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
e-mail:  ">Betty Martini <[email protected]>

From Michael Evangelisia, former FDA investigator -
 

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