Posted: 27 October 2007
(REQUIRED TO BE ANSWERED IN LESS THAN TWO WEEKS) SENT CERTIFIED MAIL
Wed, Oct 24, 2007 11:45 am
ALSO SENT VIA EMAIL TO: Commissioner-fda.gov, mitchell.cheeseman-fda.hhs.gov, laura.tarantino-fda.hhs.gov, firstname.lastname@example.org, DHATTAN-CFSAN.FDA.GOV, LJAFFE@OC.FDA.GOV, email@example.com, firstname.lastname@example.org, david.acheson-fda.hhs.gov
Subject: Amendment to Citizens Petition to Ban Aspartame, Imminent Health Hazard of this Addictive Excitoneurotoxic Carcinogenic Drug. Sent by Certified Mail
"No new chemical or no chemical that is subject to any question as to safety should be employed until its possible injurious effect, both on an acute and on a long-time chronic basis, has been shown to be nonexistent. In other words, any chemical that is proposed for use ought to be proved in advance of distribution in a food product to be utterly and completely without the possibility of human injury." Dr. Paul B. Dunbar (1950), former FDA Commissioner
H. J. Roberts, M.D., who authored the 1038 page medical text on the global plague of Aspartame Disease: An Ignored Epidemic, said: "In the author's opinion, based on five decades as a practicing physician and corporate neutral researcher, aspartame disease can be considered a contemporary "thirteenth plague" in the wake of biological and chemical warfare, and the AIDS epidemic. Others support this conviction. Dr. William Campbell Douglass stated in Second Opinion (April 1999): "Right up there with the fluoride and mercury-in-your fillings scandals is the aspartame mass poisoning of the world."
He also said the issue of aspartame's safety ought not be whitewashed by reassuring pronouncements, pseudoscientific arguments based on limited or flawed doubleblind tests from corporate sponsored researchers, disinformation rebuttals to valid "anecdotal" reports, or medical campaigns waged by vested interests. Senator Howard Metzenbaum stated during the Nov 3, l987 Senate hearing on aspartame: "We need new, independent tests of safety. We don't need the company or nonprofit institutes fronting for the company, telling us this product is safe."
Today many independent scientific peer reviewed studies have been done confirming aspartame's toxicity from the Ramazzini Study confirming original studies the FDA reviewed proving aspartame is a multipotential carcinogen, to the Trocho Study showing the formaldehyde converted from the free methyl alcohol embalms living tissue and damages DNA. Anything that shows the true toxicity of aspartame is either ignored or rebutted by the FDA in defense of the manufacturers.
The food additive amendment approved by the Congress in 1958 was intended to offer the public the same degree of protection against unsafe food additives as unsafe drugs. According to Congressional and Administrative News: Legislative History of Food Additives Amendment of l958 (p. 5302), "Safety requires proof of reasonable certainty that no harm will result from the proposed use of an additive." It also clarified the "Concept of Safety" for food additives in these terms.
The Imminent Health Hazard Regulation:
A House of Representatives report on the Food Additives Amendment stated, "Safety requires proof of a reasonable certainty that no harm will result from the proposed use of the additive" (H.R. Report No. 2284, 85th Congress, 2nd Session, l958).
A Legal Overview:
The pertinent FDA regulation (21 CFE 2.5) concerning imminent public health hazards reads
"(a) Within the meaning of the Federal Food, Drug and Cosmetic Act an imminent hazard to the public health is considered to exist when the evidence is sufficient to show that a product or practice, posing a significant threat of danger to health, creates a public health situation (1) that should be corrected immediately to prevent injury and (2) that should not be permitted to continue while a hearing or other formal proceeding is being held. The imminent hazard may be declared at any point in the chain of events which may ultimately result in harm to the public health. The occurrence of the final anticipated injury is not essential to establish that an "imminent hazard" of such occurrence exists.
"(b) In exercising his judgment on whether an "imminent hazard exists, the Commissioner will consider the number of injuries anticipated and the nature, severity, and duration of the anticipated injury."
Provision for the "Amendment or Repeal of Regulations" was set forth in Section 409 (h) of the Food, Drug and Cosmetic Act.
"(h) The Secretary shall be regulation prescribe the procedure by which regulations under the foregoing provisions of this section may be amended or repealed and such procedure shall conform to the procedure provided in this section for the promulgation of such regulations."
The law states the FDA has 180 days to answer a Citizens Petition for ban. It has been over 6 years. This amendment contains information on the last 13 studies showing aspartame toxicity. http://www.wnho.net/the_fda_fable.htm
Delaney Lives: http://www.wnho.net/delaney_lives.htm
Citizens Petition for ban of aspartame never answered: http://www.wnho.net/citizens_aspartame_petition.htm
Based on the fact aspartame is an Imminent Health Hazard and continuing research shows the toxicity a ban must be immediate. FDA's own report shows 92 documented symptoms from four types of seizures to coma and death. Additives are required by law to be inert. Murder is not inert and disability and death are not acceptable costs of business. As Dr. H. J. Roberts pointed out in "Protecting Mankind: One Physician's Quest": http://www.sunsentpress.com "The vast majority of corporate-sponsored studies denying aspartame disease had significant flaws in their design, biased interpretation of the data, or both. Most failed to use real-world products obtained at markets, whose duration of storage and exposure to heat were unknown. Similarly, many of the critics refused to consider the possibility of methanol toxicity resulting from the release of considerable free methyl alcohol (constituting ten per cent of the aspartame molecule) after ingestion."
"Not withstanding intense corporate, bureaucratic and "peer-reviewed" denials, I believe that the current prodigious consumption of products containing aspartame and its analogs constitutes an imminent public health threat. Its manifestations include major neuropsychiatric afflictions, the aggravation of diabetes mellitus and its complications, paradoxic obesity, addition and brain tumors - for starters. Moreover, aspartame reactions can simulate multiple sclerosis, Alzheimer's disease and a host of other conditions. --- The behavioral and psychiatric features of aspartame disease in teenagers have erroneously ascribed to conventional drug abuse, such as use of "meth" ... culminating in added personal misery." The case of Matthew Hobson is attached in this regard.
Dr. Roberts also states that "Subtle aspartame-induced hyperthyroidism can have profound ramifications, especially among older persons. The serious complications of "subclinical" hyperthyroidism (as determined by low thyrotropin levels) include increased mortality from all causes - especially circulatory and cardiovascular diseases, fractures and dementia. There are ongoing attempts to evolve acceptable diagnostic criteria for the diagnosis of multiple sclerosis, especially as new drugs are introduced to modify this disease. Some incorporate the presence of oligoclonal bands in the cerebrospinal fluid and abnormalities by magnetic resonance imaging (MRI). Their shortcomings, however, pose a threat to aspartame reactors who simulate the disorder, and are given drugs with considerable toxicity."
"A correspondent from the United Kingdom who had suffered aspartame disease - along with her brother and son --- gave this broad assessment of exposure to aspartame ---- " I find it very disturbing that the so-called protectors of our health (FDA) encourage us to consume a poison that ultimately I can see bringing the entire population to its knees and rendering the people of this world drastically defective as a species." Continuing complaints of disability and death from aspartame are ignored by FDA.
The attached Report For Schools http://www.mpwhi.com/report_on_aspartame_and_children.htm shows that aspartame is destroying the brains of our children by several eminent physicians including Dr. John Olney. FDA knew it from the beginning because of Dr. John Olney's Report to the Board of Inquiry: http://www.wnho.net/dr_olney1.doc FDA had agreed with Dr. Olney and cannot deny aspartame is a teratogen, carcinogen and excitoneurotoxin. This does not come under the heading of "inert additive"!
Aspartame interacts with drugs making no drug safe to an aspartame user and this is documented in Aspartame Disease: An Ignored Epidemic by H. J. Roberts, M.D.
It is outrageous the Ramazzini Study peer reviewed by 7 world experts was rebutted by FDA when they already knew it was a carcinogen and their own FDA toxicologist testified before Congress to this effect. The excuses by FDA are answered by Dr. Russell Blaylock in his CD, The Truth About Aspartame, attached to this amendment. Dr. Blaylock, author of Excitotoxins: The Taste That Kills pointed out in this text the brain tumor issue and discussed how the Aspartame Board of Inquiry told Dr. John Olney the high incidence of tumors was the result of spontaneous development of brain tumors in rats. "That is, that some rats develop brain tumors naturally, just as humans do. Dr. Olney is a trained neuropathologist as well as a neuroscientist. He reviewed the incidence of spontaneously occurring brain tumors in rats and found that out of seven studies using a total of 59,000 rats, only 0.08% developed brain tumors - the aspartame fed rats had a forty-seven fold higher incidence. But to be fair, he even accepted G. D. Searle's references for spontaneously developing brain tumors in rats and arrives at a figure of 0.015%. This was still a twenty-five fold higher incidence in the aspartame fed rats than in the controls." Dr. Blaylock further stated, "It was then observed that when brain tumors develop spontaneously in rats, the rate at which they appear begins to accelerate after two years of age, exactly when the Searle's study ended. Importantly, brain tumors are extremely rare before age one and one -half in the rat. So in truth, the incidence of spontaneously occurring brain tumors would be even less than cited above. Yet, the aspartame fed rats developed two tumors by sixty weeks of age, and five tumors by seventy weeks."
This is pointed out by Dr. Blaylock's book because FDA has always known it can trigger brain tumors and allowed it to be marketed anyway. In the Bressler Report, FDA audit, it was stated Searle was excising tumors from the rats, putting them back in the study, and then when they died resurrected them on paper. From Excitotoxins: "Dr. Olney hypothesized that one possible cause of the tumor induction was a by-product of aspartame metabolism called diketopiperazine (DKP). When nitrosated by the gut it produces a compound closely resembling a powerful brain tumor causing chemical - N-nitrosourea." With all the damning evidence in the Bressler Report: http://www.dorway.com/bressler.txt Jerome Bressler personally admitted when FDA retyped this audit they removed the most damning 20%, then requested by Dr. H. J. Roberts Congressman. FDA has steadfastly refused to give the congressman and Dr. Roberts this 20% which by law is part of public records showing refusal to serve within the law? Aspartame also violates Adulteration statutes, both State and Federal: http://www.rense.com/general67/aspar.htm
It is immediately petitioned as an amendment to the unanswered original Citizens Petition of 2002 aspartame be banned because it's an imminent health hazard. FDA must answer to malfeasance having violated their own law that a Citizens Petition be Answered in 180 days, and the Delaney Amendment as testified by their own FDA toxicologist, Dr. Adrian Gross. The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which this petition relies, and include representative data. The only unfavorable point to this petition is that aspartame producers who are poisoning the world will lose their revenue and ability to buy bureaucracies.
Dr. Betty Martini, D.Hum.
Founder, Mission Possible World Health International
9270 River Club Parkway
Duluth, Georgia 30097
Aspartame Toxiocity Center: http://www.holisticmed.com/aspartame
CD, "The Truth About Aspartame", Russell Blaylock, M.D.
"13 Mainstream Research Studies in 24 Months Showing Aspartame Toxicity"
"Report For Schools"
"Aspartame Violates State & Federal Adulteration Statutes"
"Aspartame Imminent Health Hazard, Must Be Banned Immediately, Violates Delaney"
"Citizens Petition For the Recall of Aspartame"
"Sweet Misery: A Poisoned World", DVD
Matthew Hobson's aspartame case
Aspartame Murders Infants, Violates Federal Domestic Genocide Code
Dr. Ralph Walton's paper on psychiatric problems
Dr. Russell Blaylock's paper on sudden cardiac death