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Meet the people who get the job done so effectively

In the United States, the glutamate industry has two arms. Both work to keep MSG hidden in food. One is the International Hydrolyzed Protein Council, which counts as members those who profit from the sale of hydrolyzed protein products (which all contain MSG.). Members include, or at one time included, Ajinomoto USA, Inc.; Arancia Ingredients Especiales, S.A. De C.V.; Basic Food Flavors, Inc.; Campbell Soup Company; Champlain Industries, Inc.; CPC International, Inc.; Deltown Specialties; Fidco, Inc.; Establissements Bio-Springer; Gist-Brocades Food Ingredients, Inc.; Griffith Laboratories; Haco Ltd.; Integrated Ingredients; Francereco S.A.; Quest International; A.E. Staley Manufacturing Co.; Sugemesa; Takeda U.S.A., Inc.; Red Star Specialty Products; and Provesta Corporation.

The second and more active arm is spearheaded by Ajinomoto’s International Glutamate Technical Committee (IGTC) and its American subsidiary, The Glutamate Association (TGA), with representative organizations throughout the world. On February 2, 2003, the Web page of the International Glutamate Information Service (IGIS) stated that:

"The International Glutamate Information Service (IGIS) provides accurate information about glutamate. IGIS bases its information on the extensive body of scientific evidence which confirms the safety and the benefits of this widely used food ingredient."

IGIS is supported by the following organizations:

Australian Glutamate Information Service
Comité des Fabricants d'Acide Glutamique (Europe)
Institute for Glutamate Sciences in South America
Southeast Asian Association of Glutamate Sciences
The
Glutamate Association (United States)
Taiwan MSG Manufacturers Association
Umami Manufacturers Association of Japan

 

Copies of IGTC letterhead received some years ago also named the Korea Association of MSG Technology as an industry supporter.

 

Structure of Ajinomoto’s 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.

 

Structure of their organization: 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 asked to remain anonymous, told us that besides Ajinomoto, Archer Daniels Midland, Campbell, Corn Products Corporation, McCormick & Company, Pet Foods, Pfizer Laboratories, and Takeda were among its members; and Nestle was a former member.

Researchers


Once established, the IGTC assembled a cadre of scientists who conducted research for them and/or spoke publicly about the safety of MSG.  The names of Altman, Anantharaman, Auer, Bunyan, Ebert, Fernstrom, Filer, Garattini, Geha, Germano, Giacometti, Goldschmiedt, Heywood, Iwata, Kenney, Kerr, Matsuzawa, Morselli, Newman, Owen, Pulce, Reynolds, Schiffman, Stegink, Stevenson, Taksaski, Tarasoff, and Yang appeared prominently (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.

 

TABLE 1

SPONSORSHIP OF SELECTED SCIENTISTS WHO HAVE CONDUCTED RESEARCH AND/OR SPOKEN PUBLICLY ABOUT THE SAFETY OF MSG

Researchers ......................................................................................Sponsors

 Altman, D.R., Fitzgerald, T. & Chiaramonte, L.T (1994)

 IGTC

 Anantharaman, K. (1979).

 Nestle

 Bunyan, J., Murrell, E.A., and Shah, P.P. (1976)

 Huntingdon Research Centre

 Ebert, A.G. (1970)

 IGTC

 Fernstrom, J.D., Cameron, J.L., Fernstrom, M.H., McConaha, C., Weltzin, T.E., and Kaye, W.H. (1996)

 IGTC; NIH

 Geha, R. Saxon, A. and Patterson, R. (1998)

IGTC 

 Germano, P., Cohen, S.G., Hahn, B., and Metcalfe, D.D. (1991)

 NIH

 Giacometti, T. (1979)

 Nestle; IGTC

 Goldschmiedt, M., Redfern, J.S., and Feldman, M. (1990)

 Ajinomoto; NIH; International Life Science Institute-Nutrition Foundation (ILSI)

 Heywood, R., James, R.W., and Worden, A.N. (1977)

 Huntingdon Research Centre

 Iwata, S., Ichimura, M., Matsuzawa, Y., Takasaki, Y., and Sasaoka, M. (1979)

 Ajinomoto

 Kenney, R.A. (1979)

 IGTC

 Kerr, G.R., Wu-Lee, M., El-Lozy, M., McGandy, R., and Stare, F.J. (1979) Ajinomoto U.S.A.

Ajinomoto U.S.A. 

 Kirby, D. (unpublished)

 IGTC

 Matsuzawa, Y., Yonetani, S., Takasaki, Y., Iwata, S., and Sekine, S. (1979)

 Ajinomoto

 Morselli, P., and Garattini, S. (1970)

 COFAG (IGTC Europe)

 Newman, A.J., Heywood, R., Palmer, A.K., Barry, D.H., 
Edwards, F.P., and Worden, A.N. (1973)

 Huntingdon Research Centre

 Owen, G., Cherry, C.P., Prentice, D.E., and Worden, A.N. (1978)

 Huntingdon Research Centre

 Reynolds, W.A., Lemkey-Johnston, N., Filer, L.J. Jr., and Pitkin, R.M. (1971)

 Gerber; International Minerals and Chemical Corp. (IMC)

 Schiffman, S.S. (1991)

International Food Information Council (IFIC) 

 Stegink, L.D., Reynolds, W.A., Filer, L.J. Jr., Pitkin, R.M., Boaz, D.P., and Brummel, M.C. (1975)

 Gerber; IMC

 Stevenson, D.D., Simon, R.A., and Woessner, K.M. (1997)

 IGTC

 Takasaki, Y., Matsuzawa, Y., Iwata, S., O'Hara, Y., Yonetani, S., and Ichimura, M. (1979)

 Ajinomoto

 Takasaki, Y, Sekine, S., Matsuzawa, Y., Iwata, S., and Sasaoka, M. (1979)

 Ajinomoto

 Tarasoff, L and Kelly, M.F. (1993)

 IGTC

 Yang, W.H., Drouin, M.A., Herbert, M., and Mao, Y. (1997)

 IGTC

 

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 their book, Food Allergy: Adverse Reactions to Foods and Food Additives (Metcalfe, Sampson, and Simon, 1991). In a letter to George R. Schwartz, M.D., Allen wrote, "Last week my friend Ron Simon from the Scripps Clinic called me and asked me to participate in a symposium at the American Academy of Allergy meeting in San Francisco in March of next year. I will be speaking on sulphites and MSG and their potential to provoke asthma" (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) (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 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 IGTC (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 the ostensibly confidential report 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 we 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 American Academy of Asthma, Allergy, and Immunology (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. (Stevenson 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, 1994 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.

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 us 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."

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.  Among them are the American College of Allergy and Immunology, Institute of Food Technologists, McNutt, Schmitz, Taliferro, Tufts University Diet and Nutrition Letter, University of California at Berkeley Wellness Letter, Wood (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, including the American Academy of Allergy and Immunology (American Academy of Allergy and Immunology, 1993); the FDA in cooperation with IFIC (FDA in cooperation with IFIC, 1992); and Scripps Clinic and Research Foundation (Scripps Clinic and Research Foundation, 1995) 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.  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. IGTC 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 has spoken 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 reviewed journals that publish their badly flawed studies. We make the argument that published glutamate-industry sponsored studies are badly flawed. If that is the case, then their publication in peer reviewed journals is difficult to justify. Consider, however, that if the peers who review the work of glutamate-industry representatives are themselves glutamate-industry representatives, or very close friends, the work of glutamate industry representatives may very well be published. Consider, also, that journals such as the Journal of Allergy and Clinical Immunology take advertising, and journals such as The American Journal of Clinical Nutrition acknowledge the generous support of members of the food and/or drug industries. Both of those journals publish glutamate-industry sponsored studies.

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.

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 in 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. In 1990, FDA practice included distributing unsolicited copies of an FDA Medical Bulletin that assured 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).

The Food and Drug Administration (FDA)      

The FDA makes and enforces food labeling laws, and determines whether or not MSG, or any other chemical, will be approved for use in food.

Evidence of close cooperation between the FDA and the glutamate industry 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 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, FDA Commissioner Kessler was asked 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."

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).

The 1995 "independent" FASEB study has been criticized 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; and for sharing the contents of that September, 1994 final draft report with agents of the glutamate industry--but no one else.

The FDA claims that the FASEB September, 1994 draft final report was seen by no one outside of the FDA and FASEB. Our requests to FASEB, to Hattan, and to Freedom of Information for copies of the report have been ignored, i.e., not even written statements denying our requests have been forthcoming. But in September, 1994, Borzelleca, editor of Food and Chemical Toxicology, commented publically that he had seen a copy of the September, 1994 FASEB draft final report.

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 have said, 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.

    

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