The Truth in Labeling Campaign


Was the FDA ever a protector of human health?

It is the FDA that makes and enforces food labeling laws; and it is the FDA that determines whether or not MSG, or any other chemical, will be approved for use in food. Thus, the FDA holds the keys to life and death for many Americans, many of whom still believe that it is the welfare of consumers, not the profits of the food and/or drug industries, that concern the FDA.

A great deal of industry’s success in keeping excitotoxic amino acids hidden (unlabeled) in processed foods can be attributed to their campaign against identifying toxic substances through labeling. In the 1970s, growing numbers of consumers realized that they reacted with things like asthma, migraine headache or seizures when they consumed something that contained monosodium glutamate (MSG). But it wasn’t until 1988 when George Schwartz, M.D. published “In Bad Taste: the MSG Syndrome,” that consumers began to understand that it was the Manufactured Free Glutamate in MSG that was causing their reactions.

This fact is relevant to the FDAs role in sustaining Ajinomoto’s push to keep the truth about the toxic effects of their product, MSG, from the public. The FDA’s failure to distinguish between the product called MSG, and the other products that contain MSG’s toxic manufactured free glutamate (MfG) has been used continuously to confuse and deceive consumers. But that’s just a pimple on the face of things that the FDA does for Ajinomoto.

In 1988, consumers were used to referring to their reactions to MfG as “MSG-reactions” even if there was no ingredient called monosodium glutamate in the offending product. And the FDA allowed manufacturers to claim “no MSG” or “no MSG added” to products that contained MfG but not MSG.

The glutamate industry, led by Ajinomoto, understood that if all MfG in all processed food was labeled, consumers would be able to determine whether or not an MfG-containing ingredient or product caused them to have irritable bowel, skin rash, migraine headache, seizures or any other adverse reaction.

Why would that be important? Because if consumers were able to identify the MfG in the things they used and food they consumed, the fact that asthma, dizziness, and/or depression, for example, always followed use of MfG use might become obvious. The glutamate industry wouldn’t like that at all. It might make it difficult to continue selling consumers—or maybe even the medical community—on the idea that MfG is harmless.

The FDA has never dealt with the toxicity of MfG. They’ve only focused on confirming the safety of Ajinomoto’s product, MSG. To that end, the FDA has cooperated with the glutamate industry at every turn. Its cooperation can be traced back to September 1969, when then FDA Commissioner Ley testified before the Senate Select Committee on Nutrition and Health, presenting evidence from four studies that, he alleged, demonstrated MSG was safe. It was later disclosed that two of those studies were incomplete, and two didn’t even exist.

The big picture

Overall

…There have never been any meaningful regulations for identifying MSG or the amount of MSG in any product. The FDA’s refusal to identify MSG through labeling is central to the success of the glutamate industry in promoting its toxic product.

…The FDA has ignored evidence of monosodium glutamate toxicity.

-The first study of MSG toxicity, actually MSG-induced brain damage, was published in 1969. There was a congressional inquiry into the possible danger of using MSG in baby food, which resulted some ten years later in industry “voluntarily” removing MSG from baby food, and replacing it with other sources of MfG. The FDA took no action.

-The flawed nature of Ajinomoto’s International Glutamate Technical Committee (IGTC) research was exposed in 1993 when evidence from the files of the FDA that the IGTC used aspartame in their placebos was brought to the attention of the FDA. In that year, FDA Commissioner Kessler was asked to investigate the FDA's use of badly flawed studies in their determination that monosodium glutamate is safe. The request was ignored. (They do that a lot. Don’t deny. Don’t respond. Just ignore.)

- In its 1995 report to the FDA, the Federation of American Societies for Experimental Biology (FASEB) acknowledged that it was inappropriate to use aspartame in placebos used in double-blind studies of the safety of MSG and the FDA did not dispute FASEB's conclusion. Nonetheless, the FDA still allows the unregulated use of MSG in processed food.

-The FDA has ignored the fact that studies presented to it by the IGTC as evidence that MSG was a harmless food additive used MSG-containing ingredients other than monosodium glutamate as well as neurotoxic aspartic acid (found in aspartame) in their placebos. (Don’t deny. Don’t respond. Just ignore.)

…The FDA cooperated with Ajinomoto in designing studies from which the industry would claim to have demonstrated that MSG was a safe food additive. Evidence to that effect exists (or existed) in the files of the FDA:

- A July 13, 1990 letter from IGTC chairman Ebert to Walter Glinsmann, M.D., Associate Director of Clinical Nutrition, Division of Nutrition, FDA, reads, in part “...attached are three [double-blind] protocols for your use...IGTC would be interested in your views, especially on the proposed work by Drs. Kirby and Kjos.”

- A January 2, 1991 letter from IGTC chairman Ebert to Fred R. Shank, Ph.D., Director, Center for Food Safety and Applied Nutrition, FDA, requested a scientific review session on MSG with FDA scientists. IGTC chairman Ebert elaborated on what the IGTC wanted covered at the meeting, and offered the names of FDA personnel who should attend. “In the past, IGTC has requested meetings with FDA staff for purposes of informal reviews of MSG research. Scientists who have carried out studies on MSG, usually in university laboratories or clinics, have presented their data to agency scientists for review and discussion….If Dr. Donald Kirby, who is currently carrying out research on MSG at the Medical College of Virginia, has sufficient clinical data by the time of an FDA meeting we would propose inviting him also.”

After elaborating on what the IGTC wanted covered at the meeting, the chairman continued: “As FASEB plans a one day Hearing on Free Amino Acids on February 4, 1991, it seems advisable to complete an FDA meeting prior to that date....FDA scientists who have participated in MSG research discussion in the past included among others: Drs. Shank, Hattan and Scheuplein. Others who would be key attendants include Drs. Rulls, Lin and Bailey...Members of the IGTC/TGA Executive Committee also would plan to join the meeting.”

- A December 9, 1991 FDA Memorandum of Conference notes that “The IGTC requested the meeting to discuss a protocol that they are currently developing for a proposed food allergy study involving MSG. We informed the visitors that we will provide our comments only after they have submitted a written protocol to us with some detailed description of the proposed study.”

- A September 4, 1992 FDA Memorandum of Conference reads: “Dr. Kimura gave me a copy of the [IGTC] request (dated 8/20/92) for a meeting with the Commissioner and a copy of the Bob MacLeod’s brief response (dated 9/3/92) to the IGTC. We both agreed that once a description of their research plan (or protocols) is given to us, a meeting will be scheduled for their scientists to discuss with our review staff regarding their research plan aimed to resolve scientific issues surrounding adverse reactions allegedly caused by monosodium glutamate consumed in food.”

- On October 23, 1992, the FDA hosted a conference at the Center for Food Safety and Applied Nutrition, FDA. Present were Geha (Harvard Medical School), Saxon (UCLA Medical School), Patterson (Northwestern University Medical School), Ebert, (Chairman IGTC), Yoshi-hisa Sugita (IGTC), Takeshi Kimura (IGTC); and Hattan, Tollefson, Glinsmann, Bailey, and Lin of the FDA. Protocols for the Geha, Saxon, Patterson study called for use of aspartame in placebos, as had all other double-blind studies receiving FDA approval.

…The FDA has suppressed information pertaining to the toxic potential of MSG.

- In 1992, the FASEB study on the safety of amino acids in dietary supplements had warned about the use of MSG in them. That information was never shared with the public.

- As early as 1990, the FDA became aware that MSG produced through acid hydrolysis of proteins contains carcinogenic mono and dichloro propanols. That information has never been shared with the public.

- MSG produced through acid hydrolysis of proteins contains carcinogenic mono and dichloro propanols. If enzymes were used to produce hydrolyzed proteins, this wouldn’t be the case, but since using enzymes is more costly than using acid, most of the hydrolyzed protein products found on grocers’ shelves contribute to the development of cancer. The FDA has been thinking about sharing that information with the public since 1990.

- In 1992, the FDA commissioned FASEB to do an independent review of research on the safety (never toxicity) of monosodium glutamate in food. The FDA has admitted, in reports of adverse reactions on file at the FDA, that headache (they don't call it migraine headache) has been reported as an adverse reaction by over 43 per cent of the people reporting reactions to monosodium glutamate. With possible rare exception, monosodium glutamate is acknowledged as a migraine headache trigger by every headache clinic in this country.

In 1991, Alfred Scopp published a study entitled "Monosodium glutamate and hydrolyzed vegetable protein induced headache: review and case studies". But neither Scopp's study nor the subject of migraine headache are discussed in the August 31,1995 FASEB report.

In FASEB’s "independent" study, questions were posed by the FDA to which FASEB responded. FASEB ignored all others. Panel members suffered from conflicts of interests; failed to consider all data relevant to the safety/toxicity of monosodium glutamate; dismissed, or attempted to dismiss, data that did not fit well with a conclusion that monosodium glutamate is safe. The FDA rejected FASEB’s September, 1994 final draft report (of the allegedly independent investigation); shared the contents of that September, 1994 final draft report with agents of the glutamate industry--but no one else; and made the final FASEB report available to glutamate industry agents--but to no one else--prior to distribution. Requests to FASEB, to the FDA’s Dr. David Hattan, and to Freedom of Information for copies of the report have been ignored.

The FDA has actively promoted the safety of MSG
-The FDA has published and distributed material attesting to the safety of monosodium glutamate in the FDA Medical Bulletin and more in the FDA Backgrounder.

-The FDA reinforces the misinformation put out by the glutamate industry, distortions of fact like, “The glutamic acid in monosodium glutamate is identical to the glutamic acid in whole protein.”

-The FDA tells people that the free glutamic acid in processed food is identical to the free glutamic acid found in unprocessed food and in higher organisms, without reference to the fact that the free glutamic acid in processed food is invariably accompanied by impurities.

-The FDA-sponsored investigations into the safety of monosodium glutamate have always been rigged. Material reviewed by FDA reviewers has been limited largely to industry-produced studies, with just enough independent research for investigators to point to and say “we’ve looked at that.” Moreover, the reviewers themselves have had industry affiliations.

- When the glutamate industry wasn’t satisfied with the outcome of an FDA investigation, the final report of that investigation would be rewritten. That was obvious of the 1978 FASEB report rewritten and republished in 1980, and in the 1994 FASEB report rewritten and published in 1995.

-The FDA has done original research for the benefit of the glutamate industry.

- We knew that in all of this, the FDA parrots the words of Ajinomoto’s The Glutamate Association, the IGTC, and whatever other front groups they have established. (Since IGTC Chairman Ebert was exposed for overseeing double-blind studies using excitotoxic aspartic acid (in aspartame) in placebos used in MSG-safety studies, the IGTC is rarely spoken of by Ajinomoto.)

Bits and pieces of FDA/industry collusion
-The FDA has allowed “monosodium glutamate” to be given as an illustration of a common safe food:

“It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as safe for their intended use.” (CFR 21 582.1)

-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, was in direct violation of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act. Yet, the FDA has allowed the words “No added MSG” and “No MSG added” to be used, illegally, on labels of foods that contain MSG.

-The FDA Adverse Reactions Monitoring System (ARMS) established to record reports of adverse reactions to sulfites, aspartame, and MSG never solicited information on MSG or aspartame. The FDA disbanded the ARMS when the lawsuit against the FDA was settled, and the need to pretend it was interested in the toxic potential of MSG and aspartame lessened. At the time, the statement was made that everyone knew that MSG and aspartame were harmless, and there was no sense in keeping reports of reactions.

- When legislators receive inquiries or calls for help from constituents, they are forwarded to the FDA which, in turn, assures both legislator and constituent that there is no cause for concern.

- On the rare occasion that the FDA acknowledged the question of MSG’s safety, evidence of possible MSG toxicity would be submitted to representatives of the glutamate industry for evaluation, in order to allow them to confirm its safety.

- When the FDA/HHS Office of the Inspector General (OIG) was petitioned to investigate the charge that the behavior of the FDA was inappropriate, the OIG turned the investigation over to the Office of Research Integrity (ORI), thereby guaranteeing that the petition would be killed. The ORI oversees and directs many Public Health Service research integrity activities on behalf of the Secretary of Health and Human Services, but does not oversee regulatory research integrity activities of the FDA. Therefore, under no circumstances would the ORI have jurisdiction in this matter.

In May, 1992, the Journal of Dental Hygiene cited the FDA’s David Hattan as saying "The FDA's findings were based on the scientific studies provided by the Glutamate Association. The work has been supported by people with an interest in glutamate: consortiums and manufacturers." Earlier Hattan had told a toxicology forum in Aspen Colorado that glutamic acid was implicated in a number of disease conditions. According to Hattan, "'developing data on exogenous and endogenous excitogens or excitotoxins has been the primary spur to the Food and Drug Administration's review of monosodium glutamate." Hattan was central to the debate on the safety/toxicity of MSG, being Deputy Director for the Division of Toxicological Review and Evaluation, at the FDA, and the FDA liaison to FASEB relative to the 1995 FASEB analysis of adverse reactions to monosodium glutamate (MSG). Yet there is no evidence that Hattan raised any question about the propriety of the research being submitted to the FDA by the IGTC as evidence that MSG is safe.

- Minutes of FDA meetings with consumers were changed when it served the purposes of the glutamate industry.

- Medical evaluations of MSG-sensitive people were altered by the FDA.

- In 1992 the FDA chose Ajinomoto’s International Glutamate Technical Committee (IGTC) Chairman Andrew G. Ebert and Kristin McNutt another IGTC operative, to serve as consumer advocates on its Food Advisory Committee.

-The FDA refused to be discovered when sued over its failure to require identification of MSG through labeling. When challenged in a suit over full and clear labeling of MSG, the Court considered nothing but the Administrative Record presented by the FDA. Studies that demonstrated the MSG had toxic potential were not allowed as evidence because they were not submitted to the Court by the FDA as part of its Administrative Record. The Administrative record was made up of material that the FDA needed in order to win its case, plus a smattering of material from the opposition that had no bite to it, but to which the FDA could point and say, "we looked at that."

- When FDA Dockets Management copied material that the Truth in Labeling Campaign requested they made extra copies, which we suspected were being sent to those who wanted to know what we were up to.

- The FDA approves the use of glutamate-blocking pharmaceuticals while encouraging industry to pour processed free glutamate into processed food.

-The FDA refuses to provide consumers with lists of ingredients that contain MfG.

-The FDA allows the term “natural” to be used in reference to excitatory amino acids.

-The FDA allows the glutamate industry to create and use sources of MfG that contain carcinogenic mono and dichloro propanols and heterocyclic amines.

Confirmation of FDA/industry cooperation will be found in the files of the FDA.

A look at the future
It had been suggested that with the Obama administration, care might be taken to turn the FDA back to its original charge of guaranteeing the safety of both food and drugs. But with the appointment of Michael R. Taylor, former partner in the law firm of King & Spalding, and former vice president for public policy of Monsanto Company, to Obama’s transition team and from there to the post of FDA Deputy Commissioner for Foods, all hope for a return to concern for consumers disappeared.

Michael Taylor is a cousin (maybe second cousin) of Tipper Gore, the wife or former wife of Al Gore, vice president under President William Clinton. The work experience he brings to his most recent job at the FDA comes from years of dedicated service to Monsanto.

Michael Taylor is the man from President Clinton’s FDA who oversaw FDA approval of rBGH (recombinant bovine growth hormone), and thereby subjected citizens of this country, and many others, to increased risk of breast, prostate, and colon cancer. rBGH is a genetically engineered, potent variant of the natural growth hormone produced by cows. Its use forces cows to increase their milk production by about 10%, makes cows sick, and facilitates the production of milk that’s chemically and nutritionally different than natural milk.

Michael Taylor has additional glutamate industry credits. He was instrumental in securing FDA approval of aspartame.

MSG-sensitive people may remember Michael Taylor from his November 3, 1991 performance on “60 Minutes,” where he represented the interests of the FDA and Ajinomoto (close friend of Monsanto) by answering Mike Wallace’s questions. All Taylor would say was that the FDA was looking into labeling. The FDA doesn’t even pretend to do that anymore.

On January 14, 2010, Lyndsey Layton wrote an article on Michael Taylor for the Washington Post. It was an excellent article, covering every aspect of his professional career, and included the following information: “Taylor is a familiar figure at the FDA. He began his career as a staff attorney at the agency in 1976. Then he worked for a decade at King & Spaulding, which represented Monsanto Corp., the agribusiness giant that developed genetically engineered corn, soybeans and bovine growth hormone.

“He returned to the FDA in 1991 as deputy commissioner for policy and pushed through requirements that producers of seafood and juices adopt measures to prevent bacterial contamination. During the same period, the FDA approved Monsanto’s bovine growth hormone, and Taylor was partly responsible for a controversial policy that said milk from BGHtreated cows did not have to be labeled as such.

“In 1994, Taylor went to the U.S. Agriculture Department to run its food safety program. He required meat and poultry producers to take measures to prevent bacterial contamination, despite strong opposition from those industries. Observers expect Taylor to impose those same kinds of preventive controls on all the foods regulated by the FDA.

“After the USDA, Taylor went to work for Monsanto as a vice president for public policy. He moved on to a think tank and then a teaching stint at George Washington University.”

“He is the quintessential revolving door,’ said Marion Nestle, a professor of nutrition, food studies and public health at New York University. Taylor’s support for BGH and Monsanto’s other genetically modified products at the FDA was ‘questionable,’ she said. ‘On the other hand, when he went to USDA, what he did there was absolutely heroic. He’s been very strong on food safety.”

You might notice that the measures Michael Taylor took at the USDA to promote food safety didn’t negatively impact Monsanto. Similarly, nothing acted on by Taylor as FDA Deputy Commissioner for Foods impacted Monsanto negatively. In cases other than those where the negative role of big business is so gross as to be undeniable, regulation will be aimed at small, generally independent, businesses.

At the FDA, protecting the American public from toxic additives intentionally added to processed food won’t be considered. Enforcing regulations prohibiting deceptive and misleading labeling, such as claims that there’s no MSG added to products that contain it, is something that will never happen.

The FDA holds incredible power. It is considered an expert in the areas of food, drug, and cosmetic safety by all branches of government; so in any argument over matters of science, the word of the FDA will, with rare exception, be the final word. In addition, the files of the FDA are privileged. Under the provisions of the Administrative Procedures Act, the FDA need disclose to the public, or the Courts, only that information which is part of the Administrative Record for the matter in question; and it is the FDA that determines what the Administrative record for any question shall be.

It doesn’t matter who is US president, or even FDA Director. The industry rule of the FDA is expressed in every agent. It’s a secure job as long as you don’t disturb either food or drug industry giants. Some look forward to taking a pension after 20 years of service and moving through the revolving door into industry – and whistle-blowers are punished.

The FDA is “a lap dog, not a watch dog.” And neither the president nor the Congress ever walks the dog.

 

The truth, the whole truth, and nothing but the truth about MSG and MfG