From: Betty Martini [Bettym19@mindspring.com] Sent: Tuesday, July 30, 2002 11:25 PM To: FDAdockets@oc.FDA.gov; RXH@CFSAN.FDA.GOV; Jaffe Lyle D Cc: info-anzfa.gov.au; annette.king-ministers.govt.nz; Miguel-Angel.Granero-Rosell@cec.eu.int; peter.wagstaffe@cec.eu.int Subject: Open Objection to approval of Neotame, Docket Number 98F-0052 abd 99 F - 0187, Request for Hearing. All studies on Neotame meaningless because they are based on aspartame which was never proven safe. Original statute of limitation defense voided by rebir Dockets Management Branch HFA - 305 - Certified Mail Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, Maryland 20852 To Docket Management/FDA A new legal case shows the US may recover 3 times its costs when a company's frauds on the FDA cost the taxpayers money. It is likely that frauds by aspartame producers have cost taxpayers billions of dollars. By lying to the FDA a chemical poison has been marketed in 100 countries creating one of the largest plagues in world history. We have epidemics of autism, ADD, Alzheimers, MS symptoms, lupus, diabetes, fibromyalgia, chronic fatigue, behavioral and psychiatric problems, sudden death, seizures, brain tumors, blindness, etc., all discussed and documented in Aspartame Disease: An Ignored Epidemic by H. J. Roberts, M.D., (www.sunsentpress.com). During the approval process of aspartame on which Neotame is based the original manufacturer lied to FDA. One of the most famous neuroscientists on the planet , John Olney, M.D. did the studies on the excitotoxin aspartic acid, 40% of aspartame (literally stimulates the neurons of the brain to death - as written on the back cover of Excitotoxins: The Taste That Kills by neurosurgeon Russell Blaylock, M.D. ). He found that it caused lesions in the brains of mice. He told Searle but Searle didn't come clean to you - the FDA. Obviously, FDA would not want an excitotoxin on the market to destroy the brains of consumers? Right? But the manufacturer continued lying and deceiving the FDA. Transcript of Document Number 3 from Congressional Record, Voluntary Submission, Confidential Trade Secret Information (12/28/70). This document is psychomanipulation, how they would convince you that assumptions were true. But here is the last paragraph: "With the spoon-for-spoon, we have no way of estimating maximum likely abuse and hence need to utilize data based on almost complete conversion to DKP. If we include this use in the original FAP, we stand a good chance of ending up with nothing in the short run and nothing in the long run whereas the other approach would give us something in the short run and quite likely as much as we would ever get in the long run. I think it becomes very important for us to start to get our sweetener into commercial channels as soon as possible to minimize the incentive that people now have to work on other sweeteners. Action in the US will tend to influence the outcome in other countries as well." They concealed the almost complete conversion to DKP, the brain tumor agent because they knew you wouldn't approve it. Lies, lies and more lies. FDA toxicologist, Dr. Adrian Gross said: "Failure to report to the FDA all internal tumors present in the experimental rats, e.g. polyps in the uterus, ovary neoplasms as well as other lesions." (Gross 1987a, page 8). "Animals which had died were sometimes recorded as being alive and vice versa.. These include approximately 20 instances of animals reported as dead and then reported as having vital signs normal again at subsequent observation periods." (Gross 1985, page S10835). Wilson, l985 - Dr. Adrian Gross, FDA Toxicologist and Task Force Member: "They (G. D. Searle) lied and they didn't submit the real nature of their observations because had they done that it is more than likely that a great number of these studies would have been rejected simply for adequacy. What Searle did, they took great pains to camouflage these shortcomings of the study. 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." Dr. Gross was not the only FDA toxicologist. There was Dr. Jacqueline Verrett who was also a member of the Task Force that investigated the authenticity of Searle's research. She believed the original aspartame studies were "built on a foundation of sand". (Testimony of Dr. Jacqueline Verrett, FDA Toxicologist before the U.S. Senate committee on Labor and Human Resources, regarding "NutraSweet Health and Safety Concerns." ( Nov 3, l987) . She testified the flawed tests conducted by Searle - used as the basis of FDA approval - were a "disaster" and should have been "thrown out". She said she believed the studies left many unanswered questions about possible birth defects and the safety of aspartame. She let it be known that the team was instructed not to be concerned with, or comment upon, the overall validity of the study. She said a subsequent review discarded or ignored the problems and deficiencies outlined by her team's original report. She said: "serious departures from acceptable toxicological protocols" that her investigative team noted in the reevaluation of these studies were also discounted. She warned that any of the improper practices would compromise and negate a safety study of a food additive. Verrett declared the data in the study was worthless, and the safety of aspartame and its breakdown products have therefore not been determined. Dr. Verrett emphasized that aspartame is in the marketplace without basic toxicity information. She said there ware no data to assess the interactions with DKP, excess phenylalanine, other aspartame metabolites, additives, drugs or other chemicals. In her testimony, Verrett elaborated on DKP problems, including significant increases of uterine polyps and changes in blood cholesterol. DKP is formed when liquids in particular are presweetened with aspartame. The production of DKP is vulnerable to increase in temperature, and higher temperatures produce increasingly amounts of DKP. She reminded members of the Congressional Committee "that is why initially, aspartame was not intended or not planned to be used in liquids because of this decomposition.. it was decided it was too unstable to be used in hot preparations, hot liquids and also in diet drinks." Dr. Richard Wurtman of MIT testified in congress in l985 how the phenylalanine in aspartame as an isolate is neurotoxic and goes directly into the brain. FDA knows that, of course, as it tried to remove it from all supplements during the era of the Dietary Supplement bill. Title 18, Section 1001 of the Criminal Code which declares: "Whoever, in any matter within the jurisdiction of the executive, legislative or judicial branch of the Government of the United States , knowingly and willfully - * (1) falsifies, conceal, or covers up by any trick, scheme, or device a material fact: * (2) makes any materially false, fictitious, or fraudulent statement or representation; * (3) or makes or uses any false writing or document knowingly the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined under this title or imprisoned. FDA chief counsel Richard Merrill recommended to U.S. Attorney Sam Skinner a grand jury investigate Searle for "apparent violations of the Federal Food, Drug and Cosmetic Act 21, USC 331 and the False Reports to the Government Act, 18 USC 1001, for their willful and knowingly failure to make reports to the FDA required by Act 21 USC 355 (i) and for concealing material facts and making false statements in reports of animal studies conducted to establish the safety of aspartame." The manufacturer was powerful, and two U.S. Prosecutors were hired by the defense team and the statute of limitations expired. Aspartame was approved when Dr. Arthur Hull Hayes over-ruled the Board of Inquiry report of the FDA refusing approval. Now they want a new patent. As Dr. Jeffrey Bada, a peptide chemist, told me when he first reviewed the formula of Neotame "they just scrambled the formula, same dangerous breakdown products," etc. Monsanto Communications Director Nancy Nevin said about Neotame in l998: "Compositionally it begins with aspartame, but a simple enhancement to the dipeptide base of aspartame uniquely and markedly changes its sweetness. It is 40 times sweeter than aspartame." Monsanto's Nick Rosa in l998 also said that Neotame is "based on the aspartame formula". Dr. H. J. Roberts who has declared Aspartame Disease to be a global plague and published the new medical text, Aspartame Disease: An Ignored Epidemic, www.sunsentpress.com or 1 800 814 - 9800, wrote the Dockets Management Branch on March 3, l998 about Neotame saying: "The timing and self-serving corporate interests of this petition are suggested by the fact that the patent on aspartame expired several years ago. The approval of any analog of aspartame for human use MUST be challenged. In my opinion, there is already sufficient evidence for aspartame products to be withdrawn from the market as an "imminent public health hazard" NOW!" He also said: "As a physician and citizen, I am appalled at the thought of American consumers being again subjected to an anticipated repeat of the aspartame fiasco" ...... Discussed even in the medical text on page 770 - 771 is: Neotame: Will History Repeat Itself? "The Monsanto Company petitioned the FDA on January 23, 1999 to approve its high intensity sweetener, N-[N-(3.3-dimethybutyl)-L-a-aspartyl]-L-phenylalanine 1- methyl ester, as an all purpose sweetener and flavor enhancer. This analog of aspartame (on which the patent had expired), named Neotame, is 30-60 times sweeter than aspartame. The author submitted detailed letters of professional opposition to such approval - dated March 3, 1998, February 25, 1999, and April 10, 1999 - pending additional data about the safety of this chemical in humans. He concluded with this opinion: "I am a totally corporate-neutral physician, who is concerned about the ongoing exposure of the population to aspartame and numerous other chemicals that were approved without adequate long term studies by corporate-neutral investigators and politically neutral regulators. Let me repeat: I anticipate a public health tragedy if the aspartame problem is allowed to be repeated in the case of Neotame without these safeguards!" Remarkably and coincidentally, my novel projecting a public health scenario caused by a fabricated analog of aspartame was published. It is titled, THE CACOF CONSPIRACY: LESSONS OF THE NEW MILLENNIUM (Sunshine Sentinel Press, 1999). When conceived a decade earlier, the author had no knowledge of Neotame." All lies are reborn via this new application plus any new ones. Statute of limitation defense is voided by rebirthing this poison. Any studies on Neotame are meaningless because they are based on aspartame which was never proven safe! Just imagine how much aspartame the government has bought. Equal even has the Presidential Seal. And think how much Diet Coke has been bought by the government. The tax-payers are owed BILLIONS, and Title 18, Section 1001 is rings loudly. Aspartame disease is now a global plague, and the medical text gives 20 years of experience with this deadly chemical poison being on the market, drug interaction, chemical hypersensitivity and the legal implications of mass poisoning the people. Dr. James Bowen wrote you 18 years ago that aspartame is mass poisoning of the American public and more than 70+ countries of the world. (www.dorway.com). He has Lou Gehrigs just like many of those who served in the Persian Gulf and drank diet pop laced with aspartame, that also interacted with vaccine. Millions of babies have been murdered in their mother's womb. Aspartame support groups contain the comments from the outraged public who have been poisoned. Aspartame Detoxification Centers are now in America and Canada. Case histories are being collected for class action. Enclosed are the documents that give the evidence the FDA was lied to and knows aspartame is a chemical poison. As you well know, it should never have been approved. Some of your documents t are on www.dorway.com And your Board of Inquiry report saying not to approve aspartame is on www.greatfallspro.com along with Dr. Olney's testimony to the Board of Inquiry and the l985 congressional record. You can purchase from Bob Flint (Mission Possible Maine) actual CD's of these documents. Read the horror stories at the Aspartame Toxicity Center, www.holisticmed.com/aspartame All it takes is one drop of Neotame on the market and the statute of limitations is voided! Betty Martini, Founder, Mission Possible International , 9270 River Club Parkway, Duluth, Georgia 30097, 770 242-2599 www.dorway.com Deadline August 8, 2002 CC: ANZFA, European Union Enclosures: Dr. John Olney's Study on Aspartic Acid, 1970 Secret Trade Information Government Record Statements admitting manufacturer Lied to FDA