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