious spirit of participation. FDA Toxicologist Dr. Adrian Gross came upon some irregularities in the submitted tests of the G.

Searle drug Flagyl. Searle did not respond for another two years. Their response raised serious questions about the validity of their tests Gross , page On March 5, , G.

Background: In August of , G. Searle conducted two week toxicity studies on rats for what was to become a best-selling heart medication, Aldactone.

One study was conducted at G. Searle and one at Hazelton Laboratories. In March , the rats for autopsied and the pathology slides were analyzed. For confirmation of the results, G. Searle sent the slides to Biological Research, Ltd. Jacqueline Mauro examined the data. She discovered that the drug appeared to induce tumors in the liver, testes, and thyroid of the rats. The report submitted to G. Searle by Dr.

Mauro was known as the MBR Report. These statistically significant findings were confirmed by G. Instead of submitting these alarming findings to the FDA, G. Searle contracted with another pathologist, Dr. Donald A. He was given 1, slides to examine.

The Willigan Report was more to G. Liver tumors are of much more concern to the FDA. At first, G. The idea that two naturally-occurring amino acids could harm someone in relatively small amounts…. Freeman, M. Searle in their petition to approve aspartame Freeman :.

It is important to note that Dr. Freeman pointed out the inadequacy of single-dose tests of aspartame as early as Since then, the NutraSweet Company has flooded the scientific community with single-dose studies. Pharmacology — Reference is made to 2 year rat studies, but no data are provided on acute or chronic toxicity. Results are reported in narrative summary form, and tabulations of mean average values only.

No information is given as to the identity of the reporting labs, methodology except rarely , or normal values. Reported units for several parameters cannot be verified at this time.

The administration of Aspartame, as reported in these studies at high dosage levels for prolonged periods, constitutes clinical investigational use of a new drug substance. The information submitted for our review is inadequate to permit a scientific evaluation of clinical safety. She went on to recommend that marketing of aspartame be contingent upon proven clinical safety of aspartame.

Construction of a large aspartame manufacturing plant in Augusta, Georgia was halted. In the G. Ninety of the aspartame studies which were submitted by G. Eighty percent of these tests were conducted by G. Searle or by their major contractor, Hazleton Laboratories, Inc. No protocols, manufacturing controls information or preclinical data were provided.

Such deficiencies in each area of required information precluded a scientific evaluation of the clinical safety of this product…. On July 26, , just 15 months after Searle petitioned for approval, FDA commissioner Alexander Schmidt approved aspartame use in dry foods, allowing a day period for public hearings and comment. It was not approved for baking goods, cooking, or carbonated beverages.

This approval came despite the fact that FDA scientists found serious deficiencies in all of the 13 tests related to genetic damage which were submitted by G. At that point, consumer attorney Turner, author of a book about food additives, objected to the short comment period. Turner was joined in his protest by a now-defunct public interest group and by Dr. John Olney, a Washington University neuropathologist who had linked aspartame to brain lesions in mice.

Schmidt promptly froze the approval. In an action that was the first of its kind, he ordered that a Public Board of Inquiry be named to look into aspartame. He named a Bureau of Drugs task force to investigate. Our investigation clearly demonstrates that, in the G.

Searle Co. The task force charged, for example, that the company removed tumors from live animals and stored animal tissues in formaldehyde for so long that they deteriorated. Instead of performing autopsies on rhesus monkeys that suffered seizures after being fed aspartame, the company had financed a new monkey study with a different methodology that showed no problems.

Alexander Schmidt appointed a special Task Force to look at 25 key studies for the drugs Flagyl, Aldactone, Norpace, and the food additive aspartame. Eleven of the pivotal studies examined involved aspartame.

All of the studies whether conducted at G. Gross a, page of US Senate Adrian Gross. About half the pivotal tests were done at Searle; about one-third were done at Hazleton Laboratories. Food industry officials also said most studies financed by Searle or the NutraSweet Co.

James Scala, former director of health sciences for the General Foods Corp. Preliminary reports of discrepancies discovered about G. Searle were discussed. Edward Kennedy D-Mass. On December 5, , Dr.

The Public Board of Inquiry is also put on hold. The evidence of the aspartame pivotal studies were protected under FDA seal on December 3, Sharp Searle had invested On December 8, , stockholders filed a class action lawsuit alleging that G.

Searle had concealed information from the public regarding the nature and quality of animal research at G. Searle in violation of the Securities and Exchange Act Farber , page On January 7, , G. Our investigation clearly demonstrates that, in the case of the GD Searle Company, we have no basis for such reliance now. Finally, we have found instances of irrelevant or unproductive animal research where experiments have been poorly conceived, carelessly executed, or inaccurately analyzed or reported.

Poorly controlled experiments containing random errors blur the differences between treated and control animals and increase the difficulty of discriminating between the two populations to detect a product induced effect. A positive finding of toxicity in the test animals in a poorly controlled study provides a reasonable lower bound on the true toxicity of the substance. The agency must be free to conclude that the results from such a study, while admittedly imprecise as to incidence or severity of the untoward effect, cannot be overlooked in arriving at a decision concerning the toxic potential of the product.

As I say, filter and just present to the FDA what they wished the FDA to know and they did other terrible things for instance animals would develop tumors while they were under study. Well they would remove these tumors from the animals. He went on to state that he had never seen anything as bad as G. The report quoted a letter written to G.

Searle on July 15, from its consultant in reproduction and teratology, Dr. Gregory Palmer, in regards to a review of some of G. Because of these twin factors, all the careful and detailed examination of fetuses, all the writing, summarization and resummarization is of little avail because of the shaky foundation.

Searle officials noted that Dr. Palmer did not look at all of the teratology studies Searle b, page However, there is no credible evidence that would lead a reasonable person to believe that the studies which were not presented to Dr. Palmer were much better. In fact, the evidence shows that it is very likely that all of the studies were abysmal. What we discovered was reprehensible. Marvin Legator, professor and director of environmental toxicology at the University of Texas and the pioneer of mutagenicity testing at the FDA from to was asked by Common Cause Magazine to review the FDA investigation results of G.

Ted Kennedy :. Adrian Gross invalidated their experiments for the following reasons:. A series of poorly conceived, flawed studies funded by G. An Associate Editor of this scientific journal was Robert G. McConnell, the Director of G. Another G. Searle employee, Carl R. Mackerer was an editor of the journal. Another editor of the journal was Thomas R. Tephly, the person responsible for conducting a series of badly flawed blood methanol and formate measurements in NutraSweet-funded studies over the last 15 years.

On August 4, , G.