"The MSDS is not appropriate nor in many cases relevant for the risk assessment of Methanol's use in aspartame because of the routes of exposure, dosages and uncontrolled nature of the human toxicity data derived from the MSDS"
Posted: 28 February 2011
From: Dr. Betty Martini, D.Hum., Bettym19@mindspring.com
To: commissioner-fda.gov, mitchell.cheeseman-fda.hhs.gov, laura.tarantino-fda.hhs.gov, ljaffe@oc.fda.gov, mherndon@oc.fda.gov, michael.herndon@fda.hhs.gov, david.acheson-fda.hhs.gov, "david.graham1-fda.hhs.gov
Date: Fri, Feb 25, 2011 2:27 am
Subject: Open letter to FDA answering letter of 1/11/11: Aspartame and methanol/etc.
February 25, 2011
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 today's corporate dominated information market truth has become to belong to those who commission it". The FDA has been using industry's 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 Methanol's 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 labeling 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 Corporation"
"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"
11. TOXICOLOGICAL INFORMATION
LDLo Human: 143 mg/kg; Eye, Pul, GIT
LD50 Mouse: 7300 mg/kg
LC50 Rat: 64,000 ppm / 4 hours (5628mg/kg)
LC50 Goldfish: 250 ppm / 11 hours
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 NOAEL 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 methanol?
(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 in nature?
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 in humans.
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 ADI's 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 mg/kg?
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 1/2 times safer?
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 ADI's 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 '70's and '80's. - 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 scientist's 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 for aspartame"
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 acid@--L-aspartic acid and L-phenylalanine. 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 sweetness"
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 ADI's 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 expert's 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 everyone's 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:
(i) The MSDS - it must surely be an appropriate document to be consulted by anyone intending to allow methanol to be consumed in food.
(ii) Were you totally unaware of the contents of the MSDS of methanol?
(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 1/2 times safer?
(vi) Question: Is it Sensible, Legal or safe to set ADI's 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 Monsanto's 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: http://www.holisticmed.com/aspartame/scf2002-response.htm
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 Epidemic, www.sunsentpress.com If someone was reviewing aspartame and they were told it's 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 decision.
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 can't 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.
Don't 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 aspartame's 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 couldn't 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 planet?
Do a google search on aspartame and you'll 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 don't? It's 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 1970's that it showed aspartame causes birth defects. In case you don't 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 laws.
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 doesn't 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 couldn't 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 studies.
While you're 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 liver's alcohol dehydrogenase) easily?
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 don't 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. Let's take this to the scientific paper level.
Also, I'm 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 won't 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 harm!
Lastly you say the reason you haven't 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 can't ignore them according to law. The imminent health hazard amendment was in 2007 and it's 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!
Please answer the questions posed above.
Sincerely,
Dr. Betty Martini, D.Hum.
Founder, Mission Possible World Health International
9270 River Club Parkway
Duluth, Georgia 30097
770-242-2599
E-Mail: BettyM19@mindspring.com
http://www.wpwhi.com
http://www.wnho.net
http://www.dorway.com
Aspartame Toxicity Center: http://www.holisticmed.com/aspartame
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