A Study In Suppression Of Information: Free Glutamic Acid, MSG.

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The Toxicity/Safety of Processed Free Glutamic Acid

(Msg):

 

A STUDY IN SUPPRESSION OF INFORMATION

 

Adrienne Samuels

850 DeWitt Place, Chicago, IL 60611, USA

 

Accountability in Research (1999) Vol 6, pp. 259-310.

 

ABSTRACT

 

Every company interested in promoting its product

should attempt to convince its clients that its

product is worth buying. However, " selective "

collection and reporting of research data would be

inappropriate. " Selective " collection and reporting of

research data, including suppression of information

contrary to that which is espoused by the industry in

question, is the subject of this paper. Using

promotion of the flavor-enhancing ingredient called

monosodium glutamate, and its active component

(variously referred to as processed free glutamic acid

or MSG) as a case study, this paper presents the case

against the safety of MSG and looks at the work of the

defenders of the safety of MSG. The structure of the

industry organization; an overview of their research;

suppression of information; dissemination of

misinformation; dirty tricks; and the special role of

agencies of the United States government will be

considered.

 

KEY WORDS

 

accountability, deception, glutamic acid, glutamate,

monosodium glutamate, MSG, suppression of information

 

CONTENTS

 

1. Introduction

 

2. The Case Against the Safety of Processed Free

Glutamic Acid (MSG)

a) The chemical in question: processed free

glutamic acid

b) The first evidence of toxicity

c) Confirmation of toxicity

d) Personal involvement

 

3. Defenders of the Safety of MSG

a) Structure of their organization

- The International Glutamate Technical

Committee (IGTC

- The Glutamate Association

b) Researchers

c) Agents

d) People and Organizations Influenced by

Glutamate-Industry Agents

e) An overview of glutamate industry research

- Animal research: 1970-1980

- Umami: the alleged fifth basic taste

- The Epidemiologic Study

- The Double-Blind Studies

f) Suppression of Information

g) Dissemination of misinformation

h) Dirty tricks

i) Agencies of the United States Government

- The Food and Drug Administration (FDA)

- The National Institutes of Health (NIH)

- The U.S. Environmental Protection Agency

(EPA)

 

4. Summary and Conclusions

 

A. Table 1

 

B. Appendices

 

C. References

 

 

 

1. Introduction

 

Some scientists carry out well-designed and properly

executed research; but when data do not come out as

" needed, " the numbers are changed. Others don't

conduct studies at all; but submit fabricated details

and results of their choosing to peers for

publication. When exposed, they may be punished with

fines and imprisonment, and may be noted by the press.

In addition, those who use money of the United States

government are subject to investigation by the U.S.

Office of Research Integrity.

 

Researchers who deceive by falsifying data seem to be

few, even if growing in number; (Slind-Flor, 1993) and

if suspected of devious practices, can be fairly

easily challenged. There seem to be others, however,

who use more subtle methods to influence public

opinion--with great success. Although more difficult

to execute than simple fabrication of data, any

question of propriety can be passed off as an error of

judgement or an honest mistake; and penalties for

getting caught are non-existent or less severe.

 

This paper will describe how easily truth can be

hidden; and how seemingly isolated incidents actually

can be badly flawed research, direct suppression of

information, and dissemination of biased information

orchestrated by one group or industry.

 

Using the safety/toxicity of MSG as the subject, I

will demonstrate how the glutamate industry has

selectively collected and reported research data in a

way that presents glutamate in a favorable fashion. In

the following, the case against the safety of

processed free glutamic acid (MSG) will be presented

first, with particular attention given to the nature

of the chemical whose safety/toxicity is being

disputed; the first evidence of its toxicity;

confirmation of toxicity; and my personal involvement.

The second section will focus on the defenders of the

safety of MSG: 1) the structure of their organization

-- the International Glutamate Technical Committee

(IGTC); The Glutamate Association; researchers;

agents; people and organizations influenced by them;

2) an overview of their research -- animal research;

umami; the epidemiologic study; and double-blind

studies; 3) suppression of information; 4)

dissemination of misinformation; 5) dirty tricks; and

6) the special role of agencies of the United States

government.

 

 

 

2. The Case Against the Safety of Processed Free

Glutamic Acid (MSG)

 

The Chinese have used certain seaweeds to enhance the

flavor of food for some 2,000 years. In 1908, the

flavor-enhancing agent was identified as glutamic acid

(Kizer, Nemeroff, and Youngblood, 1978). Shortly

thereafter, methods for extracting glutamic acid from

seaweed were developed; the Ajinomoto Company was

established in Japan; and their flavor-enhancing

product, monosodium glutamate, became commercially

available.

 

In 1968, the safety of MSG was challenged.

 

a) The chemical in question: processed free glutamic

acid

 

The glutamic acid in the initial Ajinomoto product was

produced by extraction. Today, the glutamic acid

component of the food additive, monosodium glutamate,

is generally made by a method referred to as microbial

fermentation. In this method, bacteria are grown

aerobically in a liquid nutrient medium. The bacteria

have the ability to excrete glutamic acid they

synthesize outside of their cell membrane into the

liquid nutrient medium in which they are grown. The

glutamic acid is then separated from the fermentation

broth by filtration, concentration, acidification, and

crystallization, and converted to its monosodium salt

(Leung and Foster, 1996).

 

The food additive, monosodium glutamate, was first

used in the United States in any quantity in the late

1940s. By the 1960s, however, Accent, the leading

brand of monosodium glutamate, had become a household

word. Simultaneously, other hydrolyzed protein

products such as autolyzed yeast, sodium caseinate,

and hydrolyzed vegetable protein gained in popularity.

Every hydrolyzed protein product, regardless of the

name given to it on a label, contains MSG.

 

Monosodium glutamate is the name of a particular

flavor-enhancing ingredient. When used in this paper,

the words " monosodium glutamate " refer to that

flavor-enhancing ingredient. MSG is not the name of an

ingredient. In fact, the FDA would consider use of the

term MSG on a label, to represent an ingredient, as

misbranding. While industry often uses the term MSG as

a shorthand for the ingredient monosodium glutamate,

consumers use MSG as shorthand for the processed free

glutamic acid in ingredients that cause adverse

reactions. According to the FDA (1995) " While

technically MSG is only one of several forms of free

glutamate used in foods, consumers frequently use the

term MSG to mean all free glutamate. "

 

Further discussion of processed free glutamic acid

will be found in Appendix A.

 

b) The first evidence of toxicity

 

The first published report of a reaction to monosodium

glutamate appeared in 1968 when Robert Ho Man Kwok,

M.D., who had emigrated from China, reported that

although he never had the problem in China, about 20

minutes into a meal at certain Chinese restaurants, he

suffered numbness, tingling, and tightness of the

chest that lasted for approximately 2 hours (Kwok,

1968).

 

The New England Journal of Medicine gave Kwok's letter

the title, " Chinese-Restaurant Syndrome. "

Subsequently, readers responded, suggesting that the

culprit was monosodium glutamate.

 

The following year, John W. Olney, M.D. reported that

laboratory animals suffered brain lesions and

neuroendocrine disorders after being exposed to

monosodium glutamate (Olney, 1969). Scientists

studying retinal degeneration in mice treated with

free glutamic acid had noted that these mice became

grotesquely obese. Olney, who speculated that the

obesity might be a sign of damage to the hypothalamus

(the area of the brain that regulates a number of

endocrine functions, including weight control), found

that infant laboratory animals given free glutamic

acid suffered brain damage immediately, and assorted

neuroendocrine disorders later in life. Pharmaceutical

grade L-glutamic acid was often used to produce these

disorders until neuroscientists observed that

monosodium glutamate, an inexpensive food additive,

could be substituted for laboratory-grade free

glutamic acid in these studies and produce the same

effects.

 

c) Confirmation of toxicity

 

In the years that followed, neuroscientists replicated

the work of Olney, and Olney spoke out repeatedly

about the toxic potential of glutamic acid freed from

protein prior to ingestion. In 1972, for example,

Olney testified before the Senate Select Committee on

Nutrition and Human Needs that ingestion of MSG places

humans at risk, with the greatest risk being for the

very young; and that a National Academy of Science

panel organized to determine whether MSG ought to be

banned from baby food had produced an " industry

arranged whitewash " by a group of scientists with

almost no experience in neuropathology (Gillette,

1972). In the early 1970s, manufacturers of baby food

voluntarily removed the monosodium glutamate from

their products, but replaced the monosodium glutamate

with MSG-containing ingredients such as autolyzed

yeast and hydrolyzed vegetable protein. In the late

1970s, manufacturers voluntarily removed all obvious

MSG-containing ingredients from baby food.

 

Today scientists know that MSG kills brain cells and

causes neuroendocrine disorders in laboratory animals;

and that it causes adverse reactions in humans.

Scientists know that the blood brain barrier, once

thought to prevent glutamate that comes from exogenous

sources (eating included) from entering the brain, is

not fully developed until puberty; is easily damaged

by such conditions as high fever, a blow to the head,

and the normal course of aging; and, in the area of

the circumventricular organs, is leaky at best at any

stage of life. Scientists know that a diverse number

of disease conditions such as ALS, Alzheimer's

disease, seizures, and stroke are associated with the

glutamate cascade (Blaylock, 1994).

 

Scientists also understand that MSG is simply

processed free glutamic acid, or processed free

glutamic acid combined with sodium (depending on how

it is defined), and that glutamic acid is a

neurotransmitter that causes nerves to fire; and when

present in excess quantities, causes nerves to fire

until they die. Scientists understand that in addition

to the L-glutamic acid found in unprocessed,

unfermented, unadulterated free glutamic acid,

processed free glutamic acid invariably contains

D-glutamic acid and brings with it pyroglutamic acid

and other contaminants--some of which, depending on

procedures used for processing and the protein source,

are carcinogenic.

 

d) Personal involvement

 

In 1988, George R. Schwartz, M.D., published a book

entitled, In Bad Taste: The MSG Syndrome (Schwartz,

1988). Prior to its publication, few consumers

realized that the adverse reactions they suffered

following ingestion of monosodium glutamate were

caused by its free glutamic acid component; or that

there was processed free glutamic acid in all

hydrolyzed protein products. It was only after reading

Schwartz' book that I realized that the Alzheimer's

disease-like symptoms that were being experienced by

Jack Samuels, my husband, disappeared when processed

free glutamic acid was eliminated from his diet.

 

In 1989, the Food and Drug Administration (FDA) and

the U.S. Department of Agriculture (USDA) heard public

testimony relevant to the National Labeling and

Education Act of 1990 (NLEA). In that year, J.

Samuels, Schwartz, and others testified before the

NLEA panel to the toxic potential of MSG and the need

to identify MSG whenever present in processed food.

Subsequently, J. Samuels and Schwartz flew to

Washington for an in-depth conference with FDA

officials.

 

Following review of Schwartz' book, I attempted to

determine what foods I could prepare for my husband

without ill-effect. Failing to find any unifying

concept by which I could identify potentially toxic

ingredients, I turned to the Medline literature where

I found two sorts of studies: 1) those sponsored by

the glutamate industry, which invariably concluded

that MSG is safe, and 2) those done by independent

neuroscientists and other researchers who found that

MSG kills brain cells, causes neuroendocrine

disorders, learning disabilities, and a variety of

disorders such as tachycardia and seizures. Although

an investment banker in 1989, I am an experimental

psychologist by training, with expertise in learning,

test construction, research design, methodology, and

statistics, and a doctorate degree in Educational

Psychology from the University of Wisconsin. Inspired

by what had become my husband's life-threatening

sensitivity to MSG, my husband and I reviewed the

medical literature, read widely in the literature of

food science and technology, researched the history of

the continued FDA approval of MSG as generally

recognized as safe (GRAS), testified before the FDA

and its agents, and monitored the activities of the

FDA. I have been a member of the consumer group NOMSG

since 1989, and am a director of, and financial

contributor to, the Truth in Labeling Campaign, both

nonprofit corporations whose work benefits the public.

 

 

 

3. Defenders of the Safety of MSG

 

In 1968, 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.

 

a) Structure of their organization

 

- The International Glutamate Technical

Committee (IGTC)

 

In 1969, the 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. According to the Encyclopedia of

Associations (International Glutamate Technical

Committee (IGTC), 1992), the IGTC, then an 8 member

organization, sponsored, gathered, and disseminated

research on the use and 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. The National Trade and Professional

Associations of the United States (International

Glutamate Technical Committee, 1994) stated that the

IGTC was an association of 25 individuals, 20

companies, and 3 staff, composed of physicians and/or

scientists employed by producers or users of glutamic

acid and its salts or doing research on it in

university laboratories. Membership was given as

$2,000/year. The budget was $250,000.

 

- The Glutamate Association

 

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 Encyclopedia of Associations (The

Glutamate Association, 1990) 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 (Food Technology,

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.

 

Membership in The Glutamate Association is

secret. However, a source from within the glutamate

industry, who has asked to remain anonymous, told me

that besides Ajinomoto, Archer Daniels Midland,

Campbell, Corn Products Corporation, McCormick &

Company, Pet Foods, Pfizer Laboratories, and Takeda

are among its members.

 

b) Researchers

 

Once established, the IGTC assembled a cadre of

scientists who conducted research for them and/or

spoke publicly about the safety of MSG (Altman, 1994;

Anantharaman, 1979; Auer, 1996; Bunyan, 1976; Ebert,

1970; Fernstrom, 1996; Filer, 1979; Garattini, 1979;

Geha, 1998; Germano, 1991; Giacometti, 1979;

Goldschmiedt, 1990; Heywood, 1977; Iwata, 1979;

Kenney, 1979; Kerr, 1979; Matsuzawa, 1979; Morselli,

1970; Newman, 1973; Owen, 1978; Pulce, 1992; Reynolds,

1971; Reynolds, 1976; Schiffman, 1991; Stegink, 1975;

Stevenson, 1997; Takasaki, 1979a; Takasaki, 1979b;

Tarasoff, 1993; Yang, 1997). Those who identified

their funding sources in their publications or in

communications with the FDA are listed with their

funding sources in Table 1.

 

Steve Taylor, Ph.D., a prominent representative of the

glutamate industry, ( Taylor, 1993) 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 (Food

Allergy News, 1994) and editorial boards such as the

Encyclopedia of Food Science Food Technology and

Nutrition (Macrae, 1993). He has 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, or Ajinomoto (Taylor, 1991, 1997).

 

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 (Auer, 1991; Kenney, 1972); while subsequent

studies and/or public statements made by those same

scientists proclaimed that MSG is safe (Auer, 1996;

Kenny, 1979). By and large, those who represent the

glutamate industry have produced research relative to

the safety/toxicity of MSG 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 MSG

is safe. Only two of the glutamate-industry

researchers or speakers have been neuroscientists:

Richard J. Wurtman, M.D. (Filer, 1979), and Roland

Auer, M.D., Ph.D. (Auer, 1996).

 

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., who had found that MSG is an asthma trigger; and

they included his study in Food Allergy: Adverse

Reactions to Foods and Food Additives (Metcalfe,

Sampson, and Simon, 1991). In a letter to George R.

Schwartz, M.D., which Schwartz forwarded to me, 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 " (D. Allen, personal communication,

August 20, 1990).

 

On August 31, 1995, the FDA released a report on the

safety of MSG in food, done by the Federation of

American Societies for Experimental Biology [FASEB]

(1995). In that report, FASEB acknowledged that MSG

was an asthma trigger, and that doses of MSG as low as

..5 grams MSG 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 MSG was

known to be an asthma trigger, for they had found

Allen's work to be lacking (Simon and Stevenson,

1995). In 1995, Simon and Stevenson were doing

research for the International Glutamate Technical

Committee (Stevenson et al. 1997).

 

Of obvious interest is the fact that Simon and

Stevenson knew what was in the August 31,1995 FASEB

report before it was released to the public. Not

obvious, is the fact that although Simon and Stevenson

spoke of having conducted MSG oral challenges on

asthmatic patients who experienced asthma attacks in

restaurants since 1980, their letter clearly states

that as of that date, they had tested only 25 patients

(Simon and Stevenson, 1995). Given that 25 per cent or

more of the population is sensitive to MSG

(Reif-Lehrer, 1977) and that approximately 2 per cent

of the MSG reactions reported to the FDA Adverse

Reactions Monitoring System are asthma reactions, on a

straight probability basis, Simon and Stevenson had

not tested enough patients to expect even one of them

to express an asthma reaction to MSG. Moreover,

according to their August 30, 1995 letter to the FDA,

Simon and Stevenson did no systematic study, but only

observed patients who came to Scripps Clinic for

treatment; and they looked for no reactions other than

asthma (Simon and Stevenson, 1995).

 

In 1996, the newsletter of the NOMSG consumer group

reported that when an MSG-sensitive person responded

to an advertisement in the Los Angeles Times for test

subjects for a new asthma study at Scripps Clinic

being conducted by Simon and Stevenson, she was told

that " 1) if she feared her asthma reactions to be

serious that she should not apply for the study; 2)

that the person who was screening the applicants

didn't believe that MSG could cause asthma reactions;

and 3) that this particular person was most likely

responding to sulfites, and not to MSG " (Schwartz,

1996).

 

In a May 28, 1997 letter, Simon responded to an

inquiry I had made, saying, " There is no study that we

are ‘doing for Ajinomoto or one of their agents, on

the general subjective sensitivity to MSG. The

abstract presented at the February 1997 AAAAI meetings

was a preliminary report of an ongoing study we

designed concerning MSG sensitivity in asthmatics. "

Included in the program for that meeting, however, was

an abstract for a poster session " The Role of

Monosodium L-Glutamate (MSG) in Asthma: Does it

Exist? " by Stevenson et al. (1997); funded by the

IGTC.

 

As is always the case, the activities of Simon and

Stevenson might appear to be isolated incidents. When

placed within the context of activities designed to

accommodate the sale of monosodium glutamate, however,

they assume great significance. In 1992, FASEB

undertook a study of the safety of MSG in food,

responding to 18 questions outlined for it by the FDA.

The September, 1995 draft final report of that study,

submitted to the FDA by FASEB, was rejected by the

FDA, " for clarification; " and the contract between

FASEB and the FDA was rewritten, directing FASEB,

through the wording in their new contract, to come up

with the conclusion that MSG reactions were not

triggered by less than 3 grams MSG. In the face of

growing recognition that MSG was causing adverse

reactions in substantial numbers of people; and that

the glutamate cascade was implicated in such disease

conditions as stroke, seizures, ALS, Alzheimer's

disease, and addiction; the glutamate industry had

changed its strategy for keeping MSG hidden in food

from claiming that essentially no one was sensitive to

MSG, to claiming that essentially no one was sensitive

to less than 2.5 or 3 grams MSG. For the FDA to

accept, as credible, research that had found subjects

to respond to as little as .5 grams MSG, as Allen had,

would not, therefore, be tolerable. It is not

inconceivable that Simon and Stevenson had been asked

to discredit Allen's research.

 

c) Agents

 

Depending on the roles they play, researchers might be

considered agents of the glutamate industry. In

addition, there are those who promote the products of

those they work for, just as public relations firms

do, but these organizations highlight the fact that

they are nonprofit corporations, while minimizing the

fact that they promote the products of those who

employ them. The International Food Information

Council (IFIC) and the International Life Sciences

Institute (ILSI) are examples of such

glutamate-industry agents.

 

In 1990, faced with the threat of a " 60 Minutes "

segment scheduled to appear on CBS television, that

might expose the toxic potential of monosodium

glutamate, IFIC became actively involved in

representing the interests of the glutamate industry.

The IFIC represents itself as an " independent "

organization. It sends attractive brochures to

dietitians, nutritionists, hospitals, schools, the

media, and politicians, proclaiming the safety of

monosodium glutamate. In 1990, an anonymous person

sent us a copy of a " Communication Plan " dated

July-December, 1991, that detailed methods for

scuttling the " 60 Minutes " segment on MSG, or,

failing, that, provided for crisis management.

(International Food Information Council [iFIC], MSG

Committee, 1991). IFIC's paid relationship to the

glutamate industry is documented in the Encyclopedia

of Associations (International Food Information

Council, 1996).

 

Support of the International Life Sciences Institute

(ILSI), an association sponsored by companies within

the food, pharmaceutical, chemical, toxicology, and

related industries, has also been observed

(International Life Sciences Institute Australia Inc.,

1990; Metcalfe, 1990). The ILSI has provided funding

for The Food Allergy Network (Food Allergy News,

1994).

 

Dean D. Metcalfe, M.D., of the National Institutes of

Health (NIH), who has spoken out publically on the

safety of MSG, and Sheldon Cohen, M.D., who evaluated

possibly MSG-sensitive subjects at NIH with Metcalfe

(Germano et al., 1991), are, or were, ILSI Allergy and

Immunology Institute Scientific Advisors

(International Life Sciences Institute, personal

communication, July 20, 1995). So were Taylor and

Sampson.

 

Sampson was recommended by The Glutamate Association

as one who might be interviewed by " 60 Minutes " about

the safety of MSG (The Glutamate Association, 1993).

 

ILSI has also funded the work of Johathan H. Pincus,

M.D., who, at the request of IFIC, reviewed the book

Excitotoxins: The Taste that Kills by Russell L.

Blaylock, M.D. Blaylock sent me a copy of the letter

he wrote to Pincus following publication of Pincus'

review (R.L. Blaylock, personal communication, August

15, 1994). Blaylock wrote,

 

" I have just finished reading your review (To tax

the meaning of the word) of my book, Excitotoxins: The

taste That kills, for the International Food

Information Council. From your ‘review' I have come to

several conclusions. First, you did not read the book

carefully, if at all....And second...apparently, you

are of the opinion that only you should be allowed to

draw conclusions from research or to propose

hypotheses based on basic scientific research. Your

review is full of errors and unfair

characterizations...For example, you open your salvo

by saying that I was ‘armed primarily with the

research of Dr. John Olney, which was published more

than 20 years ago, and his own interpretation of a few

more recent studies.' Dr. Olney has not retired and he

is not dead. He is still engaged in primary research

in the area of excitotoxins and his work has been, and

continues to be, published in highly respected

scientific journals. "

 

d) People and Organizations Influenced by

Glutamate-Industry Agents

 

Some individuals and some organizations with alleged

interest in food safety have reviewed the safety of

MSG favorably (American College of Allergy and

Immunology, 1991a; American College of Allergy and

Immunology, 1991b; American College of Allergy and

Immunology, n.d.; Institute of Food Technologists,

1980; " Chinese restaurant syndrome, " 1990; McNutt,

1991; Schmitz, 1990; Taliferro, 1995; Tufts University

Diet and Nutrition Letter, 1992; University of

California at Berkeley Wellness Letter, 1989;

University of California at Berkeley Wellness Letter,

1996; Wood, 1991). Others have prepared brochures

either stating that there is no evidence that

ingestion of monosodium glutamate or other

MSG-containing food additives should cause consumers

concern; or listing food additives that might cause

consumers concern while omitting mention of

MSG-containing ingredients (American Academy of

Allergy and Immunology, 1993; FDA in cooperation with

IFIC, 1992; Scripps Clinic and Research Foundation,

1995). The American Academy of Family Physicians

Foundation allowed IFIC to claim " Favorable Review by

the American Academy of Family Physicians Foundation "

on a 1991 brochure (International Food Information

Council [iFIC], 1991). The American Medical

Association refused to implement a Resolution passed

by its membership at its 1991 annual meeting calling

for the AMA to " ...encourage all appropriate

regulatory agencies, including the Food and Drug

Administration, to mandate labeling of all foods

containing even small amounts of additive L-glutamic

acid so that individuals wanting to avoid this

substance may do so " (American Medical Association ,

1991).

 

Whether or not these people and/or organizations are

literally agents of the glutamate industry or simply

influenced by them is irrelevant. Either way, they

publish material that is read by others who respect

their opinions; and that material is uncritical of

anything said or done by the glutamate industry.

Characteristic of those referenced here is their

unwillingness to print any addition, correction, or

retraction after errors or omissions in published

material are pointed out to them.

 

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 (McNutt, 1991).

 

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 publicly about the

safety of monosodium glutamate, often with Taylor. The

IFIC promotes 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 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

review journals that publish their badly flawed

studies. An argument is made later in this paper that

published glutamate-industry sponsored studies are

badly flawed. If that is the case, then their

publication in peer review 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

publish glutamate-industry sponsored studies.

 

The subject of glutamate industry influence in peer

review journals is discussed in some detail in the

section entitled " Suppression of Criticism of Badly

Flawed Research. "

 

The potential for glutamate industry influence over

the media is obvious. Radio, TV, and newspapers all

carry food, drug, and cosmetic advertisements; and

members of boards of directors may also be directors

of food and/or drug companies.

 

Mention of MSG by major media sources has been

virtually nonexistent since " 60 Minutes " aired a story

about the toxic effects of MSG in 1991. Some time

after the " 60 Minutes " program aired, Nancy Millman,

writing for the Chicago Tribune, did an article

focusing on the activities of J. Samuels and his fight

to have MSG labeled. According to Millman, prior to

beginning her work, Millman had cleared the story with

her editor; but the article was never published.

Similarly, the Baltimore Sun accepted and then refused

to print an article on MSG by Linda Bonvie; and an

editor at the New York Times told Bonvie that she

wouldn't take a story that even mentioned MSG.

According to Bonvie, the editor had said she was

unwilling to face the pressure that she knew she would

face if she did. In 1991, Don Hewett of " 60 Minutes "

said, on television, that he had never had so much

pressure applied to him by industry as he had prior to

the airing of the MSG segment. Although rated by TV

guide as one of the two most watched segments of the

1991 year, " 60 Minutes " won't now touch a story about

MSG.

 

Since 1991, little if any coverage outside of CNN and

CBN has said anything other than that MSG-containing

food is safe. The only coverage of a law suit filed by

consumers against the FDA for failure to require

labeling where labeling was needed to protect the

public from excitotoxic MSG hidden in food was carried

by CNN, CBN, and the St. Louis Post Dispatch when the

suit was filed, and by CBN and the Post Dispatch when

the court's decision was handed down.

 

Glutamate-industry involvement is rarely obvious.

That's what makes it so effective. An InHealth article

(Schmitz, 1990) ran next to an advertisement from

McCormick, a member of The Glutamate Association. Had

the McCormick ad not been placed so close to the

article, the possibility that McCormick might have

commissioned the article might not have been

considered. (Magazines often do stories about, or on

behalf of, companies that purchase advertising.)

 

Over the last two decades, the glutamate industry has

distributed material designed to convince the public

that MSG is safe. Their influence has been so great

that as recently as 1989, when consumers raised

questions about the safety of free glutamic acid, the

FDA commonly referred consumers directly to The

Glutamate Association or sent them material prepared

by The Glutamate Association. Present FDA practice

includes distributing unsolicited copies of an FDA

Medical Bulletin that assures physicians that MSG is

safe; and distributing similar material to food

service people.

 

The scientific community has been given information by

the IGTC and The Glutamate Association, and through

intermediaries such as IFIC and ILSI; and members of

the scientific community have been encouraged to pass

that information on to the public. Allergists,

dieticians, and nutritionists appear to have been

particularly targeted. Further, the media appear to

have been well supplied with glutamate industry

materials and to be under tremendous pressure from

food and drug advertisers to comment only positively

about the value of monosodium glutamate, or not

comment at all. IFIC claims that " some three out of

four journalists [surveyed] said they use [the IFIC

newsletter] Food Insight as background for news

stories " (Food Insight, 1994).

 

It would appear from records of his correspondence and

meetings with the FDA, that IGTC chairman Ebert has

been designing, or has been instrumental in designing,

glutamate-industry sponsored double-blind studies for

years with the blessings of the FDA (Ebert, 1990;

Ebert, 1991a; FDA, 1992a). In the section entitled

" Research, " I will make the point that

glutamate-industry sponsored research is badly flawed.

Industry involvement with the FDA is discussed more

fully in the section entitled " The Food and Drug

Administration (FDA). "

 

e) An overview of glutamate industry research

 

- Animal research: 1970-1980

 

When Olney and others demonstrated that MSG causes

brain lesions and causes neuroendocrine disorders in

maturing animals fed MSG as neonates and infants,

glutamate industry researchers produced studies that

they claimed were failed attempted replications; but

their procedures were different enough to guarantee

that toxic doses had not been administered, or that

all evidence that nerve cells had died would be

obscured. Industry-sponsored researchers said they

were replicating studies, but did not do so. Instead,

discussion was phrased to suggest that studies were

" replications, " and the conclusions were based on what

was said, not on what was done.

 

Examination of the methodology sections of

representative studies ( Newman, 1973; Reynolds, 1971;

Stegink, 1975). 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.

(1975) and a study by Reynolds, Butler, and

Lemkey-Johnston (1976), which are discussed in more

detail in the section titled " Suppression of criticism

of badly flawed research. " 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 studies were underwritten by Ajinomoto, Gerber,

International Minerals and Chemical Company, Nestle,

and others, in cooperation with the IGTC.

 

In the 1970s, 1980s, and early 1990s, cooperation

between individual researchers, universities and/or

medical schools, government, and industry was openly

displayed. For example, studies from the University of

Iowa College of Medicine and the University of

Illinois Medical Center were financed and/or

orchestrated by Ajinomoto, Gerber Products Company,

G.D. Searle & Company, the IGTC, and Searle

Laboratories. Funding also included grants from

various institutes of the National Institutes of

Health (NIH). Olney had demonstrated earlier that

aspartic acid (a structural analog of glutamic acid)

and glutamic acid had the same toxic effects, killing

brain cells in certain areas of the hypothalamus, and

causing endocrine disorders later in life in those

animals that had been given either substance as

infants.

 

Monosodium glutamate manufactured by Ajinomoto

contained essentially pure glutamic acid and sodium;

and Gerber used monosodium glutamate and other forms

of glutamic acid in their baby food. In the 1970s,

Searle was having difficulty getting aspartame, a new

sugar substitute made of approximately 50 per cent

phenylalanine, 40 per cent aspartic acid, and 10 per

cent a methyl esther, approved by the FDA.

 

The University of Iowa College of Medicine has a long

history of cooperation with food and drug industry

interests. In 1967, the Mead-Johnson Professorship in

the Department of Pediatrics was established by the

Mead-Johnson and Company Foundation, Inc., and Lloyd

J. Filer, Jr., M.D., Ph.D., moved from Mead-Johnson (a

producer of infant formula) to the University of Iowa

College of Medicine, where he served as Mead-Johnson

Professor from 1967 through 1977.

 

In 1969-70, Filer chaired a special FDA " scientific "

committee to evaluate the safety of glutamic acid

(often referred to as " glutamate " ) for babies. Not

withstanding the fact that Olney had demonstrated that

glutamic acid caused brain lesions and neuroendocrine

disorders in laboratory animals, with infant animals

being most at risk, Filer's committee concluded that

glutamate was safe.

 

Subsequently, the committee was investigated, and most

of its members were found to have close financial ties

to the food industry (Gillette, 1972). Chairman Filer,

then Mead-Johnson Professor at the University of Iowa,

was found to be receiving money from both the baby

food industry and the glutamate industry. But the FDA

never challenged the Filer committee's conclusion that

glutamate fed to infants was safe.

 

In 1979, Filer, Garattini, Kare, Reynolds, and

Wurtman, edited the book Glutamic Acid: Advances in

Biochemistry and Physiology. Stegink contributed to

six articles. The book was a compilation of the papers

from a symposium held in Milan, Italy, in 1978. The

symposium was organized in response to a less than

satisfactory outcome of the Federation of American

Societies for Experimental Biology (FASEB)'s 1978

" Evaluation of the Health Aspects of Certain

Glutamates as Food Ingredients, " and became the basis

for FASEB's 1980 " Evaluation of the Health Aspects of

Certain Glutamates as Food Ingredients Supplemental

Review and Evaluation. " (FASEB, 1980) Glutamate

industry spokespersons claim the book demonstrates

that MSG is " safe. "

 

The Iowa/Illinois animal studies were done between

1971 and 1979. In 1991, Olney testified before a FASEB

Expert Panel reviewing data on the safety/toxicity of

MSG. An excerpt from the text of that presentation,

which follows in Appendix B, describes some of his

interaction with these researchers, and concludes:

 

In summary, the record shows that FDA for two

decades has been assuring the public that glutamate is

safe, based almost exclusively on certain

industry-generated monkey data which appear upon close

scrutiny to be seriously flawed, unreliable and

spurious. However, even if these data were not flawed,

unreliable and spurious, it is obvious from industry's

own finding, shown in Fig. 1 above, that the

pharmacokinetics of glutamate absorption and/or

metabolism are so disparate between monkeys and man

that monkeys, despite their phylogenetic closeness to

humans, must be regarded as a singularly inappropriate

animal model for evaluating oral glutamate safety. The

same oral dose of glutamate that causes a dramatic

increase in blood glutamate concentrations in humans,

causes no increase at all in monkeys. Therefore, it is

difficult to understand why so much money and effort

was expended on oral glutamate monkey studies, unless

the goal was to amass an unchallengeable mountain of

negative evidence that could serve as basis for

fostering the misleading impression, and fueling the

spurious argument, that if monkeys are resistant to

glutamate-induced brain damage, other primates,

including humans, must be similarly resistant (Olney,

1993).

 

Lest there be any confusion, note that it is the study

of sub-human primates, not the study of mice, that is

largely irrelevant to an understanding of the effects

of MSG on humans. Mice quite closely approximate the

human condition.

 

The work that demonstrates that glutamic acid causes

brain lesions and neuroendocrine disorders in

experimental animals has been replicated hundreds of

times by neuroscientists. In contrast, almost every

published study sponsored by the glutamate industry

has concluded that glutamic acid is " safe. " Nemeroff

(1981), reviewing studies of the safety/toxicity of

MSG stated unequivocally that " ...not one single

[primate] study has truly replicated the methods

utilized by Olney, making evaluation of the available

[industry] data impossible. "

 

- Umami: the alleged fifth basic taste

 

Ajinomoto has attempted to establish that there is a

unique taste, a fifth basic taste, associated with

monosodium glutamate. To debate the veracity of such a

claim is beyond the scope of this paper. However,

considering the fact that such a claim has been made

is germane to a discussion of the safety of monosodium

glutamate. The scientific literature suggests that

only those in the employ of Ajinomoto are interested

in proving that Umami is a fifth taste sensation.

Moreover, reports from MSG-sensitive consumers suggest

that if monosodium glutamate (and other MSG-containing

ingredients) had a unique taste, people who were

sensitive to the substance, who claim to want to avoid

it, would be highly motivated to identify that taste

and thereby avoid ingesting MSG–which they claim they

are not able to do. It is my personal opinion that the

concept of umami has been developed in an effort to

legitimize the use of monosodium glutamate in food.

 

- The Epidemiologic Study

 

To defend themselves against epidemiologic studies

indicating that 25-30 per cent of the population

reacted to monosodium glutamate (Reif-Lehrer, 1977),

and against individual reports of human adverse

reactions that included migraine headache, seizures,

asthma, and depression, the glutamate industry built

the fiction that a few people might react to

monosodium glutamate with the " Chinese restaurant

syndrome: " " burning, " " tightness, " and " numbness, " all

occurring at the same time, within two hours following

ingestion. Virtually unchallenged, they effectively

suppressed the information that other reactions to

monosodium glutamate occurred as well, and that some

reactions are delayed by as much as 48 hours.

 

The industry produced a questionnaire study that

listed " 18 food-associated symptoms, " and asked

subjects " the time of onset of each symptom [if any]

after the start of a meal. " (No test meal was

provided.). Finding that 1.8 per cent of their 3,222

respondents marked " burning, " " tightness, " and

" numbness, " all occurring at the same time, and

commencing between 10 minutes and 2 hours after the

start of a meal, the authors concluded that 1.8 per

cent of the population suffered " Chinese restaurant

syndrome " or sensitivity to monosodium glutamate (Kerr

et al, 1979). The fact that an additional 41.2 per

cent of the subjects reacted with chest pain,

dizziness, headache, palpitation, weakness,

nausea/vomiting, abdominal cramps, chills, diarrhea,

heartburn, unusual thirst, unusual perspiration,

flushing sensation in face or chest, and tingling was

ignored. Migraine headache, seizures, tachycardia,

hives, skin rash, and depression, which were not

offered as options, were not considered. Soon the FDA

began to disseminate the misinformation that

approximately 2 per cent of the population might be

sensitive to MSG, reacting with the mild and

transitory reactions of " Chinese restaurant syndrome. "

 

- The Double-Blind Studies

 

In the 1980s, in the face of overwhelming evidence

that monosodium glutamate kills brain cells in

laboratory animals (Olney and Price, 1978, 1980),

industry researchers changed their 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.

 

A number of industry-sponsored double-blind studies

followed the epidemiologic study. 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. 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

reported since 1968.

 

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

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 (Stegink, 1986).

 

8. Continue subjects on medications that might

block the effects of MSG.

 

9. Using 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 as yet unpublished

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. One of my children, a

Northwestern student at the time, saw the study

advertised, found out the details of participation,

applied for the study, and was rejected when she told

the researchers that she was not very sensitive to

MSG.

 

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 MSG in the test material,

makes it virtually inevitable that there will be

approximately as many reactions to placebos as there

are reactions to MSG test material.

 

Sometimes glutamate-industry researchers use MSG

in placebos, but use sources of MSG different than the

ingredient called monosodium glutamate. Gelatin, which

always contains 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 (Ebert, 1991b). 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. 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.

 

Placebo reactions have also been noted in

industry-sponsored animal studies. It was noted by

Nemeroff (1981) that Abraham, Doughtery, Goldberg, and

Coulston (1971) and Abraham, Swart, Goldberg, and

Coulston (1975) 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.

 

On February 4, 1991 at the FASEB open hearing on the

safety of amino acids in dietary supplements, J.

Samuels raised the question of the propriety of

placebo material used by the glutamate industry. Ebert

rebutted, leading to a request from Sue Anne Anderson,

R.D., Ph.D., Senior Staff Scientist with the Life

Sciences Research Office at FASEB for information

about the vehicle for administration of monosodium

glutamate in IGTC-sponsored double blind studies. In a

March 22, 1991 letter to Anderson, IGTC chairman Ebert

responded that " since the completion of the work

described in [1978], the sample has been modified to

replace the sucrose with the low calorie sweetener

Aspartame in both the placebo and sample with MSG. "

Still, no one at the FDA raised any question about the

propriety of the research being submitted to the FDA

by the IGTC as evidence that MSG is safe.

 

In 1993, J. Samuels came across the March 22, 1991

letter to Anderson in the files of the FDA; and

brought the information to the attention of both FASEB

and the FDA. Still, no one at the FDA raised any

question about the propriety of the research being

submitted to the FDA by the IGTC as evidence that MSG

is safe. Not long afterward, IGTC chairman Ebert was

named by FDA Commissioner David A. Kessler, M.D., to

the FDA Food Advisory Committee.

 

The IGTC has amassed a number of double-blind studies

concluding--but not demonstrating--that MSG 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. Subsequently, studies may be

published in peer reviewed journals--accepted by

editors who, themselves, may have ties to the food

and/or drug industries.

 

Given the methodological flaws inherent in their work,

and their unwillingness to change their protocols

after flaws were pointed out to them, it would appear

that IGTC researchers move from a predetermined

conclusion (that their product is " safe " ) to design

and implementation of research guaranteed to bring the

reader back to that predetermined conclusion.

 

f) Suppression of Information

 

Interwoven with the assertion that research has

demonstrated that monosodium glutamate is " safe, " has

been the suppression of any and all commentary or data

that would say otherwise.

 

When there was no getting around the fact that MSG

caused adverse reactions, as is the case in migraine

headache, the glutamate industry and colleagues at the

FDA simply did not discuss those reactions. The FASEB,

in a report done for the FDA and published July, 1995,

(FASEB, 1995) covered the subject of asthma in some

detail, but virtually ignored the subject of migraine

headache, despite the fact that 43 per cent of the

reactions reported to the FDA's Adverse Reactions

Monitoring System by MSG-sensitive people were

reactions of migraine headache.

 

Suppression of information relative to the toxic

potential of monosodium glutamate has included

industry/FDA refusal to identify MSG when present in

processed food (making confirmation or denial of

MSG-sensitivity extremely difficult); industry/FDA

suppression of evidence that demonstrates that

ingestion of MSG places humans at risk; industry/FDA

use of poor research, imprecise and contradictory

terms, half-truths, and misrepresentation of fact; and

FDA refusal to provide either consumers or the Court,

when a defendant in a legal action, with all of the

evidence that the FDA has in its files on the

safety/toxicity of MSG.

 

As consumer pressure to expose the toxic potential of

MSG continues; as the growing science on

neurodegenerative disease continues to implicate

glutamic acid; as a growing number of diverse disease

conditions are being linked to the glutamate cascade;

and as members of the United States Congress are

admitting that they, personally, are sensitive to MSG,

industry-inspired articles attesting to the safety of

MSG are being published.

 

A recently published article in The Washington Post by

Robert L. Wolke is a case in point (Wolke, 1998).

 

According to Wolke, " ...a lack of scientific

understanding hasn't stopped people from enjoying the

benefits of MSG for more than 2,000 years. " But MSG

was only invented in 1908.

 

According to Wolke, " [FDA] remains convinced that MSG

and related substances are safe food ingredients for

most people when eaten at customary levels.' " But

Wolke fails to mention that could leave 49 percent of

the population reacting to MSG.

 

According to Wolke, there are only small amounts of

MSG in typical servings of prepared foods. He suggests

that we " contrast this with the FDA's best scientific

information, which is that even hypersensitive people

must eat between 500 and 2,000 milligrams of pure MSG

to cause CRS symptoms. " But Wolke refers to " CRS

[Chinese restaurant syndrome] symptoms, " and not to

all of the known reactions to MSG; and Wolke ignores

the fact that the FDA's " best scientific information "

is not based on any scientific study; because no study

even attempting to determine the least amount of

processed free glutamate that might cause an adverse

reaction in an MSG-sensitive person has ever been

done.

 

The source of Wolke's information is not given.

 

I wrote to the Editor of the Washington Post,

expounding on the bias in Wolke's article. Several

days later, I found the following message from Fanny

Zollicoffer of the Washington Post on my answering

machine: about your " ...letter to the editor about

MSG, and the article we had in the food section. We'd

like to publish your letter. It's being considered for

the free fall page on Saturday. And I'm just calling

to confirm that you wrote the letter and put your name

on it and sent it to no other newspaper. " When I

called several days later to inquire why my letter had

not appeared in the paper, I was told that the editors

had decided not to print it.

 

Suppression of criticism of badly flawed research has

been similarly effective. Questions in the form of

Letters to the Editor have been refused publication by

the Journal of Allergy and Clinical Immunology

(Goldschmiedt et al., 1990) and Food Additives and

Contaminants (Daniels, Joe, and Diachenko, 1995). (The

Daniels et al. study was done at the FDA.)

 

When a critique of the work of Tarasoff and Kelley was

sent to Food and Chemical Toxicology in the form of a

Letter to the Editor, (Samuels, 1995) the Letter was

accepted for publication; but approximately seven

weeks later, I was informed that " after

reconsideration we cannot accept your comments on the

paper by Tarasoff and Kelly for publication....Our

concern is that your critique could be wrongly

exploited by different groups of people involved in

the MSG issue, and we therefore believe it is

preferable that our journal should be kept away from

any possible complications " (T. Ho, personal

communication, June 1, 1994).

 

I protested that having been accepted, I had informed

others that the Letter was " in press, " and that in

rejecting the letter as it had, the journal was not

only acting in an unprofessional manner, but would

cost me a great deal of embarrassment.

 

After considerable correspondence with the Journal,

with Bibra Toxicology International, and with Elsevier

Science, I was informed that their battery of

expensive solicitors had assured them that by

publishing the letter the damage to reputation, if

any, had been sufficiently allayed (P. Shepherd,

personal communication, February 9, 1995).

 

According to correspondence from Christopher Lloyd,

Editorial Director, Life Sciences/Earth Sciences,

Elsevier Science, " ...the editorial decisions both to

initially accept, and then reject [the] letter were

made by the Journal's Editor, Dr. J. Borzelleca. " In

September, 1994, Editor-in-Chief Borzelleca had told

me that the delay of publication should not be of

concern because he, Borzelleca, had seen a copy of the

draft final report sent to the FDA by FASEB, and knew

that it would be rejected by the FDA; causing there to

be sufficient time for my letter to be published and

considered by FASEB.

 

The fact that the FASEB draft final report seen by

Borzelleca was allegedly confidential, will be

discussed in the section entitled " The Food and Drug

Administration (FDA). "

 

The Letter to the Editor of Food and Chemical

Toxicology was published more than a year after

publication of the original article. Borzelleca, who

is on the faculty of the Medical College of Virginia,

had blocked publication of criticism of the Tarasoff

and Kelly study for almost a year. Donald F. Kirby,

M.D., who has done double-blind studies for the IGTC

(Ebert, 1990) is also on the faculty of The Medical

College of Virginia.

 

Borzelleca served on the Select Committee on GRAS

(Generally Regarded As Safe) Substances that published

reviews of the safety of monosodium glutamate for the

FDA in 1978 and 1980.

 

When professional peer review journals hesitate to

take articles from glutamate industry researchers

because their studies are badly flawed and those flaws

have been pointed out to journal editors, researchers

hold seminars and/or present their papers at

professional meetings with abstracts printed in

appropriate journals (Altman, 1994; Stevenson, 1997).

Studies reported in abstract form are not peer

reviewed, and letters to the editor criticizing

abstracts are not generally published. The principal

forum for such papers has been the American Academy of

Asthma, Allergy, and Immunology (Altman, 1994;

Stevenson, 1997). In addition, there are a few

journals that, by policy, do not accept critical

letters. Food Additives and Contaminants is one (R.

Walker, personal communication, September 1, 1995).

 

By the end of the 1970s, industry-sponsored

researchers had basically given up doing animal

studies designed to convince people that MSG poses no

risk to humans. They continued, however, to claim that

their research had demonstrated that MSG poses no risk

to humans. Through verbal argument, they attempted to

suppress contradictory information.

 

The work of Filer, Reynolds, and Stegink has been

discussed earlier (Reynolds, 1971; Reynolds, 1976;

Stegink, 1975). Filer retired from academia, but

continued to serve as a spokesman for The Glutamate

Association and the IGTC until his death (Filer,

1993).

 

Reynolds moved into administration, spending time at

the University of California before moving on to New

York State. However, she continued to proclaim the

safety of MSG. In a five page letter to FASEB, for

example Reynolds, Filer, and Stegink (1991) explained

that cross sections presented in their 1975 and 1976

reports, discussed briefly earlier, although labeled

differently, were, indeed, identical, because the 7

day-old Macaca fascicularis monkey that ingested MSG

(reported by Reynolds, et al.) was the same " ...infant

rhesus monkey which received 4 g/kg of MSG by stomach

tube 6 h prior to brain perfusion " (reported by

Stegink et al.). They assured FASEB that they could

find no evidence to support the allegation that the

micrograph being challenged by critics came from a

previously unreported monkey (an allegation that had

not been made), and explained how " the differences

between [the] captions [in the Stegink et al. article

and the Reynolds et al. article] may confuse the

casual reader. " No reader would have cause to question

the contents of the Reynolds, Filer, Stegink letter

unless he or she had both the 1975 and 1976 articles

in hand; and then only close scrutiny will reveal that

none of the animals given 4g/kg MSG in1971 referred to

by Stegink et al. (one of which was allegedly the same

animal pictured by Reynolds et al.) had been 7

day-old-animals. (Table 1 of the Stegink et al. study

contains that information.) Reynolds et al. had

claimed that the section pictured in their paper, and

alleged to have been from one of the animals given

4g/kg MSG in 1971 referred to by Stegink et al., came

from a 7-day-old animal.

 

Stegink appears to write on behalf of the safety of

MSG whenever the safety of MSG is challenged (Stegink,

1993a, 1993b).

 

g) Dissemination of misinformation

 

The Glutamate Association has disseminated masses of

misinformation designed to suppress reports of adverse

or toxic reactions, and to convince consumers that

monosodium glutamate is safe.

 

Some of their information is based on distortion of

fact. For example, the statement that monosodium

glutamate has been used in the orient for more than

2,000 years, or the statement that the glutamic acid

in monosodium glutamate (a manufactured product that

invariably contains D-glutamic acid and pyroglutamic

acid as well as L-glutamic acid) is chemically

identical to the glutamic acid found in unadulterated

protein (which is composed of L-glutamic acid, only).

One of their favorites over time has been the

assertion that " other authoritative bodies " have found

MSG to be safe. In general, those " other authoritative

bodies " have read the FDA's summaries concluding that

MSG is safe, 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 MSG 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. (National Food

Review, 1987) They did not consider that to be an

endorsement of the safety of MSG (Hellen Keller

International, personal telephone communication,

n.d.).

 

Half-truths also constitute misinformation. When The

Glutamate Association's Richard Cristol wrote to FASEB

on April 9, 1993 that researchers had received no

funding from The Glutamate Association, he didn't rule

out receipt of funding from the IGTC, Ajinomoto,

Campbells or other members of the glutamate industry.

On page 5 of a brochure titled " Sweet, sour, salty,

bitter and umami, the statement is made that

" ...researchers confirmed that glutamate had an

L-configuration. " (Umami Information Center, n.d.) It

was not, however, made clear that when glutamate is

generated through a manufacturing process, the

glutamate will contain D-glutamate as well as

L-glutamate; that pyroglutamic acid will invariably

accompany manufacture; and that under certain

circumstances. carcinogenic substances will also be

generated.

 

The balance of the information disseminated by the

glutamate industry has been based on conclusions drawn

from their badly flawed studies.

 

h) Dirty tricks

 

In October, 1994, the Truth in Labeling Campaign (TLC)

was formed to promote truth in labeling, with its

first project being full and clear labeling of MSG. In

August, 1995 TLC sued the FDA and announced plans for

fund raising.

 

In October, 1995, the Washington Post ran a story

about the Truth in Food Labeling Campaign--formed by

Public Voice for Food and Health Policy and the

National Consumers League for the purpose of raising

funds to combat the use of mechanically separated

poultry (MSP). It seemed like an innocent

coincidence–until the sponsors refused to reveal the

source of the grant money given to them to set up the

Truth in Food Labeling Campaign, or to elaborate on

projects that had been planned for the future.

 

In an effort to generate publicity, TLC contracted

with Bacons Communications to send out press releases

announcing the suit filed against the FDA. Bacons

provides clipping services, mailing services, and

media directories. They have offices in Chicago,

Illinois. On the day following the day the releases

were to go out, TLC began getting inquiries about

incomplete information that had been received by

fax--often a cover page, only. After receiving several

such inquiries, it was ascertained that Bacons had

held the releases, sending them out the day after the

suit was filed, making them non newsworthy. When I

made inquiry into what had happened, it became clear

that the error was not due to a misunderstanding of

instructions or to equipment breakdown.

 

In 1994, I attended an IFT Short Course " Allergies and

other Adverse Reactions to Foods, Additives and

Ingredients " sponsored by the IFT, The Food Allergy

Center, and the University of Nebraska Food Processing

Center. Presenters were Altman; Betty P. Rauch,

M.B.A., Allerx Inc.; Daniel J. Skrypec, Ph.D. Kraft

General Foods; and Sean F. Altekruse, D.V.M., M.P.H.,

FDA. According to Altman, who said what little was

said about MSG, presenters had been told that I would

be in the audience. It was only after the presentation

was over that I discovered that prior to the

presentation, Altman had given the press a manuscript

that was replete with misinformation about the safety

of MSG; while in her limited oral presentation, Altman

had said nothing that I might question in public.

 

i) Agencies of the United States Government

 

- The Food and Drug Administration (FDA)

 

Reference to the FDA has been made throughout this

paper; and rightly so. Because it is the FDA that

makes and enforces food labeling laws; and it is the

FDA that determines whether or not MSG, or any other

chemical, will be approved for use in food. Thus, the

FDA holds the keys to life and death for many American

people, who would hope that it is the welfare of

consumers, not the profits of the food and/or drug

industries, that is of concern to the FDA.

 

Evidence of FDA/industry cooperation will be found in

the files of the FDA.

 

A July 13, 1990 letter from IGTC chairman Ebert to

Walter Glinsmann, M.D., Associate Director of Clinical

Nutrition, Division of Nutrition, FDA reads, in part

" ...attached are three [double-blind] protocols for

your use...IGTC would be interested in your views,

especially on the proposed work by Drs. Kirby and

Kjos. " (Ebert, 1990).

 

A January 2, 1991 letter from IGTC chairman Ebert to

Fred R. Shank, Ph.D., Director, Center for Food Safety

and Applied Nutrition, FDA, requested a scientific

review session on MSG with FDA scientists. " In the

past, IGTC has requested meetings with FDA staff for

purposes of informal reviews of MSG research.

Scientists who have carried out studies on MSG,

usually in university laboratories or clinics, have

presented their data to agency scientists for review

and discussion. " After elaborating on what the IGTC

wanted covered at the meetings, the chairman

continued: " As FASEB plans a one day Hearing on Free

Amino Acids on February 4, 1991, it seems advisable to

complete an FDA meeting prior to that date....FDA

scientists who have participated in MSG research

discussion in the past included among others: Drs.

Shank, Hattan and Scheuplein. Others who would be key

attendants include Drs. Rulls, Lin and

Bailey...Members of the IGTC/TGA Executive Committee

also would plan to join the meeting " (Ebert, 1991a).

 

A December 9, 1991 FDA Memorandum of Conference (FDA,

1991) notes that " The IGTC requested the meeting to

discuss a protocol that they are currently developing

for a proposed food allergy study involving MSG. We

informed the visitors that we will provide our

comments only after they have submitted a written

protocol to us with some detailed description of the

proposed study. "

 

A September 4, 1992 FDA Memorandum of Conference (FDA,

1992b) reads: " Dr. Kimura gave me a copy of the [iGTC]

request (dated 8/20/92) for a meeting with the

Commissioner and a copy of the Bob MacLeod's brief

response (dated 9/3/92) to the IGTC. We both agreed

that once a description of their research plan (or

protocols) is given to us, a meeting will be scheduled

for their scientists to discuss with our review staff

regarding their research plan aimed to resolve

scientific issues surrounding adverse reactions

allegedly caused by monosodium glutamate consumed in

food. "

 

On October 23, 1992, the FDA hosted a conference at

the Center for Food Safety and Applied Nutrition, FDA.

Present were Geha (Harvard Medical School), Saxon

(UCLA Medical School), Patterson (Northwestern

University Medical School), Ebert, (Chairman IGTC),

Yoshi-hisa Sugita (IGTC), Takeshi Kimura (IGTC); and

Hattan, Tollefson, Glinsman, Bailey, and Lin of the

FDA (FDA, 1992a). Protocols for these studies called

for use of aspartame in placebos.

 

In May, 1992, the Journal of Dental Hygiene (1992)

cited Hattan as saying " The FDA's findings were based

on the scientific studies provided by the Glutamate

Association. The work has been supported by people

with an interest in glutamate: consortiums and

manufacturers. " Earlier, (August, 1990) Hattan had

told a toxicology forum in Aspen Colorado that

glutamic acid was implicated in a number of disease

conditions. According to Hattan, " 'developing data on

exogenous and endogenous excitogens or excitotoxins

has been the primary spur to the Food and Drug

Administration's review of monosodium glutamate " (Food

Chemical News, 1990). Hattan is central to the debate

on the safety/toxicity of MSG, being Deputy Director

for the Division of Toxicological Review and

Evaluation, at the FDA, and the FDA liaison to FASEB

relative to the 1995 FASEB analysis of adverse

reactions to monosodium glutamate (MSG). Yet there is

no evidence that Hattan raised any question about the

propriety of the research being submitted to the FDA

by the IGTC as evidence that MSG is safe.

 

The IGTC has brought badly flawed studies to the FDA

for approval, and the FDA has accepted them as

demonstrating that the glutamate industry's product is

" safe. " The FDA has refused to share with either the

public, the Congress, or the Court all that it knows

about the toxic potential of monosodium glutamate. The

FDA has done original research for the benefit of the

glutamate industry (Daniels et al, 1995). Thus, the

FDA has been actively engaged in the suppression of

information pertaining to the toxic potential of

monosodium glutamate.

 

The FDA appears to have cooperated with the glutamate

industry at every turn, and has ignored its mandate to

protect the public from potentially toxic material. In

turn, much of our government has cooperated with the

FDA. The flawed nature of the IGTC's research was

exposed in 1993 when evidence from the files of the

FDA that the IGTC used aspartame in their placebos was

brought to the attention of the FDA. In that year, J.

Samuels and I asked FDA Commissioner Kessler to

investigate the FDA's use of badly flawed studies in

their determination that monosodium glutamate is safe.

The request was ignored. Even the FDA/HHS Office of

the Inspector General, when called upon to investigate

charges that the behavior of the FDA was

inappropriate, guaranteed that the investigation would

be killed by turning the investigation over to the

Office of Research Integrity, which, under no

circumstances, would have jurisdiction in this matter

(C.C. Maddox, Office of the Inspector General,

personal communication, March 13,1995). When

legislators receive inquiries or calls for help from

constituents, they are forwarded to the FDA which, in

turn, assures both legislator and constituent that

there is no cause for concern.

 

The FDA is considered an expert in the areas of food,

drug, and cosmetic safety by all branches of

government; so in any argument over matters of

science, the word of the FDA will, with rare

exception, be the final word. In addition, the files

of the FDA are privileged. Under the provisions of the

Administrative Procedures Act, the FDA need disclose

to the public, or the Courts, only that information

which is part of the Administrative Record for the

matter in question; and it is the FDA that determines

what the Administrative record for any question shall

be.

 

When challenged in a suit over full and clear labeling

of MSG (August 29, 1995), the Court considered nothing

but the Administrative Record presented by the FDA.

Studies that demonstrated the MSG had toxic potential

were not allowed as evidence because they were not

submitted to the Court by the FDA as part of its

Administrative Record. The Administrative record was

made up of material that the FDA needed in order to

win its case, plus a smattering of material from the

opposition that had no bite to it, but to which the

FDA could point and say, " we looked at that. " I was a

plaintiff in that law suit.

 

In 1992, the FDA commissioned FASEB to do an

independent review of research on the safety (never

toxicity) of monosodium glutamate in food. The FDA has

admitted, in reports of adverse reactions on file at

the FDA, that headache (they don't call it migraine

headache) has been reported as an adverse reaction by

over 43 per cent of the people reporting reactions to

monosodium glutamate. With possible rare exception,

monosodium glutamate is acknowledged as a migraine

headache trigger by every headache clinic in this

country. In 1991, Alfred Scopp published a study

entitled " Monosodium glutamate and hydrolyzed

vegetable protein induced headache: review and case

studies " (Scopp, 1991). But neither Scopp's study nor

the subject of migraine headache are discussed in the

August 31, 1995 FASEB report (FASEB, 1995).

 

J. Samuels and I have criticized the 1995

" independent " FASEB study for responding to just those

questions posed by the FDA, and ignoring all others;

for conflicts of interests of Expert Panel members;

for failing to consider all data relevant to the

safety/toxicity of monosodium glutamate; for

dismissing, or attempting to dismiss, data that did

not fit well with a conclusion that monosodium

glutamate is safe; for rejecting the FDA's September,

1994 final draft report of FASEB's allegedly

independent investigation; for sharing the contents of

that September, 1994 final draft report with agents of

the glutamate industry--but no one else; and for

making the final FASEB report available to glutamate

industry agents--but to no one else--prior to

distribution.

 

The FDA claims that the FASEB September, 1994 draft

final report was seen by no one outside of the FDA and

FASEB. My requests to FASEB, to Hattan, and to Freedom

of Information for copies of the report have been

ignored, i.e., not even a written statement denying my

request has been forthcoming. But when I spoke to

Borzelleca in September, 1994 about the

inappropriateness of keeping my letter to the editor

of Food and Chemical Toxicology from being published,

he told me that he had seen a copy of the September,

1994 FASEB draft final report. (This was discussed

more fully under " Suppression of Information. " )

 

For years, the FDA has had clear evidence that

monosodium glutamate causes brain lesions and

neuroendocrine disorders in laboratory animals, and

adverse reactions in humans. Moreover, FASEB, in its

1995 report to the FDA, acknowledged that it was

inappropriate to use aspartame in placebos used in

double-blind studies of the safety of MSG (FASEB,

1995) and the FDA did not dispute FASEB's conclusion.

However, the FDA still allows the unregulated use of

MSG in processed food, basing its approval on the

flawed aspartame-in-the-placebo studies; and refuses

even to require that when present in food, its

presence be disclosed.

 

The FDA allows a meaningless distinction to be made

between the processed free glutamic acid in the

ingredient called " monosodium glutamate " and the

processed free glutamic acid in " other hydrolyzed

proteins " (Federal Register, 1977). They allowed the

words " No added MSG " or " No MSG added " to be used on

labels of food that contain MSG (a practice, they say,

is no longer sanctioned). They allow the term

" natural " to be used in reference to excitatory amino

acids. (The FDA definition of " natural " is any product

that has its original source in nature.) The FDA

allows the glutamate industry to create and use

sources of MSG that contain carcinogens (mono and

dichloro propanols or heterocyclic amines). The FDA

tells people that the free glutamic acid in processed

food is identical to the free glutamic acid found in

unprocessed food and in higher organisms. In all this,

the FDA parrots the words of The Glutamate Association

and the IGTC.

 

The FDA sends out, unsolicited, copies of their

bulletins informing physicians and food service

providers that MSG is not a potential health hazard;

but they won't tell consumers in which ingredients MSG

is hidden.

 

- The National Institutes of Health (NIH)

 

Ties between the NIH and the glutamate industry are

not immediately obvious. Review of the literature,

however, will demonstrate that the NIH has funded some

of the industry-sponsored studies designed to

demonstrate that MSG is safe for use in food

(Fernstrom, 1996; Goldschmiedt, 1990), and has done

limited MSG research of its own (Germano et al.,

1991). Review of statements made to the media in

support of the safety of MSG will further demonstrate

that Metcalfe, of the National Institute of Allergy

and Infectious Diseases, has spoken out on the safety

of MSG ( Neergaard, 1994).

 

On May 4-5, 1998, the NIH hosted a conference designed

to explore the evidence that the glutamate cascade

appears to be associated with several seemingly

diverse disease processes of the central nervous

system. According to the conference brochure " ...the

‘glutamate cascade' appears to be associated

with...addiction, stroke, epilepsy, degenerative

disorders, brain trauma, neuropathic pain,

schizophrenia, anxiety, and depression. " The only

reference to the role that exogenous free glutamic

acid might play came from a member of the audience.

 

- The U.S. Environmental Protection Agency (EPA)

 

The EPA has only recently become involved with the

issue of the safety/toxicity of MSG.

 

In July of 1998, with time on my hands, I determined

to teach myself how to do a keyword search of the

Federal Register. The details of my labors are

irrelevant, except to say that when I plugged in the

key word " glutamate, " I discovered that on January 7,

1998, the EPA had approve spraying processed free

glutamic acid, used in plant " growth enhancers, " on

all agricultural products (Federal Register, 1998).

 

Application to register AuxiGro, the first

MSG-containing product to seek registration, had been

published in the August 8, 1997 Federal Register

(Federal Register, 1997a). Knowing that the product

was being offered for sale, I called the EPA pesticide

registration department to ask if and when that

registration had been granted; and was informed that

there was no such product on their computer. Having in

hand the EPA registration number being used by the

manufacturer, I insisted that the product had been

registered. It was finally determined that AuxiGro had

been registered on January 14, 1998. But people still

call to inform me that they have called the EPA and

been told that no such thing as AuxiGro has been

registered; and I have not yet seen notice of the

registration published in the Federal Register.

 

On July 14, 1998, J. Samuels wrote to the EPA Freedom

of Information office (FOI) to request background

material on the approval of glutamic acid spray on

agricultural products. The FOI responded in a timely

fashion that they could provide no information at this

time, because the product had not yet been registered.

When I supplied FOI with the product registration

number, I was told that as soon as the file had been

purged for proprietary information, it would be sent

to J. Samuels. But first it had to be retrieved from

the office of Edward Allen, who had borrowed it. I was

told there was no other copy than that which had been

taken by Mr. Allen. On August 26, 1998 I called FOI to

determine the status of J. Samuels' FOI request. On

August 28, 1998, I called and left a message for

Frances Mann and later called, again; at which time

Ms. Mann of the FOI office told me she was putting the

Request for Registration into the mail. When I pointed

out that I had requested the Administrative File, not

the Request for Registration, she said she would look

into it and get back to me.

 

On July 13, 1998, J. Samuels wrote to the EPA,

alerting the EPA to the fact that a grievous error had

been made in approving the use of a neurotoxic amino

acid in a spray for use on food. Initial

correspondence with the EPA was directed to Lynn

Goldman, M.D., Assistant Administrator for Prevention,

Pesticides, and Toxic Substances, with a follow-up

conversation with her assistant, Douglas Parsons.

 

Subsequently, a phone call was received from Edward

Allen (Regulatory Action Leader, Biopesticides and

Pollution Prevention Division (BPPD), Office of

Pesticide Programs, EPA; Roy Sjoblad, Ph.D., Branch

Chief, Biochemical Branch; and Freshteh Tothrol,

Ph.D., (the scientist who reviewed the Auxein

applications); who called to assure J. Samuels that

the research relating to Auxein's submission had been

thoroughly reviewed, and that the product posed no

risk to humans. In response to J. Samuels'

protestations that the literature clearly indicated

that ingestion or other use of free glutamic acid

placed both humans and wildlife at risk, Dr. Sjoblad,

told J. Samuels that

 

" We're simply asking you to support the claims you

made that. You can do that. You have these claims.

We're not aware of it. It's your responsibility... "

 

By e-mail, J. Samuels immediately submitted 75

references sufficient to demonstrate that ingestion of

free glutamic acid places consumers at risk; and

followed that, on July 29, with approximately 500

additional citations and abstracts. A more recent

letter contained additional information.

 

Subsequently, J. Samuels received an e-mail from Janet

Andersen, Ph.D., Division Director, BPPD, addressed,

evidently, to all those who had written to the EPA by

that time (J. Andersen (personal communication, July

27, 1998). The short letter contained basic

misinformation and misquoted J. Samuels. That letter

read, in part,

 

" The glutamic acid EPA has approved is 99.3% pure

(pharmaceutical grade) L-glutamic acid and is NOT MSG

(monosodium glutamate). The Auxein Corporation product

contains L-glutamic acid and gamma aminobutyric acid.

The product does not contain MSG; EPA is aware of the

potential for allergic reactions to MSG. "

 

As this is written, I have questions, but no answers,

about the activities of the EPA. From the Auxein

Corporation's request for glutamic acid: pesticide

tolerance exemption, and publication of the Final Rule

granting that exemption, I know that either Auxein

Corporation did not comply with the requirements of

the Federal Food, Drug and Cosmetic Act (FFDCA) when

making its application, or the EPA failed to publish

all of Auxein Corporation's submission when it

published the request for exemption and the Final

Rule. That fact has been pointed out to the EPA.

 

I also know, and the EPA has received material,

including citations and abstracts of studies that

contain the information that: 1) pharmaceutical grade

L-glutamic acid was used to destroy retinas, kill

brain cells, and cause neuroendocrine disorders before

neuroscientists realized that they could accomplish

the same effect using an inexpensive food additive

called monosodium glutamate; 2) food additive

monosodium glutamate, by FDA definition, must contain

78 percent free L-glutamic acid and 21 per cent

sodium; and 3) it is the free glutamic acid that

occurs as a consequence of manufacture that causes

adverse reactions, regardless of the name of the

ingredient or product that contains it.

 

But I do not know why the EPA has ignored the fact

that Auxein Corporation violated the FFDCA, has

ignored the hard science that says that the free

glutamic acid in the Auxein Corporation product has

toxic potential, and has said that J. Samuels said " In

an email message to EPA on July 23rd, Mr. Samuels has

indicated he is not concerned about L-glutamic acid, "

when J. Samuels never did, and never would, make such

a statement. Neither do I know why Andersen responded

to a letter from J. Samuels with the answer to one of

his many question while ignoring all of the others.

 

In a letter to J. Samuels dated August 21, 1998,

Andersen made the following statements:

 

1) " There is no scientific evidence that oral

consumption of L-glutamic acid normally found in

plants and animal proteins causes adverse effects. "

 

The statement is true. It is not the L-glutamic

acid normally found in plants and animal proteins that

causes brain lesions, neuroendocrine disorders,

learning disabilities, and adverse reactions; it is

processed free glutamic acid (which consumers refer to

as MSG)–the type of glutamic acid found in

AuxiGro–that causes those disease conditions.

 

2) " We have reviewed the scientific studies you

sent us showing adverse effects of L-glutamic acid

resulting from either direct injection or high-volume

force feeding to rodents. None of this data is

relevant to the effects of oral ingestion by humans. "

 

Andersen did not respond to the fact that J.

Samuels also sent the EPA feeding studies that

demonstrated that free glutamic acid caused adverse

reactions both in laboratory animals and in humans.

 

3) " Prior to registering ‘AuxiGro,' the

Biopesticides and Pollution Prevention Division (BPPD)

in OPP performed a risk characterization on L-glutamic

acid as mandated by the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA), and Federal

Food, Drug, and Cosmetic Act (FFDCA) as amended by the

Food Quality protection Act (FQPA). "

 

Both the references provided to me by the EPA and

the statements made in publication of the Final Rule,

demonstrate that the EPA has violated Sections 408

(b)(2)(D), 408©(2)(A)(i), and 408©(2)(B) of the

Federal Food, Drug and Cosmetic Act, and ignored

Executive Order 13045 entitled Protection of Children

from Environmental Health Risks and Safety Risks (62FR

19885, April 23, 1997). Andersen did not address that

issue.

 

According to Section 408 (b)(2)(D) of the Federal

Food, Drug and Cosmetic Act, it is the responsibility

of the EPA to review the scientific data and other

relevant information in support of any action to be

taken, and consider its validity, completeness,

reliability, and relationship to human risk

 

According to Section 408 ©(2)(A)(i) of the

Federal Food, Drug and Cosmetic Act, the EPA is

allowed to establish an exemption from the requirement

of a tolerance (the legal limit for a pesticide

chemical residue in or on food) only if there is a

reasonable certainty that no harm will result from

aggregate exposure to the pesticide chemical residue,

including all anticipated dietary exposures and all

other exposures for which there is reliable

information. This includes exposure through drinking

water.

 

According to Section 408 © (2) (B) of the

Federal Food, Drug and Cosmetic Act, in considering an

exemption from the requirement of a tolerance, EPA is

required to give special consideration to exposure of

infants and children.

 

According to Executive Order 13045 entitled

Protection of Children from Environmental Health Risks

and Safety Risks, " ...each Federal agency: (a) shall

make it a high priority to identify and assess

environmental health risks and safety risks that may

disproportionately affect children. "

 

Approval of the use of free glutamic acid in a

spray to be used on agricultural products was based,

in part, on 14 toxicological studies published in 1979

or before, either found or referenced in one book

published in 1979 on behalf of The Glutamate

Association, (Filer, 1997) with no reference to the

fact that those studies have long since been refuted,

and no consideration of the fact that glutamic acid is

a neurotransmitter and a neurotoxin known to cause

endocrine disorders later in life when ingested by the

young. There were no other toxicological studies from

the literature considered.

 

4) " The amount of L-glutamic acid in the pesticide

product ‘AuxiGro,' when used according to the label

instructions, results in a final application rate of

0.125 to .75 pounds of product or 0.04 to 0.25 pounds

(0.64 to 4 oz) per acre. In addition, the L-glutamic

acid is applied three to four weeks prior to harvest.

Virtually no residues of L-glutamic acid will remain

on the crops at the time of harvest. "

 

Andersen uses the word " virtually. " I wonder how

she knows. The EPA Final Rule establishing a temporary

exemption from the requirement of a tolerance for

residues of glutamic acid (Federal Register, 1997b),

reads, in part, " ...because this amino acid is found

naturally in plants, the Agency has determined that

residue analysis would not yield meaningful results,

i.e., the analysis would not discern whether the

glutamic acid source was the plant or the product

treatment. " No claim is made that there will be no

residue. The Final Rule goes on to say, " Residues

remaining in or on the raw agricultural commodity

after this expiration date will not be considered

actionable... " Andersen seems to know something that

those who wrote the Final Rule didn't know. Those who

wrote the Final Rule establishing a temporary

exemption from the requirement of a tolerance for

residues of glutamic acid spoke of " residues

remaining. "

 

 

 

4. Summary and Conclusions

 

This paper has described how one giant industry has

selectively collected and reported research data in a

way that presents its product, monosodium glutamate,

in a favorable fashion.

 

The technique has three basic components. First, there

is research that claims to have demonstrated that

their product is safe. Procedures used to develop the

research, and/or the statistics used to evaluate its

results, produce data that will allow researchers to

conclude that their product is safe. Few will notice

if between abstract and conclusion, in that wasteland

of ponderous detail and scientific terminology read

only by the most concerned and conscientious

scientists, a program of deception has been executed.

 

Second, there is suppression of information. When

contradictory or embarrassing information has been

published, those in positions of power block

dissemination of that published information. When

critiques of deceptive and misleading research reports

are offered for publication, those in positions of

power refuse to publish the critiques. When, prior to

publication, critiques of deceptive and misleading

research reports are anticipated, researchers publish

their questionable research in journals that do not

accept comment following publication; present their

findings orally at industry-sponsored or professional

meetings; or publish their findings in abstract form,

only. Neither oral presentations nor published

abstracts are subject to peer review or to published

criticism. In no case is it immediately obvious that

either data or criticism of data have been suppressed.

 

Other subtle ways to suppress information involve

drawing attention away from the truth, and focusing,

instead, on the trivial or untrue. Critics are

disparaged or made the subject of jokes. (Critics

don't report adverse reactions, they " complain. " )

Irrelevant information is given in response to serious

questions about the safety of a product. ( " If you eat

too much of anything you'll get sick. " ) Falsehoods are

recited by alleged authorities. ( " A blood-brain

barrier prevents amino acids that you eat from

entering the brain. " )

 

Existing data may be distorted or trivialized. Every

report of human suffering is labeled an anecdote and

dismissed. Research misconduct, if detected, is

excused as error of judgement or sloppy research.

Suppression of information, in all of its many forms,

is ignored. And those in positions of power to do

otherwise, ignore the fact that quantities of badly

flawed research and repeated instances of direct

suppression of information have contributed to the

acceptance of this product. That which has been

portrayed here is a system wherein data and other

information can be suppressed without accountability.

 

The third component is the industry's success in

convincing those elected or appointed to attend to the

welfare of the nation to follow the industry's lead in

finding this product to be safe. The FDA, the NIH, and

the EPA are the agencies that have been singled out

for attention here. But the Department of Agriculture

is equally culpable, approving labels of products that

say " No MSG, " or " No Added MSG, " for example, when

those products contain MSG in any ingredient except

the one called monosodium glutamate. Even the FDA

states that such practice is illegal.

 

This paper has described how Ajinomoto, its corporate

friends, and its many agents have convinced others to

purchase their product; and have made false

representations of matters of fact, by words and by

conduct, and by concealment of that which should have

been disclosed.

 

The information presented in this paper is factual.

The interpretation is my own. But anyone who takes the

time to review the facts with detachment and without

the bias of special interests will come to the same

conclusions I do. The key to having the system work

for those who use it to deceive others is the fact

that few, if any, will take the time to review the

facts with detachment and without prejudice; and

whistle-blowers are punished.

 

Go to Table 1

Go to Appendices

Go to References