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FDA Complaints on NutraSweet 4/20/95
There has been so much discussion on the symptoms caused by NutraSweet I thought perhaps it would be helpful to have the actual report from the FDA. They did not want to release it and I had to file under Freedom of Information to get it. Also, in the Food Chemical News of June, the FDA says they will no longer compile a complaint file on aspartame. Dr. Kessler admits that only 1% report serious problems and, of course, many do not know to associate their neurological symptoms with aspartame, un- aware of the history or original lab tests that produced seizures and brain tumors.
Symptoms Attributed to Aspartame: Health Hazard Evaluation Board
Headache 1847 Dizziness, Poor 736 equilibrium Change in Mood 656 Vomiting or Nausea 647 Abdominal Pain and 453 cramps Change in vision 362 Diarrhea 330 Seizures and Convulsions 290 Grand Mal Seizures 174 Memory Loss 255 Fatigue, Weakness 242 Other Neurologial 230 Rash 226 Sleep Problems 201 Hives 191 Change in Heart Rate 185 Itching 175 Change in Sensation 172 (Numbness, Tingling) Local Swelling 114 Change in Activity Level 113 Difficulty Breathing 112 Oral Sensory Changes 108 Change in Menstrual Pattern 107
The NutraSweet Company and the FDA both use the excuse that methanol occurs naturally in fruit. Here is the answer to that excuse from the report: ASPARTAME; METHANOL AND THE PUBLIC HEALTH, Dr. Woodrow C. Monte Journal of Applied Nutrition, Volume 16, Number 1, 1984
"Ethanol, the classic antidote for methanol toxicity, is found in natural food sources of methanol at concentrations 5 to 500,000 times that of the toxic. Ethanol inhibits metabolism of methanol and allows the body time for clearance of the toxin through the lungs and kidneys."
There is no ethanol in aspartame. The FDA and the NutraSweet Company knows this and their excuse is a smokescreen.
Dr. Monte goes on to say:" Methanol (methyl alcohol, wood alcohol), a poisonous substance, is added as a component during the manufacture of aspartame. This methanol is subsequently released within hours of consumption after hydrolysis of the methyl group of the dipeptide by chymotrypsin and in the small intestine. Absorption in primates is hastened considerably if the methanol is ingested as free methanol as it occurs in soft drinks after decomposition of aspartame during storage or in other foods after being heated. Regardless of whether the aspartame derived methanol exists in food in its free form or still esterified to phenylalanine, 10% of the weight of aspartame intake of an individual will be absorbed by the bloodstream as methanol within hours after consumption."
"Methanol has no therapeutic properties and is considered only as a toxicant. The ingestion of two teaspoons is considered lethal in humans."
"Methyl alcohol produces the Methyl alcohol syndrome, consistently, only in humans and no other test animal, including monkeys. There is a clear difference between "toxicity", which can be produced in every living thing, and the "toxic syndrome." .. "The greater toxicity of methanol to man is deeply rooted in the limited biochemical pathways available to humans for detoxification."
There has been a good deal of blindness from NutraSweet because the methanol converts to formaldehyde in the retina. Dr. Monte says: "The localized retinal production of formaldehyde form methanol is still thought to be principally responsible for the optic papillitis and retinal edema always associated with the toxic syndrome in humans."
Further: "If formaldehyde is produced from methanol and does have a reasonable half life within certain cells in the poisoned organism the chronic toxilogical ramifications could be grave. Formaldehyde is a known carcinogen producing squamous cell carcinomas by inhalation exposure in experimental animals."
What Dr. Monte wrote back in l984 and saw coming is what we are seeing in the population. He said about chronic human exposure: "Many of the signs and symptoms of intoxication due to methanol ingestion are not specific to methyl alcohol. For example, headaches, ear buzzing, dizziness, nausea and unsteady gait (inebriation), gastrointestinal disturbances, weakness, vertigo, chills, memory lapses, numbness and shooting pains in the lower extremities, hands and forearms, behavioral disturbances, and neuritis. The most characteristic signs and symptoms of methyl alcohol poisoning in humans are the various visual disturbances which can occur without acidosis although they unfortunately do not always appear. Some of these symptoms are the following: misty vision, progressive contraction of visual fields (vision tunneling), mist before the eyes, blurring of vision, and obscuration of vision."
While this report was written in 1984 please note that the FDA admits they are receiving complaints on exactly what is mentioned in the above paragraph on its recent report. Please folks take it seriously.
To my private email I get case histories like the above and we have the classic ones we see over and over again listed on the auto-responder to warn the public. If you want instructions to the auto-responder please let me know by private email and I'll forward it with other information that is requested.
Prior to the flyers that Mission Possible started distributing worldwide about a year and a half ago many people did not know to associate their symptoms with this culprit. They keep on consuming aspartame and perished never knowing the problem. Today some of the 92 documented symptoms are listed and the diseases triggered. If you remember but one case history remember this one:
"Aspartame killed my wife. No words can express the agony and horror sweet Joyce endured. This poison destroyed her brain, ravaged all her organs and blinded her. She died at age 46 in 1991.
When we filed suit we were harassed and threatened. Our gung ho attorneys with a medically documented case suddenly seemed scared away. The case had to be dropped. Joyce deteriorated so quickly she would not have been able to participate in the legal proceedings anyway.
Don't listen to the paid Judas-goats and TV celebrities who say its safe. Save your life and those you love, and avoid the grief I endured. The makers of this poison considered her death an acceptable cost of business. I'm a man without a wife because the NutraSweet Company is as business without a conscience. April is Anti-Aspartame month. Take dead serious the warnings you will hear. The life you save may be your own." Richard Wilson (written in a local Atlanta paper in April, 1994)
I spoke to Richard only a couple of days ago. He lives in Stockbridge, Georgia. Joyce testified before Congress before she died hoping to ban this product from the marketplace so this wouldn't happen to another human being. The power of Searle/Monsanto (who bought Searle) and the FDA is too powerful. The only way we could warn the public was to go directly to the people.
In September Joyce Wilson's son married and on her empty chair was a long stem rose. On October 1 when MISSION POSSIBLE exposed the American Diabetic Assn. here in Atlanta for taking money from Monsanto and endorsing this for diabetics with full knowledge of the consequences, we dedicated the day to Joyce. Press packs were garnished with a single yellow rose and were covered with black lace for mourning.
Today the patent has expired and aspartame is in 5000 products and climbing. Be warned! As Richard said: "The life you save may be your own."
Betty Martini Domain: Betty Martini <Mission-Possible-USA@altavista.net> |
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From Michael Evangelisia, former FDA investigator - |
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CREATIVE LOAFING MAGAZINE - 2/4/95
LETTER TO THE EDITOR..
BITTER SWEET The Editors:
I am a former FDA Investigator. Along with my investigative experience, my background in the medical sciences, training and education have led me to write to you and uncover some facts. I have no stake in this debate, except to clear the air about NutraSweet, objectively and logically, and raise some serious questions about this issue.
Referring to the letter from Dr. Robert Moser [Jan.14], one has to question Dr. Moser's objectivity. To begin with, as he is under contract to the NutraSweet Co., it would be safe to assume that anything in Dr. Moser's article would support NutraSweets claims to being safe. After all, that's his job. As such, there are serious doubts as to the objectivity and accuracy of his letter, and that's just for starters.
In my opinion, NutraSweet is a poisonous neurotoxin.
In 1965, while searching for an anti-ulcer drug, NutraSweet's producer, G.D. Searle, found that it had a strong sweet taste. A few years later, at the manufacturer's request, Dr. Harry Waisman (physician and biochemist) from the University of Wisconsin conducted a study of aspartame and its PKU (pheylketonuria) effects. Although there were reports of negative findings, Searle deleted this information before sending the report to the FDA.
In 1971, another doctor, from Washington University School of Medicine, informed Searle Co. that aspartic acid caused holes in the brains of the animals he was testing. A researcher, hired by Searle itself, confirmed these findings. Searle had submitted 13 tests. FDA scientists who reviewed these tests found serious deficiencies in all of them. Despite these major concerns (and, in my opinion, a need for further investigation), FDA managers decided that the tests could be relied upon.
In July of 1974, aspartame was approved for use in dry goods, including chewing gum.
Just one month later, an objection to FDA's approval of aspartame was filed. The objection cites brain lesions and neuro-endocrine disorders in test animals. A hearing was requested on the purported safety of aspartame. An investigation was ordered in July of 1975 to determine if Searle submitted false information to the FDA.
By December 1975, FDA investigators concluded that Searles research practices were so severely flawed, they were basically unreliable. Contradicting the findings of their own investigators, the FDA upheld the aspartame approval.
On April 8, 1976, at a U.S. Senate subcommittee hearing regarding G. D. Searle Co. and the FDA, it was stated that an astonishing, almost unbelievable scope and range of abuses or deficiencies uncovered by the FDA on several Searle products was profoundly disturbing>
Even more disturbing, many people associated with this issue had questionable motives. One U.S. Attorney left the case and then received a position with the law firm Sidley and Austin, of which Searle is a client. This happened with the assistant U.S. Attorney, too. A member of Congress became Searle's president.
The bureaucratic whitewash went on like this for three more years, until, in direct contradiction to accumulated evidence, aspartame was approved for many food types, including a packaged, tabletop sweetener in 1981. Just a year before, a Public Board of Inquiry concluded that it had not been shown any proof that aspartame was safe as a food additive. A six-person review panel was established to review these issues. Three of the six advised against approval. The FDA commissioner approved aspartame for its proposed uses, citing a study to support that fact. The study, by the was, was conducted by Ajinomoto, the Japanese manufacturer of aspartame.
NutraSweet, a.k.a. aspartame, is a compound of the following chemicals: methanol (wood alcohol); aspartic acid; and phenylalanine. Aspartame readily breaks down into its component parts, and this decomposition is hastened by heat. Methanol breaks down further into formaldehyde and formic acid (ant sting poison).
In 1983, a warning that phenylalanine is present was placed on some labels of aspartame-containing products for individuals with phenylketonuria. During this period, the Arizona Dietetic Association and the Central Arizona District of the Association filed a suit seeking to order the FDA to hold a hearing regarding adverse effects of aspartame. Supported by too-numerous-to-ignore consumer complaints, reports about aspartame poured in.
By early 1994, the federal government reported 6,888 complaints concerning the adverse effects of aspartame. As a matter of fact, aspartame accounted for 75 percent of all complaints in the Adverse Reaction Monitoring System.
Hardly a counter-placebo effect, Dr. Moser. how much did they pay you for that psychological cow-chip?
NutraSweet adverse reactions suggested this was a strong neurotoxin. Some of these symptoms are: aggressive behavior, disorientation; hyperactivity; numbness of the extremities; excitability; memory loss; visual impairments and loss of depth perception; liver dysfunction; seizures; tumors; severe mood swings; and major neurological degeneration.
If we carefully scrutinize Dr. Moser's letter, we can see that he clearly name-calls those people who have spoken out against aspartame, yet cannot offer any evidence or rationale to support the product itself.
A. Michael Evangelisia Consultant, F.D.A. Regulatory Affairs Atlanta
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Click here to see the famous "92 Symptoms" report in its original form that Betty got from the FDA under the Freedom of Information Act. |
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