Tag: FDA

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Industry’s FDA

MSG is a flavor-enhancing additive used in so many processed foods you probably couldn’t count them all.

No doubt you’ve read that it is perfectly “safe,” only causing transient adverse reactions in a small set of people sensitive to it.

The Truth in Labeling Campaign, independent scientists and journalists (not on the glutamate payroll) will tell you a different story, how MSG and other sources of free glutamate can trigger adverse reactions ranging from simple skin rash to migraine headache, heart irregularities, seizures and anaphylactic shock.

However, no one — even those in the glutamate industry — can say that ingestion of MSG doesn’t cause adverse reactions. Despite that, there is no restriction imposed by the FDA on use of either MSG or its toxic free glutamic acid component in foods or beverages.

But here’s the really interesting part — food scientists and neuroscientists are turning out study after study exploring the “protective effects” of various chemicals, dietary supplements and even foods to shield against monosodium glutamate-induced abnormalities. On January 30, 2022, there were 377 such studies listed by the National Library of Medicine. And all this research is going on while the FDA, along with those who profit from the manufacture and sale of MSG, claim that MSG is totally safe for use in food.

The FDA has been representing the interests of the glutamate industry since 1968 if not before. The Truth in Labeling Campaign has told that story many times. See: https://www.truthinlabeling.org/fda.html and, https://www.truthinlabeling.org/assets/manuscript2.pdf

There are laws that specify just what the FDA must do to proclaim an ingredient GRAS (generally recognized as safe), which is how it lists MSG. And in claiming that monosodium glutamate is GRAS, the FDA violates its own rules.

That little fact was revealed in a citizen petition filed by TLC co-founder Adrienne Samuels in January of 2021, requesting that monosodium glutamate and its toxic component have its GRAS status withdrawn. The FDA has yet to respond.

Adrienne also filed two other petitions related to MSG last year. Check out this page link to learn the details of them all. Even better, click on the link there that says “vote,” and leave your own comment at the FDA docket.

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In memory of Jim Turner, attorney, consumer advocate and champion in the fight against chemical sweeteners

A crusader in the war against aspartame, Jim passed away at his home in Washington, DC on January 25. Below is a tribute to Jim published by the Children’s Health Defense Team at its website the Defender.
****************

The Children’s Health Defense team was deeply saddened to learn of the death of attorney James Turner on Jan. 25.

Turner, 81, was a consumer crusader and champion in the fight against chemical sweeteners who began his public advocacy career as one of Ralph Nader’s Raiders.

In 1970, Turner wrote “The Chemical Feast, a best-seller that exposed the food industry’s failure to protect the food supply. His fight to remove cyclamate from the U.S. Food and Drug Administration’s (FDA) Generally Recognized as Safe list led to the book being removed from the market, but it was republished in 1976 by Penguin Books.

A graduate of The Ohio State University (OSU) on a U.S. Navy scholarship, Turner served in the OSU student senate for three years. He received his law degree from The Ohio State University College of Law (now Moritz College of Law) where he served as Chief Justice of the Moot Court.

Between undergraduate and law school, Turner was a lieutenant on active duty in the U.S. Navy. He graduated with distinction from the Naval Justice School and served as a nuclear weapons handling officer and gunnery officer aboard the U.S.S. Purdy and the U.S.S. Austin.

Turner played a major role in the fight against the artificial sweetener aspartame. He also worked with Dr. John Olney in the late 1960s during the Senate hearings about monosodium glutamate (MSG) in baby foods.

Turner was concerned about Olney’s research proving aspartame caused brain lesions in baby rats and he fought to make sure it would not get approved as an artificial sweetener. He discovered that the aspartic acid in aspartame had similar properties to glutamate — an ingredient in MSG.

Representing a Washington, D.C. public interest group, Consumer Nutrition Institute, Turner and Olney filed formal objections with the FDA and challenged the validity of some of the key aspartame safety tests that the manufacturer, Searle, had submitted to the FDA.

Turner and Olney highlighted evidence that aspartame was causing brain damage, brain tumors, seizures and changes in animal brain chemistry and therefore it may have the potential to affect pregnant women and young children.

Turner and Olney were worried there was no way to control how much NutraSweet (aspartame) children were ingesting. Searle had not tested aspartame on humans and safe dosage data for children was not available. Turner and Olney insisted if children ate too many products containing NutraSweet they could easily cross the threshold that could trigger seizures.

After the Ramazzini Institute studies in Italy demonstrated for the second time that aspartame was a multipotential carcinogen, Turner wrote:

“When I testified before Congress in 1987 … I stated that just because a substance reaches the market it should not be treated as sacrosanct. It must be recognized that over time a substance that we know harms people will continue to harm people… If the standard of food safety is that a substance that only harms some people, but not all people is going to be allowed on the market, then special policies should be adopted to protect those at risk.

“This was never done… victims of aspartame continue to develop neurodegenerative disease, suffer diabetes, drug interactions, obesity, heart disease and loss of vision. Never has the public been warned that it triggers birth defects, a catastrophe the eminent Dr. Louis Elsas warned Congress about.

“In fact the average consumer of aspartame is not aware that the European Food Safety Authority (EFSA) says that an acceptable daily intake (ADI) of aspartame is 40 milligrams/kilogram of body weight ­— about the amount in a six-pack of diet soda for a 10-year-old boy. Nor do they now know how to tell if that amount is being exceeded by intake of the more than 5000 food and drug products currently sweetened with aspartame.”

Turner worked fiercely to get aspartame banned — especially after Sen. Gerald Ortiz y Pino wrote a bill to ban it in 2007 with the help of Stephen Fox of Mission Possible NM in Santa Fe.

In a documentary on aspartame, “Sweet Misery: A Poisoned World,” Turner definitively points out that Donald Rumsfeld had total complicity in the forced approval of the toxin.

In 2021, Turner was instrumental in forcing the FDA to release its documents on aspartame.

At the time of his death, Turner had been preparing a lawsuit to get aspartame banned, using the Delaney Clause, incorporated into the Federal Food, Drug and Cosmetic Act by the Food Additives Amendment of 1958. The clause requires the FDA to ban food additives found to cause or induce cancer in humans or animals as indicated by testing.

He wrote:

“The only responsible thing to do is ban the sweetener. And if they refuse to ban it then it should carry heavy warnings… To loose upon an entire unwarned continent a chemical that destroys the fetus, triggers mental illness and cancer, and sickens millions without a word of warning is corrupt and depraved. EFSA is responsible to prevent such depredations, not simply protect the greedy pockets of the poison producers.”

Turner’s longtime friend and associate, Dr. Betty Martini, stated:

“I’ve known Jim for decades. Never once has he deterred from his passion to get this toxin removed. He told me the FDA told Dr. Olney and him that they would never allow children to ever get aspartame because it causes birth defects and mental retardation, yet it’s in countless children’s products, and many have perished.”

Martini said she was exhilarated about Turner’s upcoming bombshell suit against the FDA — a gigantic step in finally removing aspartame from the marketplace.

Unfortunately, Turner became ill, robbing him of the chance to complete his last courageous act to free people from the dreadful addictive excitoneurotoxic, carcinogenic drug masquerading as an additive, she said.

Dr. Ralph Walton said of Turner: “The world has lost a powerful, courageous and consistent voice in the decades-long effort to demonstrate the hazards of aspartame.”

We, at the Children’s Health Defense Team, salute a great man who spent decades working to remove deadly toxins like aspartame from the market making the food and drug supply a safer place for the public.

Many more of his accomplishments could be listed but this is what he should most be remembered for.

Watch this podcast in which Turner discussed the horrors of aspartame.

Note from the Truth in Labeling Campaign: Aspartame is what the FDA approves for use in glutamate-industry double blind study placebos, having the nerve to claim that they have demonstrated that MSG is “safe.”

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‘Recycled FDA commissioner’ with Big Pharma ties, returns to head agency. But does it really matter?

Dr. Robert Califf, a prominent cardiologist with extensive clinical research experience and big ties to Big Pharma, who served as FDA commissioner during Obama’s final year in office has once again been appointed top boss at the FDA.

Califf, who was dubbed the “ultimate industry insider” in 2015, hasn’t changed much during the years since he last was tagged to run the FDA. He may have even improved on his Pharma connections.

The consumer group Public Citizen notes that after Califf left the FDA in 2017 he “revived his lucrative ties with FDA-regulated pharmaceutical companies, receiving consulting fees totaling tens of thousands of dollars…”

The group called for the Senate to reject “Biden’s recycled FDA commissioner pick.”

But they didn’t. Despite being close, 50 YEAs to 46 NAYs, Califf’s nomination was confirmed. But in the scheme of how things work at the FDA, does the name of the FDA head really matter?

Big Food and Big Pharma run the show at the FDA, with agents in place at every level saving the commissioner from making hard decisions – such as how to continue to claim that toxic MSG and its toxic manufactured free glutamate (MfG) are harmless. 

But thinking on the bright side, maybe the Senate confirmation hearings could be made to serve a different purpose. Perhaps someone could get those 46 Senators who voted against Califf to have the use of toxic glyphosate (Roundup) banned – or even just limited. Or, maybe they could order an investigation as to why the FDA continues to serve the glutamate industry and not have MfG banned from use in processed foods – or at least labeled.  Now that would really be something.

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Had they listened, the obesity epidemic would have been stopped before it took hold, and infertility would never have reached crisis proportions

Dr. John Olney

Sections below taken in part from the obituary of John W. Olney posted at Washington University in St. Louis, THE RECORD.

“John W. Olney, MD, the John P. Feighner Professor of Psychiatry and a professor of pathology and immunology, died April 14, 2015. He was 83.

“A longtime leader in the Department of Psychiatry at Washington University School of Medicine in St. Louis, Olney remained active in research until the last few days of his life.

“He studied neurotransmitters in the brain and how they can become toxic under certain circumstances. He was the first scientist to propose that when high concentrations of the neurotransmitter glutamate were released from brain cells, the glutamate could overexcite cellular receptors and destroy cells through a process he named ‘excitotoxicity.’” 

Dr. John Olney in 1991 appearing on a 60 Minutes segment on MSG.

More than a talented researcher, John Olney was a kind and caring human being.  Seeing the dangers posed by use of free glutamate in food, he published articles on the subject and spoke out on the dangers of MSG, putting his reputation and research funding at risk. In 1972 he testified before the Senate Select Committee on Nutrition and Human Needs, warning that ingestion of MSG places humans at risk, with the greatest risk being for the very young.  He gave evidence to a National Academy of Science panel organized to determine whether MSG ought to be banned from baby food, only to find that it had been an “industry arranged whitewash” carried out by a group of scientists with almost no experience in neuropathology.  In 1991 he was interviewed for the only 60 Minutes segment ever aired questioning the safety of MSG.

In 1993 he gave testimony to the FDA’s review of the safety of monosodium glutamate – and convinced other neuroscientists to join him.  Never hesitating to do what he could to stem the tide of the growing use of MSG, he then was a plaintiff in a lawsuit designed to force the FDA to require appropriate labeling of monosodium glutamate when present in food.

“John was truly a unique individual who had an enormous impact in psychiatry and across many scientific and clinical disciplines,” said Charles F. Zorumski, MD, the Samuel B. Guze Professor, professor of neurobiology and head of the Department of Psychiatry. “He was an innovator and a pioneer. Literally, the field of studying glutamate as an excitotoxin, and even the word ‘excitotoxicity’ itself, can be traced to John’s seminal studies in the late 1960s and 1970s. And his most recent work on the effects of drugs on the developing brain has changed how pediatric anesthesia is done.

“Olney came to Washington University in 1964 as a resident in psychiatry and joined the faculty in 1968. He started his medical training at age 28, leaving a job in the U.S. Army to pursue a medical degree when his sister was diagnosed with multiple sclerosis. Born in Marathon, Iowa, Olney earned his bachelor’s and medical degrees from the University of Iowa.

“In addition to working with glutamate, Olney studied the effects of anesthetic drugs, such as ketamine, on the developing brain. He did important and much-cited research into fetal alcohol syndrome, concluding that if a pregnant woman consumed as few as two drinks, the alcohol could cause nerve cells in the fetal brain to die. And Olney found that as the brain continued to develop in the years after a baby was born, anesthetic drugs also had the capacity to do damage. Consequently, he recommended that elective surgery be avoided in very young children whenever possible.

“Olney was a member of the Institute of Medicine of the National Academy of Sciences. He was a recipient of the Wakeman Award for Research in the Neurosciences, the Dana Foundation Award for Achievement in Health and the Lifetime Achievement Award from the Society of Biological Psychiatry.”

Maybe now that it has been demonstrated that excitotoxic glutamate ingested by a pregnant woman will cause brain damage in her fetus and newborn, leading to intractable obesity (the obesity epidemic) and reproductive disorders (the infertility crisis), someone will listen. Adrienne Samuels

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Industry’s FDA

MSG is a flavor-enhancing additive used in so many processed foods you probably couldn’t count them all.

No doubt you’ve read that it is perfectly “safe,” only causing transient adverse reactions in a small set of people sensitive to it.

The Truth in Labeling Campaign, independent scientists and journalists (not on the glutamate payroll) will tell you a different story, how MSG and other sources of free glutamate can trigger adverse reactions ranging from simple skin rash to migraine headache, heart irregularities, seizures and anaphylactic shock. 

However, no one – even those in the glutamate industry — can say that ingestion of MSG doesn’t cause adverse reactions. Despite that, there is no restriction imposed by the FDA on use of either MSG or its toxic free glutamic acid component in foods or beverages.

But here’s the really interesting part — food scientists and neuroscientists are turning out study after study exploring the “protective effects” of various chemicals, dietary supplements and even foods to shield against monosodium glutamate-induced abnormalities. On January 30, 2022, there were 377 such studies listed by the National Library of Medicine. And all this research is going on while the FDA, along with those who profit from the manufacture and sale of MSG, claim that MSG is totally safe for use in food.

The FDA has been representing the interests of the glutamate industry since 1968 if not before. The Truth in Labeling Campaign has told that story many times. See: https://www.truthinlabeling.org/fda.html and, https://www.truthinlabeling.org/assets/manuscript2.pdf

There are laws that specify just what the FDA must do to proclaim an ingredient GRAS (generally recognized as safe), which is how it lists MSG.  And in claiming that monosodium glutamate is GRAS, the FDA violates its own rules.

That little fact was revealed in a citizen petition filed by TLC co-founder Adrienne Samuels in January of 2021, requesting that monosodium glutamate and its toxic component have its GRAS status withdrawn. The FDA has yet to respond.

Adrienne also filed two other petitions related to MSG last year. Check out this page link to learn the details of them all. Even better, click on the link there that says “vote,” and leave your own comment at the FDA docket.

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Food for Thought

Who has more clout with the FDA?  Is it Big Food or Big Pharma?

The FDA requires this statement to appear on all direct-to-consumer drug advertising:

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

But you won’t find a phone number dedicated to taking reports of negative side effects of food.

In the mid 1990s, when there was consumer pressure (and a lawsuit) on the FDA to identify and label MSG and its toxic manufactured free glutamate (MfG), one could report reactions to the FDA’s Adverse Reactions Monitoring System (ARMS) if you could figure out a way to reach them. But ARMS was eventually shut down, not because it was no longer receiving reports, but because “They” knew that MSG and MfG and aspartame and sulfites were harmless.

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They’re having trouble keeping up with the Truth in Labeling Campaign

From the time they began revving up their propaganda until Kate Bratskeir’s article appeared in GoodRx (June 23, 2021), the Glutes had proclaimed that the glutamate in MSG was identical to the glutamate in plants, animals, and the human body. It’s one of their favorite things to say.

But now we find that the story has changed.  Indeed, Kate Bratskeir informed us that “The glutamate in MSG is chemically different from glutamate present in food proteins.”  And that, she said was “according to the FDA.”

This reminds me of the Glutes’ mantra about MSG having been safely used in food for over 2,000 years.  That changed shortly after The Truth in Labeling Campaign began pointing out, repeatedly, that MSG was invented in 1908.  Looks like now someone in one of Ajinomoto’s public relations firms read ‘Seven lines of evidence leading to the conclusion that manufactured free glutamate, no matter where it is found, is excitotoxic,’ or read one of Adrienne Samuels’ Citizen Petitions providing data to support the request that the GRAS (generally recognized as safe) status of monosodium glutamate be revoked.

You may not be paying a great deal of attention to the warnings of the Truth in Labeling Campaign but the Glutes certainly are.  They seem to be extremely careful about being caught in a lie.  And while one way to avoid that is to cautiously not respond to allegations (just like they never responded when it was pointed out that the placebos used in their double-blind studies cause reactions identical to those caused by MSG), a second way is to change out the lie they’ve been telling for a lie less likely to be discovered.

In this case, the Glutes have moved their emphasis from “the glutamate in MSG is identical to the glutamate in plants, animals, and the human body,” to “Our bodies metabolize both [the glutamate in MSG and the glutamate present in food proteins] in the same way.”

Why bother?  What’s the big deal?  The big deal is that while the Glutes have insisted that the two glutamates are identical, Adrienne Samuels has explained how the two forms of glutamate differ.  And rather than take the chance that some media source slips out from behind the veil of silence that the Glutes have had in place since the 1991 60 Minutes program on MSG, and actually broadcasts the truth about the toxicity of MSG, they’ll change out one lie for another one that won’t be as easily invalidated.

The fallback to the metabolism of glutamate is a no-brainer, for there’s no research on the subject.  Certainly there are studies of the metabolism of glutamic acid (on November 28, 2021, 8,223 such studies were cited on pubmed.gov).  But there’s been no study of the metabolism of MSG. While “metabolism” of MSG has been mentioned many times, often by Glutes saying that the metabolism of the glutamate in MSG and the metabolism of glutamate from plant and animal proteins do not differ, there has been no study of the metabolism of MSG.

Another way to avoid being caught in a lie about the safety of MSG would be to simply stop lying about the safety of MSG.

Resources

Seven lines of evidence leading to the conclusion that manufactured free glutamate, no matter where it is found, is excitotoxic. https://7lines.org and https://bit.ly/3vkZ6Cl

Citizen Petition #1

https://www.regulations.gov/document?D=FDA-2021-P-0035-0001


Citizen Petition #2

https://www.regulations.gov/document/FDA-2021-P-0267-0001

Citizen Petition #3

https://www.regulations.gov/document/FDA-2021-P-0301-0001

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FDA panel approves Pfizer’s COVID vaccine … but there’s no FDA panel that ever said that MSG is ‘safe’

According to an article by Jackie Salo in the November 1, 2021 New York Post, the FDA has a panel that approves food and drugs submitted to them.   At least that’s what I took from her article, “FDA panel approves Pfizer’s COVID vaccine for kids ages 5-11.”

I was truly impressed. Although the article didn’t name the panel members, I thought there might be some real people from the FDA involved. And there might even be records in the Federal Register of past meetings held by panel members, and maybe even discussion of the data they had considered before making their recommendation.

But here’s the rub.  If you ask the FDA about the safety of monosodium glutamate or the free glutamic acid in it, the FDA will respond with the statement that MSG is “safe.”  And most often they will offer as evidence an allegedly “independent” review done by the Federation of American Societies for Experimental Biology, or FASEB, for the FDA by persons with serious conflicts of interest – an “independent” review that was rejected by the FDA and sent back to FASEB for an additional year’s study.  Or they will offer something called “Questions and Answers on MSG” that contains no evidence/data but instead reads like an excerpt from the glutamate-industry propaganda that is widely circulated by the U.S. manufacturer of MSG.

So, I decided to ask the FDA for the evidence – the data – behind making the assertion that MSG is “safe,” and spent the whole day Monday searching for someone who could answer that question – or even someone who could tell me how to ask that question. And before FDA closing time on Monday, I had filed the following Freedom of Information Act (FOIA) request:

“Requested are copies of data used by the FDA for determining to give GRAS (generally recognized as safe) status to free glutamic acid used in food.   Requested also are copies of data used by the FDA for determining to give GRAS (generally recognized as safe) status to monosodium glutamate (MSG) and other ingredients that contain free glutamic acid.  

“Also requested are copies of the scientific procedures used to produce those data.

“According to its U.S. manufacturer, the free glutamic acid produced by genetically modified bacteria for use in monosodium glutamate (MSG) was first used in food in 1957.  Since neither it nor its ensuant MSG had been used in food prior to that time, the newly developed MSG and manufactured free glutamate (MfG) could not have been found to be safe by reason of a history of safe use.  It is not possible for MSG produced in this manner to have been found safe by reason of a history of safe use.

“According to the Federal Food, Drug, and Cosmetic Act and the FDA Code of Federal Regulations, the use of a food substance may be GRAS only through scientific procedures or, for a substance used in food before 1958, through experience based on common use. I am not familiar with any data gathered through scientific procedures that demonstrate that free glutamic acid – which neuroscientists recognize as an excitatory – brain damaging – amino acid, is “safe.”  It is for that reason that I ask you to please send me all data, complete with the scientific procedures used to produce those data, that establish that free glutamic acid, MSG, or any other free-glutamate-containing food ingredient has met the requirements established by the FDA for establishment of GRAS status. I don’t believe that such data exist.”

The FOI request was submitted electronically.  Turnaround time should be 2-3 days, unless, of course, the FDA is short-staffed as they usually are when the Truth in Labeling Campaign asks for information.

In the meantime, I spent the evening anticipating just how the FDA would respond to a question about the safety of an excitotoxic – brain damaging – amino acid.  They’ve had fifty years’ experience fronting for the glutamate industry (1), and having chosen to ignore three Citizen Petitions filed with the FDA requesting that the FDA strip GRAS status from free glutamic acid, MSG and the other ingredients that contain free glutamic acid (2), I would expect them to be extremely creative.

They will of course offer the paper titled “Questions and Answers on Monosodium glutamate (MSG)” that is posted on the FDA website. It has the requisite number of MSG-is-safe statements and talks about reviews by authoritative bodies (all of whom did no reviews of data, but reviewed material brought to them by the FDA or other agents of the glutamate industry).  They will undoubtedly refer to the many negative studies that failed to conclude that MSG is harmful, without mentioning that in their double-blind studies, their agent in charge of glutamate-industry research supplied his researchers with placebos containing aspartic acid, an excitotoxic amino acid that produces both brain damage and reactions identical to those cause by the excitotoxic glutamic acid in MSG.

We’ll keep you posted.

Adrienne Samuels

References

Industry’s FDA https://www.truthinlabeling.org/fda.html

Webpage petition post summaries https://www.truthinlabeling.org/petition.html

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FDA/industry collusion: here’s how it works

The fiction about the safety of monosodium glutamate (MSG) is written by the U.S. manufacturer of MSG and distributed throughout the world by its many “outlets,” described in part in “Meet the Glutes:” https://www.truthinlabeling.org/glutes.html.

A large part of the Glutes’ post-1957 success in marketing MSG has been due to the close cooperation of the Food and Drug Administration (FDA) – the Glutes official mouthpiece for the “safety” of MSG. They’ve been partners since 1968 when the toxicity of MSG was first recognized. (https://www.truthinlabeling.org/assets/industrys_fda_final.pdf)

The Glutes rely heavily on repeating the statement that the FDA finds MSG to be GRAS (generally recognized as safe). The fact that in assigning GRAS status to MSG the FDA has violated its own rules is just one of many examples of the FDA’s allegiance to the glutamate industry (https://www.truthinlabeling.org/assets/FDA_is_in_violation_FINAL.pdf).

The story of FDA/glutamate-industry collusion is told in the pages of “Industry’s FDA” which can be accessed at https://www.truthinlabeling.org/assets/industrys_fda_final.pdf    

It details:

  • Blatant lies told about the safety of MSG, lies originating with the glutamate industry and repeated by the FDA,
  • Dispensing positive information about MSG while withholding information that might be considered negative,
  • Officially approving study protocols for MSG-is-safe studies that used placebos known to cause the same adverse reactions as those caused by MSG test material,
  • Refusing to collect reports of reactions to MSG “because we know that no one reacts to MSG,” and
  • Withholding key information from dietitians, nutritionists, consumers, and the medical community.

The most recent FDA contribution to the Glutes’ marketing plan has been the FDA’s failure to post my scathing response to the Glutes’ attack on my Citizen Petition FDA-2021-P-0267. Suppression of information such as that is often used by the glutamate-industry to promote their product.

My Citizen Petition FDA-2021-P-0267 was posted by the FDA on February 28, 2021. The Glutes sent in a condemnation of the Petition, received on August 15 and posted on August 19 (a four-day delay in posting).  In turn, I submitted a comment in which I tore apart the Glutes’ criticism, pointing out that platitudes but no data made up the body of their retort. My comment was marked received by the FDA on October 20, but as of November 3 it had not been posted (14 days without posting).

My guess (based on past glutamate-industry behavior) is that my critique of the glutamate-industry response would never have been posted had I not had the temerity to search out a way to contact Docket’s Management and disputed the omission.

“Oh” was what I heard from the person who picked up the phone when I finally got connected. “It must have been because it was so large that it got overlooked. Just give me half an hour to 45 minutes, and you’ll be able to see it posted.” (And in an hour, it was posted.)

More on suppression of information can be found in The toxicity/safety of processed free glutamic acid (MSG): a study in suppression of information. Account Res. 1999;6(4):259-310. doi: 10.1080/08989629908573933. PMID: 11657840.

We invite you to learn more about the FDA at https://www.truthinlabeling.org/assets/industrys_fda_final.pdf where you can get a feel for how your tax dollars are being spent for the benefit of the glutamate industry.

Adrienne

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Do they really think they can keep the FDA from removing the GRAS (generally recognized as safe) status from MSG and the other products that contain excitotoxic free glutamic acid?

As I mentioned in last week’s blog, on March 18 of this year, I submitted a Citizen Petition to the FDA requesting that the FDA Commissioner remove misleading and incorrect information presently displayed on the FDA website in a post titled “Questions and Answers on Monosodium Glutamate” (Q&A), and replace it with accurate information about monosodium glutamate (MSG) toxicity, which I supplied. 

On August 16, 2021, The Glutamate Association (TGA) and the International Hydrolyzed Protein Council (IHPC) submitted comments to Citizen Petition Docket No FDA-2021-P-0301, challenging my Petition.  They maintain that the Q&A accurately reflects the data and information on MSG, and that my proposed changes should be rejected.

Completely unrelated to the filing of my Citizen Petition, Kumar et al. published results of a study that looked at the relationship of dietary glutamic acid to obesity and depressive symptoms in patients with schizophrenia, and on October 24, 2021, Kahn, Sievenpiper, and Fernstrom (a long-time resource proficient in creating and spreading glutamate-industry disinformation) published a response – a criticism — of  the Kumar study. 

In analyzing that response, I found it to be generally characteristic of glutamate-industry propaganda, even inventing and using words and phrases that were not used in the Kumar et al. article, and then criticizing their own untruthful creative writing for containing statements that were untrue.

For those of you interested in things like fake news and scientific fraud, I have reproduced my response below, sent to the journal that published the Kahn, Sievenpiper, and Fernstrom piece, and included a question about how the journal allowed a critique, with no presentation of evidence/data, written by persons with conflicts of interest, to be published.

Adrienne Samuels

Samuels analysis of: Commentary: Dietary Glutamic Acid, Obesity, and Depressive Symptoms in Patients With Schizophrenia

Introduction

Kahn et al. (1) have criticized the article written by Kumar et al.(2), (The Article), attributing to it content that it did not have, stating as fact information that is not true, and criticizing information that is not relevant to the message of The Article.

Fabrications of content that The Article did not contain

Fabrication: “Their interpretation of the findings in non-obese individuals seems to be that ingesting dietary protein, which contains glutamate, raises blood glutamate concentrations sufficiently to cause an increase in glutamate penetration into brain, where it acts on neuronal glutamate receptors to cause depression.” [Emphasis added]

Fact: The phrase “raises blood glutamate,” the word “blood,” and the word “penetration” appear nowhere in The Article.

Fabrication: “The authors infer in their introduction that ingesting glutamate can lead directly to increases in brain glutamate levels and adversely modify brain functions via its neurotransmitter role.” 

Fact: Kumar et al. state that “Data shows that over activation of the NDMA receptors by glutamate can be neurotoxic and result in cell death (5).”

Falsehoods

Falsehoods are woven into the text of the Khan et al. criticism as misleading statements, untenable suppositions, and distortions of fact.

Misleading statements

Statement: “The authors conclusions are based on a linear regression analysis…”

Fact: The authors conclusions are based only in part on a linear regression analysis.

Untenable suppositions

“In Table 1 of their paper, the BDI data appear to be non-normally distributed…”

“Furthermore, it is possible that…”

“A non-linear or threshold analysis may show interesting…”

“We believe that the conclusions based upon a linearity assumption in this paper are spurious. If the authors were to run the analysis with appropriate transformation or explore non-linear or threshold analysis using appropriate methods (6), then we surmise that…”

“A more likely path through which dietary glutamate could influence the brain is via its interaction in the alimentary canal with glutamate receptors that occur in the mouth, stomach and intestines.

Distortions of fact / misleading statements 

Distortion: “Such increases in plasma glutamate are insufficient to push glutamate into brain, owing to…”  

Fact: plasma glutamate has never been shown to be relevant to glutamate induced brain damage.

Distortion: ‘These cells are joined by tight junctions, and form the “blood-brain barrier” (BBB)… that prevent glutamate passage from blood into brain (16).”

Fact: I know of only one author (reference 16) who alleges to demonstrate that the blood brain barrier (BBB) prevents glutamate passage from blood into brain, while there are studies that report BBB permeability. The five studies identified here are examples. (3-7).

Distortion: “humans do not willingly consume such large amounts of pure MSG, because it tastes unpleasant (26),” 

Fact: It is the free glutamate in MSG that is excitotoxic, and while the amount of free glutamate in any one ingredient may not be sufficient to cause adverse reactions or brain damage, since the 1957 change in method of MSG production, there are so many products that contain excitotoxins that it is easy for a consumer to ingest an excess of excitotoxic material during the course of a day (8-12).

When glutamic acid accumulates in quantities greater than needed for normal body function, glutamic acid becomes excitotoxic with glutamate neurotransmitter firing repeatedly at glutamate receptors until the cells associated with those glutamate receptors die. 

Brain damage done by excitotoxic glutamate to the fetus and neonate, passed to the fetus across the placenta and to newborns though mothers’ milk, causes obesity and behavior disorders, and reproductive dysfunction during maturity.  MSG (which contains free glutamate) can cross the placenta during pregnancy (13-15), cross the blood brain barrier (BBB) in an unregulated manner during development(16), and pass through the five circumventricular organs which are leaky at best at any stage of life (17-18). At one time it would have been meaningful to note that the excitotoxic material in a particular ingredient would not be sufficient to cause brain damage or adverse reactions.  But since the 1957 change in method of MSG production, there are so many products that contain excitotoxins that it is easy to ingest an excess of excitotoxic material during the course of a day (8-12). 

Information irrelevant to the subject of The Article

1) “Each antipsychotic (and antidepressant) should have been identified.… smoking should have been included as a factor in this study.”

2) The topics cited by Kahn et al. in their criticism of The Article (glutamate metabolism, the contribution of free glutamate to metabolism of glutamate, and plasma glutamate levels) as being misunderstood by Kumar et al. are topics without evidence/data relating them to glutamate-induced brain damage. None are relevant to the subject of The Article.

(Studies alleging these subjects are relevant to glutamate safety have always been sponsored by the glutamate industry.)

3) Information about taste, glutamate binding, and a distinction between protein ingestion and MSG ingestion are irrelevant to The Article.

Conflicts of interest of the critics

Sievenpiper admits working for a large segment of the processed food industry as well as the International Life Science Institute (ILSI), the International Food Information Council (IFIC), and the International Glutamate Technical Committee (IGTC), three representatives of the U.S. manufacturer of MSG.

In the face of a 1991 60 Minutes program on monosodium glutamate, the IFIC ran damage control for MSG manufacturer Ajinomoto.  Prior to being exposed for inappropriate conduct, the IGTC‘s chairman designed and implemented double-blind studies claiming there was no evidence that MSG is toxic.  Their “fail-safe” tactic was to use excitotoxic aspartic acid in placebos.  Aspartic acid is an amino acid known to cause adverse reactions identical to those caused by the glutamate in MSG.

Fernstrom has represented the interests of the glutamate industry for more than four decades. And given the extremes to which he has gone to reinvent the article being criticized, this work gives every appearance of suffering from conflicts of interest.

Summary and conclusions

The article, Commentary: Dietary Glutamic Acid, Obesity, and Depressive Symptoms in Patients With Schizophrenia by Khan, Sievenpiper and Fernstrom is nothing but an exercise in disinformation.

References

1. Kahn TA, Sievenpiper JL, Fernstrom JD.  Commentary: Dietary Glutamic Acid, Obesity, and Depressive Symptoms in Patients With Schizophrenia. Front Psychiatry. (2021) 14 October 2021 | https://doi.org/10.3389/fpsyt.2021.725786

2. Kumar P, Kraal AZ, Prawdzik AM, Ringold AE, Ellingrod V. Dietary Glutamic Acid, Obesity, and Depressive Symptoms in Patients With Schizophrenia. Front Psychiatry. (2021) Jan 21;11:620097. doi: 10.3389/fpsyt.2020.620097. PMID: 33551881; PMCID: PMC7859478.

3. Pollak TA, Drndarski S, Stone JM, David AS, McGuire P, Abbott NJ. The blood-brain barrier in psychosis. Lancet Psychiatry. (2018) Jan;5(1):79-92. doi: 10.1016/S2215-0366(17)30293-6. Epub 2017 Aug 3. PMID: 28781208.

4. 8. Vazana U, Veksler R, Pell GS, Prager O, Fassler M, Chassidim Y, Roth Y, Shahar H, Zangen A, Raccah R, Onesti E, Ceccanti M, Colonnese C, Santoro A, Salvati M, D’Elia A, Nucciarelli V, Inghilleri M, Friedman A. Glutamate-Mediated Blood-Brain Barrier Opening: Implications for Neuroprotection and Drug Delivery. J Neurosci. (2016) Jul 20;36(29):7727-39. doi: 10.1523/JNEUROSCI.0587-16.2016. PMID: 27445149; PMCID: PMC4951577.

5. Michinaga S, Koyama Y. Dual Roles of Astrocyte-Derived Factors in Regulation of Blood-Brain Barrier Function after Brain Damage. Int J Mol Sci. (2019) Jan 29;20(3):571. doi: 10.3390/ijms20030571. PMID: 30699952; PMCID: PMC6387062.

6. Gynther M, Petsalo A, Hansen SH, Bunch L, Pickering DS. Blood-brain barrier permeability and brain uptake mechanism of kainic acid and dihydrokainic acid. Neurochem Res. (2015) Mar;40(3):542-9. doi: 10.1007/s11064-014-1499-4. Epub 2014 Dec 9. PMID: 25488153.

7. Zhang C, Jiang M, Wang WQ, Zhao SJ, Yin YX, Mi QJ, Yang MF, Song YQ, Sun BL, Zhang ZY. Selective mGluR1 Negative Allosteric Modulator Reduces Blood-Brain Barrier Permeability and Cerebral Edema After Experimental Subarachnoid Hemorrhage. Transl Stroke Res. (2020) Aug;11(4):799-811. doi: 10.1007/s12975-019-00758-z. Epub 2019 Dec 12. PMID: 31833035.

8. Hashimoto S. Discovery and History of Amino Acid Fermentation.  Adv Biochem Eng Biotechnol. (2017)159:15-34. https://pubmed.ncbi.nlm.nih.gov/27909736/

9. Sano C. History of glutamate production. Am J Clin Nutr. (2009) 90(3):728S-732S.  https://pubmed.ncbi.nlm.nih.gov/19640955/

10. Market Research Store. Global Monosodium Glutamate Market Poised to Surge from USD 4,500.0 Million in 2014 to USD 5,850.0 Million by 2020.https://www.globenewswire.com/news-release/2016/03/17/820804/0/en/Global-Monosodium-Glutamate-Market-Poised-to-Surge-from-USD-4-500-0-Million-in-2014-to-USD-5-850-0-Million-by-2020-MarketResearchStore-Com.html  (Accessed 5/29/2020.)

11. Open PR Worldwide Public Relations for Verified Market. Global Flavor Enhancers Market. https://www.bccresearch.com/partners/verified-market-research/global-flavor-enhancers-market.html (Accessed 5/29/2020.)

12. Dataintelo. Global Food Flavor Enhancer Market Report, History and Forecast 2014-2025, Breakdown Data by Manufacturers, Key Regions, Types and Application.  https://dataintelo.com/report/food-flavor-enhancer-market   (Accessed 5/29/2020)

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14. Gao J, Wu J, Zhao XN, Zhang WN, Zhang YY, Zhang ZX. [Transplacental Neurotoxic Effects of Monosodium Glutamate on Structures and Functions of Specific Brain Areas of Filial Mice.] Sheng Li Hsueh Pao. Acta Physiologica Sinica. (1994) 46(1), 44–51. 

15. Yu, T.; Zhao, Y.; Shi, W.; Ma, R.; Yu, L. Effects of Maternal Oral Administration of Monosodium Glutamate at a Late Stage of Pregnancy on Developing Mouse Fetal Brain. Brain Res. (1997) 747(2), 195–206. DOI: 10.1016/S0006-8993(96)01181-X. 

16. Skultetyova, I.; Tokarev, D.; Jezova, D. Stress-induced Increase in Blood-brain Barrier Permeability in Control and Monosodium Glutamate-treated Rats. Brain Res. Bull. (1998) 45(2), 175–178. DOI: 10.1016/S0361-9230(97)00335-3. [Crossref], [PubMed], [Web of Science ®], [Google Scholar]

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