toxic.”(1) December 28, 1970 Confidential internal memo at Searle indicates concern or lack of complete toxicological data on diketopiperazine (DKP), an aspartame by-product.(2) March 5, 1973 Searle petitions the Food and Drug Administration (FDA) for approval of aspartame for use in food.(3) July 26, 1974 FDA Commissioner Alexander Schmidt, M.D., approves aspartame as a food additive for dry foods only, including chewing gum.(4) August 1974 Consumer attorney James Turner and Dr. John Olney, Washington University researcher, file objections to FDA’s approval of aspartame citing evidence of brain lesions and neuroendocrine disorders in animal studies and concerns that it may cause brain damage and mental retardation in humans. They request a hearing on the safety of aspartame. (5,6) July 23, 1975 FDA Commissioner Schmidt appoints a task force to investigate Searle’s animal studies on aspartame to determine if Searle submitted false information to FDA.(7) December 5, 1975 Turner and Olney waive their right to a public hearing and agree to a Public Board of Inquiry to hear safety concerns.(8,9) December 5, 1975 The FDA task force concludes that some of Searle’s research practices were so severely flawed that tests results were unreliable. Based on this conclusion FDA upholds aspartame approval. The Public Board of Inquiry is delayed.(6,9) March 24, 1976 The FDA’s task force reports, “At the heart of the FDA’s regulatory process is its ability to rely upon the integrity of the basic safety data submitted by sponsors of regulated products. Our investigation clearly demonstrates that, in the G.D. Searle Company, we have no basis for such reliance now.” The task force further says, “Some of our findings suggest an attitude of disregard for FDA’s mission of protection of the public health by selectively reporting the results of studies in a manner which allays the concerns of questions of an FDA reviewed.”(10) July 1976 In response to the task force findings, FDA decides to investigate aspartame studies to determine whether FDA could rely on these studies to assess aspartame’s safety.(11) January 10, 1977 In a 33-page letter, FDA Chief Counsel Richard Merrill recommends to U.S. Attorney Sam Skinner that a grand jury investigate Searle for “apparent violations of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 331(3) and the False Reports to the Government Act, 18 U.S.C. 1001, for “their willful and knowing failure to make reports to the Food and Drug Administration required by the Act, 21 U.S.C. 355(I), and for concealing material facts and making false statements in reports of animal studies conducted to establish the safety of (aspartame).” The FDA calls special attention to studies investigating the effect NutraSweet on monkeys and hamsters.(12) January 26, 1977 Searle’s law firm, Sidley and Austin, request a meeting with Skinner prior to the submission of any matters relating to Searle to a grand jury.(13) February 2, 1977 Skinner is offered a job with Sidley and Austin.(7) March 8, 1977 Skinner sends a confidential memo citing his preliminary employment discussions with the law firm of Sidley and Austin. He states it would be inappropriate for him to make any decision on the Searle investigation. He says a decision on the grand jury investigation should wait until a new U.S. attorney is appointed. (Note: The statutes of limitation on any prosecution against Searle regarding violations of the Food, Drug and Cosmetic Act regarding aspartame would expire for the monkey study on October 10, and on December 8, 1977 for the hamster study.)(14) April 13, 1977 A Justice Department memo advised Skinner to proceed with the grand jury investigation as soon as possible, citing the statute of limitations deadline.(15) July 1, 1977 Skinner leaves his post with U.S. Attorney General’s office and joins Searle’s law firm, Sidley and Austin.(7) August 1977 The Bressler Report, compiled by FDA investigators and headed by Jerome Bressler, is released. The report found that 98 of the 196 animals died during one of Searle’s studies and weren’t autopsied until later dates, in some cases over one year after they died. Records for approximately 30 animals showed substantial differences between original observations on pathology sheets and the observations on pathology sheets submitted to the FDA. There were numerous other inconsistencies and errors noted. For example, a rat was reported alive, then dead, then alive, then dead again; a mass, a uterine polyp, and ovarian neoplasms were found in animals but not reported or diagnosed in Searle’s reports. The FDA investigators found dose-related uterine polyps in 15% of 34 animals.(16) August 1977 Aspartame is dropped from the Department of Justice investigation of Searle.(7) September 28, 1977 The FDA’s Bureau of Foods Task Force reports that the studies concerning aspartame conducted by Searle “appear to be authentic.” H.R. Roberts, the primary recipient of this paradoxical document, subsequently left the FDA and became the vice president of the U.S. National Soft Drink Association.(7,18,19) October 10, 1977 The statute of limitations expires on Searle’s longitudinal study of the effects of aspartame on monkeys which showed seizures in some primates that were never autopsied.(7) December 8, 1977 The statute of limitations expires on the study of aspartame toxicity in hamsters.(7) March 1979 The FDA’s Center for Food Safety and Nutrition concludes that the deficiencies noted in the reviews by the FDA and by the Universities Associated for Research and Education in Pathology, Inc. were not significant enough to invalidate Searle’s aspartame studies. The FDA decides to convene a Public Board of Inquiry.(11) June 1, 1979 The FDA establishes a Public Board of Inquiry to rule on safety issues surrounding NutraSweet.(21) January 15, 1980 The Public Board of Inquiry holds hearings on objections to aspartame approval.(6.22) September 30, 1980 The Public Board of Inquiry concludes NutraSweet should not be approved pending further investigations of brain tumors in animals. The board states it “has not been presented with proof of reasonable certainty that aspartame is safe for use as a food additive.”(6,8,23,24) March 1981 An FDA commissioner’s panel is established to review issues raised by the Public Board of Inquiry.(11) May 19, 1981 Three of six in-house FDA scientists, Dr. Robert Condon, Dr. Satya Dubey, and Dr. Douglas Park, advise against approval of NutraSweet, saying the Searle tests are unreliable and not adequate to determine the safety of aspartame.(25) July 15, 1981 Dr. Arthur Hull Hayes, Jr., FDA commissioner, overrules Public Board of Inquiry and approves NutraSweet for dry products saying that aspartame has been shown to be safe for its proposed uses. He says additional evidence, including a third long-term study, assessing aspartame’s carcinogenic potential using a different strain of rat confirms that conclusion. The studies he cited were conducted by Ajinomoto, the Japanese manufacturer of aspartame. He says few compounds have withstood such detailed testing and repeated close scrutiny.(5,7,8,26,78) October 22, 1981 The FDA approves aspartame for table-top sweetener, tablets, cold breakfast cereals, chewing gum, dry bases for beverages, instant coffee and tea, gelatins, puddings, fillings, dairy-product- analog toppings, and flavor enhancer for chewing gum.(24,28) October 15, 1982 The FDA announces Searle has filed a petition that aspartame be approved as a sweetener in carbonated beverages and other liquids.(6,29) July 1, 1983 The National Soft Drink Association urges the FDA to delay approval of aspartame for carbonated beverages pending further testing. The FDA responds that it is aware that temperature may affect carbonated liquids containing aspartame, “but believes proper shipping and marketing procedures should ‘solve’ the problems.”(30) July 8, 1983 Acting commissioner of the FDA, Mark Novitch, approves NutraSweet for use in carbonated beverages and carbonated beverage syrup bases, even though levels of aspartame remaining in beverages stored in eight weeks at 68 degrees F were between 84% and 89% of the original amount. “Lost” aspartame degrades to DKP, methanol (methyl alcohol), aspartic acid, and phenylalanine.(31) July 28, 1983 The National Soft Drink Association drafts an objection to the final ruling, which permits the use of aspartame in carbonated beverages and carbonated beverage syrup bases and requests a hearing on the objections. The association says that Searle has not provided responsible certainty that aspartame and its degradation products are safe for use in soft drinks. The drafted document is not filed with the FDA. NSDA members feel the case was not strong enough.(32) August 8, 1983 Consumer attorney James Turner of the Community Nutrition Institute and Dr. Woodrow Monte, Arizona State University’s Director of Food Science and Nutritional Laboratories, filed suit with the FDA objecting to aspartame approval based on unresolved safety issues. They request a stamp of approval and a public hearing to address aspartame’s safety.(6) September 1983 Searle files and FDA petition for approval of aspartame use in bulk amounts.(33) September 1983 Commissioner Hayes of the FDA resigns and Buson- Marsteller, Searle’s public relation firm hires him as senior scientific consultant. Hayes is unavailable to the press for the next ten years.(19) Fall 1983 The first carbonated beverages containing aspartame are sold for public consumption.(34) November 16, 1983 The FDA denies Turner and Monte’s request for stay of approval for aspartame use.(35) December 8, 1983 The FDA proposes to declare aspartame suitable for use as a sweetener in drug products as long as the label warns phenylketonurics that phenylalanine is present.(8( December 9, 1983 The Arizona Dietetic Association and the Central Arizona District Dietetic Association file a joinder of petition to request a public hearing and to add their objections to FDA’s approval of aspartame. December 23, 1983 The Arizona Dietetic Association and the Central Arizona District Dietetic Association file suit in district court seeking an order requiring FDA to hold a hearing. They cite consumer complaints of adverse effects and new medical evidence against aspartame.(6) February 17, 1984 The FDA denies the request for a public hearing. The district court grants FDA’s motion to dismiss the complaint on the ground the “jurisdiction was lacking.”(6,36) March 1984 The FDA and the Centers for Disease Control begin investigations of cases of adverse reactions to aspartame.(7) May 30, 1984 The FDA approves aspartame for use in multivitamins.(37) July 10, 1984 Florence Graves, vice president of publications and editor of COMMON CAUSE magazine, writes “NutraSweet has been touted as the most tested food additive in history, but our investigation reveals such serious flaws in the government’s approval of NutraSweet that Congress should begin its own investigation immediately.”(38) November 1984 The Center for Disease Control reviews 213 of 592 cases of aspartame complaints. Ages of the complainants ranged from four months to 77 years: 77% were between the ages of 21 and 60 years, 75% were female, and 94% were white. Twenty-eight percent reported repeated episodes of symptoms, and 26 people experienced identical symptoms. Some of the reported symptoms included: aggressive behavior, disorientation, hyperactivity, extreme numbness, excitability, memory loss, loss of depth perception, liver impairment, cardiac arrest, seizures, suicidal tendencies, severe mood swings, and death. The CDC recommends future investigations of aspartame investigate the neurological and behavioral problems, and focus on symptoms such as headaches, mood alterations, and behavioral changes. Frederick L. Trowbridge adds an executive summary to the report which conflicts with the information in the report. He states, “Currently available information, based on data with limitations as described in the report indicated a wide variety of complaints that are generally of a mild nature. Although it may be that certain individuals have an unusual sensitivity to the product, these data do not provide evidence for the existence of serious, widespread, adverse health consequences to the use of aspartame.”(39) July 17, 1985 An association called “Aspartame Victims and Their Friends” forms.(40) July 13, 1985 EDITOR AND PUBLISHER magazine cites “The Food and Drug Administration NutraSweet cover-up” as one of the most under-reported stores of the year.(44) August 1, 1985 U.S. Senator Howard Metzenbaum (D-OH) introduces The Aspartame Safety Act of 1985 to Congress.(44) September 25, 1985 During a visit to the University of Tennessee, then President Ronald Reagan tells a student that he used to carry a vial of sweetener with him but recently quit using sugar substitutes because no one knows what’s in them. (43) October 1, 1985 Monsanto Company purchase G.D. Searle Company, including NutraSweet , for $2.7 billion. Searle’s Pharmaceuticals and NutraSweet become separate subsidiaries. (44) 1986 George R. Verrilli, M.D., and Anne Marie Mueser publish WHILE WAITING: A PRENATAL GUIDEBOOK. The book says “aspartame is suspected of causing brain damage in sensitive individuals. A fetus may be at risk for these effects...some researchers have suggested that high doses of aspartame may be associated with problems ranging from dizziness and subtle brain changes to mental retardation.”(45) February 3, 1986 Sen. Metzenbaum’s investigation reveals that “during a Searle sponsored monkey test, all the animals receiving medium or high dosages of NutraSweet experienced grand mal seizures.”(7) July 17, 1986 Turner files a petition on behalf of the Consumer Nutrition Institute to seek reconsideration of FDA’s regulations about safe use of aspartame and to repeal the regulations.(46) October 16, 1986 Turner files a citizen’s petition regarding hazards of seizures and eye damage from aspartame.(27) November 21, 1986 The FDA denies Turner’s petition.(46) November 28, 1986 The FDA approves aspartame for noncarbonated frozen or refrigerated concentrated and single-strength fruit juice, fruit drinks, fruit flavored drinks, imitation fruit flavored drinks, frozen stock-type confections and novelties, breath mints, and tea beverages.(37) December 1986 The FDA declares aspartame safe for use as an inactive ingredient provided labeling meets certain specifications.(11) December 16, 1986 The FDA lists 73 aspartame symptoms, including four deaths, by aspartame complainants.(47) January 2, 1987 The FDA quarterly report on adverse reactions associated with aspartame reactions associated with aspartame states the majority of the complaints by 3,133 individuals refer to neurological effects.(48) June 18, 1987 The General Accounting Office (GAO) report to Sen. Metzenbaum regarding the approval process for aspartame mentions that 12 of 69 scientists responding to a GAO questionnaire expressed major concerns about aspartame safety, and that during as examination of aspartame animal studies Olney found 12 brain tumors in 320 rats who had received aspartame and that none of the 120 control rats had brain tumors.(11) August 1987 Mary Stoddard forms the Aspartame Consumer Safety Network in Dallas, Texas. November 3, 1987 Dr. Jacqueline Verrett, FDA toxicologist and a member of the investigation task force, says the original aspartame studies were “built on a foundation of sand.”(20) February 2, 1988 Four hundred ninety-three U.S. consumer products and 18 over-the-counter pharmaceuticals contain NutraSweet.(49) February 26, 1988 A letter from David Baine, associate director of the U.S. GAO, states methyl alcohol was not included in the initial description of aspartame because aspartame is only 10% methyl alcohol (by weight).(50) April 14, 1988 The GAO assignment manager, Michelle L. Roman, admits that some definitions of methyl alcohol define it as a toxic substance.(51) June 7, 1988 The FDA approves aspartame in yogurt products; frozen desserts; ready-to-serve non-refrigerated, pasteurized, aseptically packaged diluted fruit juice beverages; fruit wine beverages (wine coolers) with ethanol content below sever percent volume; and ready-to- serve gelatin.(37) October 1, 1988 The FDA quarterly report on adverse reactions associated with aspartame includes 4,204 consumer complaints.(52) October 19, 1988 The FDA approves aspartame for wafer cookies.(37) December 21, 1988 Senator Metzenbaum issues a press release saying senators should not approve the appointment of Sam Skinner as Department of Transportation secretary without an inquiry concerning Skinner’s failure, as U.S. District attorney in the Northern Illinois District, to pursue allegations about fraudulent testing of NutraSweet. Metzenbaum raises the issue of Skinner accepting a position with Searle’s law Firm, Sidley and Austin, during the time the FDA asked Skinner to review allegations of fraudulent safety tests by Searle and urges the Senate to convene a grand jury to investigate the charges.(53) January 25, 1989 Senator Metzenbaum issues a press release saying that Skinner acknowledged he may have made mistakes in the NutraSweet investigation, but Metzenbaum says he supports Skinner’s nomination as secretary of Department of Transportation.(54) June 2, 1989 The FDA approves aspartame for frozen, ready-to-thaw-and- eat cheesecakes; fruit and fruit toppings; and dairy and non-dairy frostings, toppings and fillings.(55) January 30, 1992 The FDA approves aspartame for malt beverages of less than seven percent ethanol by volume and containing fruit juice; dry, free-flowing sugar substitutes for table use in package unit not exceeding the sweetening equivalent of one pound of sugar; breakfast cereals; and refrigerated ready-to-serve puddings and fillings.(55) April 16, 1993 The FDA approves aspartame for hard and soft candies.(55) April 19, 1993 The FDA approves aspartame for all ready-to-serve non- alcoholic flavored beverages, tea beverages, fruit-juice based beverages and their concentrates, baked goods and baking mixes, and as a flavor enhancer in malt beverages containing less than three percent alcohol by volume.(55) September 17, 1993 The FDA approves additional uses in frostings, toppings, and fillings for baked goods.(55) February 28, 1994 The Department of Health and Human Services report on adverse reactions attributed to aspartame lists 6,888 complaints, including 649 reported by the Centers for Disease Control, and 1,305 reported by the FDA. Aspartame accounts for the majority (75.7%) of all the complaints in the Adverse Reaction Monitoring System.(56) ******* References: 1. Stegink, L.: Filer, L.J.Jr. Aspartame, Marcel Dekker, Inc. (1984). 2. G.D. Searle Company, Confidential internal memorandum entitled “Food and Drug Sweetener Strategy. Documents supplied by Sen. Howard Metzenbaum’s office (December 28,1970). 3. Federal Register 38: 5921 (March 5, 1973). 4. Federal Register 39: 27317 (July 25, 1974). 5. Federal Register 46: 38285 (July 24, 1981). 6. U.S. Court of Appeals for the District of Columbia Circuit, No. 84- 1153 Community Nutrition Institute, et al., Petitioners v. Dr. Mark Novitch, Acting Commissioner, Food and Drug Administration, Respondent, G.D. Searle Co., Intervenor, Petition for Review of an Order of the Food and Drug Administration, No. 84-5253 Community Nutrition Institute, et al., Appellants v. Dr. Mark Novitch, Acting Commissioner, Food and Drug Administration, Appellee (September 24, 1985). 7. Documents supplied by Sen. Howard Metzenbaum’s office (February 6, 1986). 8. Federal Register 48: 54993-54995 (December 8, 1983). 9. Federal Register 40: 56907 (December 5, 1975). 10. Food and Drug Administration Searle Investigation Task Force Chaired by Carlton Sharp. “Final Report of Investigation of G.D.Searle Company.” (March 24, 1976). 11. U.S. General Accounting Office. “Report to the Honorable Howard M. Metzenbaum, U>S>Senate: Food and Drug Administration Food Additive Approval Process Followed for Aspartame.” GAO/HRD-87-46 (June 1987). 12. Letter from Richard A. Merrill, Chief Counsel, Department of Health, Education, and Welfare, Food and Drug Administration, to Honorable Samuel K. Skinner, U.S. Attorney, Northern District of Illinois, requesting that Skinner’s office convene a Grand Jury investigation into G.D.Searle Co., for submitting false reports. (January 10, 1977). 13. Letter from Howard J. Trienens, Sidley & Austin, to Samuel K. Skinner, U.S. Attorney, Northern District of Illinois (January 26, 1977). 14. Confidential memorandum from Samuel K. Skinner, U.S. Attorney, Northern District of Illinois, to William Conlon and Fred Branding. Document supplied by Sen. Howard Metzenbaum’s office. (March 8, 1977). 15. Memorandum from Charles P. Kocoras, First Assistant U.S. Attorney, to Samuel K. Skinner, U.S. Attorney, regarding G.D. Searle Company. (April 13, 1977). 16. Food and Drug Administration, Bressler, J. The Bressler Report, investigation of Searle Laboratories. (August 7, 1977). 17. Minutes of a meeting between Thomas P. Sullivan, U.S. Attorney, Arthur Levine, Food and Drug Administration, and other Department of Justice people, with Sidley & Austin, counsel for G.D. Searle Co. (August 18, 1977). 18. Memorandum from Bureau of Foods Task Force, Food and Drug Administration, to Howard R. Roberts, Ph.D., Acting Director, Bureau of Foods, regarding “Authentication Review of Data in Reports Submitted to the Food and Drug Administration Concerning Aspartame.” (September 28, 1977). 19. U.S. General Accounting Office. “Briefing Report to the Honorable Howard Metzenbaum, U.S. Senate: Food and Drug Administration, Six Former HHS Employees’ Involvement in Aspartame’s Approval.” GAO/HRD-86- 109BR (July 1986). 20. Testimony of Dr. Jacqueline Verrett, Food and Drug Administration Toxicologist, before the U.S. Senate Committee on Labor and Human Resources, regarding “NutraSweet Health and Safety Concerns.” (November 3, 1987). 21. Federal Register 44: 31716-31718 (June 1, 1979). 22. Federal Register 45: 2908 (January 15, 1980). 23. Food and Drug Administration Public Board of Inquiry, Nauta, W.J.H., Lampert, P.W., Young, V.R. “Aspartame (Docket No. 75F-0355): Decision of the Public Board of Inquiry.” (September 30, 1980). 24. Federal Register 46: 38288-38289 (July 24, 1981). 25. Internal memoranda from three Food and Drug Administration scientists: Dr. Robert J. Condon, Dr. Satya D. Dubey and Dr. Douglas Park, to Joseph A. Levitt, Food and Drug Administration, advising against approval of NutraSweet (May 19, 1981). 26. Food and Drug Administration, Public Health Service, Department of Health and Human Services. “Aspartame (Docket No. 75F-355): Summary of Commissioners’ Decision.” (July 15, 1981). 27. Committee on Labor and Human Resources. “‘NutraSweet’-Health and Safety Concerns. Hearing before the Committee on Labor and Human Resources, U.S. Senate, One Hundredth Congress, First Session on Examining the Health and Safety Concerns of NutraSweet (Aspartame).” (November 3, 1987). 28. Federal Register 46: 50947 (October 16, 1981). 29. Federal Register 47: 46140 (October 15, 1982). 30. Food and Drug Administration. “Aspartame in Carbonated Beverages Approved.” FDA Talk Paper (July 1, 1983). 31. Federal Register 48: 31376 (July 8, 1983). 32. Congressional Record 131 (58): S5489-S5517 (May 7, 1985). 33. Federal Register 48: 40562 (September 8, 1983). 34. Porter, D.V. “Aspartame: An Artificial Sweetener.” Washington, DC: Congressional Research Service, Library of Congress (March 23, 1984). 35. Federal Register 48: 52899 (November 16, 1983). 36. Federal Register 49; 6672-6682 (February 22, 1984). 37. Letter from F. Owen Fields, Ph.D., Novel Ingredients Branch, Division of Product Policy, Center for Food Safety and Applied Nutrition, Department of Health and Human Services, to Barbara A. Mullarkey regarding “Pre-1988 Aspartame Approvals.” (February 25, 1994). 38. Graves, F. “Results of Common Cause Magazine Investigation of FDA’s Approval of Aspartame.” Common Cause (July 1984). 39. Centers for Disease Control, Division of Nutrition, Center for Health Promotion and Education. “Evaluation of Consumer Complaints Related to Aspartame Use.” (November 1984). 40. 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Department of Health and Human Services, Health and Injury Related Surveillance Subprogram Postmarketing Surveillance System. “Quarterly Report on Adverse Reactions Associated with Aspartame Ingestion.” Submitted to Health Hazards Evaluation Board (January 2, 1987). 49. NutraSweet Co. “U.S. Consumer Products Containing NutraSweet Brand Sweetener.” (February 2, 1988). 50. Letter from David P. Baine, Associate Director of the U.S. General Accounting Office, to Barbara A. Mullarkey, regarding methyl alcohol content of Aspartame. (February 26, 1988). 51. Letter from Michelle L. Roman, Assignment Manager of the U.S. General Accounting Office, to Barbara A. Mullarkey, regarding methyl alcohol content of Aspartame. (April 14, 1988). 52. Food and Drug Administration, Department of Health and Human Services. “Quarterly Report on Adverse Reactions Associated with Aspartame Ingestion.” (October 1, 1988). 53. Sen. Howard Metzenbaum press release (December 21, 1988). 54. Sen. 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Waggoner, W.F. “Aspartame - A Review.” Pediatric Dentistry 6(3): 153-158 (1984). 70. Random House Dictionary, New York: Random House (1988). 71. Louis, R. J. Sax’s Dangerous Properties of Industrial Materials, Eighth Edition, New York: Van Nostrand Reinhold (1992) pp. 2251-2252. 72. Thomas-Dobersen, D. “Calculation of Aspartame Intake in Children.” Journal of the American Dietetic Association 89 (6): 831-833 (1989). 73. Beardsley, T. “Sour Welcome for Aspartame.” Nature 305: 175 (1983). 74. Aspartame Consumer Safety Network, P.O. Box 780634, Dallas, TX 74378. (214) 352-4268. 75. Roberts, J.H. Aspartame (NutraSweet): Is It Safe?, The Charles Press (1990). 76. Natow, A.; Heflin, J.A. No-Nonsense Nutrition for Kids, N.Y: McGraw-Hill (1985). 77. Sen. Orrin Hatch, Chairman, Senator Labor and Human Resources Committee (February 3, 1986). 78. Hiroyuki Ishii, “Incidence of Brain Tumors in Rats Fed Aspartame.” Life Science Laboratories, Central Research Laboratories, Ajinomoto Co., Inc., Yokohama Japan. Unpublished and Undated. Alexander Mullarkey, B. 79. Bittersweet Aspartame, A Diet Delusion, Oak Park, IL: NutraVoice, Inc. (1992).