Australia/New Zealand
Proposal for Mandatory Declaration of MSG by Restaurants and Food Outlets

Comments from the Truth in Labeling Campaign

On June 19, 2002, the Australia New Zealand Food Authority (ANZFA) announced that an application had been received from the New South Wales Department of Health (NSW Health) seeking to require restaurants and other food outlets to notify consumers if monosodium glutamate had been added during food preparation.

On June 18, 2002, the Truth in Labeling Campaign submitted comments to ANZFA.  The text of those comments follows. On October 10, 2002, Food Standards Australia New Zealand (FSANZ) announced the decision of its Board not to require the mandatory declaration of added monosodium glutamate (MSG) in foods served in restaurants and other food outlets.
 

Comments from the Truth in Labeling Campaign

Introduction

Definitions: "Monosodium Glutamate" and "Processed Free Glutamic Acid"

Research   (Animal; Human; Cancer)

Adverse reactions

Declaring the presence of "monosodium glutamate" would enable consumers to make better informed choices

Declaring "monosodium glutamate" would lay bare the false, deceptive, and misleading claims made by those who fund research and underwrite propaganda designed to convince consumers that "monosodium glutamate" is "safe."

Comments

Summary and conclusions

Submission
June 18, 2002

To: Australia New Zealand Food Authority
PO Box 7186
Canberra BC ACT 2610
Australia

From: Adrienne Samuels, Ph.D., Director
Truth in Labeling Campaign
1547 Santa Sabina Court
San Diego, CA 92075
U.S.A.
(858) 481-9333

Re: Submission
Application A432
Mandatory Declaration of MSG by Restaurants and Food Outlets

Dear Sir or Madam:

The material in this paper constitutes the main body of the submission of the Truth in Labeling Campaign re: Application A432 - Mandatory Declaration of MSG by Restaurants and Food Outlets. It is being sent by e-mail today, June 19 your time, with a number of attachments. In addition, I am mailing a packet of material that includes copies of a number of references given in this paper. I have tried to send you all of the material that would not be readily available at a medical school library plus copies of published studies that illustrate the comments made in this Submission.

I apologize for not enclosing more material. I only recently read of the NSW Health initiative, and upon going through my copious materials, found that copies of some of the material referenced were not brought with me to California from my home in Chicago. My husband and I spend a great deal of time in California where produce that has not been treated with "processed free glutamic acid" can still be grown or identified by dealing directly with farmers. My husband finds it much more difficult to avoid "processed free glutamic acid" in Chicago.

In its statement of Initial Assessment, ANZFA indicated that technical information presented should be in sufficient detail to allow independent scientific assessment. We have tried to accomplish that by providing references in the body of the Submission whenever possible, and by sending, under separate cover, copies of material referenced that may be difficult to find.

We have not, however, sent copies of all of the studies referred to. Neither have we tried to guess in which studies ANZFA might be interested. We would like, instead, to offer to deliver to ANZFA, in a timely fashion, copies of any material referenced that ANZFA would like to see.

Introduction

We are writing at this time in support of the application from the New South Wales Department of Health (NSW Health) seeking to require restaurants and other food outlets to notify if monosodium glutamate (MSG) has been added during food preparation.

We are writing to be on record as supporting the application to require mandatory declaration of "monosodium glutamate" by restaurants and other food outlets. We feel strongly that disclosing the presence of "monosodium glutamate" in food additives/ingredients will benefit public health and safety because "monosodium glutamate," which contains neurotoxic "processed free glutamic acid," causes adverse reactions ranging from simple skin rash to asthma, migraine headache, tachycardia, seizures, and depression. Declaring "monosodium glutamate" when it has been used in restaurants and food outlets would not only alert consumers to the presence of the "monosodium glutamate," but would enable consumers to choose whether or not to eat food that contains it.

This submission would be incomplete if we did not point out that it is the "processed free glutamic acid" (glutamic acid that has been freed from protein through a manufacturing process) in the food additive/ingredient "monosodium glutamate" that causes the adverse reactions that are popularly referred to as reactions to "MSG." This submission would be incomplete if we did not suggest that while requiring mandatory declaration of "monosodium glutamate" would be of immense benefit to public health and safety, requiring declaration of all "processed free glutamic acid" would be of even greater benefit.
 

"Monosodium Glutamate" and "Processed Free Glutamic Acid"

"Monosodium glutamate," the popular flavor enhancer, contains approximately 78 per cent glutamic acid, with the balance made up of sodium, and moisture.

The glutamic acid in "monosodium glutamate" is neurotoxic. In 1968, the first published report of an adverse reaction to "monosodium glutamate" appeared in The New England Journal of Medicine.(1) In 1969, the first evidence that "processed free glutamic acid" causes brain lesions and neuroendocrine disorders in laboratory animals was published in Science.(2) In 1969 and the early 1970s, the safety of using "monosodium glutamate" (referred to as MSG) in baby food was questioned.(3-5)) In the mid 1970s, epidemiological studies indicated that 25 per cent or more of adults in the United States reacted adversely to "monosodium glutamate."(6-9) In the early 1970s, baby food manufacturers eliminated the "monosodium glutamate" from baby food, replacing it with other food additives/ingredients that contained "processed free glutamic acid." The controversy over the use of "monosodium glutamate" in baby food continued until 1978, when baby food manufacturers "voluntarily" stopped using any form of "processed free glutamic acid" in baby food.(10)

We now know that glutamic acid, including "processed free glutamic acid," functions as a neurotoxin, killing brain cells; causes retinal degeneration; causes endocrine disorders; and, as part of what is referred to as the glutamate cascade, is associated with a number of pathological conditions such as addiction, stroke, epilepsy, brain trauma, neuropathic pain, schizophrenia, anxiety, depression, and degenerative disorders such as Parkinson's disease, Alzheimer's disease, Huntington's disease, and amyotrophic lateral sclerosis (ALS).(11)

The glutamic acid in "monosodium glutamate" also causes adverse reactions in humans. Those reactions are popularly referred to as reactions to "MSG."

All "processed free glutamic acid" causes the same overt human and animal adverse reactions as those caused by the "processed free glutamic acid" found in the food additive/ingredient called "monosodium glutamate" when ingested in amounts that exceed the consumer's tolerance level.

The source of the "processed free glutamic acid" (soy, corn, etc.), the amount of time used in processing, and the method used for processing, may all influence the amount of "processed free glutamic acid" in an additive/ingredient; but all "processed free glutamic acid," regardless of source, processing time, or processing technique, causes adverse reactions when ingested in amounts that exceed the consumer's tolerance level.

All "processed free glutamic acid," regardless of the use or function for which it was designed, causes adverse reactions when ingested in amounts that exceed a consumer's tolerance level.

Today, there is growing recognition that the reactive component of "monosodium glutamate" is "processed free glutamic acid;" and that "processed free glutamic acid" causes adverse reactions regardless of the names of the ingredients that contain it or the uses to which it is put.(12-15),(31) This growing awareness and concern come in spite of the close cooperation the glutamate industry gets from the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA).(16)

It must be noted that in 1969, following the first published report of human adverse reactions to "processed free glutamic acid," the International Glutamate Technical Committee (IGTC) was formed by the Ajinomoto Co., Inc.(Ajinomoto), the world's largest producer of "monosodium glutamate." The IGTC sponsors, gathers, and disseminates research on the use and safety of "monosodium glutamate," designs and implements research protocols, provides financial assistance to researchers, and promotes the sale of "monosodium glutamate." The IGTC has been generous in its support of physicians, researchers, universities, medical schools, newsletters, journal editors, media representatives, and publishers who, directly or indirectly, promote the fiction that "monosodium glutamate" and the "processed free glutamic acid," contained in it, do not place humans at risk.(16)  The extent of the industry's contributions to individual politicians and/or political parties is unknown.

The glutamic acid contained in "monosodium glutamate" occurs as a consequence of manufacture, i.e., it is not simply extracted from plants and animals.

The glutamic acid found in unprocessed, unadulterated food and in the human body is composed of one form of a single amino acid, L-glutamic acid, and nothing else.(17-21) In contrast, the processed free glutamic acid used in processed food is always composed of two forms of glutamic acid (L-glutamic acid and D-glutamic acid) and a variety of other chemicals commonly referred to as contaminants.(22) In addition to the D-glutamic acid, contaminants may include, but are not limited to, pyroglutamic acid, mono and dichloro propanols, heterocyclic amines, and peptides. Mono and dichloro propanols and heterocyclic amines are carcinogenic. The consequences of the interactions of these various chemicals are unknown.

One of the arguments offered by the defenders of the safety of "monosodium glutamate" and the other ingredients/additives that contain "processed free glutamic acid" is that the glutamic acid in them is ubiquitous in nature. Protein is ubiquitous in nature. L-glutamic acid is found in unprocessed, unadulterated protein and in higher organisms. L-glutamic acid which is bound in protein is ubiquitous in nature. But "processed free glutamic acid," a chemical compound which contains D-glutamic acid, pyroglutamic acid, and a variety of other contaminants in addition to L-glutamic acid, is not ubiquitous in nature. The glutamic acid used in "monosodium glutamate" has been described as a white, practically odorless, free flowing crystalline powder. This writer knows of no white, practically odorless, free flowing crystalline powder that is ubiquitous in nature.

The glutamic acid portion of "monosodium glutamate" has, in the past, been manufactured by a number of processes. Contaminants vary depending on the methods used in fabricating/ manufacturing "processed free glutamic acid."

The first "processed free glutamic acid" was isolated in 1886 from the acid hydrolysate of wheat gluten and thus named Glutaminsaure. The flavor-enhancing potential of glutamic acid was discovered independently in Japan in 1908. Prior to that time, the Japanese had used seaweed as a favorite flavor enhancer, without understanding that glutamic acid was its flavor-enhancing component. The first "monosodium glutamate" was made by extracting glutamic acid from seaweed. Commercial production of "monosodium glutamate" began in Japan in 1909.(23)

From 1910 until 1956, the process underlying production of glutamic acid and "monosodium glutamate" in Japan was one of extraction, a slow and costly method.(24) Elsewhere, crude gluten or other starting materials were hydrolyzed by heating with hydrochloric acid.(25)

"Monosodium glutamate" was brought to the United States in the years following World War II at which time it was still manufactured through extraction. In 1956, the Japanese succeeded in producing glutamic acid by means of fermentation; and after considerable research to identify suitable strains of microorganisms for starting the requisite cultures, large-scale production of glutamic acid and "monosodium glutamate" through fermentation began.(23-25) In this fermentation process, bacteria (some, if not all of which are genetically modified)(26) are grown aerobically in a liquid nutrient medium. These bacteria have the ability to synthesize glutamic acid outside of their cell membranes and excrete it into the medium to accumulate there.(27)

At this time, "processed free glutamic acid" is made through use of chemicals (hydrolysis or autolysis), enzymes (enzymolysis), fermentation, and/or bacterial fermentation.

The chemical hydrolysis with hydrochloric acid is said to be efficient, but almost any organic substance in the raw material is hydrolyzed, resulting in desired reactions such as hydrolysis of proteins, carbohydrates, fats (triglycerides), and the unwanted formation of mono and dichloro propanols."(20)

The FDA has admitted, and even pretended to address the fact, that "processed free glutamic acid" created by acid hydrolysis contains carcinogenic mono and dichloro propanols.(28)

The FDA has also admitted that "processed free glutamic acid" found in reaction flavors which are produced from a combination of specific amino acids, reducing sugars, and animal or vegetable fats or oils, and optional ingredients including hydrolyzed vegetable protein is also carcinogenic.(29-30)

The FDA allows the glutamate industry to create and use sources of "processed free glutamic acid" that contain unspecified quantities of carcinogenic mono and dichloro propanols and heterocyclic amines.

There are over 40 commonly used food additives/ingredients in addition to "monosodium glutamate" that contain "processed free glutamic acid." All cause adverse reactions in people who ingest amounts of "processed free glutamic acid" that exceed their tolerance levels. "Processed free glutamic acid" is found in food additives/ingredients with names such as autolyzed yeast, yeast extract, calcium caseinate, sodium caseinate, hydrolyzed soy protein (or other protein sources), and natural flavoring. It is also created when enzymes and protein in a recipe come together during product processing. Consumers who suffer adverse reactions from ingestion of "processed free glutamic acid" suffer those reactions regardless of the names of the ingredients that contain the "processed free glutamic acid." In the United States, if not elsewhere, many consumers refer to "processed free glutamic acid" in any form, as "MSG."(31)
 

Declaring the presence of "monosodium glutamate" would be in the best interests of public health

In the body of this submission, we will make the case for requiring restaurants and other food outlets to notify consumers if "monosodium glutamate" has been added during food preparation. We have already made the distinction between "monosodium glutamate" and the "processed free glutamic acid" contained in it, and pointed out that "monosodium glutamate" is only one of over 40 ingredients and food additives that contain toxic "processed free glutamic acid." Here we will review the evidence that says that use of "monosodium glutamate" and other food additives/ingredients that contain "processed free glutamic acid" places humans at risk; that, contrary to what the glutamate industry would have you believe, adverse reactions to "monosodium glutamate" and other food additives/ingredients that contain "processed free glutamic acid" include reactions that are debilitating and/or life-threatening; and that small amounts of "processed free glutamic acid" can cause adverse reactions in some people.

The research that says that ingestion of "monosodium glutamate" places humans at risk

The scientific literature relevant to the safety/toxicity of "processed free glutamic acid" (MSG) falls into two categories:

a) Those studies done by independent researchers - studies wherein "processed free glutamic acid" is almost always found to be toxic.

b) Those studies underwritten by Ajinomoto, its IGTC, various other associations, agents, and friends in the food and drug industries -- studies wherein "processed free glutamic acid" is invariably alleged to be "safe."

Animal studies

Animal feeding studies done by independent researchers have demonstrated that "processed free glutamic acid" causes brain lesions in the area of the hypothalamus; that animals fed "processed free glutamic acid" as infants express neuroendocrine disorders, including reproductive disorders and gross obesity, as the animals approached or reached puberty; and that 100 per cent of the offspring of studied rats fed "processed free glutamic acid" while pregnant had clearly evident learning disabilities.

The first published report of human adverse reactions to "processed free glutamic acid" appeared in The New England Journal of Medicine in 1968.1 That report was followed by published confirmations of adverse reactions;(32-39) studies that demonstrated that processed free glutamic acid, whether laboratory grade or found in "monosodium glutamate," cause retinal degeneration,(40-50) and brain lesions when given to immature animals after either subcutaneous (2),(50-(72) or oral ( (58,64,65,67),(73),(74),(75),(76),(77) doses; studies detailing neuroendocrine disorders, (2,50,59,61,77),
(78-95) possible locomotor and learning deficits either immediately or in later life,(81,84-85,9-105) learning and memory, (106-109) behavioral reactions including somnolence and seizures, (110-120) tail automutilation,(83,110) learned taste aversion,(121) and conspicuous emotional change.83 In addition, there were epidemiologic studies completed in the 1970's demonstrating that at least 25 per cent of the population react to "processed free glutamic acid," the substance popularly referred to as MSG.(6-9) Later there were studies that demonstrated that free glutamic acid (including "processed free glutamic acid") can cross the placenta during pregnancy,(120-123) can cross the blood brain barrier in an unregulated manner during development, and can pass through the five circumventricular organs, which are "leaky" at best at any stage of life.(124-127) Moreover, the blood brain barrier is easily damaged by fever, stroke, trauma to the head, seizures, ingestion of processed free glutamic acid, and the normal process of aging.(114,127) It is generally accepted that the young are particularly at risk from ingestion of MSG.

The reader should note that most of the neuroendocrine studies cited here are from1980 or before. By 1980, the consensus that processed free glutamic acid causes brain lesions and neuroendocrine disorders was so clear that there was little need to repeat the phenomenon.(128-132) Therefore, from 1980 to the present time, studies of the effects of processed free glutamic acid on neuroendocrine function were undertaken primarily to answer questions having to do with function, histology, or histopathology of parts of the endocrine system. The following is an example taken from a 1995-2001 Medline search:

Miskowiak, B; Partyka, M. Neonatal treatment with monosodium glutamate (MSG):structure of the TSH-immunoreactive pituitary cells. Histology and Histopathology. 15(2):415-9, 2000.

Indeed, since the 1980s, "processed free glutamic acid" has been used as an ablative tool to selectively kill brain cells to facilitate study of, and develop drugs for, endocrine dysfunction, neurodegenerative disease, and other disorders involving the brain.(129) The following are examples taken from a 1995-2001 Medline search:

Ishikawa, K, Kubo, T, Shibanoki, S, Matsumoto, A, Hata, H, Asai, S. Hippocampal degeneration inducing impairment of learning in rats: model of dementia? Behavioural Brain Research 83(1-2):39-44, 1997.

Arletti, R, Benelli, A, Mazzaferro, M, Calza, L. The effect of oxytocin on feeding, drinking, and make copulatory behavior is not diminished by neonatal monosodium glutamate. Hormones & Behavior. 4:499-510, 1993.

Herrmann, G., Steunitz, H., Nitsch, C. Composition of ibotenic acid-induced calcifications in rat substantia nigra. Brain Research 786:(1-2)205-14, 1998.

The reader should also note that because independent study of glutamic acid was being done by neuroscientists trying to understand amino acids, neurotransmitters, and glutamic acid in particular as opposed to selling a food additive/ingredient, in the majority of these studies "processed free glutamic acid" was administered to laboratory animals by gavage or subcutaneously. There were only a few oral feeding studies done by independent psychologists and neuroscientists; but there were oral feeding studies, and the studies done demonstrated that brain lesions, neuroendocrine disorders, and behavioral disorders could be caused by feeding animals "monosodium glutamate."

Review of studies financed by the glutamate industry demonstrates that the individual studies are badly flawed. Taken as a whole, the studies are flawed to the point of being fraudulent. The glutamate industry's animal studies can be characterized as looking for the wrong thing, at the wrong time, in the wrong place, using poor technique. The comments of John W. Olney, M.D. made in April, 1993, address the integrity of the glutamate industry's animal studies.(10)  (John W. Olney is a neuroscientist of international reputation. He has published hundreds of articles in leading medical journals and has won numerous awards.)(133)

Historically, glutamate industry researchers, led by Andrew G. Ebert of the IGTC and the Robert H. Kellen Company, have focused on research designed with the single purpose of convincing the public that "processed free glutamic acid" is "safe." To accomplish this, they compared two groups of subjects, a test group and a control, and chose their subjects, methodology, and statistics to find no difference between the two groups. Probably their most productive researchers have been L.D. Stegink, Lloyd J. Filer, and W. Ann Reynolds, who together did a number of studies designed to refute the findings of Olney and others of brain lesions and neuroendocrine disorders, and thus quell any concerns the public might have had about the toxic potential of their product, the flavor enhancer called "monosodium glutamate." It can be said of the Stegink/Reynolds/Filer group that they studied Olney's procedures carefully, having sent a representative to Olney's laboratory in the early 1970s where every courtesy was afforded her. It is particularly bothersome, therefore, that subsequent studies coming from the Stegink/Reynolds/Filer laboratory looked for evidence of brain lesions in areas of the brain that would not, according to Olney, have been affected; waited to examine the brain samples taken for 24 hours or more after insult - after which time all evidence of lesions would have been obscured; and used inappropriate methods of fixation and staining.(10)

Examination of the methodology sections of representative industry-sponsored studies(134-136) will demonstrate that subjects, test materials, overall procedures, and/or methods of analysis differed from the studies being "replicated." For example, although it had been established that brain lesions could not be identified if examination was not done within 24 hours after insult, glutamate-industry researchers routinely examined the brains of test animals after 24 hours had elapsed. They also used inappropriate methods and materials for staining the material they were examining.

Of particular interest were a study by Stegink et al.(136) and a study by Reynolds, Butler, and Lemkey-Johnston.(137) Careful examination will show that researchers used a single slide of the brain of one animal as evidence that free glutamic acid failed to produce brain damage in two different monkeys.

Those industry studies were underwritten by Ajinomoto, Gerber, International Minerals and Chemical Company, Nestle, and others, in cooperation with the IGTC.

Feeding studies were of particular concern to the defenders of the safety of "monosodium glutamate." One of their prime defenses on behalf of the "safety" of "monosodium glutamate" was that animal studies that showed that "monosodium glutamate" was toxic to animals did not reflect the human condition.

As always, the industry-sponsored feeding studies were badly flawed. In these animal feeding studies, researchers accounted for the amount of food consumed by experimental and control groups, but did not account for the amount of "processed free glutamic acid" consumed as opposed to being left on the table. According to the few methodology sections that covered the subject, "processed free glutamic acid" was added to each test animal's diet. Most studies outlined, in great detail, the amount of food given to test and control animals, the name (but not the components) of the basic diet (which might very well have contained "processed free glutamic acid" or some other neurotoxic amino acid like aspartic acid or L-cysteine), and the amount of "processed free glutamic acid" added to the diets of each animal or test group.

One industry-sponsored study provided an unusual amount of detail, including detail of the exact nature of the basal diet provided wherein "yeast food" was listed as a component of the protein.(138) In 1990, yeast food invariably contained either protease (which creates processed free glutamic acid during manufacture) or L-cysteine which produces neurotoxic effects(139) somewhat different from, but more extensive than, the effects of "processed free glutamic acid." In this study, as well as in industry-sponsored studies from literature submitted by Auxein Corporation (now known as Emerald BioAgriculture) to the EPA in support of their application to register "processed free glutamic acid" for use in pesticide, fungicides, and plant "growth enhancers," failure to find differences in animals' growth or the adverse reactions of control and experimental groups may very well have been due, in part, to the fact that control groups were receiving neurotoxic substances in their basal diets.

In studies submitted by Auxein Corporation to the EPA, detail pertaining to the amount of food consumed was also given. But sorely lacking was any discussion of the amount of processed free glutamic acid consumed by animals in various test groups. The casual reader may assume that processed free glutamic acid would be ingested in proportion to the amount of basic diet ingested by test animals. But that is not true. Every animal owner knows that animals are quite adept at ferreting out and rejecting (not eating) pills or other goodies "hidden" in their food, and in avoiding food in which they have no interest. Thus, the "processed free glutamic acid" could have been left on the table by the test animals, causing there to be no difference in reactions expressed by test and control animals. Had this not been the case, both the form of the "processed free glutamic acid" added to each animal's diet and the consumption of "processed free glutamic acid" would certainly have been discussed in research reports.

By 1980, those studies done by glutamate-industry funded researchers in the 1970s that alleged to demonstrate that the food additive "monosodium glutamate" failed to cause brain lesions in laboratory animals had been refuted. Today, the neurotoxic effects of processed free glutamic acid are so clear cut that scientists use processed free glutamic acid as an ablative tool to selectively kill brain cells in order to study brain function and the effects of drugs on brain function.(140)

Glutamate-industry sponsored researchers never actually replicated the work of Olney and others who had demonstrated that processed free glutamic acid causes brain lesions and subsequent neuroendocrine disorders. In a 1981 review of the literature, Nemeroff stated unequivocally that "...not one single [primate] study has truly replicated the methods utilized by Olney, making evaluation of the available data impossible."(132)

Human experimental studies

Human studies of the safety/toxicity of "monosodium glutamate" are rarely done by independent researchers, because no one from industry will support them. From time to time, however, a physician will investigate the relationship between "monosodium glutamate" and his or her area of interest such as skin problems, irritable bowel, asthma, cardiac arrhythmia, or migraine headache.

The asthma studies of Allen and Baker are of particular interest because their finding, that as little as .5 grams "monosodium glutamate" would trigger an "MSG" reaction, caused Ajinomoto a great deal of embarrassment. That embarrassment was evidently exacerbated when FASEB, in its 1995 report on "The Safety of Monosodium Glutamate (MSG) in Food" commented on the Allen et al. study, noting that "The studies of Allen et al. (1987)(141) provide scientific evidence for a role of MSG in the onset of severe asthma in selected asthmatic patients."(142)

The study on hydrolyzed vegetable protein induced headache done by Alfred Scopp, published in 1991, is also of particular interest because that study is never mentioned by the defenders of the "safety" of "monosodium glutamate." Neither is it mentioned in the 1995 FASEB Report. In 1991, Alfred Scopp published a study entitled; "MSG and hydrolyzed vegetable protein induced headache: review and case studies." In 1993, Martinez et al.(143) measured glutamic and aspartic acid levels in plasma and cerebrospinal fluid (CSF) of patients with common and classic migraine during attacks, making comparisons with controls suffering from stress. Plasma levels of amino acids in migraine patients were lower than in controls, while CSF concentrations of glutamic acid were higher in migraineurs than in controls. The authors concluded that "... results suggest an excess of neuroexcitatory amino acids in the [central nervous system] of migraine patients during attacks, possibly favoring a state of neuronal hyperexcitability." Martinez et al. had found a relationship between glutamate levels in the CSF of the central nervous system and migraine headache. But neither Scopp's article, the Martinez et al. article, nor the subject of migraine headache are discussed in the August 31, 1995 FASEB report.

In 1992, the FDA had commissioned FASEB to do an independent review of research on the safety (never toxicity) of MSG. The FDA has admitted, in reports of adverse reactions on file at the FDA, that migraine headache (they call it headache) has been reported as an adverse reaction by over 43 per cent of the people reporting reactions to MSG. Moreover, with possible rare exception, "monosodium glutamate" is acknowledged as a migraine headache trigger by every headache clinic in the United States. Yet the subject of migraine headache is not even mentioned in the August 31, 1995 FASEB report. In the FASEB report, reports of migraine headache are reported as reports of headache.

On June 16, 2002, the Migraine Information Center page of the Web page of the Journal of the American Medical Association stated that "There are a number of dietary triggers that have been reported, these include: alcohol, especially red wine; foods with monosodium glutamate (MSG) (see Table2); foods that contain tyramine...and preserved meats with nitrates and nitrites (see Table 3)."(144)

It must be noted that FASEB's failure to discuss "monosodium glutamate" as a migraine headache trigger is consistent with the tone of the entire 1995 FASEB report which, in its verbiage, minimizes the severity and extent of "monosodium glutamate" induced adverse reactions. Tachycardia and atrial fibrillation, for example, are described as "change in heart rate;" asthma is described as "difficulty breathing;" and depression is described as "change in mood quality or level." The ultimate we have seen of this sort of thing from the FDA is, in their list of adverse reactions reported following ingestion of aspartame, to list each of the deaths under "other."

The 1995 FASEB study has been criticized for conflicts of interests of Expert Panel members, for failure to consider all data relevant to the safety/toxicity of MSG, for dismissing, or attempting to dismiss, data that did not fit well with a conclusion that MSG is safe, and more.(145-149)

Those criticisms plus the names and addresses of over 650 people who wrote to FASEB about their sensitivities to "monosodium glutamate" and "processed free glutamic acid" appear on the log sheets relevant to FDA Docket No. 92N-0391. All are public record and names, addresses, and testimony can be accessed through the FDA.

Interestingly enough, IGTC studies, themselves, have added to the weight of evidence that says that subjects react to "monosodium glutamate." In the epidemiological study done by Kerr et al.,(8) 43 per cent of the people studied claimed to have reactions that are known to be produced by "monosodium glutamate." In the double blind study done by Tarasoff and Kelly, approximately 33 per cent of the subjects in the study reacted to "monosodium glutamate" test material, and almost that same number reacted to the placebos laced with "processed free glutamic acid" or aspartic acid (in aspartame).(156)

In the 1980s, in the face of overwhelming evidence that monosodium glutamate kills brain cells in laboratory animals,(128-129) industry researchers changed their original strategy. They began to claim that animal studies were not relevant to humans. They initiated a series of double-blind human studies that, they would claim, "proved" that "monosodium glutamate" was safe.

Detailed analysis of those double-blind studies revealed that subjects, materials used, and protocols for administering test and placebo material, minimized the chance that subjects would react to the MSG test material; and that if subjects did react to the MSG test material, they would also react to the placebo.

The primary strategy used in most, if not all, glutamate-industry-sponsored research is to look for evidence of toxicity in subjects least likely to be sensitive to "processed free glutamic acid" (eg. "well subjects" -- people who had never in their lives had any of the adverse reactions attributable to "monosodium glutamate"); to use test materials least likely to produce observable reactions; to use placebos laced with neurotoxic amino acids and/or other substances that will cause identical or similar reactions to those caused by "processed free glutamic acid" test material; to serve "drinks," or a "standard breakfast" laced with neurotoxins with both test material and "placebo" material; to set up protocols that will obscure evidence of toxicity (eg. accepting as adverse reactions only those that occurred within two hours of testing, and those that might be considered mild and transitory, while excluding such reactions as heart irregularities, migraine headache, seizures, nausea and vomiting, and asthma); to allege that finding no evidence of toxicity constitutes proof that their product is "safe;" and to allege that adverse reactions to their reactive "placebos" constituted evidence that reactions to the test material are not reactions to "processed free glutamic acid."

Industry researchers:

1. Use variables and methods known to minimize or be irrelevant to identification of the toxic effects of glutamic acid; then conclude that glutamic acid never produces adverse effects. Studies have focused on the relationship between "objective" parameters such as blood pressure and body temperature and ingestion of MSG.

Unless MSG sensitive people are studied, one can not legitimately draw conclusions about the relationship of the variables being studied (no matter how objective they are) to people who are sensitive to MSG. Often, these studies are used to allegedly "prove" that people who are not sensitive to MSG are not sensitive to MSG.

2. Limit the recorded adverse effects to a few generally mild and transitory reactions occurring simultaneously, such as those first reported in 1968 by Kwok and dubbed "Chinese- restaurant syndrome" (CRS): "...numbness at the back of the neck, gradually radiating to both arms and the back, general weakness and palpitation." Industry researchers do not consider migraine headache, asthma, tachycardia, arrhythmia, depression, anxiety attacks or other obviously debilitating and/or life-threatening reactions to "monosodium glutamate" reported since 1968, when they tally up the reactions to MSG.

3. Make no attempt during a study to prevent subjects from ingesting food to which they might be allergic or sensitive.

4. Record reactions as reactions to "monosodium glutamate" or placebo material only if they occur 2 hours or less following ingestion of test or placebo material, even though many symptoms are commonly expressed much later, and reactions may persist for much longer periods.

5. Fail to report all data.

6. Draw conclusions that do not follow from the results of the study. The IGTC researchers have inappropriately concluded, for example, that because approximately one third of their subjects reacted adversely to placebos containing MSG and/or aspartame, they have "proved" that reactions to MSG-containing test material are not reactions to MSG.

7. Use test material that will minimize the effect of any stated amount of glutamic acid test material in producing adverse reactions. One gram monosodium glutamate encased in capsules, and therefore guaranteeing slow release, will cause less effect than 1g monosodium glutamate sprinkled on food; and 1g monosodium glutamate modified with sucrose will cause less effect than otherwise because sucrose is known to slow monosodium glutamate uptake.(150)

8. Continue subjects on medications that might block the effects of MSG.

9. Use placebos to which MSG-sensitive people would react (placebos containing MSG, aspartame, carageenan or enzymes, for example), test potential subjects for sensitivity to those placebos, and eliminate any subjects who react to placebos. Researchers can be fairly certain that those who do not react to their reactive placebos will not react to monosodium glutamate test material.

10. Advertise for, and presumably use, "well subjects" - people who had never experienced any of the symptoms with which reactions to MSG are associated. (If 50 per cent of the population were sensitive to MSG, but research design precluded inclusion of that 50 per cent who were sensitive, a study claiming to assess the number of people sensitive to MSG would be invalid.)

11. Refer to studies as "randomized double-blind crossover design studies," which gives the casual reader the impression that subjects were drawn randomly from the general population. In fact, subjects are often carefully selected people who tell researchers that they have never experienced any of the adverse reactions associated with monosodium glutamate, and, under those conditions, are paid to participate in the studies. Other subjects are people, often students, paid for participating in industry-sponsored studies only if they say that they are sensitive to monosodium glutamate. In either case, the only thing in those studies that is "random" is whether subjects get their monosodium glutamate test trial first and their placebo second, or vice versa. Subjects recruited in 1993 for an IGTC-sponsored studies begun in 1992 by Harvard Medical School, Northwestern University Medical School, and UCLA Medical School, were paid hundreds of dollars each--only if the applying subjects (many of them students) claimed that they were sensitive to monosodium glutamate.

12. Use placebos virtually guaranteed to produce as many reactions as might be produced following ingestion of the "monosodium glutamate" test material. Using toxic material in both test material and placebo, researchers argue that the reactions to MSG-containing test material are not reactions to MSG because subjects also react to placebos, which are assumed to be inert. However, the use of toxic material in placebos, particularly when it is identical or similar to the "monosodium glutamate" in the test material, makes it virtually inevitable that there will be approximately as many reactions to placebos as there are reactions to "monosodium glutamate" test material.

Sometimes glutamate-industry researchers use "processed free glutamic acid" in placebos, but use sources of "processed free glutamic acid" different than the ingredient called "monosodium glutamate." Gelatin, which always contains "processed free glutamic acid," has been a favorite. Beginning in 1978, before aspartame was approved by the FDA for use in food, glutamate-industry researchers used aspartame in placebos.(151)

Over and above the fact that use of aspartame in placebos is grossly inappropriate, the fact that aspartame-containing products are supposed to carry a warning on their labels did not deter industry from using the substance, or the FDA from allowing its use. Aspartame contains phenylalanine (which adversely affects one in 15,000 Americans); aspartic acid (an excitatory amino acid); and a methyl esther. Aspartic acid and glutamic acid load on the same receptors in the brain, cause the same brain damage and neuroendocrine disorders in experimental animals, and, with the exception of blindness related to aspartame ingestion, cause virtually the same adverse reactions in humans. In addition, aspartic acid and glutamic acid act in an additive fashion. There are over 7,000 unsolicited reports of adverse reactions to aspartame filed with the FDA. It should surprise no one, therefore, that glutamate industry researchers find as many reactions following ingestion of an aspartame-containing placebo as they find following ingestion of monosodium glutamate test material.

Strong, in a study entitled "Why do some dietary migraine patients claim they get headaches from placebos?" tested the hypothesis that it was the gelatin capsules used to conceal placebo material that caused headaches from placebos, and concluded that capsules may give headaches to dietary migraine patients that are similar to those from foods.(152) This, Strong said, would explain some of the headaches of patients from placebos.

In a previous study, Strong had found that 18 per cent of his subjects reported headaches from placebos which were all concealed in gelatin capsules. Glutamate-industry double-blind studies of the "safety" of "processed free glutamic acid" almost always use gelatin capsules. Of interest is the fact that a gelatin capsule is over 11 per cent "processed free glutamic acid."

It should be noted that placebo reactions have also been noted in industry-sponsored animal studies. It was noted by Nemeroff(132) that Abraham, Doughtery, Goldberg, and Coulston(66) and Abraham, Swart, Goldberg, and Coulston(153) found in both control and glutamic acid treated monkeys a "very small proportion of necrotic or damaged neuronal cells and oligodendrocytes... in the arcuate nuclear region of the hypothalamus." This might happen if the placebo, as well as the test material, contained small amounts of an excitotoxin identical or similar to glutamic acid.

In response to studies that demonstrated that ingestion of "monosodium glutamate" places humans at risk, Ajinomoto, their IGTC, and their agents produced studies alleging the "safety" of "monosodium glutamate." By and large, the human studies were described as double blind placebo controlled studies to evaluate alleged reactions to monosodium glutamate (MSG).

The hallmark of the glutamate industry double blind human studies has been use of a neurotoxic amino acid in their "placebos." Sometime it was aspartic acid (found in aspartame). Sometimes it was "processed free glutamic acid" in some food additive or ingredient other than "monosodium glutamate." Upon being confronted with questions about their placebos, Andrew G. Ebert, Chairman of the IGTC, admitted (in 1991) that since 1978, studies underwritten by the IGTC have used aspartame in "placebos."(154) In response to suggestions from this author that materials used in double-blind tests of the safety of "monosodium glutamate" contained free amino acids, Ebert responded that "the only glutamate or other free amino acids ingested in these controls would have been from natural sources."(155) According to the FDA, both "monosodium glutamate" and aspartame come from "natural sources."

Never were the contents of the glutamate industry's "placebos" disclosed in any publication before Jack Samuels wrote to the FDA in 1993, telling the FDA that the alleged "placebos" contained "processed free glutamic acid" and aspartic acid (in aspartame), and that as such, the IGTC was responsible for scientific fraud.

Typical of the IGTC's human studies is a study done by Tarasoff and Kelly from the Faculty of Business and Technology, University of Western Sydney, Australia, Macarthur Campus, published in Food and Chemical Toxicology in 1993.(156) The first hint that there was something seriously wrong with the study was the fact that 16 out of 38 subjects (42 per cent) reacted to "placebos."

The Tarasoff and Kelly study embodies most of the 12 flaws elaborated earlier in this section. A critique of the Tarasoff and Kelly study was published in January, 1994.(157)

In 1993, Tarasoff and Kelly were still using neurotoxic amino acids in placebos, but the contents of the placebos were elaborated -- as they had not been previously. In June, 1994, Harvard University Medical School, Northwestern University Medical School, and UCLA Medical School were engaged in an IGTC sponsored study designed to convince the public that "monosodium glutamate" was "safe."(158)

On June 16,1994, when I wrote to Vice Dean Donald Nutter, M.D., Northwestern University School of Medicine about the impropriety of participating in a study wherein neurotoxic amino acids were being used in placebos, study protocols called for using aspartame in placebos. After I spoke to, and wrote to Dr. Nutter, who told me he would do nothing to interfere with any study that had been reviewed and approved by the appropriate School and University bodies, the protocols were changed to exclude the use of aspartame. Protocols did, however, use a source of "processed free glutamic acid" that would not be recognized as such by most people.

As part of our submission to FASEB during the study that was published in 1995, we alerted FASEB to the fact that those human studies that pretended to have demonstrated that "monosodium glutamate" was "safe," had used neurotoxic amino acids in their placebos. FASEB did not find that such use of neurotoxic amino acids invalidated the glutamate sponsored studies. FASEB did, however, suggest that in the future, neurotoxic amino acids should not be used in placebo materials.

I tell these little stories because they say to me that those School and University bodies, once alerted to the fact that neurotoxic amino acids were being used in studies being carried on in their schools, found such protocols inappropriate; and so did FASEB. But since the rich and powerful glutamate industry did not want their studies questioned, there were no questions raised.

The IGTC has amassed a number of double-blind studies concluding--but not demonstrating--that "monosodium glutamate" is "safe." The fact that these studies are often done at generally respected universities or medical schools, all of which required that the research be approved by medical research review committees, has public relations value. Often, studies are eventually published in peer reviewed journals--accepted by editors who, themselves, may have ties to the food and/or drug industries. If not published in their entirety, abstracts of these studies, which have been presented at professional meetings, are finally published. They then appear in the Medline data base, and that has public relations value.

Given the methodological flaws inherent in their work, and their unwillingness to change their protocols after flaws are pointed out to them, we can only conclude that IGTC researchers move from a predetermined conclusion (that their product is "safe") to design and implementation of research guaranteed to bring the reader to that predetermined conclusion.

Human epidemiologic studies

Studies done in the 1970s demonstrated that 25 to 30 percent of the population of the United States reacted to "processed free glutamic acid" at that time. In 1969, Schaumburg et al. determined that approximately 30% of the population of the United States suffered adverse reactions when fed "monosodium glutamate" in an ordinary diet.(9) Reif-Lehrer(6) and Kenney and Tidball(7) confirmed their findings.

Those studies were challenged by Kerr et al. in a 1979 glutamate industry sponsored study.(8) Kerr et al. found that 43 per cent of respondents reported one or more unpleasant symptoms associated with eating, but concluded that only 1.8 per cent of the population might be sensitive to "monosodium glutamate." To accomplish this, Kerr et al. decreed that the only true symptoms of MSG-sensitivity (called "Chinese restaurant syndrome"), were "burning, tightness, and numbness," experienced simultaneously, that commenced between 10 minutes and 2 hours after the start of a meal, and lasted 4 hours or less. Kerr et al. had to ignore all other reported symptoms, even migraine headache,(159) in order to come up with this 1.8 per cent figure. They also had to ignore the fact that MSG-sensitive people react from immediately to 48 hours following ingestion of "MSG."

Given increased use of "monosodium glutamate" and other food additives/ingredients that contain "processed free glutamic acid" since 1979, we would now expect more than 30% of the population to suffer adverse reactions from time to time.

Carcinogenicity

The FDA has admitted, and even pretended to address the fact, that "processed free glutamic acid" created by acid hydrolysis contains carcinogenic mono and dichloro propanols.(160)

The FDA has also admitted that "processed free glutamic acid" found in reaction flavors which are produced from a combination of specific amino acids, reducing sugars, and animal or vegetable fats or oils, and optional ingredients including hydrolyzed vegetable protein is also carcinogenic.(161-162)

The subject is discussed more fully in the section titled "Monosodium Glutamate" and "Processed Free Glutamic Acid" above.

Adverse reactions caused by "monosodium glutamate" and other food additives/ingredients that contain "processed free glutamic acid" are the same reactions recognized as side effects of other neurotropic drugs.

Ingestion of "processed free glutamic acid" causes adverse reactions in susceptible individuals. Those reactions are diverse, but no more diverse than reactions to other neurotropic drugs such as Valium. The fairly recent discovery of glutamate receptors in many locations outside of the central nervous system(163) suggests that the readily observable toxic effects of processed free glutamic acid, referred to as adverse reactions, are facilitated by glutamate receptors in the mouth, lungs, intestines, and muscle, for example; and that the fate of ingested "processed free glutamic acid" is not to come to rest in the plasma as elevated plasma glutamate and from there to be excreted by the liver. Rather, it would appear that the fate of ingested "processed free glutamic acid" is to move with dispatch to any glutamate receptors available to it; and to create an adverse or toxic reaction if any one of those peripheral glutamate receptors is weak, crippled, diseased, or otherwise unhealthy.

Today, virtually every headache clinic in the United States acknowledges that "processed free glutamic acid" (popularly referred to as MSG) is one of the triggers of migraine headache. According to Alfred Scopp of the Northern California Headache Clinic, at least 33 per cent of migraine patients have some migraine headaches triggered by "MSG."(164)

A report from the Federation of American Societies for Experimental Biology (FASEB) reads, in part:

"The continuing controversy over the potential effects of glutamate on growth and development of neonatal animal models suggests that it is prudent to avoid the use of dietary supplements of L-glutamic acid by pregnant women, infants, and children. The existence of evidence of potential endocrine responses, i.e., elevated cortisol and prolactin, and differential responses between males and females, would also suggest a neuroendocrine link and that supplemental L-glutamic acid should be avoided by women of childbearing age and individuals with affective disorders."(165)

There is government prohibition against producing or importing "monosodium glutamate" in Myanmar.(166)

Today, reports of adverse reactions submitted to the FDA are on file in FDA Dockets including Docket # 96N-0244 and Docket # 92N-0391. The FDA, which discourages consumer reports of reactions to "processed free glutamic acid," has reports of reactions to "processed free glutamic acid" on file in its Adverse Reactions Monitoring Section (ARMS). The FDA's ARMS accepts (but does not solicit) reports of MSG-sensitivity. Neither does the FDA record all comments received regarding "processed free glutamic acid."

The Truth in Labeling Campaign, a nonprofit organization that champions the identification of "processed free glutamic acid" in food and on food, has compiled a list of the adverse reactions to "processed free glutamic acid" reported to it, and receives daily correspondence, primarily by e-mail and telephone, from people looking for help in avoiding ingesting "processed free glutamic acid."

A list of the adverse reactions reported to and collected by the Truth in Labeling Campaign will be found in the table titled "Collected Reports of Adverse Reactions to MSG Ingestion" that follows this paper as part of our Submission.

Adverse reactions to "monosodium glutamate" and other food additives/ingredients that contain "processed free glutamic acid" include reactions that are debilitating and/or life-threatening

One of the core strategies of the defenders of the safety of "monosodium glutamate" is to insist that the alleged "few" reactions to "monosodium glutamate" are "mild and transitory." Originally, there was only one reaction recognized by the defenders of the safety of "monosodium glutamate:" Chinese restaurant syndrome" ("burning," "tightness," and "numbness," all occurring at the same time, and commencing between 10 minutes and 2 hours after the start of a meal). In 1995, with the publication of the 1995 FASEB "Analysis of Adverse Reactions to Monosodium Glutamate (MSG)," the glutamate industry, with the cooperation of the FDA, gave up the term "Chinese restaurant syndrome" for the term "MSG Symptom Complex, and expanded the approved list of reactions to "processed free glutamic acid" to include:

burning sensation back of neck, forearms, chest
facial pressure/tightness
chest pain
headache
nausea
numbness in back of neck radiating to arms and back
tingling, warmth, weakness in face, temples, upper back, neck and arms
bronchospasm (observed in asthmatics only)
drowsiness
weakness

In contrast, the Truth in Labeling Campaign knows that adverse reactions to "monosodium glutamate" include all of the adverse reactions listed in the table titled "Collected Reports of Adverse Reactions to MSG Ingestion" that follows this paper as part of our Submission. Clearly, any one of the cardiac, circulatory, gastrointestinal, neurological, visual, respiratory or urological/genital reactions could be debilitating or life-threatening.

Small amounts of "processed free glutamic acid" cause adverse reactions in some people.

Human adverse reactions to ingestion of as little as 1.5 g and .5 g of processed free glutamic acid have been reported in the literature. (9),(167) The Truth in Labeling Campaign has received reports of adverse reactions to the minute amounts of processed free glutamic acid that would be contained in products such as vitamin and mineral enrichments, gelatin capsules, and produce treated with fertilizers, pesticides, fungicides, and plant "growth enhancers" that contain "processed free glutamic acid." A number of those reports are on file with the FDA and the EPA. In both the 1995 FASEB report and in a 1992 report on the safety of amino acids in dietary supplements, FASEB concluded that there is insufficient evidence to determine safe concentrations of dietary supplements of L-glutamic acid in the diets of normal healthy humans.(165),(168) And no study of the least amount of processed free glutamic acid needed to trigger reactions in MSG-sensitive people has ever been done. Thus, while there are data to suggest that as little as .5g of processed free glutamic acid will trigger an adverse reaction, and there are anecdotal reports that reactions are triggered by much lesser amounts, there are no data to even suggest what the least amount of processed free glutamic acid needed to cause an adverse reaction in an MSG-sensitive person might be.

It is common knowledge that minute amounts of certain allergens will trigger adverse reactions, including anaphylaxis, in people who are acutely sensitive to those allergens.(169-171) There is nothing in the literature that says that similarly minute amounts of neurotoxic amino acids such as glutamic acid, aspartic acid, and L-cysteine will not trigger adverse reactions, including anaphylaxis, in people who are acutely sensitive to those neurotoxins. "Monosodium glutamate" contains neurotoxic "processed free glutamic acid."
 

Declaring the presence of "monosodium glutamate" would enable consumers to make better informed choices

A second reason for identifying "monosodium glutamate" and any other food additives or ingredients that contain "processed free glutamic acid" in restaurant and other food outlets pertains to providing adequate information relating to food to enable consumers to make informed choices.

It is fairly obvious that if "monosodium glutamate" and other food additives/ingredients that contained "processed free glutamic acid" were identified as such whenever present, people who were overtly sensitive to "processed free glutamic acid" could choose, or choose not, to avoid it. And if they chose to avoid it entirely, or limit their intake of "processed free glutamic acid" to an amount below the level of their tolerance, consumers could potentially avoid suffering adverse reactions.

Less obvious is the fact that declaration of "monosodium glutamate" would facilitate the diagnosis of MSG-sensitivity. If "monosodium glutamate" and other food additives/ingredients that contained "processed free glutamic acid" were identified as such whenever they were present, people would know when they were eating "processed free glutamic acid," and people who were overtly sensitive to "processed free glutamic acid" could recognize, fairly easily, that they were reacting to "processed free glutamic acid."

Similarly, if "monosodium glutamate" and other food additives/ingredients that contained "processed free glutamic acid" were identified as such whenever they were present, people who suffered adverse reactions following eating who were not sensitive to "processed free glutamic acid" could rule out "processed free glutamic acid" as the culprit if it was not present, and could pursue identifying those foods, food additives, and/or physical maladies that were truly causing their adverse reactions.

Whether or not to consume "monosodium glutamate" is a fairly obvious choice afforded by declaration of "monosodium glutamate." But those who are affected by ingestion of "monosodium glutamate" have another choice to make after becoming ill in a restaurant or other food outlet: what to do about it. Do you call the paramedics? Do you go immediately to the emergency room of the nearest hospital? Do you use those facilities? Do you incur medical costs? The choice of someone who knew he or she had "ingested "monosodium glutamate" might well be different from the choice of someone who knew he or she had not ingested "monosodium glutamate" or any other food additive/ingredient that contained "processed free glutamic acid."
 

Declaring "monosodium glutamate" would lay bare the false, deceptive, and misleading claims made by those who fund flawed research and underwrite the false, deceptive, and misleading propaganda designed to convince consumers that "monosodium glutamate" is "safe"

In their list of Objectives, ANZFA lists "the prevention of misleading or deceptive conduct." Although comments regarding deceptive and misleading conduct have not been expressly solicited in addressing the issue of the mandatory declaration of "monosodium glutamate" by restaurants and food outlets, we submit that declaration of "monosodium glutamate" would indeed serve to counter the deceptive and misleading behavior of the people who promote the use of "monosodium glutamate" and other food/additives that contain "processed free glutamic acid" as "safe."

It is certainly conceivable that a supplier or manufacturer might innocently believe that his product is "safe," when in fact it is not. But every bit of evidence I have seen tells me that Ajinomoto knows that "processed free glutamic acid" and that "monosodium glutamate," one of the food additives/ingredients that contains it, are toxic. After 14 years of study, I can only conclude that Ajinomoto knows that their product is toxic; that their product causes adverse reactions; that some of those reactions are debilitating and life-threatening; and that Ajinomoto has been less than truthful about the safety of "processed free glutamic acid" and "monosodium glutamate."

A 1993 article (published in a peer reviewed journal) entitled "The Toxicity/Safety of Processed Free Glutamic Acid (MSG): A Study in Suppression of Information"16 details how Ajinomoto and their agents have engaged in selective collection and reporting of research data including suppression of any information that might suggest that "monosodium glutamate" is toxic or that it causes adverse reactions. The study presents the case against the safety of "monosodium glutamate" and "processed free glutamic acid," with particular attention given to the nature of the chemical whose safety/toxicity is being disputed, and looks at the work of those who claim otherwise. The structure of the industry organization (the IGTC, The Glutamate Association, the International Food Information Council {IFIC}, researchers, agents, people and organizations influenced by them); an overview of their research (animal research; umami; the epidemiologic study; and double-blind studies); suppression of information; dissemination of misinformation; dirty tricks; and the special role of agencies of the United States government are all considered.

This study describes how easily truth has been hidden; and how seemingly isolated incidents are actually badly flawed research, direct suppression of information, and dissemination of biased information orchestrated by Ajinomoto. We have already discussed, in this Submission, some of the tactics that glutamate industry researchers have employed in both their animal and human research.

We believe that declaring "monosodium glutamate" would help lay bare the false, deceptive, and misleading claims made by those who fund the flawed glutamate industry research and underwrite the false, deceptive, and misleading propaganda designed to convince consumers that "monosodium glutamate" is "safe." We believe that declaring "monosodium glutamate" in restaurants and other food outlets would make consumers more aware of the role that "monosodium glutamate" plays in their experiencing adverse reactions, and, therefore, might well serve to counteract the deceptive and misleading propaganda efforts of Ajinomoto, their IGTC, The Glutamate Association, and agents such as the IFIC.

Selected Industry Strategies

Over the years, glutamate-industry public relations people have alleged that compared to the amount of "naturally occurring" glutamic acid available in food, the amounts of glutamic acid in their "monosodium glutamate" or other products would be negligible - and that the addition of such relatively small amounts of glutamic acid to such relatively large amounts of glutamic acid already present, could not possibly cause adverse reactions.

This argument assumes that the glutamic acid in "monosodium glutamate" or other processed foods is chemically identical to the L-glutamic acid found in unadulterated/unprocessed/ unfermented food -- but we have already demonstrated that such is not the case. Once one recognizes that there is "processed free glutamic acid" in "monosodium glutamate" and that there is no "processed free glutamic acid" in unadulterated/ unprocessed/unfermented meat or produce that has not been treated with fertilizers, fungicides, pesticides, or plant growth enhancers, the glutamate industry argument becomes transparently false.

There are variations of this industry-inspired argument. Glutamate-industry public relations people claim that a variety of products (tomatoes, mushroom, and Parmesan cheese are among their favorites) contain substantial amounts of free glutamic acid; and that if people were truly sensitive to "monosodium glutamate" or other products that contain free glutamic acid, they could not eat tomatoes, mushrooms, or Parmesan cheese without having adverse reactions.

But here, again, glutamate-industry public relations people fail to distinguish between free glutamic acid and "processed free glutamic acid." If, indeed, there are minute amounts of free glutamic acid associated with unadulterated/unprocessed/unfermented tomatoes or mushrooms, that free glutamic acid will not cause adverse reactions. Only processed free glutamic acid causes adverse reactions in MSG-sensitive people who ingest amounts that exceed their tolerance levels. Parmesan cheese is a manufactured product, differing somewhat between manufacturers. It will always contain some "processed free glutamic acid."

We are confident that Ajinomoto knows that only "processed free glutamic acid" causes adverse reactions in MSG-sensitive people. The defenders of the safety of "monosodium glutamate" talk about the glutamic acid in "monosodium glutamate" being "naturally occurring." They talk about the amount of glutamic acid in "monosodium glutamate" being relatively little when compared with the amount of glutamic acid ingested when protein is eaten. But the defenders of the safety of "monosodium glutamate" never actually deny that only "processed free glutamic acid" causes adverse reactions in MSG-sensitive people.

Glutamate-industry public relations people also fail to distinguish between produce that is truly unadulterated/unprocessed/unfermented (as tomatoes or mushrooms might be) and processed ingredients/products such as Parmesan cheese. The amount of processed free glutamic acid found in a given Parmesan cheese will vary depending on such things as the milk or cream used, the nature of the enzymes used to break down the protein in the milk or cream used, and the time that the enzymes are working; but Parmesan cheese will always contain "processed free glutamic acid," and will cause adverse reactions in MSG-sensitive people who ingest amounts that exceed their tolerance levels.

Thinking of strategies, it is interesting to think about the effect that treating crops with AuxiGro will have on all of us. Five years ago, the glutamic acid found in higher organisms was L-glutamic acid, only.(172), (173), (174), (175), (176), (177) Today, if they look, researchers will find small amounts of D-glutamic acid in higher organisms because animals, and now plants, are being fed or otherwise treated with "processed free glutamic acid." (It would appear that at least in humans, D-glutamic acid accumulates in the body and is not excreted by the liver.) I expect that very soon, Ajinomoto and others in the glutamate industry will make their case for "processed free glutamic acid" being identical to the glutamic acid found in higher organisms because they will have made sure that higher organisms have all been dosed with "processed free glutamic acid."

Faced with allegations that MSG has toxic potential, Ajinomoto U.S.A., Inc., established a nonprofit corporation, recruited scientists and others to defend the safety of its product, and unleashed a public relations campaign.

In 1969, the International Glutamate Technical Committee (IGTC) was organized to represent the interests of the glutamate industry. The IGTC was founded as an association of member companies engaged in the manufacture, sale, and commercial use of glutamates. The IGTC, then an 8 member organization, sponsored, gathered, and disseminated research on the use and alleged safety of monosodium glutamate; designed and implemented research protocols and provided financial assistance to researchers; promoted acceptance of monosodium glutamate as a food ingredient and "glutamate" as its generic term; and represented members' collective interests. Those collective interests were to sell monosodium glutamate.

In 1977, the IGTC spun off The Glutamate Association, with both organizations accommodated under the umbrella of The Robert H. Kellen Company of Atlanta, Georgia and Washington, DC., a trade organization and association management firm, specializing in the food, pharmaceutical, and health care industries. The 1990 Encyclopedia of Associations listed Robert H. Kellen as president of The Glutamate Association. Richard Cristol, executive director of The Glutamate Association, was also Vice President of The Kellen Company. Cristol assumed management of the Washington, DC operations of The Kellen Company and its subsidiary, HQ Services, in 1993. In 1992, and still in 1998, Andrew G. Ebert, Ph.D., Chairman of the IGTC, was also Senior Vice President of The Kellen Company.

Influence of the IGTC can be felt at every level. International Glutamate Technical Committee chairman Ebert has served on the FDA Food Advisory Committee; the Grocery Manufacturers of America (Technical Committee on Food Protection, the Codex Subcommittee on Food Additives and the GRAS-FASEB Monograph Committee); the National Food Processors Association; the Institute of Food Technology (Technology, Toxicology, and Safety Evaluation Division, and Scientific Lecturer); the National Research Council of the National Academy of Sciences Assembly of Life Sciences (Food and Nutrition Board: the Committee on Food Protection, and the GRAS List Survey); the American Medical Association (Industry Liaison Panel); the FAO/WHO Codex Alimentarius Food Standards Program as an Industry Observer; and the International Food Additives Council as Executive Director.

As a food-industry pharmacologist and toxicologist, Ebert has provided scientific and technical expertise for programs of many associations managed by The Kellen Company. His nomination to the FDA Food Advisory Committee did not refer to his affiliation with the IGTC, but listed him only as Senior Vice President of The Kellen Company. With him on the FDA Food

Advisory Committee, was Kristin McNutt, a paid spokeswoman for the glutamate industry.(178)

Ebert is also an active member of the Institute of Food Technologists (IFT). Daryl Altman, M.D., a spokesperson for the glutamate industry, worked for former IFT president Al Clausi, Vice Chairman of Allerx, Inc. and its medical affiliate, The Food Allergy Center. Altman speaks (or spoke) publicly about the safety of monosodium glutamate, often with Steve Taylor of the University of Nebraska. The IFIC has promoted them as speakers without mention of the fact that they represent the glutamate industry. L.T. Chiaramonte, M.D., who has co-authored work for the IGTC with Altman, has served on the medical advisory board of The Food Allergy Center.

Glutamate industry representatives and friends sit on boards of "independent" organizations. Glutamate industry researcher and spokesman Simon has been a member of the Scientific Advisory Board of the Center for Science in the Public Interest (CSPI). Monsanto's Robert Shapiro sits (or sat) on the board of the Tufts University School of Nutrition. Allergy support groups often include industry-friendly allergists on their medical advisory boards. Taylor has served on the Medical Advisory Board of The Food Allergy Network. "Independent organizations" whose medical advisory board members have ties to the glutamate industry have not provided information to their members about MSG-containing ingredients.

Glutamate industry influence is also seen in peer reviewed journals that publish their badly flawed studies. An argument has been made elsewhere in this Submission that published glutamate-industry sponsored studies are badly flawed. If that is the case, then their publication in peer reviewed journals is difficult to justify. Consider, however, that if the peers who review the work of glutamate-industry representatives are themselves glutamate-industry representatives, or very close friends, the work of glutamate industry representatives may very well be published. Consider, also, that journals such as the Journal of Allergy and Clinical Immunology take advertising, and journals such as The American Journal of Clinical Nutrition acknowledge the generous support of members of the food and/or drug industries. Both of those journals (and only these journals) publish glutamate-industry sponsored studies.

Of major importance has been the influence exerted on what the defenders of the safety of "monosodium glutamate" like to call "authoritative bodies:" institutions such as the World Health Organization (WHO). There are a number of "authoritative bodies" that, according to the defenders of the safety of "monosodium glutamate," have endorsed "monosodium glutamate" as being "safe." In general, those "other authoritative bodies" have read the FDA's summaries concluding that MSG is safe, and have read nothing more, or have received selected data provided to them by The Glutamate Association and have called that their data. When questioned, however, Hellen Keller International, one of the "authoritative bodies," was not at all pleased to hear that their name was being used in this way. They had never considered that "monosodium glutamate" might have toxic potential. Hellen Keller International was supplementing "monosodium glutamate," a widely used food additive, with vitamin A in Indonesia to counteract xerophthalmia, an eye disease caused by lack of vitamin A.(179) They did not consider that to be an endorsement of the safety of MSG.(180)

Membership in The Glutamate Association is secret. However, a source from within the glutamate industry told me that besides Ajinomoto, Archer Daniels Midland, Campbell, Corn Products Corporation, McCormick & Company, Nestle, Pet Foods, Pfizer Laboratories, and Takeda are (or were) among its members.

Once established, the IGTC assembled a cadre of scientists who conducted research for them and/or spoke publicly about the safety of MSG. Their first research stronghold was the University of Iowa, where, in cooperation with W. Ann Reynolds (who was elsewhere) Lloyd Filer, Lewis Stegink, and others poured out badly flawed studies that they alleged demonstrated that "monosodium glutamate" and aspartame were "safe." Those who identified their funding sources in their publications or in communications with the FDA are listed with their funding sources in Table 1 of "The Toxicity/Safety of Processed Free Glutamic Acid (MSG): A Study in Suppression of Information."(16) (Also: http://www.truthinlabeling.org/L-table-2.html)

Steve Taylor, a prominent representative of the glutamate industry, has done little or no basic research related to monosodium glutamate safety/toxicity but is respected for his knowledge about food allergy, having served, for example as an officer of the Toxicology and Safety Evaluation Division, and a member of the Expert Panel on Food Safety and Nutrition of the Institute of Food Technologists. His name appears prominently on advisory boards such as the Food Allergy Network and editorial boards such as the Encyclopedia of Food Science, Food Technology, and Nutrition. On only one occassion that we are aware of, he acknowledged being a paid, glutamate industry spokesman. Yet, when he introduces himself, he typically refers to his University of Nebraska affiliation, but not to the fact that he is an agent of The Glutamate Association, the IGTC, IFIC, or Ajinomoto.

The focus of researchers who represent the glutamate industry has been to demonstrate that various food additives are "safe." Scrutiny of the literature will demonstrate that for some of these scientists, early research relevant to the safety/toxicity of glutamic acid suggested that glutamic acid might have toxic potential; while subsequent studies and/or public statements made by those same scientists proclaimed that "monosodium glutamate" is safe. By and large, those who represent the glutamate industry have produced research relative to the safety/toxicity of "monosodium glutamate" only in response to encouragement from the glutamate industry to do so; and the only research that they have published has been research from which they have concluded that "monosodium glutamate" is safe. Only two of the glutamate-industry researchers or speakers have been neuroscientists: Richard J. Wurtman, M.D., and Roland Auer, M.D., Ph.D. Wurtman was inventor of Redux, a weight loss drug approved by the FDA, but withdrawn from the market after users were found to be developing heart valve disease.

A special role has been played by Ronald Simon, M.D. and Donald D. Stevenson, M.D. of Scripps Clinic and Research Foundation, LaJolla, California. In 1991, Simon, with Dean D. Metcalfe, M.D., and Hugh R. Sampson, M.D., had praised the work of David Allen, M.D., an Australian researcher, who had found that MSG is an asthma trigger; and they included his study in Food Allergy: Adverse Reactions to Foods and Food Additives. In a letter to George R. Schwartz, M.D., Allen wrote, "Last week my friend Ron Simon from the Scripps Clinic called me and asked me to participate in a symposium at the American Academy of Allergy meeting in San Francisco in March of next year. I will be speaking on sulphites and MSG and their potential to provoke asthma."

On August 31, 1995, the FDA released a report on the safety of MSG in food, done by FASEB.168 In that report, FASEB acknowledged that "monosodium glutamate" was an asthma trigger, and that doses of "monosodium glutamate" as low as .5 grams "monosodium glutamate" had triggered MSG reactions. On the day before that allegedly secret report was released, Simon and Stevenson wrote to inform the FDA that they believed that the FASEB report to be released the next day had made a grave error in stating that "monosodium glutamate" was known to be an asthma trigger, for they had found Allen's work to be lacking. In 1995, Simon and Stevenson were doing research for the IGTC.
 

The Best Scientific Evidence says that use of "monosodium glutamate" places humans at risk.

Under their list of objectives, ANZFA states that ANZFA will give due regard to the need for standards to be based on risk analysis using the best available scientific evidence. We must emphasize, therefore, that throughout the body of this Submission we have repeatedly pointed out, and illustrated the fact, that the data presented to the American public by the defenders of the safety of "monosodium glutamate" are flawed to the point of being fraudulent. There are no reputable studies that even suggest the ingestion of "monosodium glutamate" is "safe."

We have also mentioned, at least in passing, that most of the so-called "authoritative bodies" that have evaluated the safety/toxicity of "monosodium glutamate" have seen only material presented to them by glutamate-industry interests, i.e., have seen only the badly flawed industry-sponsored studies that allege to have found that "monosodium glutamate" is "safe." Having not done their own reviews, it is possible that these "authoritative bodies" have knowledge of no other data.

The exception, of course, would be the FDA and its agent, FASEB. The core strategy of the FDA vis-a-vis evaluation of the safety of "monosodium glutamate" has been to structure their "independent" evaluations so that:

Questions that are asked (which are defined by the FDA) could not possibly be answered in a way that would cast doubt on the "safety" of "monosodium glutamate"

Expert Panels are staffed with people who have ties to the glutamate industry.

In as far as possible (unless public testimony is required) data presented to the evaluators come from glutamate-industry sources - and none other.

It is relevant here to note that the investigating body (FASEB -- since the FDA's former agent was fired for blatant, and widely discussed, conflicts of interest) is looking to the FDA for future contracts. (Last time we checked, we found that never had FASEB found one of the products it was called on by the FDA to evaluate to be unsafe.)

In addition, it must be noted that the FDA has never solicited reports of adverse reactions to "monosodium glutamate."

On the other hand, it has been repeatedly demonstrated that "monosodium glutamate" kills brain cells, causes endocrine disorders, and causes behavior and learning deficits in laboratory animals. (Some of those studies were feeding studies.) Any studies that claimed otherwise have long since been refuted.

There are a few human studies and case studies of adverse reactions following ingestion of "monosodium glutamate." Why only a few such studies? Because there is no industry that will pay for studies from which they will reap no profit.

There are countless individual reports of adverse reactions following ingestion of "monosodium glutamate," from people whose maladies have been ameliorated following avoidance of "monosodium glutamate."

With possible rare exception, every migraine headache clinic in the United States lists "monosodium glutamate" as a migraine headache trigger.(181) Why so many? Because at least 33 per cent of all migraine sufferers find that "monosodium glutamate" is a migraine trigger; and a migraine clinic that didn't provide that information to its patients would find itself without patients. (Without income).

Clearly, the best scientific evidence we have today says that use of "monosodium glutamate" places humans at risk.
 

Comments relating to the Initial Assessment of Application A432

Objective.  In its statement of Objective, ANZFA noted that in justifying the need for its application, NSW Health stated that a report compiled by FASEB in 1995 concluded that an unknown percentage of the population may react to "monosodium glutamate" and develop "MSG symptom complex."

That, of course is true. The FASEB did make that statement. But that simple statement does not even begin to describe the severity and extent of human adverse reactions to "monosodium glutamate."

In the body of this Submission we have discussed some of the shortcomings of the 1995 FASEB report. It should be clear to the reader that the Truth in Labeling Campaign believes that the FASEB study was far from "independent," and that FASEB minimized and trivialized the extent and severity of reactions to "monosodium glutamate." Should you have any doubt about that, please simply remember that migraine headache, the adverse reaction most often reported to the FDA, was not mentioned in the 1995 FASEB report.

The Truth in Labeling Campaign would like to suggest that the declaration of "monosodium glutamate" in food additives/ingredients in restaurants and other food outlets is an even more serious issue than suggested in the NSW Health application. We submit that the risk posed by ingestion of "monosodium glutamate" in restaurants and other food outlets as well as in packaged food is greater by far than that characterized by FASEB; and that requiring the declaration of "monosodium glutamate" will be of greater benefit to society than ANZFA would have ever suspected.

Background.  In its background section, ANZFA has failed to distinguish between the glutamic acid that has been manufactured for use in food ("processed free glutamic acid") and the L-glutamic acid which is found in nature without having had the benefit of human intervention (truly natural free glutamic acid). The former causes adverse reactions in MSG-sensitive people who ingest amounts that exceed their individual tolerance levels. The latter does not cause adverse reactions.

L-glutamic acid clearly exists both as free glutamic acid and bound with other amino acids into protein. L-glutamic acid is found in free form in animals where it serves a myriad of functions. In humans one of those functions is as a neurotransmitter, causing nerves to transmit messages. When excess amounts of glutamic acid are present in the nervous system, glutamic acid causes nerves to fire repeatedly until they die. It is because of the toxic action of glutamic acid that it is called a neurotoxin.

L-glutamic acid also appears to be found in minute amounts in free form in some plants. Historically the amounts of such free L-glutamic acid have been overstated. An FDA study by Daniels, Joe, and Diachenko(182) overstated the amount of free L-glutamic acid in tomatoes by 100 times. Figures cited by Auxein Corporation in its application to the EPA to have L-glutamic acid exempted from a tolerance level were from a 1979 paper by a man who did not do a study himself, but took figures from studies done years earlier. In 1979 and before, techniques for determining amounts of free glutamic acid in food were not as well refined at they are today, and glutamine was often inadvertently converted to glutamic acid. Thus, the figures for free glutamic acid content given by Auxein would have been grossly overstated.

The "monosodium glutamate" which is produced today in the United States by Ajinomoto is produced by a process of bacterial fermentation wherein bacteria (some, if not all of which are genetically modified)26 are grown aerobically in a liquid nutrient medium. These bacteria have the ability to synthesize glutamic acid outside of their cell membranes and excrete it into the medium to accumulate there.27 I question whether there is any "monosodium glutamate" produced today using molasses from sugar cane or sugar beet, or starch hydrolysates from corn unless that is being used as the liquid nutrient medium. Ajinomoto does not discuss its mode of manufacturing "monosodium glutamate."

Substances such as autolyzed yeast extract, hydrolyzed vegetable protein (HVP), and sodium caseinate contain "processed free glutamic acid," the reactive component of the food ingredient/additive "monosodium glutamate." The "processed free glutamic acid" is created during the course of substance manufacture. There is no ingredient/additive called "monosodium glutamate" in any of these substances. These substances, like the ingredient known as "monosodium glutamate," can be significant sources of "processed free glutamic acid." In the United States, MSG-sensitive consumers refer to all such substances as containing "MSG."

The use of "monosodium glutamate" became controversial in the late 1960s when the IGTC was formed by Ajinomoto to defend the safety of "monosodium glutamate" against published reports of adverse reactions following ingestion of "monosodium glutamate" in certain Northern Chinese restaurants. The ongoing debate exists because the glutamate industry is rich and powerful. Their studies are badly flawed, and the text of their propaganda is less than truthful.
 

Issues Relevant to this Application: Previous consideration

Studies done in the United States under the sponsorship of the FDA have been sorely biased in favor of finding "monosodium glutamate" and "processed free glutamic acid" to be "safe." All were advertised as being "independent studies." But in most cases, the "evidence" provided to the "independent experts" was provided by The Glutamate Association or the IGTC (both agents of Ajinomoto); and the "independent experts" were found to have had close ties to the glutamate industry. Thus I must ask ANZFA, what evidence was considered by the ANZFA Expert Panel, and how was the ANZFA Expert Panel's independence from the glutamate industry verified?

Similarly, I must ask what evidence the ANZFA Expert Panel considered as evidence that severe reactions to "monosodium glutamate" were not strong enough to warrant mandatory declaration. Was the evidence provided by the IGTC or the Australian version of The Glutamate Association? Was the evidence taken from the 1995 FASEB report, without consideration of the 1992 FASEB report? Certainly, if medical experts running headache clinics in the United States were asked if "monosodium glutamate" caused severe, systemic reactions resulting in severe illness or mortality, their overwhelming answer would be "yes." On the other hand, since the reaction to "monosodium glutamate" is not an allergic reaction, and certain allergists in the United States have close ties to the glutamate industry, if allergists in the United States were asked if "monosodium glutamate" caused severe, systemic reactions resulting in severe illness or mortality, their answer might be "no."
 

Issues Relevant to this Application: Review of the safety of MSG

In the body of this Submission, we have already addressed the fact that "authoritative bodies" such as the Joint FAO/WHO, in evaluating the safety of "monosodium glutamate," were given material selected for them by the IGTC or The Glutamate Association. Similarly, we have also addressed the issue of FASEB not being an "independent" evaluator, and the fact that the studies since published in the scientific literature by researchers funded by the glutamate industry or their agents are, like their predecessors, badly flawed - with the entire body of glutamate-industry sponsored literature flawed to the point of being fraudulent.

The issues that ANZFA has listed under "Review of the safety of MSG" are issues used time and time again by the glutamate industry in its propaganda campaigns to convince the public that "monosodium glutamate" poses no risk to health. Might I respectfully suggest that ANZFA rather investigate the role of "monosodium glutamate" in migraine headache, and solicit reports of adverse reactions from its citizens, and health care professionals who have helped patients by recognizing their sensitivities to "monosodium glutamate" and "processed free glutamic acid."

Issues Relevant to this Application: Proposed NSW regulations

In discussion of the proposed NSW Health regulations, ANZFA stated that "The proposed regulation will apply where additional quantities of MSG are added during cooking or food preparation and will not apply to MSG naturally present in foods or to the use of an ingredient such as a sauce or base to which MSG has already been added during manufacture."

How, pray tell, do you define "MSG naturally present in foods?" To this point, it has been my understanding that when ANZFA referred to "MSG," ANZFA was talking about the food additive/ingredient "monosodium glutamate." But there can be no "monosodium glutamate" "naturally present in foods." "Monosodium glutamate" is a manufactured additive/ingredient.

In the United States, the word "natural," as used by the food industry and the FDA, merely means that the food ingredient started out in nature, regardless of whether or not it has been processed. Under this definition, the "processed free glutamic acid" in "monosodium glutamate" is naturally occurring as is the "processed free glutamic acid" in over 40 other food ingredients.

Is there confusion here between "naturally occurring" (starting from a source in nature) and "truly natural," (which would be unprocessed, unadulterated)? This distinction means a great deal to people who are sensitive to "monosodium glutamate" and the other additives/ingredients that contain "processed free glutamic acid." It is important because "truly natural glutamic acid" does not cause adverse reactions in MSG-sensitive people, while "processed free glutamic acid" - regardless of whether or not it is found in an additive/ingredient that meets the FDA definition of "naturally occurring" -- will cause MSG-reactions in MSG-sensitive people who ingest amounts that exceed their tolerance levels.

Glutamic acid is found naturally in unadulterated, unprocessed protein. That glutamic acid does not cause adverse reactions. However, when a protein is processed in order to free up glutamic acid, that glutamic acid is not L-glutamic acid, only, i.e., that glutamic acid is not "truly natural." "Truly natural" glutamic acid in higher organisms is only L-glutamic acid. We have already discussed in the body of this Submission that fact and the fact that glutamic acid found in processed ingredients is L-glutamic acid plus D-glutamic acid, pyroglutamic acid, and other contaminants.

Is there also a distinction being made in this discussion of the Proposed NSW Regulations between "naturally present" or "naturally occurring" and "added?"

We have found that historically, the glutamate industry has thrived on confusion it has caused by not defining terms in some cases, and/or in defining them differently under different circumstances. Any ingredient/additive used in a recipe is "added" to the end product. Any "processed free glutamic acid" in an ingredient/additive used in a recipe is "added" to the end product. We are concerned that terms used in the Proposed NSW regulations be carefully defined. Defenders of the safety of "monosodium glutamate" won't like that.

We have already noted that in this section, it is stated that the proposed regulation will apply where additional quantities of "monosodium glutamate" are added during cooking or food preparation and will not apply to "monosodium glutamate" naturally present in foods or to the use of an ingredient such as a sauce or base to which "monosodium glutamate" has already been added during manufacture.

If one is writing a regulation that will give consumers information about the presence of "monosodium glutamate," why would you not tell consumers about the "monosodium glutamate" that came in ingredients that were brought into the restaurant or food outlet? We accept the fact that unless and until all "processed free glutamic acid" is disclosed on the labels of all processed foods, one cannot expect all restaurant operators to be able to identify all of the hidden sources of "processed free glutamic acid" that may be in the processed foods that he/she may use in preparation of recipes. However, to claim to be declaring the presence of "monosodium glutamate," and then not declare all of the "monosodium glutamate" that may be in a restaurant meal, could cause both confusion and severe problems for MSG-sensitive people.

If "monosodium glutamate" or any other form of "processed free glutamic acid" causes adverse reactions, it won't matter how the offending substance(s) got to the customers' plate, what they were called, or what someone said they were being used for. The reactions will occur.

We suggest that all "monosodium glutamate," whether added to a recipe by restaurant staff or contained in labeled ingredients be declared. We also suggest that the ingredients "yeast extract," "autolyzed yeast," "sodium caseinate," "calcium caseinate" and any ingredients that begin with the word "hydrolyzed," be declared along with "monosodium glutamate." Further, we suggest that restaurant menus include a statement outlining the regulations regarding "monosodium glutamate" and these other ingredients/additives that contain "processed free glutamic acid;" and that a caution that processed foods used in the restaurant may include other ingredients that may include free glutamic acid also be provided.
 

Draft Impact Analysis

Parties listed as being affected by the Draft Regulatory Options outlined in the Initial Assessment, included:

Consumers who are intolerant, or perceive themselves to be intolerant, to "monosodium glutamate;"

Businesses involved in the preparation and manufacture of foods containing added "monosodium glutamate;" and

Government agencies responsible for enforcing food regulation.

The Truth in Labeling Campaign suggests that the following be added to the list:

Physicians -- Once "monosodium glutamate" can be pinpointed as an MSG-reaction trigger, consumers will need to make fewer visits to hospital emergency rooms and to their personal physicians.

Benefit: Improved diagnosis

Cost: Possible decreased revenues

Laboratories and hospitals. With "monosodium glutamate" declared on both labels of packaged food and in restaurants and other food outlets, diagnosis of MSG-sensitivity will be made easier; in may cases, eliminating the need for expensive diagnostic procedures. Cost savings will be particularly great for government health programs and others that provide health care benefits to Australians.

Benefit: Improvement in accuracy of diagnoses

Benefit: Decrease in costs of medical care

Cost: Possible decreased revenues

Insurance companies

Benefit: Decrease in costs of medical care

Benefit: Reduction in insurance premium costs to policy holders

Cost: None

Anyone who employs an MSG-sensitive person. The incidence of inefficiency and absenteeism in the work place due to such reactions as light-headedness, stomach distress, and migraine headache will be less if "monosodium glutamate" is declared on both labels of packaged food and in restaurants and other food outlets.

Benefit: Improved production

Benefit: Fewer accidents

Cost: none

Workers.

Benefit: Improved health

Benefit: Improved job performance

Benefit: Fewer injuries

Benefit: Reduction in sick days taken

Cost: None

Teachers and their students. Every teacher in the United States knows that children become more unruly following lunch period than they were in the morning. Declaration of "monosodium glutamate" would enable school administrators and/or concerned parents to limit the amount of "monosodium glutamate" available to their children at lunch time.

Benefit to teachers: Ease in controlling the classroom

Benefit to teachers: Lessening of physical and mental strain

Benefit to students: Increase in ability to focus on the learning task at hand

Benefit to parents and taxpayers who bear the cost of education: Saving of dollars

Cost: none

Consumers who are intolerant, or perceive themselves to be intolerant, to "monosodium glutamate" (an impact considered at least in part in the Draft Impact Analysis)

Added Benefit: less dollars spent on dealing with adverse reactions.

Added Benefit: reduction in feelings of helplessness/depression (often caused by the medical industry's inability to diagnosis MSG-sensitivity)

Restaurant owners. Those who are not sensitive to "monosodium glutamate" have no idea how many people who are sensitive to "monosodium glutamate" avoid eating in restaurants.

In the table provided, The ANZFA assessment of costs and benefits for Option 2 lists as a cost to consumers: "May cause unnecessary avoidance of certain food products or food establishments."

Could you please clarify how knowing which food in a restaurant or food outlet could cause unnecessary avoidance of certain food products or food establishments?

In that same section of the table there is a statement that reads, "...restaurants...will have the option to provide the information on request..." This is the first reference I have seen to there being an option about declaring "monosodium glutamate." I thought the declaration would be mandatory. Could you please clarify?
 

Consultation: Public Consultation

Under Public Consultation, ANZFA asked for comments, particularly information about any recent research conducted on the adverse effects of "monosodium glutamate" or the results of any reputable studies in relation to the severity and prevalence of adverse reactions to "monosodium glutamate in the Australian and New Zealand community.

We must suggest that ANZFA also consider looking into disreputable studies done in relation to the severity, prevalence, and nature of adverse reactions to "monosodium glutamate." We have already pointed out that few studies are done by independent researchers; and that the studies done by glutamate industry researchers are flawed to the point of being fraudulent. While there are a few studies, a few case studies, and countless reports of adverse reactions following ingestion of "monosodium glutamate" and other food additives/ingredients that contain "processed free glutamic acid" that indicate that "monosodium glutamate" causes adverse reactions ranging through the whole spectrum of reactions that are found to occur as side effects of other neurotropic drugs, there is not one reputable study that alleges to have found that "monosodium glutamate" or "processed free glutamic acid" is "safe."

There have been two large industry-sponsored studies in the last 10 years that allege to have found that "monosodium glutamate," is "safe." The first was done by Tarasoff and Kelly from the Faculty of Business and Technology, University of Western Sydney, Australia, Macarthur Campus.156 The flawed nature of that study was discussed earlier in some detail. The second study was done by Raif Geha, Roy Patterson, and Andrew Saxon at Harvard University Medical School, Northwestern University Medical School, and UCLA Medical School, respectively.(183) In that study, which took something like seven years to complete, subjects were alleged to be sensitive to "MSG." Subjects were primarily students who were paid hundreds of dollars each if they said they were sensitive to "MSG," and could spend one, or at most two days participating.

Allegedly, a third study was done to demonstrate that "monosodium glutamate" does not cause or exacerbate asthma. The questionable work of Woessner, Simon, and Stevenson was published in the Journal of Allergy and Clinical Immunology in 1999.(184) A discussion of what may appear to some people to be lack of integrity of Simon and Stevenson, both of whom represent the glutamate industry, is included with this material.

Again. There is scattered evidence that "monosodium glutamate" causes adverse reactions; that for some people those reactions are debilitating and life threatening; and that although no study designed to determine the least amount of "processed free glutamic acid" that will cause a reaction has ever been done, the amounts of "processed free glutamic acid" in gelatin capsules will trigger reactions in highly sensitive people. At the same time, there is not one reputable study that alleges to have found that "monosodium glutamate" or "processed free glutamic acid" is "safe."


Summary and conclusions

We have demonstrated that "monosodium glutamate" causes adverse reactions in over 25 per cent of the population of the United States. We have demonstrated that some of those reactions are debilitating and life-threatening. We have further demonstrated that although the least amount of "monosodium glutamate" needed to induce an MSG-reaction has never been identified, in highly sensitive people, minute amounts of "monosodium glutamate" will trigger an adverse reaction.

We have further demonstrated that there are no reputable data that attest to the "safety" of "monosodium glutamate"-- that the industry-sponsored studies that allege to do so are flawed to the point of being fraudulent. We have also pointed out the biased nature of the allegedly independent studies commissioned by the FDA to study the safety of "monosodium glutamate," noting that all have served to underestimate and trivialize the extent and severity of reactions of "monosodium glutamate."

We have provided data to demonstrate that glutamic acid found in processed food ingredients are not "naturally occurring," and that the glutamic acid in processed food ingredients is different from the glutamic acid found in unadulterated, unprocessed protein. Truly natural glutamic acid in higher organisms is only L-glutamic acid. Glutamic acid found in processed ingredients is L-glutamic acid plus D-glutamic acid, pyroglutamic acid, and other contaminants.

We are aware, as ANZFA seems to be, that the reactive ingredient in "monosodium glutamate" is the "processed free glutamic acid" contained in it. We cannot, therefore, deny the fact that if all "processed free glutamic acid" in packaged food, in restaurants, and in other food outlets would be declared, the greatest benefit would accrue to consumers. Given that such declaration has not been proposed, however, and given that declaring "monosodium glutamate in restaurants and other food outlets would provide information that is presently missing, we stand to go on record as supporting the declaration of "monosodium glutamate" in restaurants and other food outlets. But it must be all "monosodium glutamate" regardless of its source. Otherwise you will be misleading your people.

In sum, we support the declaration of any and all "monosodium glutamate" in restaurants and other food outlets as a starting point. However, only requiring disclosure of the food ingredient/additive "monosodium glutamate" when it has been added to food in the restaurant will provide MSG-sensitive customers with a false feeling of security, and potentially will lead to some serious MSG-induced adverse reactions and human suffering.

Clearly, there is need for full disclosure of "processed free glutamic acid" on all processed food labels. We suggest that there should be a requirement that would require that food producers or distributors test all processed food, post production, for free glutamic acid, and if it is found to be present, that it be disclosed on the food label, with the amount stated in milligrams.

Such a labeling requirement would allow consumers to identify if they are MSG-sensitive, or to rule out such sensitivity. It would also allow MSG-sensitive people to determine their tolerance for "processed free glutamic acid," and select foods with their tolerance levels in mind. Such labeling would also provide restaurant operators with the ability to accurately respond to customers who ask about "MSG" to avoid adverse reactions.

Without full disclosure of "processed free glutamic acid" on processed food labels, it is asking too much to ask restaurant operators to disclose all "processed free glutamic acid" used in a customer's meal. On the other hand, to only require that restaurant operators disclose the "monosodium glutamate" that they have added, as such, to a recipe will confuse customers who may have been mislead to believe that all "monosodium glutamate" has to be declared in restaurants and other food outlets. Declaring some "monosodium glutamate," but not all "monosodium glutamate," will mislead customers who must avoid "processed free glutamic acid" to remain well.

Your consideration of disclosure of any "monosodium glutamate" in restaurant meals is laudatory. However, short of requiring full disclosure of "processed free glutamic acid" on processed food labels, we urge you to expand the regulation you are considering regarding disclosure of "monosodium glutamate" in restaurant meals. We urge you to require that restaurant operators advise customers if "monosodium glutamate" has been used in a meal, whether added to the recipe or in the labeled ingredients used, and in advising customers of the presence of "monosodium glutamate" in meals, include the following as other sources of "processed free glutamic acid:"

1. Any food ingredient, added to food or included in a labeled processed food, that includes the word "hydrolyzed."

2. Any "yeast extract" or "autolyzed yeast" that is added to food or included in a labeled processed food.

3. Any "sodium caseinate" or "calcium caseinate" that is added to food or included in a labeled processed food.

To protect restaurant operators, it is further suggested that restaurant menus include a statement outlining the regulation regarding MSG, and a caution to customers that processed foods used in the restaurant may include other ingredients that may include free glutamic acid.

We hope that you take this submission seriously and that Australia and New Zealand set a standard for the disclosure of free glutamic acid in food that will set a standard for the world. The result of such action will certainly improve the health of your citizens and markedly reduce health care costs.

Thank you for your consideration. (References follow.)

Respectfully submitted,

Adrienne Samuels

The Truth in Labeling Campaign
by Adrienne Samuels, Ph.D.
1547 Santa Sabina Court
Solana Beach, CA 92075
U.S.A.

E-mail:adandjack@aol.com
Web site: http://www.truthinlabeling.org
Phone: 858-481-9333
 

REFERENCES

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2. Olney, J.W. Brain lesions, obesity, and other disturbances in mice treated with monosodium glutamate. Science 164: 719-721, 1969.

3. Senate Select Committee on Nutrition and Health. September, 1969.

4. Baltimore Sun. Nader Says Agency Lied: Claims FDA Falsified Data on Baby-Food Safety. September 19, 1969. P A12.

5. Senate Select Committee on Nutrition and Human Needs. Part 4A. Food Additives. September 19, 1972.

6. Reif-Lehrer, L. A questionnaire study of the prevalence of Chinese restaurant syndrome. Federation Proceedings 36:1617-1623,1977.

7. Kenney, RA and Tidball, CS Human susceptibility to oral monosodium L-glutamate. Am J Clin Nutr. 25:140-146,1972.

8. Kerr, G.R., Wu-Lee, M., El-Lozy, M., McGandy, R., and Stare, F. Food-symptomatology questionnaires: risks of demand-bias questions and population-biased surveys. In: Glutamic Acid: Advances in Biochemistry and Physiology Filer, L. J., et al., Eds. New York: Raven Press, 1979.

9. Schaumburg, H.H., Byck, R, Gerstl, R, and Mashman, J.H. Monosodium L-glutamate: its pharmacology and role in the Chinese restaurant syndrome. Science 163:826-828,1969.

10. Olney, J.W. Prepared Statement for the Public Meeting (April 1993) Pertaining to Adverse Reactions to Monosodium Glutamate (MSG). FDA Docket #92N-0391, Item #TS7.

11. National Institutes of Health. The glutamate cascade: common pathways of central nervous system disease states. Bethesda, Maryland. May 3-5, 1998.

12. U.S. Public Health Service, FDA. Food Code Annex 5:HACCP Guidelines. Table 2, page HACCP 8. 1995.

13. Olney, J.W. Excitotoxic food additives-Relevance of animal studies to human safety. Neurobehavioral Toxicology and teratology. 6: 455-462, 1984.

14. Olney, J.W. Food additives, excitotoxic. In. G. Adelman, Ed. Encyclopedia of Neuroscience. Volume I., Pages 436-438. Boston: Birkhauser, 1987.

15. Olney, J.W. Excitotoxins in Foods. NeuroToxicology 15(3): 535-544, 1994.

16. Samuels, A. The Toxicity/Safety of Processed Free Glutamic Acid (MSG): A Study in Suppression of Information. Accountability in Research 6(4): 259-310, 1999.

(http://www.truthinlabeling.org)

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