I bet that you will be shocked to learn that the FDA never approved aspartame. The FDA has not always believed that aspartame is safe. Actually, it’s the opposite. They denied its public approval – twice. It’s approval came from one man.
After an unsuccessful approval attempt in the 1970s, the corporations applying for the patents petitioned the FDA to review their objections to its approval. Routinely, Administrative Law Judges held public hearings, but in this case, the FDA was asked that a Public Board of Inquiry be assembled with three scientists as opposed to judges.
The Public Board of Inquiry was impaneled. The Board members were: Peter J. Lampert, M.D., Professor and Chairman of the Department of Pathology, University of California, San Diego; Vernon R. Young, PhD. Professor of Nutritional Biochemistry, M.I.T., and Walle Nauta, M.D., PhD., Institute Professor, Department of Psychology and Brain Science, M.I.T. Dr. Nauta chaired the Board.
The Board’s investigation focused on the findings of the Rockville, Maryland firm, UARP (investigators from the 1977 Task Force). After a full review, the Board voted unanimously to ban aspartame for human consumption.
Dr. Nauta expressed the Board’s concerns on aspartame safety based on the fact that Searle never submitted their testing procedures and protocols to the FDA, but submitted only their final research findings. The Board concluded that: “the available data on laboratory rats does not rule out the possibility of aspartame causing brain tumors, and indeed, the evidence suggests that aspartame might induce brain tumors.”
After these recommendations were submitted, yet another investigative team was assembled to study the Public Board of Inquiry’s findings. A five member Commissioner’s Team of Scientists was impaneled. By this time, so much data had been assembled; each team member was given a different review assignment.
Three team members investigated the brain tumor issue, and two members were assigned brain damage, mental retardation, and endocrine problems. The three members investigating the brain tumor studies expressed serious concerns with the data provided, showing aspartame caused tumors. The other two scientists were satisfied with the tests that showed aspartame did not cause brain tumors.
A sixth member was then appointed to the team, who voted that aspartame did not cause brain tumors. The vote was now deadlocked; three votes for aspartame approval, and three votes against.
Jacqueline Verrett, PhD., toxicologist and senior member of the review team, criticized how the safety review was performed. She stated, “It was pretty obvious that somewhere along the line, the bureau officials were working up to a whitewash. The Bureau of Foods under Howard Roberts either discarded or completely ignored problems and deficiencies outlined by the Team report.”
She concluded, “It is unthinkable that any reputable toxicologist giving a completely objective evaluation of the data resulting from such a study could conclude anything other than the study was uninterpretable and worthless, and should be repeated as the safety questions still remain unanswered.”
The scientific journal, Neurobehavorial Toxicology, Brain Damage in Mice from Voluntary Ingestion of Glutamate and Aspartate published the research results of harmful effects of aspartate; salt from aspartic acid and 40 percent of aspartame. Their research showed that aspartate could not be detected after years of exposure except in the form of obesity or neuro-endocrine disturbances, which is known to occur in rodents following treatment in infancy.
The FDA Public Board of Inquiry denied aspartame approval pending further brain tumor testing. The Board also formally revoked aspartame’s 1974 approval granted by Commissioner Schmidt.
In September, Searle announced that they were repetitioning for aspartame approval for NutraSweet.
In November, Ronald Reagan was elected President of The United States.
In January, Searle officially reapplied for NutraSweet approval.
In April, President Ronald Reagan appointed Arthur Hull Hayes, Jr., M.D. the new FDA Commissioner.
In July, Dr. Hayes overruled the Public Board of Inquiry’s recommendation that aspartame “not be approved until further animal testing be conducted to resolve the brain tumor issue.”
Hayes granted FDA approval for aspartame in dry foods (marketed as NutraSweet®), and as a tabletop, sugar substitute (marketed as Equal®).
The FDA approval of aspartame was for a food additive, as opposed to a drug, which exempted Searle from future safety monitoring. Searle was no longer obligated to defend the corporate studies, nor required to submit additional reports to the FDA.
Four FDA officials accepted jobs with NutraSweet companies: S.M. Pape, Associate Chief Counsel for Foods, Health and Human Services and Special Assistant to FDA Commissioner; Sherwin Gardner, FDA Deputy Commissioner; Mike Taylor, attorney with the Board of Inquiry; and Albert Kolbye, Associate Director for the Bureau of Foods for Toxicology.
G.D. Searle presented campaign contributions to the following Senators and Representatives: Senator Robert Byrd, Democrat, W. Virginia; Senator Orrin Hatch, Republican, Utah; Senator Howell Heflin, Democrat, Alabama; and Representative Henry Waxman, Democrat, California.
Senator Heflin, Chairman of the Senate Ethics Committee, proposed an amendment to change the laws to extend the US Patent for aspartame. Senator Robert Byrd initiated the amendment on Senator’s Heflin’s behalf. Senator Orrin Hatch, Chairman of the Labor and Human Resources Committee, spoke on the Senate floor supporting the proposed extension.
The patent extension for NutraSweet was approved as an amendment to the Orphan Drug Act.
Representative Henry Waxman sponsored the Orphan Drug Act.
NutraSweet’s patent was extended until 1992.
FDA Commissioner Hull Hayes resigned his position to accept a position as senior medical advisor to Searle’s public relations firm, Burston Marsteller.
Anthony Brunetti, FDA Consumer Product Officer, drafted notice to approve NutraSweet in soft drinks.
Brunetti accepted a position with the Soft Drink Association as their Science Advisor later that year.
Acting FDA commissioner, Mark Novitch, approved aspartame for use in carbonated beverages. NutraSweet was officially approved in carbonated beverages and carbonated beverage syrup bases.
The FDA raised the acceptable maximum daily intake of aspartame from 20mg/kg/day (milligrams per kilograms of body weight per day) to 50mg/kg/day, the equivalent of increasing from two cans per day to 17 cans per day for a 150-pound person. The acceptable maximum daily intake of 50mg/kg/day for a 25 to 30 pound child was raised to accumulative levels of three cans of soda per day, or a pack of chewing gum, a multi-vitamin, cereal, pudding, or sugar-free ice cream combined per day.
A two-liter bottle of Diet Coke®; contained 1,200 mg of aspartame.
Aspartame was approved in children’s chewable multivitamins.
Seven million pounds of NutraSweet were now consumed in the United States.
NutraSweet sales exceeded $600 million.
Woodrow Monte, PhD., Director of the Science and Nutrition Laboratory, Arizona State University, announced that there were presently no animal nor mammalian studies that had evaluated the possible mutagenic or carcinogenic effects of chronic intake of methanol, now 10 percent of aspartame.
Based on the methanol issue, Dr. Monte requested an Arizona State hearing on a petition to ban NutraSweet in Arizona. He was granted the hearing in April the following year. Pushing his efforts to get Arizona to recognize the dangers of consuming aspartame, he did not succeed. The Arizona legislature changed the laws without public notice, barring any state regulation of FDA-approved food additives. The measure passed under a “toxic waste bill.”
Searle hired over a dozen lobbyists. United Press International traced nearly $200,000.00 in campaign contributions, including contributions to House Majority Leader, Burton Barr and Representatives Don Aldridge, Karen Mill, and Jan Brewer.
Searle hired the following lobbyists to oppose Dr. Monte’s efforts to ban aspartame in Arizona: Andrew Herwitz (Arizona Governor Babbitt’s former Chief of Staff), Charles Pine (Arizona lobbyist), Roger Thies (Searle lawyer), and David West (Searle official).
Richard Wurtman, M.D., Department of Brain and Cognitive Science, M.I.T. began research on NutraSweet.
Drs. Monte and Wurtman received over 1,000 complaints against aspartame. The most common complaints were: dizziness, visual impairment, disorientation, ear buzzing, pancreatitis, tunnel vision, loss of equilibrium, severe retinal hemorrhaging, menstrual flow changes, and depression.
The Center for Disease Control (CDC) submitted the report, “Evaluation Of Consumer Complaints Related To Aspartame Use.”
Sixteen million pounds of aspartame were added to the US food supply.
NutraSweet sales exceeded $1 billion.
Monsanto Chemical Company acquires G.D. Searle & Company, and creates a G.D. Searle unit. Donald Rumsfeld, President of Searle, played an instrumental role in the acquisition.
The FDA petitioned the CDC (Centers for Disease Control) to review the first 650 complaints they received about aspartame; a record number of complaints filed for one product after only three years on the market.
The CDC reported that between 25 percent and 30 percent of female users experienced some form of symptom from aspartame use, and when all use stopped, all health symptoms stopped.
Ohio Senator Howard Metzenbaum called for a hearing on NutraSweet. Metzenbaum introduced the Aspartame Safety Act of 1985 in the Senate. The bill called for:
- Clinical studies on brain chemistry, behavioral and neurological effects on children, pregnant women, and fetuses;
- A study into the sudden increases in seizures;
- Drug interactions with aspartame;
- A moratorium on the introduction of aspartame into new products until independent testing was completed;
- Labeling of products to include the amount of aspartame in each serving, as well as allowable daily intake;
- A warning that aspartame is not intended for infant use;
- Mandates for the FDA to set up a Clinical Adverse Reaction Committee to compile reports, establish a telephone service information hotline, and send written notices to physicians about aspartame concerns.
Senator Metzenbaum’s press secretary, Drew Von Bergen, drafted the statement: “Members of the scientific community have grave reservations about the safety of aspartame. The Senator is not out to ban aspartame, but to set up independent tests to clear up the problem.”
Dr. Louis Elsas, M.D., Director of Medical Genetics at Emory University School of Medicine, performed a study on the effects of phenylalanine on the fetus and on infants. He examined two groups ranging from eight to 24 years of age, monitoring the reaction time and the reduction in the production of adrenaline-like chemicals in the brain. He concluded that both pregnant women and infants should not consume foods containing aspartame because of the danger of brain damage to the fetus and to infants.
Keith Conners, M.D., Children’s Hospital, Washington, D.C., documented a study of children who suffered extreme agitation when consuming aspartame in an amount equivalent to a 6-oz. serving of Kool-Aid®; sweetened with NutraSweet.
Roger A Coulombe, Jr., PhD., Center for Environmental Toxicology, Utah State University, demonstrated that it was possible for aspartame to produce nervous system and behavioral affects, particularly in children and susceptible individuals.
Ronald Gautieri, PhD. and Michael Mahalik, PhD., Department of Pharmacology, Temple University, demonstrated in a study that aspartame produced brain dysfunction in newborn mice.
William Pardridge, M.D., University of California at Los Angeles, testified along with Dr. Wurtman before a Senate Committee on Labor and Human Resources, urging that labeling requirements for aspartame be amended to include quantity consumed. They brought into the discussion two important points:
- Children may be at risk of suffering brain damage from excessive intake of aspartame;
- Aspartame consumed at the same time as simple carbohydrates, as in carbonated soft drinks, could double the effect on the brain as ingesting aspartame alone.
Dr. Pardridge released a study in the American Medical Association of Scientific Affairs Review, stating the two amino acids found in aspartame, aspartic acid and phenylalanine, were neurotoxic. He recorded a drop in IQ in babies born to mothers with elevated phenylalanine levels, and noted a decrease in choice reaction time in adults with slightly elevated phenylalanine levels.
Current sales figures were no longer available.
The 1986 Quarterly Report submitted by the Department of Health and Human Services showed 3,000 complaints against aspartame were reported to the FDA and the Center for Disease Control (CDC). Most of the complaints related to brain function and to behavior disorders.
Food Chemical News, 1986, reported the Community Nutrition Institute had petitioned the FDA to ban aspartame, citing cases of seizures and visual problems. Request denied.
The Department of Psychology, Leeds University, Leeds, England, reported in the British medical journal, Lancet, May 10, 1986, that consumption of aspartame caused an increase in appetite and weight gain. Leeds researchers Blundell and Hill stated in their findings that aspartame increased the rated motivation to eat and decreased the ratings of fullness in the test volunteers. They concluded that people using aspartame receive ambiguous signals important for the control of appetite and ingestion, and that aspartame may contribute to disordered patterns of eating prevalent among certain groups of normal weight individuals.
NutraSweet petitioned for FDA approval in baked goods and baking products. Petition pending. The US General Accounting Office reported they were monitoring the food additive process for aspartame. A third United States Senate Hearing was summoned on “NutraSweet; Health and Safety Concerns.” Senator Howard Metzenbaum chaired the Committee on Labor and Human Resources overseeing the hearings.
Many research scientists and medical researchers responded to the Senate Hearings, addressing letters to Senators Edward Kennedy, Howard Metzenbaum, and Orrin Hatch, particularly concerning the safety issues concerning pregnant women and fetuses.
Dr. Louis Elsas, M.D., Emory University Medical School, determined that pregnant women’s blood phenylalanine levels increased from aspartame use, resulting in the placenta magnifying phenylalanine levels four to six times the normal levels. This resulted in mental retardation and birth defects in his studies.
Alfred Miller, M.D., San Antonio, Texas, noted in clinical observations that aspartame was linked to mood swings and severe headaches in many of his patients.
Researchers began tallying increases in headaches, seizures, tumors, depression, and brain lesions – all confirming the predictions and warnings of aspartame’s neurotoxicity from twenty years before.
Aspartame critics come upon strong corporate resistance.
NutraSweet’s patent was due to expire in four years.
NutraSweet was now found in over 2,000 products worldwide.
Media advertising intensified; information against NutraSweet became more suppressed.
United Press International announced the “Aspartame Technical Committee“, consisting of the NutraSweet Company, Ajinomoto Company (Searle’s Japanese aspartame supplier), the Coca-Cola Company, Pepsico, Inc., Royal Crown Cola Company, and General Foods, along with various smaller food manufacturers utilizing aspartame. The Committee launched a campaign to discourage researchers and critics from receiving Research Funding Awards grants, in particular those awarded by the International Life Sciences Institute, an organization predominant in awarding grants to research scientists.
Samuel Molinary, Co-chairman of the International Life Sciences Institute grant panel, accepted employment as G.D. Searle’s Director of Scientific Affairs.
Shortly afterward, Molinary accepted a position as Pepsico’s Research Director.
As you can see, the safety of aspartame in the 1980s shifted from quality research and public concern to political maneuvering for profit.
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