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Regulatory history

If the glutamate industry has its way, consumers will never know how much MSG there is in a given product.  If consumers were able to identify the amounts of MSG in the things they used, and the food they consumed, the fact that migraine headache, skin rash, or depression, for example, always followed use of MSG might become obvious.  And the glutamate industry wouldn’t like that at all.  The fact that there are no meaningful regulations pertaining to this neurotoxic, endocrine disrupting manufactured product intentionally added to processed food, testifies to the power of the glutamate industry.  The history related to regulation of MSG tells a very interesting story.

 

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) regulate the use of food, drugs, and cosmetics in the United States.  The FDA is responsible for the safety of most foods, while the USDA is responsible for the safety of meat, poultry, and egg products.  The USDA, unlike the FDA, requires that the labels of the foods that they regulate be approved by the USDA.

 

The FDA and USDA appear to work closely with the food and glutamate industries to make certain that processed free glutamic acid (MSG) is, and remains, hidden in products where it is used. In this endeavor, the FDA and USDA have been joined by the U.S. Environmental Protection Agency (EPA), the California Department of Food and Agriculture (CDFA), and the California Department of Pesticide Regulation (CDPR) – all of which appear to be working to assure the glutamate industry that MSG will also be used, and remain hidden, in fertilizers, plant growth enhancer, fungicides, and other pesticide products, used on growing crops.

In general, regulations pertaining to processed free glutamic acid (MSG) are simple and straightforward.  The FDA and USDA require that the names of ingredients used in processed foods be listed on the labels of those processed foods by their “common or usual names” -- names such as “monosodium glutamate”, “hydrolyzed soy protein”, and “yeast extract”.  However, according to the FDA, processed free glutamic acid (MSG) is a constituent of a food ingredient, not an ingredient in and of itself -- so there is no requirement that MSG in processed food be listed, or identified in any other way, on product labels.

The EPA, CDFA and the CDPR, in turn, have:

1) Chosen to ignore the flagrant violations of Sections 408 (c)(2)(A)(i) and 408 (c)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act committed by Emerald BioAgriculture (formerly known as Auxein Corporation) in its applications to the EPA, the CDFA, and the CDPR for approval of  use of processed free glutamic acid (MSG) in agricultural products to be sprayed on or otherwise applied as pesticides, fungicides, plant growth enhancers, and/or fertilizers to growing crops; and

2) Approved the use of processed free glutamic acid (MSG) with no restriction on the amount of processed free glutamic acid (MSG) that might be left in or on crops when brought to market.  

The history of regulation of MSG in food goes back to 1958 with passage of the Food Additives Amendments (Code of Federal Regulations, Title 21) wherein the GRAS (generally regarded as safe) list was established.  Prior to 1958, there had been little or no comment to the FDA on the food ingredient called "monosodium glutamate," so following passage of the Food Additives Amendments, "monosodium glutamate" was grandfathered as GRAS.  Grandfathered? Yes.  But tested for safety? No. The safety of "monosodium glutamate" was not then, and has never been, established.

Beginning in 1969, and every time thereafter that the safety of "monosodium glutamate" was challenged, industry designed and funded research to be carried out by persons hired to produce one or more studies that would persuade the public that "monosodium glutamate" is "safe," i.e., that "monosodium glutamate" deserves a place on the GRAS list.  We have found those studies to be individually flawed; and are of the opinion that taken as a whole, they are flawed to the point of being fraudulent.  The subject is discussed more fully on this Web sit under “Controversy”.

As this is written, GRAS status has not been awarded to "monosodium glutamate" by the FDA, but industry claims that "monosodium glutamate" is GRAS go unchallenged by the FDA.

Over the years, the FDA has changed its posture relative to the toxicity/safety of "monosodium glutamate."  While the Federal Food, Drug, and Cosmetic Act requires that manufacturers provide the FDA with proof that their products are "safe," the FDA is presently allowing manufacturers to tell the FDA that their products are "safe," and allowing manufacturers to claim that their products are GRAS unless consumers can prove, to the FDA's satisfaction, that their products are toxic.

Finally, it should be noted that the "monosodium glutamate” that was grandfathered GRAS in 1959 is not the same "monosodium glutamate" readily available today in the United States. The “monosodium glutamate” that was grandfathered GRAS in 1959 was made by extracting glutamic acid from protein rich sources such as beets. In the late 1950s, Ajinomoto, Co., Inc., the world's largest supplier of "monosodium glutamate," changed it manufacturing practices and began producing "monosodium glutamate" through a process of bacterial fermentation wherein the glutamic acid used in "monosodium glutamate" was secreted from the cell walls of specially selected genetically engineered bacteria.  It was not until 1968, when the method of producing monosodium glutamate had changed to a process of bacterial fermentation wherein the glutamic acid used in "monosodium glutamate" was secreted from the cell walls of specially selected genetically engineered bacteria, that the first recorded report of an adverse reaction to "monosodium glutamate" appeared in the medical literature.


Background: regulation of MSG in food

 

The FDA requires that every ingredient used in food be assigned a "common or usual name", and that with some (often significant) exceptions, the common or usual name of every ingredient used in a food product must be listed on the label of that product.  Before Ajinomoto began producing monosodium glutamate through bacteria fermentation, "monosodium glutamate" was the name of an ingredient that contained 78%-79% processed free glutamic acid (MSG), with the balance made up of salt, moisture, and up to 1 per cent impurities.  When an ingredient contained 78%- 79% processed free glutamic acid (MSG), and the balance was made up of salt, moisture, and up to 1 per cent impurities, the product had to be called "monosodium glutamate," and the product had to be labeled as such. "Apple" is the common or usual name of a food ingredient.  When a product contains "apple," and/or "monosodium glutamate" the words "apple" and/or "monosodium glutamate" must appear in the list of the product's ingredients.  Presently, the FDA refers to the 6th edition of the Food Chemical Codex for their definition of "monosodium glutamate."

 

MSG-containing ingredients have names like "autolyzed yeast extract," "sodium caseinate," and "hydrolyzed pea protein."  Often those names are chosen by flavor-enhancer manufacturers to serve as "clean labels," i.e., names that would give the consumer no clue to the fact that they contained processed free glutamic acid (MSG).  Historically, the FDA has tended to ignore the fact that any MSG in any processed food, regardless of the ingredient name of the food that contains it, can cause MSG adverse reactions; and the FDA, ignoring any challenge to the safety of other MSG-containing ingredients, has focused largely on perpetuating the fiction that "monosodium glutamate" is "safe." It is for that reason that only ingredient labeling regulations relevant to "monosodium glutamate" are discussed here.  It is important to remember that although there are many MSG-containing ingredients, "monosodium glutamate" is the only food ingredient with a name that gives consumers even a clue to the fact that it contains MSG.

 

One might argue that consumers could learn the names of the seemingly infinite number of MSG-containing ingredients on the market at any given time. But even that wouldn't protect consumers from hidden processed free glutamic acid (MSG) because current FDA regulations allow that certain products such as "stock" and "broth" can be used as ingredients in products without listing/naming the ingredients contained in the "stock" or "broth." Thus, "stock" or "broth" that contain "hydrolyzed soy protein," "autolyzed yeast," and/or "sodium caseinate," for example, could be used in "mushroom soup" and labeled "stock" or "broth" without mentioning the three sources of processed free glutamic acid (MSG): "hydrolyzed soy protein," "autolyzed yeast," and "sodium caseinate."

 

Current regulations also allow certain MSG-containing ingredients to be included under the label descriptors "flavor(s)", "flavoring(s)", "natural flavor(s)", and "natural flavoring(s)" without disclosure of the processed free glutamic acid (MSG) in them, or even mention of the names of the MSG-containing ingredients used. Although called “ingredients” by the FDA, since they are invariably made up of a number of ingredients, they are really products – just like the ingredient called “chicken broth” may be made up of chicken, water, salt, vegetables, and spices.  But unlike “chicken broth”, these flavoring ingredients have been deemed “proprietary” by the Senate and Congress, which means that by law, the producer does not have to identify the ingredients in the proprietary ingredients either on the labels of the products that contain them or in response to consumer inquiries.  The ingredients in these proprietary “ingredients” are, so to speak, trade secrets, which makes “flavor(s)", "flavoring(s)", "natural flavor(s)", and "natural flavoring(s)" the ultimate hiding place for MSG.

 

In recent years, the FDA issued a regulation requiring that when used in the proprietary ingredients flavor(s)", "flavoring(s)", "natural flavor(s)", or "natural flavoring(s)", the ingredients “monosodium glutamate” and “hydrolyzed…protein” had to be disclosed.  That leaves autolyzed yeast, sodium caseinate, maltodextrin, citric acid, and more than 40 other MSG-containing ingredients to be used in these proprietary products without disclosure.  And given the fact that the FDA makes no attempt to enforce its regulations pertaining to use of “monosodium glutamate” and “hydrolyzed…protein”, these proprietary ingredients may contain “monosodium glutamate” and “hydrolyzed…protein”, also.

 

Finally, processed free glutamic acid (MSG) can be produced during processing. For example, certain enzymes combined with protein will create processed free glutamic acid (MSG) during product processing. Under present FDA regulations, "enzymes" would be listed as ingredients with no indication that during processing enzymes would create processed free glutamic acid (MSG). Certain processes, such as ultrapasteurization, can similarly produce processed free glutamic acid.

 

That every food ingredient must be listed by its "common or usual name" on the label of a product that contains it, provides the consumer with little or no information about the presence, absence, or amount of processed MSG that might be in a product.
 

It is clear to those of us who have followed the work of the glutamate industry and their agents, that they find it imperative that information about the amount of processed free glutamic acid (MSG) in food ingredients not be available to consumers.  We know, and they know, that the processed free glutamic acid (MSG) in "monosodium glutamate" and other MSG-containing ingredients is toxic to those who ingest amounts that exceed their MSG-tolerance levels.  If MSG and the amount of MSG in every ingredient were listed on the labels of every product that contained MSG, consumers who suspected that they might be reacting adversely to the MSG in a product could determine if they were MSG-sensitive, and they could get an idea of their tolerance level, i.e., approximately how much MSG had to be ingested to cause an adverse reaction. If the amount of MSG in a product was specified on the label of every product that contained MSG, no glutamate industry propaganda testifying to the "safety" of MSG would be effective.
 

Most fundamental to the hiding of processed free glutamic acid (MSG) in food is the FDA's decree that processed free glutamic acid (MSG) is not a food ingredient, and does, therefore, not need to be identified on labels of processed food. According to the FDA, processed free glutamic acid (MSG) is a constituent of an ingredient.  When "autolyzed yeast," for example, is made in a food processing plant, the protein in the yeast that is being autolyzed will be broken apart into its constituent amino acids, one of which will invariably be glutamic acid (processed free glutamic acid) i.e., MSG.  When "autolyzed yeast" is used as a food ingredient in a larger product, the "autolyzed yeast" will be listed on the label of that larger product, but there will be no mention of the fact that the "autolyzed yeast" contains such things as aspartic acid and MSG.  According to the FDA, since processed free glutamic acid (MSG) is not a food ingredient, processed free glutamic acid (MSG) does not have to be listed on the labels of the products that contain it.

 
There is no ingredient with the common or usual name “MSG”. There is no ingredient called “MSG”.  Legally, one will never see an ingredient called “MSG” listed as an ingredient in processed food.

 

Essential to an understanding of the regulatory history of MSG is an understanding of FDA/industry cooperation/collusion.  The first record of such co-operation that we have in our files is from September of 1969, when then FDA Commissioner Ley testified before the Senate Select Committee on Nutrition and Health, and presented evidence from four studies that, he alleged, demonstrated that MSG was safe. It was later disclosed that two of the studies Commissioner Ley cited were incomplete and two did not even exist.

Why 1969?  Because before that time there had been no need for industry to look to the FDA for assistance.  It was only in 1968 that the first report of adverse reactions to "monosodium glutamate" was published in The New England Journal of Medicine; and in 1969 that the first evidence that "monosodium glutamate" caused brain lesions and endocrine disorders in experimental animals was published in Science.

History: regulation of MSG in food

The first record of FDA/industry cooperation/collusion that we have in our files is from September of 1969, when then FDA Commissioner Ley testified before the Senate Select Committee on Nutrition and Health, and presented evidence from four studies that, he alleged, demonstrated that MSG was safe. It was later disclosed that two of the studies Commissioner Ley cited were incomplete and two did not even exist.

Why was it 1969 before FDA/industry collusion was first demonstrated?  Because before that time there had been no need.  It was only in 1968 that the first report of adverse reactions to "monosodium glutamate" was published in The New England Journal of Medicine; and in 1969 that the first evidence that "monosodium glutamate" caused brain lesions and endocrine disorders in experimental animals was published.

FDA/industry collusion has been demonstrated time and time again over the course of the last 34 years.

The FDA first built, and then reinforced its case for the "safety" of MSG, on misleading and deceptive studies sponsored by the glutamate industry.  FDA regulations require that those who manufacture food additives must provide evidence demonstrating that they are "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, they have been known to draw conclusions that did not follow from the results of their studies.

Over the course of the last 34 years, 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 studies that might suggest that use of processed free glutamic acid (MSG) places humans at risk.  The FDA suppressed results of a study that found processed free glutamic acid (MSG) in supplements to be unsafe.  In July, 1992, the Federation of American Societies for Experimental Biology (FASEB) concluded and suppressed the results of 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 L-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, the FDA's D.H. Daniels, F. L. Joe, Jr. and G.W. Diachenko reported as fact, data that came from their own potentially unreliable procedures.  In that study, they also misrepresented the research findings of others.

 

The FDA has acknowledged that to advertise products as "No MSG," "No Added MSG," or "No MSG Added" when they contain ingredients that are sources of free glutamic acid such as hydrolyzed protein, is in direct violation of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act.  Yet the FDA has refused to recall MSG-containing foods advertised as "No MSG," "No Added MSG," or "No MSG Added".

The USDA has gone a step farther.  They approve labels that advertise "No MSG Added" even though the labels declare hydrolyzed proteins in their ingredient panels - in direct violation of Section 403 (a) (1) of the Federal Food, Drug, and Cosmetic Act.

Historically, every time complaints about MSG toxicity have intensified, the FDA has called for an "independent" review of the safety of MSG and has, 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," or "FDA won't be bound by its conclusions."

In 1992, the FDA contracted with FASEB to do an "independent" review of the safety of MSG in food.  Every aspect of that study was 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; the FDA allowed FASEB to appoint Expert Panel members (at least four of the eight members selected by FASEB) who had ties to the glutamate industry (conflicts of interest); the FDA attempted 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, found unacceptable to them, and was sent back to FASEB by the FDA for "clarification."

Release of the final report had initially been delayed a month or two at a time beyond its original March,1994 target date. In September, 1994, when the draft final report was finally submitted to the FDA, it was leaked to members of the glutamate industry and finally rejected, 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 (IGTC) that would be used to convince the Expert Panel of the safety of MSG.

Text of a "new" FDA/FASEB contract to provide "clarification" (signed February 1, 1995) 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 had asked of researchers conducting double-blind studies for the IGTC had made them cautious: possibly made them unwilling to expose themselves to almost certain criticism for poor methodology.

Whatever the reason, the objective of the new contract appeared to have been 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.   As if to guarantee the outcome of the FASEB report, the FDA, in the Background Section of its contract, referred to evidence that people react to doses of 3 grams or more MSG, but failed to refer to evidence (from the same study as well as others) that people react to doses of less than 3 grams MSG.  The FDA also mentioned, in its new contract, that asthma can be "worsened" with doses of more than 2.5 grams MSG, but failed to mention that asthma can also be "worsened" with doses of less than 2.5 grams MSG, and that MSG can trigger asthma-type attacks in non-asthmatics.  Because FASEB was required, or chose, to respond directly to questions asked by the FDA, and to respond only to questions asked by the FDA, structuring the contract to the point of directing FASEB to consider certain data, while ignoring certain other data, guaranteed the study's outcome.

It must be repeated that evidence suggests that the February 1, 1995 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 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 had been sponsored by the glutamate industry, and, with rare exception, the research reported had been sponsored by them, too.

Controlling reviews of the "safety" (never "toxicity") of MSG has not been the glutamate industry’s only outlet. Their power can be seen in the FDA's appointment of Andrew G. Ebert, Ph.D. Chairman of the International Glutamate Technical Committee, and Kristen McNutt, Ph.D., J.D., a spokesperson sponsored by The Glutamate Association, to the FDA Food Advisory Committee -- and the FDA's refusal to appoint a single person who might be considered a consumer advocate.

The appointment of McNutt and Ebert, and the refusal to appoint a consumer advocate demonstrates clear cut conflict of interest.  Appointment of Ebert, and subsequent refusal to dismiss him, also demonstrates the FDA's complicity in clear cut scientific fraud.

Is this fraud?  You decide. Ebert, who was chairman of the International Glutamate Technical Committee (IGTC), distributed both test materials and materials that he called placebos (inert substances that could not possibly cause a physical reaction in a person who ingested them) for use in double-blind studies designed to demonstrate that MSG is safe. And the supposed placebos that Ebert distributed were not inert substances at all, but actually contained aspartame, a substance made up of aspartic acid, phenylalanine, and a methyl esther. Aspartic acid is a neurotoxic amino acid and structural analog of glutamic acid, the primary ingredient in MSG.  Both aspartic acid and glutamic acid cause brain lesions, retinal deterioration, and neuroendocrine disorders in laboratory animals.  In addition, not only are there are over 7,000 complaints of adverse reactions to aspartame on file with the FDA, the reactions mentioned are the same reactions reported by people who are sensitive to MSG.  Even the relative frequency with which the reactions occur is the same.  Could it be other than by purposeful intent that Ebert not only defiled the integrity of the placebo, but used a substance outside of glutamic acid that would not only guarantee adverse reactions in people who are exposed to amounts that exceeded their dose tolerance levels, but would precipitate the same reactions as MSG?

You have to understand just how the game is played in order to appreciate the hold that industry has on every branch of government in this country; on a large part of the scientific community; and on the media.  We have come to believe that the glutamate industry believes that if processed free glutamic acid (MSG) were ever labeled, consumers would realize that processed free glutamic acid (MSG) was causing or exacerbating illness and disease; and that exposing that fact would cost the glutamate industry billions of dollars in lost revenues. So researchers are hired to turn out research that claims to have demonstrated the safety of processed free glutamic acid (MSG); physicians, "scientists," and public relations firms are hired to fabricate stories about the safety of processed free glutamic acid (MSG); the FDA, USDA, and EPA, possibly through the revolving door system that has become commonplace, appear to do the bidding of the rich and powerful food, drug, and cosmetic industries, saying -- with authority -- that their toxic products are "safe;" and legislators ignore the fact that millions of pounds of neurotoxic MSG are being fed to our children, ourselves, and the elderly, and that millions of people are suffering because of it.

And if you, the taxpayer, are concerned what do you do?  If you are aggressive, you protest to the EPA, FDA, or USDA that MSG is toxic and should be regulated in some way. If the agency responds, they might tell you that they have seen no evidence that MSG is toxic. (They won't be honest enough to tell you that the evidence is there, but they are not permitted to look at it.) They might tell you that the animal studies that show that MSG is toxic were done on animals and are, therefore, irrelevant to humans. (They will ignore the fact that in this country we do toxicity studies on laboratory animals. We do not do toxicity studies on humans.)  And if the agency is caught with its pants down, and has no excuse what-so-ever, the agency simply will not respond. They may write you a letter, but the contents of the letter will not speak to your concerns.

Undaunted, you, the rare aggressive taxpayer, may write to your congressperson and/or senators, tell them that MSG is toxic, and ask them to see to it that MSG is regulated in some way. They, in turn, pass your inquiry on to the EPA, FDA, or USDA as appropriate, and send you a letter telling you that the agency in question has been asked to respond. And what does that agency do? They fill a page or two with ambiguous words and phrases, half-truths, and downright lies and send it off to your legislator(s), who, in turn, forward the agency's letter to you.

History of MSG used in fertilizers, fungicides, pesticides, and plant growth enhancers

The EPA and individual states have refused to regulate the use of processed free glutamic acid (MSG) in fertilizers, fungicides, pesticides, and plant growth enhancers. 

In the good old days, processed free glutamic acid (MSG) was hidden in cosmetics, drugs, vaccines, processed food, baby food, and infant formula. However, raw produce purchased at a market or in a grocery store used to be "safe."  But all that has changed.

In 1997, a company called Auxein Corporation (later known as Emerald BioAgriculture) asked the EPA to approve spraying processed free glutamic acid (MSG) on all growing agricultural commodities including grass, nuts, seeds, fruits, grains, and vegetables. Auxein/Emerald BioAgriculture also asked the EPA to register their pesticide product called AuxiGro WP Plant Metabolic Primer (AuxiGro) as a plant growth enhancer for use to increase yields and the quality of crop plants and early ripening in certain vegetables.  Approximately 30 per cent of AuxiGro is made up of processed free glutamic acid (MSG).

Testing of AuxiGro was approved by the EPA in September, 1997, and test crops that had been sprayed with processed free glutamic acid (MSG) were brought to market without telling consumers.  By and large, individual states rubber stamped the EPA's approvals.  For those few exceptions, Auxein/Emerald BioAgriculture set in motion the processes needed for individual state approvals.  At the same time, Auxein/Emerald BioAgriculture was working to secure organic certification for its AuxiGro and the processed free glutamic acid (MSG) contained in it.

On January 7, 1998, processed free glutamic acid (MSG) used as a plant growth and crop yield enhancer was granted an exemption from establishment of a tolerance limit by the EPA -- meaning that any amount of processed free glutamic acid (MSG) could be used as a plant growth and crop yield enhancer without restriction.  The January 7, 1998 Final Rule sanctioned the use of unregulated amounts of processed free glutamic acid (MSG) (calling it "the biochemical glutamic acid") regardless of how much processed free glutamic acid (MSG) residue might be left in or on any or all food commodities when bought by consumers -- when the processed free glutamic acid was applied as a plant growth and crop yield enhancer. Shortly thereafter, the EPA began to approve AuxiGro for use on specific crops.  By the time the Truth in Labeling Campaign became aware that the EPA had approved spraying processed free glutamic acid (MSG) on crops, it was too late to formally object to the 1998 Final Rule.

On December 6, 2000, Auxein/Emerald BioAgriculture petitioned the EPA to remove all restrictions from use of processed free glutamic acid (MSG), and asked, also, that all restrictions be removed from a second neuro-active amino acid, Gamma Aminobutyric Acid (GABA).  Both are used as active ingredients in AuxiGro.  Prior to December 6, 2000, AuxiGro had been approved in California for use as a fungicide, but at that time, the EPA had not approved the processed free glutamic acid (MSG) in AuxiGro for use as a fungicide; the EPA had only approved processed free glutamic acid (MSG) for use as a plant growth enhancer.  So this new broader approval was needed before California approval of AuxiGro for use as a fungicide could be finalized.  In its December 6, 2000 petition, Auxein/Emerald BioAgriculture asked that there be no limits to the amounts of those chemicals when used on any food commodities for any uses regulated by the EPA.

As required by law, the Auxein Corporation petition was published in the Federal Register.  But the law evidently doesn't require that the public be told what is being proposed, because when the EPA published the petition on December 6, 2000, they called it a "Notice of Filing Pesticide Petitions to Establish Tolerances for Certain Pesticide Chemicals in or on Food," -- never mentioning glutamic acid, L-glutamic acid, glutamate, monosodium glutamate, MSG, or GABA in the title.

The December 6, 2000, Notice to "Establish Tolerances for Certain Pesticide Chemicals in or on Food" asked the EPA to sanction the use of unregulated amounts of processed free glutamic acid (MSG) --

Regardless of how much processed free glutamic acid (MSG) residue might be left in or on raw agricultural commodities when purchased for eating;

No matter what the product containing the processed free glutamic acid (MSG) might be called, i.e., a fertilizer, fungicide, pesticide, plant growth enhancer or anything else regulated by the EPA;

No matter what crops or plants the processed free glutamic acid (MSG) might be used on;

Without mentioning, in either the title or the summary, that those "Certain Pesticide Chemicals" were processed free glutamic acid (MSG) and GABA, and that the product in which they would be used was called AuxiGro.

 

Needless to say, since no Federal Register search for "glutamic acid,"  "gamma aminobutyric acid (GABA)," or "AuxiGro" would have identified the December 6 Notice, we were not aware that the December 6, 2000 EPA Notice had been published in the Federal Register until long after the time had run for commenting on the Notice.

Clever, wasn't it?  Both Auxein/Emerald BioAgriculture and the EPA knew that we were vehemently opposed to use of processed free glutamic acid (MSG) on food crops and other plants.  They both knew that given the opportunity, we would formally object to additional EPA approvals of use of processed free glutamic acid (MSG) and/or AuxiGro.  So the Notice, that by law the EPA was required to publish in the Federal Register, gave no clue to the fact that it had anything to do with processed free glutamic acid (MSG) or AuxiGro.

The Notice that was published on December 6, 2000 became a Final Rule on June 21, 2001.  But unlike the Notice, and for reasons we may never know, the EPA used the words "L-glutamic acid" in the words used to describe the June 21, 2001 Final Rule, and a concerned consumer brought the Final Rule to our attention.  Thus, for the first time, the Truth in Labeling Campaign had the opportunity to file a formal Objection to the use of processed free glutamic acid (MSG) on crops.

The period for filing objections to the June 21, 2001 Final Rule ended on August 20, 2001. The Objection filed by the Truth in Labeling Campaign on August 20, 2001 with the EPA was an objection to the June 21, 2001 Final Rule: L-Glutamic Acid and Gamma Aminobutyric Acid; Exemptions from the Requirement of a Tolerance.  It was an objection to the exemption granted to processed free glutamic acid (MSG) -- which was then (and is) still being referred to as "L-glutamic acid" by Auxein/Emerald BioAgriculture and the EPA.

The text of the June 21, 2001 Final Rule contains very little information, but refers the reader to the December 6, 2000 Notice.  In turn, the December 6 Notice states that the petitions to establish tolerances for "certain pesticide chemicals in or on food" should be granted; saying only that supporting data were submitted with Pesticide Petitions 7F4842 and 7F4843, but not even alluding to what those data were.  Thus, to see how the EPA excused itself in 2001 for feeding consumers to the glutamate industry while laying the groundwork for lining the glutamate industry's pockets, you will have to go all the way back to the January 7, 1998 Final Rule.

On June 21, 2001 the EPA published the Final Rule stemming from the December 6, 2000 Notice. The June 21, 2001 Final Rule says that unrestricted amounts of processed free glutamic acid (MSG) can be sprayed on crops and other plants -- food crops -- all crops -- any crops -- without any restrictions on the amount sprayed, on the amount that would remain on fruit, grains, seeds, nuts, and vegetables when brought to market, and without any restriction on the amount of processed free glutamic acid (MSG) that could have been taken up by the treated produce and be in those fruit, grains, seeds, nuts, and vegetables when eaten.

The exemptions from the requirement of a tolerance were based on a series of unproved assumptions, on data from the 1970s that have long since been refuted, on a number of studies that are irrelevant to the safety of amino acids, and on short term acute toxicity studies that neither reflected the real world conditions under which the amino acids would be applied, nor considered their endocrine disrupting potential.  In sanctioning the unregulated use of processed free glutamic acid (MSG) -- which was then being calling  "L-glutamic acid" -- the EPA used words like "expected to be minimal;" "not likely to result in potential chronic exposure" and "exposure is anticipated to be negligible."  No relevant data from non-industry researchers were examined.

A formal Objection to the June 21, 2001 Final Rule was filed with the EPA by the Truth in Labeling Campaign prior to the cut off date of August 16, 2001.  You will find a copy of the Objection on this web site because:

We think consumers have the right to know what is in and on their food;

We think that Americans need to see, close up and personal, how a company gets government approval for a product that places consumers at risk;

We think that Americans need to see, first hand, how government agencies like the EPA cooperate with the companies they are supposed to be regulating -- even violating the provisions of the Federal Food, Drug and Cosmetic Act; and

Everything we see and hear from the EPA says that they have approved a toxin and endocrine disrupter that causes adverse reactions in MSG-sensitive people, for spray on crops -- placing the health of every American at risk -- with the greatest risk faced by fetuses, newborns, infants, children, and the elderly.

By law, being faced with a formal and properly executed Objection to a Final Rule, the EPA is required to study the Objection and respond to it by producing a Final Order.

It has been our observation, however, that the EPA does not always do what is required by law, so we made inquiry.  In September, 2001, we asked and were told that the EPA was drafting a draft Final Order that should be available for review and comment approximately 6-8 months from that time -- and that we would be notified when the draft Final Order was done.

On July 30, 2002, we asked again when the draft Final Order would be available to consumers, and Janet Andersen, Ph.D., Director of the Biopesticides and Pollution Prevention Division (BPPD), told us they were working on it and would let us know as soon as they had a draft for distribution and comment.

Let there be no mistake.  Today, we know of no crop that was not approved for spray with processed free glutamic acid (MSG) by the EPA. The EPA approved the use of processed free glutamic acid (MSG) and the use of AuxiGro, a product that uses processed free glutamic acid (MSG) and GABA as active ingredients. Those approvals would remain in force, and those products would continue to be used, even though objections had been filed protesting them. Those chemicals have been used, and will continue to be used without restriction in accordance with the June 21, 2001 Final Rule in every state except California unless the EPA withdraws its approval of the June 21, 2001 Final Rule.  The Truth in Labeling Campaign has asked the EPA to withdraw its approval.  The EPA has not seen fit to do so.

In 2007, Emerald BioAgriculture failed to renew its registration of AuxiGro with California.  (To date, we have been unable to confirm its registration status with the EPA.) We noted that the date (2007) coincided with heightened national concern about the bee disappearance epidemic.  We know from research done in the 1970s and 1980s that test animals have become unable to find their way through a maze when given MSG.  Wouldn’t that be similar to having a bee that had ingested MSG sprayed on plants be unable to find his way back to the bee hive – and therefore die?

History of MSG use in pesticides in California

The California Department of Food and Agriculture (CDFA) and the California Department of Pesticide Regulation (CDPR) have approved the use of processed free glutamic acid in agricultural products to be sprayed on, and otherwise applied to fruits, vegetables, grains, and ornamentals.  That approval came with input from the International Glutamate Technical Committee (IGTC) through faculty at UC Davis and UCLA.

In May, 1999, spraying MSG on wine grapes (calling the spray a fertilizer) was approved by the CDFA. Steven D. Wong, Branch Chief, Agricultural Commodities and Regulatory Services told us that there was no demonstration that use according to label directions would present a significant health hazard to workers, consumers of products grown with the aid of the MSG-containing product, or to the general public. At that time, to have a product approved for use as a fertilizer in California, a company needed do little more than make application.

In April, 2000, and again in July, 2001, spraying MSG on wine grapes (calling it a fungicide) was approved by the CDPR. At that time, Barry Cortez, Branch Chief, CDPR, told us that the CDPR would only turn down a product if it appeared to be ineffective, and AuxiGro didn't appear to be ineffective.  After reading the law, however, we found that according to Section 12825 of the Food and Agricultural Code:

"Pursuant to Section 12824, the director,...may cancel the registration of, or refuse to register, any pesticide:

 

 (a) That has demonstrated serious uncontrollable adverse effects either within or outside the agricultural environment.

 (b) The use of which is of less public value or greater detriment to the environment than the benefit received by its use.

 (c) Concerning which any false or misleading statement is made or implied by the registrant or his or her agent, either verbally or in writing, or in the form of any advertising literature."

AuxiGro met each of those three criteria.

Does spraying processed free glutamic acid onto crops and into the environment pose a problem? We think it does. Does applying processed free glutamic acid to the soil pose a problem? Yes, we think so, and we have made our thoughts known. On June 8, 1999, even though we knew full well that the glutamate industry had been generous in funding chemists and food scientists at UC Davis and underwritten research at UCLA, and that those chemists and food scientists, and/or their friends at Davis or at the CDFA or CDPR, might be asked to evaluate our comments, we formally presented our concerns to the CDPR.

It was not until the spring of 2001, however, that we found that AuxiGro contained more awful ingredients than the "L-glutamic acid" -- the neurotoxic, endocrine disrupter that can cause adverse reactions such as asthma, migraine headache, heart irregularities, and seizures in people who were sensitive to it.  AuxiGro, we learned from government documents, contains hydrolyzed casein (milk) protein, a substance known to have caused the death of milk-sensitive children who consumed minute quantities of milk protein hidden in processed food.  AuxiGro, we learned from other government documents, also contains carcinogens.

As of August 20, 2004, California had already approved the following crops for spraying with MSG

ALMOND
APRICOT
CANTALOUPE
CHERRY
GRAPES
GRAPES (ALL OR UNSPECIFIED)
GRAPES, WINE
MELONS
NECTARINE
ONION (DRY, SPANISH, WHITE
PEACH
PLUM (INCLUDES WILD PLUMS)
PRUNE
TOMATO
TOMATOES, FOR PROCESSING
WATERMELONS

 

On July 9, 2004, California proposed to also allow cole crops to be sprayed with MSG.  Cole crops include:

 

BROCCOLI
BRUSSELS SPROUTS
CABBAGE
CAULIFLOWER
KALE, COLLARDS
TURNIPS
RUTABAGA
MUSTARD
WATERCRESS
KOHLRABI

 

Just as we provided evidence of MSG toxicity to the EPA, that same evidence was presented to the CDPR.  And like the EPA, the CDPR essentially ignored that evidence.  According to the statement of Barry Cortez, Chief, Pesticide Registration Branch, CDPR, "As a result of scientific evaluation, it has been determined that no direct or indirect significant adverse environmental impact is anticipated from the registration of [AuxiGro]; therefore, no public report on the individual products will be filed."

The following are some of the questions that the CDPR refused to address and comments made by Adrienne Samuels

Question 1: How, and by what company, is the processed free glutamic acid used in AuxiGro produced?  Is it produced by Ajinomoto or others by a method of bacterial fermentation wherein "...bacteria...excrete glutamic acid they synthesize outside of their cell membrane into [a liquid nutrient] medium and accumulate there.  The glutamic acid is separated from the fermentation broth by filtration, concentration, acidification, and crystallization..." (Leung, A., and Foster, S. Encyclopedia of Common Natural Ingredients. NY: Wiley, 1996).

Question 2: What are the specific contaminants in the processed free glutamic acid used in the manufacture of AuxiGro?

Question 3: What is the amount of processed free glutamic acid residue that will be left in and on produce from application of AuxiGro?

Question 4: What amount of processed free glutamic acid causes adverse reactions in highly MSG-sensitive people?

Question 5: We have been told that the CDPR has determined that the small amounts of L-glutamic acid being applied would not have an adverse effect on people consuming treated produce.  How was that determination made?  What data were used in making that determination?

Question 6: Material coming from the EPA states that AuxiGro contains carcinogens.  Why are the CDFA and the CDPR licensing a product that contains carcinogens?

Question 7: Material in hand states that AuxiGro contains hydrolyzed casein (milk) protein. We know, therefore, that in treating crops with AuxiGro, a form of milk protein is being deposited on and in those crops.  We know that no consumer would ever dream that unprocessed produce would have been treated with a product that contained milk in any form; and the rights of vegetarians and certain religious groups -- and anyone else, for that matter -- to choose what they will eat will be violated. We also know that it is common knowledge that minute amounts of certain allergens, including milk, will trigger adverse reactions, including anaphylaxis, in people who are acutely sensitive to those allergens.  (Laoprasert, N, Wallen, ND, Jones, RT, Hefle, SL, Taylor, SL, Yunginger, JW. Anaphylaxis in a milk-allergic child following ingestion of lemon sorbet containing trace quantities of milk. Journal of Food Protection 61(11):1522-4,1998.)  Why are the CDFA and the CDPR licensing a product that will not only be offensive to particular groups of people, but one that contains a hidden potentially lethal allergen?

Question 8: Material in hand states that there is processed free glutamic acid in AuxiGro over and above the 29.2% active ingredient listed on the label.  Therefore, AuxiGro is misbranded.  Why are the CDFA and the CDPR licensing a product that is misbranded?

Question 9: We are aware that on June 21, 2001, the EPA published the Final Rule: L-Glutamic Acid and Gamma Aminobutyric Acid; Exemptions from the Requirement of a Tolerance.  According to the June 21, 2001 publication of that Final Rule in the Federal Register, that Final Rule establishes exemptions from the requirement of a tolerance for residues of what the EPA refers to as "L-glutamic acid" and also gamma aminobutyric acid on all food commodities when applied/used in accordance with good agricultural practices.

We are also aware that MSG-sensitive people have reacted to processed free glutamic acid in potatoes sprayed with agricultural products that contained processed free glutamic acid.  I believe that your office has received letters from some of those people.  I know that my husband, Jack Samuels, was one of them.  Since potatoes are tubers, and it is the tubers that grow under ground that are eaten (and not the stems or leaves of the potato plants), we know that when potatoes are treated with agricultural products that contain processed free glutamic acid, there is residue remaining in the potato. The EPA Final Rule promulgated on June 21, 2001, did not exempt the processed free glutamic acid (they call it "L-glutamic acid") from the requirement of a tolerance for residues of "L-glutamic acid" in all food commodities.

Since the June 21, 2001 Final Rule did not address the issue of an exemption from the requirement of a tolerance for residues of "L-glutamic acid" in all food commodities, the EPA has not taken a final tolerance action that would allow the CDPR to license AuxiGro.

In licensing AuxiGro for use in California, the CDPR is acting inappropriately.  Why is the CDPR licensing a product that will cause there to be residue of processed free glutamic acid in crops when the EPA has not issued an exemption from the requirement of a tolerance for those residues in crops?

The Truth in Labeling Campaign has asked Mr. Cortez how a proper scientific evaluation could be made without having the answers to those questions.  The answer, of course, is that a proper scientific evaluation could not be made without this information.  The answer is that a proper scientific evaluation has not been done.  The question, of course, is one that Mr. Cortez has not, and will not, answer.  My guess is that the big business interests that profit from the sale of processed free glutamic acid (MSG) as a food additive and an agricultural stimulant are extremely pleased with Mr. Cortez and the CDPR.

 

At the end of the year 2007, Emerald BioAgriculture failed to renew its registration of AuxiGro in California.

Internationally

Internationally, the glutes ply their wares just as they do in the United States.  Even so, some European countries have limits on the amounts of MSG that can be used in processed foods.  Restrictions are largely related to levels of carcinogenic mono and dichloro propanols found in MSG produced through acid hydrolysis.