Felicia M. Ellison, M.S.
Consumer Safety Officer, HFS-265
Division o Petition Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
College Park, MD
Dear Mrs. Ellison:
Thank you for answering my letter faxed to you on December 4,
2010. I would like to go over your answers. Cynthia Crossen
in her book The Tainted Truth: The Manipulation of Fact in
America, said: In todays corporate dominated information market truth
has become to belong to those who commission it. The FDA has been using
industrys propaganda so long they don't realize how it conflicts with
reality and scientific documentation. I will give you in brief my
questions you answered in red and my comments in black. .
1. How could aspartame possibly have been considered as a suitable
food additive in the first place, if the MSDS had been considered?
You have told us:- The MSDS is not appropriate nor in many cases relevant for the
risk assessment of Methanols use in aspartame because of the routes of
exposure, dosages and uncontrolled nature of the human toxicity data
derived from the MSDS
Our response:- The MSDS for methanol (Methyl Alcohol) is a mandatory health and
safety document prepared by the producers of pure methanol setting out in
an international formalized way the hazards associated with their
product. It is required by OSHA to be provided to employers and employees
using Pure methanol, from manufacturing industries all the way down to
research labs, hospitals, Pharmacies and school laboratories; the
mandatory hazard labelling for any container in which pure methanol is
sold is shown above.
If an MSDS is legally required to protect the health of anyone just
handling pure methanol,(i) it must surely be an appropriate document to
be consulted by anyone intending to allow methanol to be consumed in
food. The severe toxicity of methanol in man has been known for 150 yrs,
below are some relevant extracts from the MSDS of the TERRA Nitrogen
Methanol is listed as a Poison-Class B; It is harmful if swallowed or
absorbed through the skin. Ingestion of as little as one ounce can cause
irreversible injury to the nervous system, blindness, or death. It cannot
be made non-poisonous in man
Ingestion: Ingestion may cause serious poisoning with effects similar to those
of inhalation and absorption through the skin. Toxic effects are more
common after ingestion. Death from as
little as one ounce has been reported
Summary of Chronic Exposure: Methanol is slowly eliminated from the body; hence repeated exposures
may result in toxic levels in the blood and tissues. Due to its slow
elimination, methanol should be regarded as
a cumulative poison. Though single exposures to fumes may cause no
harmful effect, daily exposure may result in the accumulation of
sufficient methanol in the body to cause illness
The route of exposure for aspartame (Ingestion) is fully covered here
also the very low (LDlo) for eye damage. The severe toxicity and
metabolic damage caused through the cumulative effect of chronic methanol
ingestion is also very clear NO one should be consuming pure methanol
in ANY quantities It is far too dangerous.
2. Show us how you established a
for free methanol - 10% of aspartame.
You have told us:- A NOAEL for methanol was never established; Even though methanol
constitutes a full 10% w/w of aspartame; you relied on setting a NOAEL by
the dosing of aspartame to rats and assumed by the absence of methanol
poisoning symptoms and the small amount of free methanol released that
methanol was not of toxicological concern
Our response:- (ii) Were you totally unaware of the contents of the MSDS of
(iii) Were you totally unaware of the destructive metabolism of methanol
in the human body :- Methanol
>Formaldehyde >Formic Acid >Co2 >H2o? (iv) Were you totally unaware of the severe toxic cumulative effect
of free methanol in the human body, building up over time (0-20yrs)
eventually causing organ, tissue and neurological damage?
NOTE: The fact that fruits and vegetables in nature deliver more methanol
than aspartame is totally irrelevant.
3. What science do you have to support the belief that the body
handles the free methanol from aspartame in the same way as for methanol
You have told us:- That there is no significant difference in the pharmacokinetics
between free methanol and dietary methanol. The overall disposition
of methanol in nature (dietary methanol) is very similar to the
biotransformation (Metabolism) of the methyl group of methanol from
aspartame (free methanol); Based on these findings there is no scientific
basis or need to differentiate free methanol form Dietary methanol.
Our response:- In your explanation you mixed up free methanol and methanol in
nature when you said -free methanol is readily absorbed from the
stomach whereas aspartame must pass into the into the small intestine---
What I would accept is - free methanol from aspartame is readily
absorbed from the stomach whereas natural (dietary methanol) must pass
into the small intestine --- the distinction between free methanol and
methanol in nature (dietary methanol) is very important and they are
both very different.
Pure methanol, free methanol and dietary methanol are all the same
chemical MEoH; Aspartame contains pure methanol in the form of its 10%
methyl ester; At a temperature of 86f the methyl ester reverts back and
releases the pure methanol; this can happen in poor storage conditions,
within the mouth (chewing gum) from tabletop sweeteners or in the
stomach. Pure Methanol released in this manner is said to be Free IE.
unbound to any inhibitors which might prevent it following its dangerous
metabolic pathway Methanol >Formaldehyde >Formic Acid > Co2
> H2o. Free methanol acts in the body in exactly the same way as pure
methanol - Pure/ Free methanol is a dangerous cumulative metabolic toxin
Methanol in nature (dietary methanol) is never Free it is always bound
to natural inhibitors which prevents the methanol following its
destructive metabolic pathway and protects us by allowing time for the
methanol to be cleared from our bodies safety. There are no ADIs for
carrots or apples or any other fruit or vegetables, which we know, can be
consumed in any quantity without harm.
The science is there (MSDS) Pure /Free methanol is a vicious toxin
in humans, a single dose of one tablespoonful (10ml) will render you
blind and 3 tablespoonfuls (30ml) could be fatal. Very small chronic
(daily) doses of free methanol from aspartame, is a slow stealthy killer
causing organ. tissue and neurological damage over time (0-20 yrs) this
is evidenced by the many tens of thousands of anecdotal reports naming
aspartame as the cause of their symptoms.
4. What science did you rely on to be certain that the chronic
(daily) ingestion of free methanol was safe at the ADI set - 50
You have told us:- Aspartame is safe for low to moderate intake. The amount used in
products is self limiting? The approval reference you quoted refers to
colorings? High levels of aspartame intake are unlikely to exceed
the ADI if used in food with no limitations? The agency concluded that
consumption of aspartame would be well below the acceptable intake and
that it would be safe for its intended use.
Our response:- This explanation falls well short of reassuring.
In July 1974 CFSAN approved aspartame for restricted use at an ADI
of 20mg/kg, then, in July 1983 they approved its use in carbonated drinks
at 50mg/kg? (v) Please explain how aspartame suddenly became 2 ½ times
According to the GAO report of June 1987, Searle, in 1982 when they
applied to use aspartame in carbonated drinks, projected a significant
increase in the daily consumption of aspartame specifically, that our
2-4 year olds could potentially consume aspartame at almost 50mg/kg
Searle (naturally) backed this up with 5 studies which showed that,
consumption at the projected level of our children in fact did not
result in any adverse effects?? After reviewing these studies and
others, CFSAN concluded that the ADI of aspartame could be raised from
20mg/kg to 50mg/kg?
(vi) Question: Is it Sensible, Legal or safe to set ADIs according to
the potential consumption of our children?
Note: in the EPA quote above point 1 Page 2, they recommend a consumption
limit for methanol of 7.8mg/kg per day - this equates to
1.11mg/kg for a 70 kilo adult.
Note: Campaign colleagues in the UK have also established an ADI for
methanol using the MSDS data and returned an ADI of 0.114mg/kg -
see attached working sheet. Conclusion: It appears the CFSAN was not in possession of all the facts it
needed regarding the metabolism of methanol when considering the approval
of aspartame in the 70s and 80s. - they did however have a strong
belief and obviously still do, that the methanol released form aspartame
is the same as methanol in nature this is a myth promulgated by the
manufacturer to conceal the real toxic poison in their product.
It is significant that when researching the aspartame story, what little
part the severe poisoning effect of methanol plays, every time it comes
up, out comes the same old story - Methanol from aspartame is OK - The
amount is so small - There is more methanol in fruits and vegetables -
Rats can eat lots of it without harm etc. These answers have been
sufficient to detract scientists attention away from the free methanol
released by aspartame since at least 1980, and there is clear proof of
this. I draw your attention again to the GAO report of June 1987 entitled
Food and Drug Administration Food additive approval process followed
The independent GAO administrators relied on briefings from FDA CFSAN and
Searle to conduct their study, if we look at the very first Paragraph
entitled What is Aspartame? here we can see the myth in action, this is
what GAO thought it was:-
What Is Aspartame?
G.D. Searle and Co. began developing aspartame-a sweetener about
180 times as sweet as sugar-in 1965. It is a white, odorless, crystalline
powder composed of 2 amino [email protected] acid and
Like sugar, aspartame produces about 4 calories per gram. However,
because aspartame is sweeter than sugar, it provides only a fraction of
the calories provided by a quantity of sugar yielding equivalent
No mention of Methanol the 3rd ingredient and 10% of the
product how could they forget to mention that? In 104 pages methanol is
only mentioned 7 times in different contexts and free methanol not at
all. Methanol does not appear in the glossary.
Because CFSAN were not aware (or were concealing) the severe toxicity of
the free methanol released form aspartame, it would appear FDA allowed a
product to be released into the US food chain without adequate safety
consideration of the methanol in the product.
1) A NOAEL was not established for Methanol.
2) Without a NOAEL for methanol it is not safe to
set an ADI for aspartame.
Considering that an ADI for methanol has been set by others at
0.114mg/kg and 1.114mg/kg which would set the aspartame ADIs at
1.14mg/kg and 11.1mg/kg respectively. This makes the US ADI at 50mg/kg
look way too high! (vii) Your comments please.
Some interesting developments are happening in Europe at present. In May
last year the EFSA Advisory Forum members at their 36th
meeting refused to endorse their own national experts recommendation
that aspartame is safe- they are now not convinced and have deferred
further consideration until June this year. The contentious issue with
them concerns the metabolism of free methanol released by aspartame. COT
and FSA are at this moment investigating the free methanol released by
aspartame. There is a Public Petition lodged with the Scottish Parliament
calling for the free methanol released by aspartame to be banned and a
campaign organized to inform Medical practitioners of the methanol in
everyones diet. Dr Soffritti has completed another
study of aspartame using mice and suggests that cancers found were caused
by the methanol in aspartame!
The questions arising from your letter are as follows:-
The MSDS - it must surely be an appropriate document to be consulted by
anyone intending to allow methanol to be consumed in food.
Were you totally unaware of the contents of the MSDS of
(iii) Were you totally
unaware of the destructive metabolism of methanol in the human body:
- Methanol >Formaldehyde >Formic
Acid >Co2 >H2o?
(iv) Were you totally
unaware of the severe toxic cumulative effect of free methanol in the
human body, building up over time (0-20yrs) eventually causing organ,
tissue and neurological damage?
(v) The ADI -
Please explain how aspartame suddenly became 2 ½ times safer?
(vi) Question: Is it
Sensible, Legal or safe to set ADIs according to the potential
consumption of our children?
(vii) DA ADI for aspartame too high
-Your comments please.
Regarding other comments in your letter. When you say other
authorities, European Scientific Committee for Foods, European Food
Safety Authority, AMA and American Dietetic Association all agree
aspartame is safe remember they got that from FDA. The American
Dietetic Association we call Monsantos media flacks are the first to
defend them. These ladies of the evening are funded by the
aspartame manufacturers and say there is no unsafe food. There is
no longer any European Scientific Committee for Foods. Here is
rebuttal to their propaganda:
OLAF (anti-fraud association in Europe) found that there was only one
person making the decision on aspartame safety on review, not a
committee Now there is only EFSA. Incidentally I flew to
Brussels to speak to the EU and brought them all the damning documents,
which they deleted. While I was there I showed them the 1000 page
medical text by Dr. H. J. Roberts, Aspartame Disease: An Ignored
someone was reviewing aspartame and they were told its a global epidemic
and presented all the proof in a medical text would you expect them to be
interested? No interest at all. Miguel Angel Granero-Rosell never
even turned the first page. Likewise Peter Wagstaffe was not
interested either. Their one person had already made the
I suspect the manufacturers of aspartame were very concerned about how
much factual information was being brought to Europe. I was met by
their welcoming committee, Immigration, who locked me in a cell for three
and a half hours and interrogated me with questions like if they allowed
me in England how many people would find out about the dangers of
aspartame. They opened my suitcases and immediately confiscated
all lecture material on aspartame. In the end they gave it back but
this shows you how worried the aspartame industry is of solid facts they
cant rebut. Now EFSA has inherited the aspartame propaganda.
So when the first Ramazzini Study was done it was rebutted.
However, Dr. Koeter did resign but not before he put out a press release
that confessed, We were pressured by industry to hijack science.
So when you throw out these names you understand the influence and
pressure by the aspartame industry.
Dont forget when you make such statements, as the FDA believes that
there is a reasonable certainty of no harm to the general population from
the use of aspartame as a sweetener the public is fully aware of the
real facts. We know it was FDA who asked for the indictment of G.
D. Searle because of the studies, even though the prosecutors hired on
with the defence team. We know FDA has had so many complaints that
in congressional hearings it was admitted that FDA was referring them to
the AIDS Hotline. We know that the outrage over aspartame poisoning the
public caused three congressional hearings where physicians and
researchers spoke out about aspartames deadly effects. If you missed
these events go to www.mpwhi.com and
read them. If aspartame is so safe, why did FDA compile a
list of 92 documented symptoms from four types of seizures to coma and
death? If aspartame is safe explain 30 years of controversy, and
the fact that almost 100 per cent of independent studies says its
not. Explain why the Board of Inquiry of the FDA revoked the
petition, which you will also find on web. Explain why President
Reagan had to write an executive making the FDA powerless to do anything
on aspartame until he could get a new commissioner, Arthur Hull Hayes, to
FDA to over-rule the revoked petition that Dr. Jeri Goyan was about to
sign into law. He got fired at 3.00 AM so he couldnt sign it. All
these events happened when you say, the FDA believes that there is a
reasonable certain of no harm!!! Why are there aspartame Detox centers,
and an Aspartame Toxicity Center? Why are there 30 years of articles
warning the public by renowned physicians and researchers? Why are
movies made warning the public of the toxicity of aspartame such as
Sweet Misery: A Poisoned World Is FDA on another
Do a google search on aspartame and youll find about 3 million
sites. What do you suppose they are writing about? A lot of
them expose aspartame using FDA records. How can FDA look at them
and say aspartame is harmless and when scientists and others look at them
they see a chemical poison that should be removed from the market.
You say FDA reviewed over 100 toxicological and clinical studies to
conclude that aspartame was safe for use as a sweetener prior to
approval. You mean you have some I dont? Its these studies
done before approvals that were the target of an indictment for fraud
requested by FDA. I notice the FDA said about studies in the 1970s
that it showed aspartame causes birth defects. In case you dont
realize, birth defects are harm. I notice FDA in reviewing those
studies made comments about Searle, for instance, saying there was benign
lymphoma when it was lymphosarcoma. Cancer also comes under the
category of harm. Aspartame violates the Delaney Amendment, which
prohibits putting anything in food you know will cause cancer. Also
aspartame is adulterated and violates interstate commerce
Also with reference to these studies done prior to approval, FDA
Toxicologist and Task Force member, Dr Adrian Gross stated (Wilson l985):
"They (G.D. Searle) lied and they didn't submit the real nature of
their observations because had they done that it is more 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."
I agree with Dr. Gross on review. Tumors also equal
harm. Adeno-carcinoma equals harm. I can understand why
Searle filed suit to have the task force results removed from the
record. It doesnt sound very good to be exposed by the FDA as
liars and involved in fraud which is why FDA wanted them indicted
under Title 18, Section 1001. They just couldnt get aspartame to
show safety. Now you tell me there were 100 toxicological and
clinical studies FDA reviewed. Please give me a list of these
While youre at it I would like to see proof that at normal doses
aspartame is completely hydrolyzed in the gut leaving the methanol there
to be detoxified. Since the amounts are small, the only way to
ascertain this fact is using labelled aspartame. Please cite the
experimental papers that prove so. How can you or anyone explain
the presence of aspartame methanol label in tissues if its tiny amounts
are freed in the intestine and detoxified (by the livers alcohol
This is a damning study and the only one dealing with these issues.
We know the aspartame industry had a flack try to rebut it, Tephly.
Maybe you dont know he confessed he used the wrong test. He must
have come from one of those rent a scientist programs Dr. Verrett
mentioned. No generalizes please, specifics. Lets take this to the
scientific paper level.
Also, Im concerned with the manufacturer using an unproven drug as a
sweetener without having done studies of possible interactions.
You say the FDA continues to closely monitor scientific literature for
information that might indicate potential public health concerns with
artificial sweeteners like any regulated food ingredient. Should
the need arise you say the agency will take the appropriate action to
protect the public health. There is so much in the scientific literature
showing how deadly this drug is, you would have to trip over it to miss
it. Almost 100 per cent of scientific peer reviewed studies show the
problems. When Dr. Ralph Walton researched he said 92% showed
problems but if you eliminate 6 studies the FDA had something to do with,
and one pro-aspartame summary, 100% of independent peer reviewed studies
show what aspartame causes. Maybe the 6 studies were eliminated
because FDA just wont tell the truth when it comes to aspartame. There
were so many shenanigans with aspartame studies by Searle that Dr. John
Olney finally had had enough and insisted Searle do the studies in his
lab so he could watch them. Indeed the studies showed brain damage
although Searle forgot to tell you. Brain damage is also
Lastly you say the reason you havent answered my citizens petition
is due to a number of competing priorities. You wrote me the same
thing 8 years ago. You must have forgotten. This is why laws
are made. In the case of citizens petitions you only have 180 days
to answer. You cant ignore them according to law. The
imminent health hazard amendment was in 2007 and its suppose to be
answered in a week or ten days.
When you answer my FOIA please deal with facts and proof. Researchers and
physicians the world over look at FDA records and independent studies and
see an excitoneurotoxic, carcinogenic drug. FDA looks at the same
records and sees no harm and discards damning studies.
Somebody is wrong!
DISCLOSURE: This information has not been evaluated by the Food drug Administration or Federal Trade Commission. This information is not intended to diagnose, treat, cure, or prevent any disease. Any information here in is for educational purpose only; it may be news related, speculation or opinion. Always consult with a qualified Medical Doctor before deciding on any course of treatment, especially for serious or life-threatening illnesses.