You Have the Right to Know What is in Your Food An Introduction to Citizen Petition #94P-0444 Subsequent Legal Action and The Truth in Labeling Campaign September 15, 1995 P.O. Box 2532, Darien, IL 60561 Why a Petition? Because the FDA has been unwilling to evaluate the toxic potential of monosodium glutamate (MSG) objectively, and provide honest information about the substance, a Citizen Petition in the Matter of PROPOSED REMEDIAL REGULATIONS REGARDING MONOSODIUM GLUTAMATE has been filed with the FDA. The Citizen Petition was filed because: - Labeling of MSG would make diagnosis of possible MSG- sensitivity easier. Millions of Americans perceive that after eating glutamic acid that occurs in food as a consequence of manufacture (MSG), they experience adverse reactions ranging from simple skin rash, sweating, and lethargy to hyperactivity and attention deficit disorders in children, and severe depression, irregular heartbeat, asthma, and seizures. Many of these people have observed that these symptoms occur regularly when they ingest MSG, but when they avoid MSG, the reactions fail to occur, or occur less frequently. But because MSG is not clearly identified on product labels, it is extremely difficult for a person to confirm or discount MSG as the cause of his reactions. Labeling would make diagnosis of MSG-sensitivity easier. - Millions of Americans are sensitive to MSG. It is estimated by people outside of the glutamate industry that at least 25 per cent of the population is sensitive to MSG at levels readily available today in food. - MSG that we eat may cause or exacerbate neurodegenerative disease. We know that elevated levels of glutamate in the brain are associated with neurodegenerative disease such as ALS, Parkinson's disease, and Alzheimer's disease. We also know that the blood-brain barrier, once thought to protect the brain from unregulated flow of MSG, is damaged by conditions such as trauma to the head, stroke, diabetes, hypoglycemia, and aging. One must consider, therefore, that the MSG we eat might cause or exacerbate neurodegenerative disease. The New England Journal of Medicine found this notion to be of sufficient merit to publish a Letter to the Editor on July 28, 1994 suggesting that "It is time to address the possibility that ingestion of neurotoxic amino acids may both cause and exacerbate pathologic conditions associated with endogenous neurotoxic amino acids." - The FDA has built its case for the "safety" of MSG on misleading and deceptive studies sponsored by the glutamate industry. FDA regulations require that those who manufacture MSG must provide evidence demonstrating that it is "safe." The glutamate industry has, indeed, pretended to provide "evidence" on the safety of MSG; but they have falsified data, not by changing test scores or research results, but by rigging the procedures used in conducting the studies so that under no circumstances would MSG be found to be unsafe. Glutamate industry studies are generally methodologically inadequate, statistically unsound, and/or irrelevant to the safety/ toxicity of MSG. Researchers have gone so far as to use aspartame and/or MSG in placebos to cause subjects to respond to placebos just as they would respond to MSG. In addition, conclusions have sometimes been drawn that do not follow from the results of the studies. - The FDA has summarily dismissed much of the research that clearly demonstrates that MSG places humans at risk. Reports of adverse reactions to MSG collected by its own Adverse Reactions Monitoring System have been dismissed because they could have been caused by something else. - The FDA has suppressed results of a study that found MSG in supplements to be unsafe. In July, 1992, FASEB concluded a study of the safety of amino acids used in dietary supplements. In the report presented to the FDA, FASEB concluded that: "...it is prudent to avoid the use of dietary supplements of L-glutamic acid by pregnant women, infants, and children.... and...by women of childbearing age and individuals with affective disorders." (MSG is called glutamic acid when used in supplements.) - The FDA has distorted results of its own research to serve the propaganda needs of the glutamate industry. In a 1995 study, D.H. Daniels, F. L. Joe, Jr. and G.W. Diachenko reported, as fact, data that came from their own potentially unreliable procedures, and misrepresented the research of others. - The FDA has refused to recall foods advertised as "No MSG Added" even though those foods declare hydrolyzed proteins on their labels - a direct violation of Section 403 (a) (1) of the Federal Food, Drug, and Cosmetic Act. - The United States Department of Agriculture endorses labels that advertise "No MSG Added" even though the labels declare hydrolyzed proteins in their ingredient panels - a direct violation of Section 403 (a) (1) of the Federal Food, Drug, and Cosmetic Act. - Historically, every time complaints about MSG toxicity intensified, the FDA called for an "independent" review of the safety of MSG and thereby stalled addressing the issue. Historically, the FDA has contracted with groups that provided consultants with strong ties to the glutamate industry and/or structured the "independent" review to rely primarily on industry sponsored data. Legislators who inquire about the safety of MSG are told that the issue is being studied. Manufacturers who inquire are told that there is a study being done, but that "If the outcome of the review raises substantive questions about the safety of MSG, FDA will require industry to conduct studies to resolve the questions,"1 or "FDA won't be bound by its conclusions."2 - Most recently (1992), the FDA contracted with FASEB to do an "independent" review of the safety of MSG in food. Every aspect of that study has been marked by lack of objectivity and FDA/FASEB pro-industry bias. For example, in their Request for Proposal, the FDA asked questions that could not be answered; FASEB selected at least four Expert Panel members with ties to the glutamate industry (conflicts of interest); FASEB tried to eliminate relevant non-industry data from consideration; and when a draft of the FASEB final report was finally submitted to the FDA in September, 1994, that report was leaked to the glutamate industry. Release of the final report was initially delayed a month or two at a time beyond its March, 1994 target date. Finally, when the draft final report was submitted to the FDA in September, 1994, the FDA rejected it, claiming that it needed "clarification." Circumstances surrounding the FDA's rejection of the draft final report and the unanticipated resignation of the FASEB project director following that rejection, suggested that the initial delays had not accomplished their purpose: that even Expert Panel members with ties to the glutamate industry could not (or would not) state that MSG is "safe;" and/or that glutamate industry researchers needed time to complete ongoing double- blind studies on the safety of MSG sponsored by the International Glutamate Technical Committee that would be used to convince the Expert Panel of the safety of MSG. Text of the new FDA/FASEB contract (February 1, 1995) to provide "clarification," tended to confirm the suggestion that evidence of MSG toxicity was so overwhelming that FASEB could not deny it, and neither could the FDA. It might even be that questions we have asked of researchers conducting double-blind studies for the IGTC have made them cautious: possibly made them unwilling to expose themselves to almost certain criticism for poor methodology. That could explain why the objective of the new contract appeared to be to provide the FDA with data they could use for refusing to identify all MSG. Specifically, the FDA asked FASEB to review data relevant to possible limitations on the use of glutamates, recommendation of special labeling requirements, and/or recommended levels of use of glutamates. That, in turn, could explain why the FDA, in the Background Section of its contract, inferred that MSG-sensitive people will not react to doses of MSG below 3 grams, and that the existing conditions of asthmatics will not "worsen" with doses less than 2.5 grams -- both inferences coming from their distortion of data -- and directed FASEB to draw conclusions based on that distorted data. Evidence suggests that the new FDA/FASEB contract was entered into in order to justify the FDA's refusal to require that all MSG in processed food be labeled. - The FDA's rejection of the FASEB September, 1994 draft final report on the safety of MSG in food was not without precedent. When a Federation of American Societies for Experimental Biology (FASEB) committee submitted its evaluation of the safety of MSG to the FDA in July, 1978, the FDA returned the report "for updating in light of new information on these substances presented at an international symposium in May, 1978." The symposium in question was sponsored by the glutamate industry, and, with rare exception, the research reported was sponsored by them, too. - The glutamate industry has in place a most aggressive and insidiously deceptive campaign to deceive the public into believing that MSG is safe. The International Glutamate Technical Committee (IGTC) structures and supervises research designed to demonstrate that MSG is safe. They have successfully persuaded the Medical College of Virginia, Harvard University, Northwestern University, U.C.L.A., The University of Ottawa, Canada, and the University of Western Sydney, Australia, to conduct studies using their methodologically flawed protocols and placebo materials (now somewhat changed since being exposed). They have, for many years, supported the work of L. J. Filer, Jr., M.D. Ph.D., Lewis D. Stegink, Ph.D. and others at the University of Iowa. Promotion of propaganda is accomplished through The Glutamate Association, the IGTC, the International Life Sciences Institute, and the International Food Information Council (IFIC), if not others. IFIC prides itself on its public relations connections to well placed media representatives. IFIC has developed brochures addressing the subjects of food additives, food allergy in general, and the safety of MSG with, or without the seal of approval of the American Academy of Family Physicians Foundation, the American Academy of Allergy and Immunology, and the FDA. The Mayo Clinic Nutrition Letter (a vehicle of the Mayo Foundation for Medical Education and Research), the University of California, Berkeley Wellness Letter, the American Association of Retired People (AARP), the American Dietetic Association, most with foundations that accept contributions from supporters, have worked closely with IFIC on a variety of projects, and/or have published glutamate industry generated materials directly, or have published accounts of the safety of MSG. Pressure applied to the media by advertisers in the food industry to limit discussion of the toxic effects of MSG has been successful. Whereas there was balanced discussion of MSG safety/toxicity in the Wall Street Journal, the Washington Post, the New York Times etc. prior to the airing of a "60 Minutes" segment on MSG in late 1991; only a few objective discussions of the problem have aired in major media in the last three and a half years. - Influence of the glutamate industry appears to extend to the "peer review" journals in which their articles are published. Some journals are supported, in part, by manufacturers and/or users of MSG. Others are staffed with editors and/or referees with close ties to the glutamate industry. Three such journals recently refused to accept Letters to the Editor that were critical of glutamate industry sponsored studies that they had published. - Individual scientists and medical schools have also benefitted from the generosity of glutamate industry. Research grants are common, and funding for attendance at conferences or trips to the orient to view glutamate production facilities are not unknown. - At this time, there are no regulations pertaining to the labeling of MSG scheduled for consideration. On January 6, 1993, regulations pertaining to the labeling of MSG were proposed in the Federal Register. Because the regulations proposed would not identify MSG whenever and wherever it occurred in food, they would have no positive value. In fact, by pretending that MSG was labeled when it was not, implementation of such regulations would actually do harm. Neither these inadequate proposed regulations, nor any other regulations, are scheduled for consideration. The Petition On December 13, 1994, a Citizen Petition was filed with the U.S. Department of Health and Human Services, Food and Drug Administration to require that Monosodium Glutamate (MSG) be clearly labeled when used in food. The Petition was filed by Dilling and Dilling, Chicago, Illinois, Attorneys for the Petitioners. It was petitioned that manufactured free glutamic acid present in end products of all manufactured or processed foods be clearly labeled as free glutamic acid, identifying it as "MSG." It was further petitioned that the amount of free glutamic acid or MSG in such products be specified in grams, expressed to the third decimal place, and that any subject food label should bear an appropriate cautionary statement. The purpose of the proposed MSG cautionary communication on food labels is to render a specific MSG caution to those groups which were identified in the FDA's own scientific report to be most at risk from MSG. That report on the safety of amino acids in dietary supplements, done by the Federation of American Societies for Experimental Biology (FASEB) for the FDA, was completed in July, 1992. MSG in its pure form has never been determined to be safe in any FDA proceeding. Its commercial use is permitted only due to its marketing before the 1958 Food Additive Amendments to the Food, Drug and Cosmetic Act, which in effect "grandfathered" hundreds of substances which had never been tested for safety, including MSG. Other hydrolyzed protein products that contain mixtures of amino acids, including glutamic acid (MSG), as a constituent, have been marketed on the basis of self-determination of GRAS. Petitioners include individuals with debilitating, even life- threatening sensitivities to monosodium glutamate (MSG). Examples of adverse MSG reactions experienced by petitioners include an 8-year old who has suffered for 4 years with migraines and seizures; a 12-year old who suffers vomiting, fever, and severe headache; a 7-year old who suffers asthma and anaphylactic shock; a physician who suffers ventricular arrhythmias and life threatening ventricular tachycardia; a physician who suffers tingling and itching in mouth, face, ears and scalp, followed by angioedema and hypovolemic shock; and a woman in her early 30's who suffers headaches, decreased ability to concentrate, and has experienced premature labor following ingestion of MSG. The grounds of this Petition are very simple, namely that MSG-sensitive consumers, numbering many millions, who presently have no full disclosure of the toxic MSG they are getting in their foods, shall have remedial full MSG disclosure, and that groups considered by FDA to be most at MSG risk receive appropriate cautionary information. The FDA failed to respond to the petition, as required by law, within 180 days of filing. On August 29, 1995, 29 individuals, including physicians, scientists, and parents on behalf of their children, filed suit in Federal Court asking the court to intercede on their behalf and require that all MSG in all processed food be labeled. The Truth in Labeling Campaign We have reviewed and critiqued the literature on MSG safety/ toxicity; are familiar with most of the "scientists" who promote the substance for the glutamate industry; have observed that the data on which the FDA, World Health Organization, and European Communities have based their contention that MSG is safe, is flawed to the point of being fraudulent; can cite instances of refusal by "peer review" journals to criticize industry-sponsored research; and can cite instances of wire services and individual newspapers issuing stories obviously prepared for them by the glutamate industry without giving balance to glutamate industry critics. We have monitored every step of the 1992-1995 FDA sponsored study on the safety of MSG in food, and have found no evidence that the FDA is acting on behalf of consumers. We are convinced that only through a grass roots effort can we resolve the problem of refusal to label MSG. To accomplish our goals, we filed the Citizen Petition. With that filing, we incorporated and launched the Truth in Labeling Campaign (TLC), an Illinois not for profit corporation. TLC's goals are simple. Awareness and involvement of individual consumers are priorities. If we could make all Americans aware of the potential hazards of MSG, and provide information on hidden sources of MSG to all consumers, their pressure would force the FDA to require full and honest labeling of MSG. Cost of developing and filing the petition was approximately $20,000. The law suit, filed August 29, 1995, will cost considerably more. Therefore, we have set as our first year goal an accumulation of $100,000 through contributions of one dollar or more from each of 100,000 people. We would have the money that we anticipate needing at this time, and we would have 100,000 people involved. We solicit the involvement of all people concerned with truth in labeling. Our number one priority is awareness -- disseminating information about our suit to label MSG -- because only through awareness and the pressure it will generate, can we expect change. TLC is an all volunteer organization, funded entirely through contributions. We are an all volunteer organization with no staff or directors who are paid and no professional fund raisers. Once our goal has been accomplished, any money not spent in support of the Citizen Petition and subsequent law suit will be used for research on the mechanisms underlying human sensitivity to MSG and/or the relationship between ingestion of MSG and precipitation of neurodegenerative disease such as ALS, Alzheimer's disease and Parkinson's disease. John W. Olney, M.D., the man responsible for getting manufacturers to take the MSG out of "baby food" in the 1970's, has agreed to serve as one or our research advisors. To contact the Truth in Labeling Campaign write: TLC P.O. Box 2532 Darien, IL 60561 A stamped, self-addressed envelope would be appreciated. _______________________________ 1Food Chemical News, April 20, 1992, page 41. 2The Wall Street Journal, February 25, 1993.