Why Did The FDA Recall L-Tryptophan In 1989?

Concealing The Truth With Politics



L-tryptophan received a lot of media attention in 1989. Why? Because numerous people fell gravely ill after taking tryptophan supplements.

After a huge number of studies examined the issue, it turned out that the culprit was product contamination of supplements containing the amino acid L-tryptophan, all of which originated from a single manufacturer. Yet shortly thereafter, defying any sound reasoning, the FDA (U.S. Food and Drug Administration) issued a general ban on tryptophan supplements, regardless of who manufactured the products.

The truth about the FDA and its prohibition of L-tryptophan is that the federal agency played politics, namely favoritism, that is, it protected the interests of specific corporate groups the FDA has unholy connections with.



The Tryptophan-Associated EMS Disaster

Caused By A Single Manufacturer Of L-Tryptophan

In 1989 some nutritional supplements containing L-tryptophan caused serious harm such as eosinophilia-myalgia syndrome (EMS) which left at least 1,500 people permanently disabled and resulted in about three dozen subsequent deaths upon the consumption of the amino acid (Hill, et al., 1993; Druker, 2001; Official US Government FDA website, accessed July 2012).

EMS, first characterized in 1989, officially marked a new human disease.

Tryptophan-associated EMS is a conglomerate of connective tissue disorders, hallmarked by debilitating flu-like symptoms epitomizing an inflammatory-allergic state. The primary syndromes of the illness are a high blood eosinophil count (eosinophilia) in conjunction with severe pain and weakness in muscles and joints (myalgias) along with chronic longterm effects, such as nerve dysfunction (neuropathy), edema, and skin thickening (scleroderma), following the discontinuation of over-the-counter preparations containing L-tryptophan (Swygert, et al., 1990; Kaufman, et al., 1991).

EMS bears striking clinical and pathological resemblance to eosinophilic fasciitis (an inflammation, swelling, and thickening of the connective tissue beneath the skin), "the fibromyalgia syndrome" (Barth, et al., 1999), and "the toxic oil syndrome" (Patterson & Germolec, 2005).

Various tests found out later that the implicated tryptophan dietary supplements were contaminated with dozens of substances (Hill, et al., 1993), including a topically used antibiotic which is toxic for ingestion (Barnhart, et al., 1996). The cause of adulteration was traced unmistakably to a single supplement manufacturer in Japan, Showa Denko K. K. (Slutsker, et al., 1990; Hill, et al., 1993; Back, et al., 1993; Henning, et al., 1993; Mayeno & Gleich, 1994; Kilbourne, et al., 1996).

In scientific experiments of several different “brands” of L-tryptophan, only the Showa Denko tryptophan was clearly and causatively linked to EMS (Kilbourne, et al., 1996).



Tryptophan-EMS... Not The Usual Case Of Product Contamination

What US Health Authorities Failed To Acknowledge: The Obfuscation Of The True Cause

In the early 1980s bacterial fermentation began to replace chemical synthesis as the method to produce amino acids, vastly enhancing obtainable yields (Sidransky, 2001). Bacteria are grown and cultivated in large containers to foster tryptophan synthesis. The supplement nutrients are then extracted from the microorganisms, purified, and finally processed into nutritional supplements.

In a research article entitled The Skeleton In The GMO Closet –Did Genetic Engineering Cause The Tryptophan-EMS Disaster Of 1989? by award-winning journalist Ingeborg Boyens she claimed the disaster was caused by the introduction of genetically engineered (GE) bacteria which were used, for the first time, in the manufacturing of the nutritional supplement by Showa Denko K. K. to increase tryptophan formation and thus product output (Boyens, 1999).

Unfortunately, the genetic modification of bacteria resulted in the inclusion of several toxic contaminants into the L-tryptophan products.

The "advanced" technology of genetic modification (also known as "genetic engineering" (GE) or "biotechnology") –that creates genetically altered foods, also known as GMO foods (What is GMO? The GMO definition is "genetically modified organism" or GMOs for "genetically modified organisms")– involves or includes the forceful, artificial (i.e., unnatural) insertion of genetic material (e.g., a genetically modified gene, a.k.a a transgene) across different species of living entities (e.g., from microbes into plants, or from plants into animals), leading to numerous mutations, and the introduction of new, untested toxicants, such as allergens and carcinogens (Smith, 2012).

The outcome of the (longterm) ingestion of GM food (genetically modified foods) is systemic inflammation in the body which raises the risk of allergies, autoimmune diseases, digestive disorders, diabetes, cancer, heart attacks, Alzheimer's Disease, and many other illnesses (Antoniou, 2012; Séralini, et al., 2012; Smith, 2012). Evidently, the dangers of GMO foods are substantial.

Boyens reported the following regarding this account of tryptophan impurity:

“According to U.S. law, the company was allowed to sell the L-tryptophan produced in gene-spliced bacteria without any safety testing because it and other firms had been selling the supplement produced in non-genetically engineered bacteria for years without ill effects.” (Boyens, 1999)

And...

“[...], this seemingly minor tinkering apparently produced a toxic brew.” (Boyens, 1999)

Another study noted that there was a strong positive correlation between EMS cases and L-tryptophan supplements from a batch of products where less filtering of the new bacteria was performed in one of Showa Denko's purification steps (Belongia, et al., 1990).

One of the contaminants in particular, known as peak E or EBT, seemed to be strongly associated with the harm caused by supplemental tryptophan tainted with impurities because this L-tryptophan toxicant (an analog of the amino acid) notably promotes inflammation and fibrosis which are prominent features of the EMS syndrome (Silver, et al., 1994; Takagi, et al., 1995; Zangrilli, et al., 1995; Buss, et al., 1996; Saito & Miyamoto, 1996).

However, the Japanese company denied that GMOs were the cause of the tryptophan eosinophilic myalgia disaster, but that it was other non-GE-related changes in the production of the tryptophan supplements which led to contaminated, harmful batches of the products (Boyens, 1999).

In other words...

Showa Denko wanted the public to believe that it was a simple case of bad manufacturing, rather than of genetic engineering.

Showa Denko destroyed all the evidence concerning the details of the manufacturing of the synthetic tryptophan supplements so that even an inspection of the facility by the US FDA produced zero relevant data, and the FDA's repeated requests for samples of the altered bacteria were refused by the company every time (Boyens, 1999).

Other investigations (e.g., Crist, 2005) unearthed data showing it was the FDA that displayed a disinterest in getting the GMO-tainted L-tryptophan samples.

Apparently, the FDA kept quiet for a long time about their knowledge of the involvement of GE bacteria, probably to protect the powerful GMO industry (Boyens, 1999).

Further evidence of the Showa Denko-FDA cover-up came from an extensive, independent investigation by William E. Crist, spanning over several years.

Crist documented that...

... Showa Denko had used GE bacteria in their L-tryptophan production as early as 1984 (which explains the hundreds of supplemental tryptophan-EMS cases prior to the 1989 disaster, using Showa Denko products), and, that...

... the FDA had knowledge about the company's prior use of GMO tryptophan supplements, using different GE strains than those responsible for the 1989 incident (Crist, 2005).

Boyens noted regarding the famed trytophan contamination case:

“The FDA had learned as early as November 1989 that the company [=Showa Denko] had genetically engineered its bacteria. However, the agency neglected to reveal the fact until August 1990, when it was forced to respond to an article in Newsday.” (Boyens, 1999) [explanation & emphasis added]

Incidentally, "November 1989" was also the time period when the FDA issued an indiscriminate, across-the-board recall of L-tryptophan preparations (Swygert, et al., 1990).

Testimonies from public hearings by FDA officials revealed that the FDA had known that the most likely culprit was GE L-tryptophan but instead had used the contamination tragedy to deceptively put the blame on the “dangers of supplements” (Druker, 2001).

Steven M. Druker, JD, pointed out that:

“Not only was the agency aware of uncertainties within its own ranks, it also knew there was considerable disagreement about the safety of genetically engineered foods in the scientific community at large.” (Druker, 2001) [emphasis added]

[Aside the L-tryptophan incident, the FDA has a rather ominous history of overlooking, denying, or covering up the warnings of its own scientists, primarily to protect big corporate industries, such as mainstream medicine –addressed in my article "Tougher Supplement Regulation: A Necessity Or Politics?" (see 'Recommended next page(s) at the end of this article)]

Ingeborg Boyens, commenting on the L-tryptophan-EMS outbreak of 1989-90, concluded with:

“It was never definitively determined if the toxic assault had been caused by slipshod production –a consequence of Showa Denko cutting back on the level of its filtration– or on genetic engineering gone wrong. More than two hundred scientific studies tried to determine what happened.” (Boyens, 1999)

Crist was more firm in his conviction about the cause of the L-tryptophan tragedy:

“The whole question surrounding Showa Denko's use of GE bacteria appears to have been downplayed or dismissed outright by researchers and government agencies, especially here in the United States –where the biotech industry would stand to lose the most if GE was implicated in, or linked to, a major epidemic like EMS.” (Crist, 2005) [emphasis added]

Thus...

"[...] US scientists and government regulators appear to have used the same tactic as the implicated manufacturer [=Showa Denko], namely, that the issue of genetic engineering is not something to be disclosed outside (to the public). Instead, they offer a vague explanation that the contaminants linked to the EMS tragedy were caused by changes in the manufacturing process." (Crist, 2005) [explanation & emphasis added]

An organization of independent scientists and doctors that appraised the evidence surrounding the deadly L-tryptophan accident (and the subsequent outlaw of L-tryptophan supplements) came to the same basic conclusions:

"Most importantly, two of the poisonous substances "IMT" and "EBT" were abnormal substances similar to tryptophan, which strongly indicates that the abnormality was caused by the manipulation of genes involved in the production of tryptophan." (PSRAST, 2007) [emphasis added]

And...

"[...] it is established beyond reasonable doubt that some product from disturbed metabolism due to genetic engineering was the ultimate cause of the deadly disease." (PSRAST, 2007) [emphasis added]



The Crux Of The L-Tryptophan EMS Incident

–Product Adulteration (With GE Bacteria), Not Innate Side Effects Of Dietary Supplements

In the article Health Risks From Dietary Supplements –Contaminated Supplements I pointed out that in most cases of (more) serious side effects of nutritional supplements it usually is product adulteration (or instances of overdosing), rather than integral toxicity issues of supplement ingredients, that is responsible for the harm.

The L-tryptophan associated EMS calamity of 1989 was too, ultimately, a matter of supplement contamination, whether it was due to low-quality manufacturing or, and much more likely, due to the introduction of GE bacteria and their toxic by-products, rather than a safety matter with the actual ingredient in and off itself because that is the customary scenario with nutritional supplements and side effects.

Although, L-tryptophan –among all of the amino acids– does seem to have an inherently higher, rather serious, toxicity profile that should not be neglected (I discussed this in Tryptophan Side Effects: L-Tryptophan Is Far From Harmless). The GE tryptophan may have exacerbated "innate" L-tryptophan toxicity.

For example, I think it isn't far-fetched to assume that some of these foreign GE substances in the tainted L-tryptophan supplements responsible for the 1989 catastrophe may have unfavorably altered certain metabolic pathways of tryptophan, thus increased poisonous tryptophan metabolites. And conceivably, vice versa, inflammatory L-tryptophan degradation products may have elevated the toxicity of GE tryptophan.

Rodent experiments, for instance, found that
both contaminated and purportedly unpolluted L-tryptophan produced EMS-like pathologies (Love, et al., 1993).

Maybe the
acuteness and severity of poisoning with GE L-tryptophan supplements was largely the result of the synergistic GMO interaction with an amino acid deemed as one of the fundamentally most toxic. On the other hand, the interaction of GE pollutants with other amino acids and other types of nutritional supplements (or foods), may not become noticeable immediately or in severe form initially, hiding the connection and its true danger.

However, the reality that proportionally few people experienced serious harmful acute L-tryptophan side effects, such as EMS, before the 1989 outbreak and after it had been addressed, supports the notion that it was primarily a problem of supplement impurity (on behalf of one manufacturer using the GMO manufacturing method).

Although some health experts erroneously claimed that before the 1989 disaster no tryptophan eosinophilic myalgia cases had been documented in the scientific literature, a number of tryptophan-associated EMS victims existed (Strongwater, et al., 1990; Kaufman, et al., 1991; Sullivan, et al., 1996).

Prior to 1989, a few EMS cases had also been found in conjunction with non-tryptophan nutritional supplements, and in one occurrence there was no ingestion of supplements (Clauw, et al., 1994; Sullivan, et al., 1996). In all of these episodes it suggested that some type of pollutant caused damage to the liver, resulting in EMS (Clauw, et al., 1994). Nearly all examples of EMS, however, implicate L-tryptophan supplements (Kilbourne, et al., 1996; Sullivan, et al., 1996).

Similar contaminants as found in the tainted tryptophan-associated EMS incident of 1989 were also found in some melatonin nutritional supplements (Williamson, et al., 1998). The consumption of large doses of these adulterated melatonin products led to certain EMS-type symptoms in some people (Williamson, et al., 1998).

Since the body converts L-tryptophan into 5-hydroxy-L-tryptophan (5-HTP) (and then to serotonin, a.k.a 5-HT), in the consumer's mind, presumably, the metabolic intermediate was regarded as an attractive alternative to tryptophan after its official withdrawal (Das, et al., 2004).

But after the 1989 casualty of the first edible GM product on the world market (GMO L-tryptophan), EMS-type of symptoms had also been recorded in some cases upon the consumption of 5-hydroxy-L-tryptophan supplements (Klarskov, et al., 1999). One study found that all eight samples of 5-hydroxy-tryptophan products tested positive for at least three contaminants (Klarskov, et al., 1999). Another similar analytical test on six samples of commercially available 5-hydroxy-tryptophan supplements also revealed adulteration of all products (Klarskov, et al., 2003).

However, extensive test on 5-HTP supplements and their public use, spanning over decades, hasn't borne the magnitude or type of product contamination or toxicity, namely EMS via GMO L-tryptophan, that had been encountered after the consumption of the Showa Denko products (Murray & Pizzorno, 1998; Das, et al., 2004).

The author of a book on amino acids, Eric R. Braverman, MD, remarked about the 1989 tryptophan-EMS epidemic that:

“The evidence trail pointed squarely to major contamination in a new processing method developed by one Japanese manufacturer.” (Braverman, 2003) [emphasis added]

A study by the US Department of Health and Human Services strongly indicated that tryptophan eosinophilic myalgia is tied to product contamination (Kamb, et al., 1992).



The FDA Tryptophan Recall

–A Matter Of Politics

The indisputable overall evidence attested to an insular, confined tryptophan supplement adulteration (most probably with genetically engineered L-tryptophan [Boyens, 1999; Crist, 2005; Druker, 2015]), as the culprit of the L-tryptophan-EMS incident of 1989.

Nevertheless...

In a political move, the FDA subsequently (in 1990) and irrationally banned basically all tryptophan supplements for over a decade thereafter.

Although, the FDA did allow, dubiously, L-tryptophan to be obtained –at a very steep price– through a doctor's order as the equivalent of a prescription drug (Manders, 1995). A situation which ignited Dean W. Manders, PhD, to point out that:

“By publicly banning L-Tryptophan from its dietary supplement status and price, while allowing L-Tryptophan to be sold as a high-priced prescription drug, the naked duplicity [=fraud] of the FDA L-Tryptophan policy is revealed.” (Manders, 1995) [explanation added]

So, the FDA called for an universal moratorium on tryptophan, rather than banning the particular manufacturer of the product (or rather prohibiting the genetically engineering of L-tryptophan) from making or importing any more nutritional supplements until adequate quality standards were implemented and upheld.

Generally, the latter is the basic approach of the public health authorities in cases of confined food poisoning due to contamination.

Food poisoning is very common, and kills several people every day (Schlosser, 2002). In the case of a severe event of food poisoning the regulatory bureaucrats may put a very temporary, transient ban on the availability of the offending food. Upon discernment of the cause, which almost always is contamination due to sloppy food production (Schlosser, 2002), the particular food manufacturer(s) is/are allowed to resume commerce after establishing appropriate food safety and hygiene standards.

Although caused by one single manufacturer, the universal ostracism of L-tryptophan, which lasted for well over a decade, is analogous in "logic" to a general, decade-long embargo on all tomatoes because severe produce contamination, which was caused by one single tomato grower, resulted in the death of several people.

When was the last time US health authorities removed all beef or chicken from the marketplace, and left this general ban in place for over a decade, after microbial tainting of the food, which was traced to a single food processing plant (or even several of them), led to the death of three dozen people (about the number of people who died from the 1989 tryptophan-EMS incident)?

The significant circumstantial evidence strongly supports the notion that the absurd FDA L-tryptophan revocation has everything to do with supplement politics.

In 1995, Dean W. Manders, PhD, drew public attention to a 1992 report by the “FDA Dietary Supplement Task Force” in which it acknowledged that:

"The Task Force considered various issues in its deliberations, including [...] what steps are necessary to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development." (Manders, 1995; FDA, May-1992)

In other words, this FDA report on nutritional supplements publicly authenticated that the FDA was planning on restricting the supplement industry because it is a direct competitor of the medical industry. The federal agency succeeded with its injunction on L-tryptophan.

The FDA's ban of tryptophan opened up the marketing avenues of the pharmaceutical industry to promote, largely unobstructed from nonpatentable competing products and substances (e.g., L-tryptophan), its alleged sleep-promoting and depression-alleviating drugs such as Prozac® and Paxil® both of which, subsequently, became blockbusters.

Much of the yearly budget of the FDA is coming from the pharmaceutical industry (Angell, 2007). Drug companies routinely entice heads of the FDA with lucrative job offers so that many FDA officials end up working for the drug companies upon leaving the FDA (Lynes, 1990).

Of course, these highly rewarding financial lures and baits cast out by the drug corporations create a strong bias in the actively-serving federal regulators to grant “favors” to the very industry they're supposed to regulate.

The totally nonsensical broad prohibition of L-tryptophan products by the FDA was nothing but a fitting example of how the federal agency was doing the pharma-medical drug cartel a huge favor.

Jonathan W. Emord, Esq., a lawyer who specializes in constitutional and administrative law, specifically FDA law, remarked in an interview:

“[...] the drug industry came to exercise extraordinary influence not only over FDA, but also over Congress, medical school education, medical journal publication and physician prescription practices. No one familiar with it could seriously doubt the degree of control the drug industry has over the Congress of the United States. […]. The drug industry has acquired effective control over a majority of the members of the House and Senate.” (Passwater, Oct. 2008)

Trust obvious facts, not absurd actions by authorities.



Is The L-Tryptophan-EMS Problem Remedied?

“[...] who would suspect that our society, those in authority, those we trust with our safety when it comes to purchasing foods and supplements would be so reckless, indeed criminal to encourage and allow a repeat tragedy to happen as did in the 80's with regards to EMS, the first GE caused disease, for the sake of profits.” (Henryk Behr, EMS Sufferer, in 2011)

Cases of tainted L-tryptophan EMS have turned up after 1989 and also after the return of tryptophan in 2005 (when the injunction on tryptophan got repealed), both in the US and abroad (Reinauer & Plewig, 1991; Grangeia, et al., 2007; Behr, 2011; Medsger, 2012). At their official website (nemsn.org), the non-profit organization National Eosinophilia Myalgia Syndrome Network had been documenting some of these occasional EMS cases based predominantly on tryptophan side effects, elicited from either L-tryptophan or 5-HTP.

The majority of victims are white, middle-aged women (Grangeia, et al., 2007; Okada, et al., 2009; Medsger, 2012). The influence of hormones is a crucial factor for this gender imbalance. Estrogen, which is usually higher in women than men, can increase serotonin and inflammatory tryptophan metabolites (particularly when deficient in vitamin B3), elevating women's risk for EMS (Ellis & Presley, 1973; Murray & Pizzorno, 1998) [for more on the interactions of estrogen, serotonin, and tryptophan read my report "Tryptophan Side Effects: L-Tryptophan Is Far From Harmless"].

Moreover, as alluded to earlier, it should be kept in mind that harmful tryptophan derivatives from purportedly uncontaminated L-tryptophan supplements appear to be capable of causing EMS pathologies not just in animals but also in humans (Allen, et al., 2011). Relatively high doses of supplements of tryptophan were found to produce the clinical EMS pathology but not because of product impurities but because of various tryptophan catabolites that induced very high histamine activity by inhibiting the natural breakdown of this inflammation-mediating substance (Smith & Garrett, 2005).

In support of Boyens proposition that genetically engineered L-tryptophan led to the disaster of 1989, a consumer of a supplement of tryptophan fell ill with EMS upon ingestion of only 1000mg of the amino acid in late 2010 (the average daily tryptophan dose in patients of the 1989 EMS calamity was around 1500-2000mg [Swygert, et al., 1990; Crist, 2005]), and after researching the matter published a book on the “mystery” of tryptophan EMS (Behr, 2011).

Behr's investigation corroborated Boyens' and Crist's sensible proposition that it is GMO adulteration that causes presumably the majority, if not all, tryptophan-associated EMS manifestations (Behr, 2011).

Henryk Behr's case illustrates that the root problem of L-tryptophan EMS –that is, genetic engineering of the amino acid– still hasn't been corrected after the first decade of the current century, contrary to statements by so-called health experts (Behr, 2011).

Behr claimed that all EMS occurrences involved GMO tryptophan (or other tainted supplements). What is certain is that EMS events correlate unmistakably with the introduction of bacterial fermentation as the prominent method to produce tryptophan in the 1980s (GE tryptophan wasn't available prior to that), and with the advancement in DNA technologies during the same time period (Behr, 2011).

Behr's case suggests that, apparently, the L-tryptophan ban by the FDA left the real culprit unscathed, even after the repeal of the embargo.

In 2011, the manufacturing of GMO tryptophan remains “a perfectly viable option” to produce a nutritional supplement (Behr, 2011).



From GMO Nutritional Supplements To Genetically Modified Foods

–The Commercialization Of GMO Products Has Its Roots In The Scam Underlying The L-Tryptophan Disaster Of 1989

"[...] the notion that GMOs are always good and safe is shockingly dismissive of the law of unintended consequences, and the innumerable unintended follies of history." (David L. Katz, MD, in 2015)

In 1992 the FDA deemed GMO foods safe and exempted them from requiring safety testing which goes against US law (FDA, 29-May-1992; Druker, 2001; Antoniou, 2012).

But contrary to the tenets of FDA officials, in the year 2000, a judge's ruling on genetically engineered foods declared that:

  • “The FDA is not regulating GE foods at all.
  • The FDA's politically appointed bureaucrats did not follow the advice and warnings of the agency's scientific staff about GE foods but disregarded them.
  • There is currently significant disagreement among scientific experts about the safety of GE foods.” (Druker, 2003) [emphasis added]

The judge's indictment that the FDA doesn't regulate GM food (at all) bears a certain striking similarity to the situation on the policies of dietary supplement regulation, whereas the nutritional supplement industry essentially regulates itself with poor federal oversight (as discussed in my articles on “Regulations”, for instance at Dietary Supplement Regulation –No FDA Approvals For Supplements!).

The judges verdict that "The FDA is not regulating GE foods at all" (Druker, 2003) uncovered the untruthful official image (i.e., myth, lie) disseminated by the FDA as a reliable public health protection agency. Although, the broader reality is that the criminality of rejecting responsibility for public welfare encompasses the entire authoritative collusion clique of government and industry with their old immoral, albeit to them practically inconsequential, game of blaming each other.

In an official FDA statement of 1992, it said:

"Ultimately, it is the food producer who is responsible for assuring safety.” (FDA, 29-May-1992)

In juxtaposition, the Monsanto corporation, a giant manufacturer of GMO products, said this in 1998 via its director of corporate communications, Phil Angell:

“Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the F.D.A.’s job” (Pollan, 1998)

Notwithstanding that judge's assessments in the year 2000, the FDA-biotech industry conglomerate keeps misrepresenting the facts about GMO foods.

In the years and decades after the manifestation of very serious L-tryptophan side effects due to a bunch of nutritionals evidently altered by genetic engineering, the FDA-GE industry cartel (Druker, 2015) pushes on with their systematic distribution of genetically modified foods into the public domain, particularly onto our lunch and dinner plates (many people are familiar with the widespread presence of Monsanto products).

In 1995, genetically modified seeds entered the marketplace and quickly became responsible for many crops bearing GMO corn, soybeans, cotton and potatoes, largely unbeknownst to the public (Pollan, 1998).

In February of 2009, U.S. government news announced that goats became the first genetically engineered animals that had been approved by the FDA (specifically, the approval was for an anticoagulant constituent, ATryn, found in the milk of the GE goats) [FDA, 2009]. ATryn was designed and marketed as a medical drug for patients with a hereditary clotting disorder (FDA, 2009).

A few years later, in November 2015, the FDA-bioengineering-industrial syndicate approved the first whole animal food item, GE salmon, as safe for human consumption (FDA, Nov-2015), opening up the floodgates for the commercialization of GE animals by GMO companies. Some health-conscious people have aptly dubbed the genetically modified fish "Frankenfish" alongside previously termed plant-based GMO foods as "Frankenplants" (Pollan, 1998) or "Frankenfoods" –using the same line of argumentation, one could also assign a genetically engineered tryptophan supplement with the nickname "Frankentryptophan".

In accordance with the U.S. government's mendacity and contortion of the 1989 L-tryptophan removal (Boyens, 1999; Crist, 2005; Druker, 2015), in 2015 you can still read on the official FDA website their denial and distortion about food items (which, in a broader sense, would include dietary supplements) afflicted by “genetic modification” (i.e., genetically altered foods or GMO products) in these statements:

"As articulated in its 1992 “Statement of Policy: Foods Derived from New Plant Varieties,” the agency is not aware of any information showing that foods derived from genetically engineered plants, as a class, differ from other foods in any meaningful or uniform way. These foods also don’t present different or greater safety concerns than their non-genetically engineered counterparts." (FDA, Oct-2015)

Ten years earlier, William Crist had mentioned this official mantra in his investigation:

"[...] government regulators did not (and do not) regard genetically engineered (GE) foods or GE-produced food supplements as potentially different from conventional ones [...]." (Crist, 2005)

Supposedly, a transgenic salmon –to take an example of a GMO food– is a healthy food item practically on par and identical to its conventional or organic equivalent.

The email alert sent out by the FDA on 23-Nov-2015 (and which I had received) included a link to their website that contained the abovecited text of the federal agency. The email subject title featured, and disseminated, a similar hyperbolic assertion about food products altered by genetic manipulation: "CFSAN Constituent Update – Food From Genetically Engineered Plants Is Safe To Eat".

Because of the alleged sameness of GMO products with non-GMO products, it means that you may not know that you ingest GE supplements or GMO products since the FDA does not require to disclose this on product labels (Behr, for instance, was consuming a tryptophan supplement from an US nutritional supplement manufacturer).

All across the planet, GMO foods are poorly regulated by governments (Antoniou, 2012). The weakest regulatory setting (“voluntary industry self-regulation”) exists in the United States, where most such foods originate from (Antoniou, 2012).

As an investigator commented on the utter absurdity of the FDA's L-tryptophan ban after the EMS fiasco of 1989:

“[...] even though no conventionally produced L-Tryptophan has been linked with an EMS outbreak, all such supplements have been banned, while all genetically engineered foods have been cleared for sale without testing, even though there are scientifically justified grounds to suspect the bioengineering process itself was the cause of the EMS epidemic.” (Druker, 2001) [emphasis added]

Just as the judge's ruling of 2000 pointed out, even many FDA scientists warned the agency that there is sufficient valid data to seriously question the safety of GMO foods, cautioning that such products cannot be declared safe until tested for safety (Druker, 2001 & 2015; Antoniou, 2012; Smith, 2012).

Yet the FDA and other health authorities have been denying that GMO products (including GE-produced tryptophan, and GMO-produced vitamins and supplements in general) pose a serious health risk, and thus have resisted GMO food labeling laws while dozens of other nations have already implemented such juridical policies.

Some two decades after FDA scientists raised serious concerns about the safety of GM food, the central body of the orthodox medical establishment, the American Medical Association, is cited twice in the "Official Voter Information Guide for the California General Election, Tuesday, November 6, 2012" as proclaiming in June of 2012 that:

"There is no scientific justification for special labeling of bioengineered foods."

Despite that...

Solid research studies have accumulated over the last few decades demonstrated that GMO products are quite toxic and harm humans (Antoniou, 2012; Séralini, et al., 2012; Smith, 2012; Druker, 2015). Hence, the admonitions about the dangers of GMO foods by the disregarded honest FDA scientists at around the 1989 L-tryptophan disaster were well justified.

Most predominantly, it's the funded, twisted, and fabricated "evidence" of the FDA-bioengineering enterprise that vouch for GMO safety (Engdahl, 2007; Antoniou, 2012; Smith, 2012; Druker, 2015).

But...

“Independent researchers who have published papers containing data that is not supportive of GMOs have been attacked by the industry and pro-GMO groups and individuals.” (Antoniou, 2012)

Why did the FDA disregard the admonitions of its own scientists?

“[...] to “foster” the growth of the GM industry.” (Antoniou, 2012)

The consumer protection advocate Steven Druker, JD, got granted free access to a plethora of copies of internal FDA documents on GMO foods because of a lawsuit he initiated against the federal agency because of lackluster GMO testing and because "the claims made in support of genetically engineered foods were substantially at odds with the truth" (Druker, 2015). After he scrutinized tens of thousands of pages of FDA reports, files, and memoranda, Druker concluded that there was:

"[...] extensive evidence of an enormous ongoing fraud. It revealed that the FDA had ushered these controversial products onto the market by evading the standards of science, deliberately breaking the law, and seriously misrepresenting the facts [...]." (Druker, 2015) [emphasis added]

And...

"This fraud has been the pivotal event in the commercialization of genetically engineered foods." (Druker, 2015) [emphasis added]

And the broader fundamental reality underlying this crime is that it is...

"[...] a story about the corruption of science and its concomitant corruption of government, not through the machinations of a scientific fringe group in league with a pack of powerful political ideologues, but through the workings of the mainstream scientific establishment in concert with large multi-national corporations –and their co-optation of government officials across the political spectrum, and across the globe." (Druker, 2015) [emphasis added]

As aforementioned, in 1992, the FDA released a policy that GM food doesn't need safety testing, nor that GMO products require labeling (FDA, 29-May-1992; Druker, 2001; Antoniou, 2012). The individual, Michael R. Taylor, responsible at the FDA for overseeing the regulation of genetically modified foods and postulating this ruling was someone who subsequently went on to work, again, for one of the giant GE biotech firms (Monsanto) in a high-level position (Smith, 2012) because he had served as a longtime Monsanto lawyer prior to his second FDA assignment (Ferrara, 1998), marking a lasting well documented pattern of operation within the government-industry collusion complex –i.e., the "revolving door syndrome".

Numerous highly credentialed and credible scientists (Druker, 2015), such as the biologist Philip Regal, PhD, were fully aware of this biased crooked regulatory backdrop as the following statements in one of his scientific publications from 1993 attest to:

"[...] there has been political resistance to the effective regulation of GEOs [=genetically engineered organisms; another term for GMOs], and a bureaucratic tendency to focus research agendas on narrow data collection. Thus there has been too little promotion by responsible agencies of studies to provide the broad conceptual base for truly science-based regulation." (Regal, 1993) [emphasis & explanation added]

Looking at the 1989 L-tryptophan-EMS cataclysm through a wider sociological frame, the first genetically engineered product brought to the mass market, Monsanto's recombinant bovine growth hormone (rBGH), reviewed by the FDA during the 1980s and approved in the early 90s, was found to increase reproductive complications, mastitis, and birth defects in cows, and cancer in humans, yet the FDA, under the tutelage of dual FDA-Monsanto cheerleader Michael Taylor, declared rBGH-milk safe for human consumption despite that some of the FDA's own officials expressed concerns about the agency's lackluster disingenuous review process of rBGH (Ferrara, 1998).

Instead, the FDA fired at least one of their employees (a high official who headed the FDA's review of rBGH for several years) who "spilled the beans" about the organization's fraudulent drug approval process and the corrupt review of rBGH (Ferrara, 1998).

Further weighty evidence that the federal rBGH approval was based on a politicized con job was that the FDA stalled the U.S. General Accounting Office (GAO) from getting Monsanto's unfavorable original test data on rBGH and that Monsanto itself ignored the GAO's request to obtain pivotal rBGH data from the corporation (Ferrara, 1998). Quintessentially, both the FDA and Monsanto "hid important information about safety concerns, masked disturbing conflicts of interest, and stifled those who were asking the "wrong" questions and telling the truth about rBGH" (Ferrara, 1998).

The writing on the wall about the 1989 L-tryptophan recall case is totally unmistakable. Yet most people, I suspect, will likely still ignore it today (albeit the rise of the internet has changed that in a positive direction) as they did, say, back in the 1990s because it doesn't fit the type of reality the authoritarian culture has constructed for them. A familiar reality they tend to closely identify with, find a liking for, and, thus, they are protective of (this human phenomenon has been called "the familiarity principle", "the exposure-attitude hypothesis" or the "mere exposure effect" [Zajonc, 1968]).

Some perceptive people of modern times, such as Jean-Paul Sartre (1905-1980), a Nobel laureate in literature, were (eventually) well aware of the bogus world manufactured by the ruling officialdom via language and other mediums of cultural indoctrination (e.g., public schooling, exposure to corporate state media). As an example, in 1964, Sartre wrote:

"[...] as a result of discovering the world through language, for a long time, I took language for the world." (Sartre, 1964)

The following words by an investigator described this state of affairs during a time period in which the L-tryptophan-EMS debacle occurred when he referred to the crafted fake reality the public is led to believe in versus the actual reality:

"Americans love to believe that the food they eat, the drugs they take, the air they breathe, and the water they drink are all safe because such agencies as the EPA and the FDA are standing guard. However, these bureaucracies are infiltrated by past and future employees of the corporation whose products they are considering." (Gorelick, 1998) [emphasis added]

The wider spectrum of this –that is, the myriad of myths the American public at large has been made to be committed to– is echoed by scholars such as Carolyn Baker, PhD, an author and former professor of history:

"Americans have been enculturated [i.e., brainwashed] to believe that other countries have dictatorships, but we don't; that other countries are imperialistic, but we aren't; that other countries have corrupt elections, but we don't; that other countries torture and maim prisoners of war or their own citizens, but we don't; that other countries perform lethal scientific experiments on their own citizens [e.g., the GMO L-tryptophan supplement atrocity of 1989], but we don't; that other countries would incite and conduct wars for natural resources or commercial markets abroad, but we don't." (Baker, 2006) [explanation & emphasis added]

In 2016 Paul Craig Roberts, PhD, economist and former US government official, makes essentially the same observations about the American people and the US culture:

"Americans live in a propaganda-fabricated world [...]." (Roberts, 2016)

The FDA's negligence and denial of the probable involvement of genetically engineering in tryptophan-EMS cases served, and continues to serve, to protect the hugely profitable self-interests of the GMO-biotech industry (Druker, 2001 & 2015). After all, the L-tryptophan disaster of 1989 closely coincides with, and preambled, the lucrative commercialization of GMO products in the US, beginning in the early 1990s (Antoniou, 2012).

The L-tryptophan ban by the FDA “to protect the public's health” was a political rather than a humanitarian move.


(Originally published: Aug-2012 | This is an updated version)


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