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Major Expansion of FDA Powers will Target Dietary Supplements. Take Action Now...
The only reason you can buy Tryptophan now is because it is sold in a form that it naturally occurs.
In 1989, a large outbreak of a new, disabling, and in some cases deadly autoimmune illness called eosinophilia-myalgia syndrome (EMS) was traced to one source of L-tryptophan. The bacterial culture used to synthesize tryptophan by a major Japanese manufacturer, Showa Denko KK, had been genetically modified several times to increase tryptophan production during the 1980s.
Along with the higher tryptophan concentrations in the modified culture media, the purification process had also been streamlined to reduce costs, and a purification step that used charcoal absorption to remove some impurities had been omitted. The manufacturer maintained that this process modification allowed another bacterial metabolite through the purification, resulting in the presence of an end-product contaminant responsible for the toxic effects. As of 1996, Showa Denko had destroyed all modified organisms without FDA receipt of culture samples. The FDA was unable to publicly establish with certainty what contaminant was the cause of the outbreak.
Most tryptophan was banned from sale in the US in 1991, and other countries followed suit. Tryptophan from one manufacturer, of six, continued to be sold for manufacture of baby formulas. A Rutgers Law Journal article observed, "Political pressures have played a role in the FDA's decision to ban L-tryptophan as well as its desire to increase its regulatory power over dietary supplements."
At the time of the ban the FDA did not know, or did not indicate, that EMS was caused by a contaminated batch, and yet even when the contamination was discovered and the purification process fixed, the FDA maintained that L-tryptophan was unsafe. In February 2001 the FDA loosened the restrictions on marketing (though not on importation), but still expressed the following concern:
"Based on the scientific evidence that is available at the present time, we cannot determine with certainty that the occurrence of EMS in susceptible persons consuming L-tryptophan supplements derives from the content of L-tryptophan, an impurity contained in the L-tryptophan, or a combination of the two in association with other, as yet unknown, external factors."
The FDA Ban of L-Tryptophan: Politics, Profits and Prozac
Posted on LEF April 6 1998
By: Dean Wolfe Manders, Ph.D.
This article first appeared in "Social Policy", Vol. 26, No. 2 Winter 1995. Dr. Manders has lectured and done extensive research on the medical politics of L-Tryptophan. The article also appeared in "Blazing Tattles" June 1996.
In the fall of 1989, the FDA recalled L-Tryptophan, an amino acid nutritional supplement, stating that it caused a rare and deadly flu-like condition (Eosinophilia-Myalgia Syndrome / EMS). On March 22, 1990, the FDA banned the public sale dietary of L-Tryptophan completely. This ban continues today. On March 26, 1990, "Newsweek" featured a lead article praising the virtues of the anti-depressant drug Prozac. Its multi-color cover displayed a floating, gigantic green and white capsule of Prozac with the caption: "Prozac: A Breakthrough drug for Depression."
The fact that the FDA ban of L-Tryptophan and the Newsweek Prozac cover story occurred within four days of each other went unnoticed by both the media and the public. Yet, to those who understand the effective properties of L- Tryptophan and Prozac, the concurrence seems "unbelievably coincidental." The link here is the brain neurotransmitter serotonin---a biochemical nerve signal conductor. The action of Prozac and L-Tryptophan are both involved with serotonin, but in totally different ways.
Elevated levels of serotonin in the body often result in the relief of depression, as well as substantial reduction in pain sensitivity, anxiety and stress. Prozac, as well as other new anti-depressant drugs such as Paxil and Zoloft, attempt to enhance levels of serotonin by working on whatever amounts of it already exists in the body (these drugs are known as selective serotonin reuptake inhibitors). None of these drugs, however produce serotonin. In contrast, ingested L-Tryptophan acts to produce serotonin, even in individuals who generate little serotonin of their own. The most effective way to elevate serotonin would be to use a serotonin producer rather than a serotonin enhancer.
The continuing FDA public ban of L-Tryptophan prevents popular access to this most effective serotonin producer. The millions of Americans who for decades safely have relied upon L-Tryptophan to relieve depression, anxiety and PMS, as well as to control pain and induce natural sleep, have been forced elsewhere for solutions.
Routinely, such solutions are pharmaceutical in nature: people are forced to use either often highly addictive, expensive, and sometimes dangerous drugs like Xanax, Valium, Halcion, Dalmane, Codeine, Anafranil, Prozac, and others, or simply suffer. Present FDA public policy maintains that L-Tryptophan is an untested, unapproved and hazardous drug. The analytical work done a few years ago by the Centers for Disease Control and the Mayo Clinic, research which traced the fall of the serious flu-like condition to contaminants found in batches of L-Tryptophan made by the Japanese company Showa Denko, has not convinced the FDA to allow L-Tryptophan back on the market. This decision is based primarily on the research of FDA and NIMH scientists who state that L- Tryptophan itself, irrespective of contaminants, is a dangerous substance. Other university-based research scientists disagree with these findings.
The public availability of L-Tryptophan is too important an issue only to be argued and shrouded within scientific debate that remains, ultimately, mystifying to the vast majority of Americans. There are many obvious facts worthy of public attention, and concern.
For example, consider the following: On February 9, 1993, a United States government patent (#5185157) was issued to use L-Tryptophan to treat, and cure EMS, the very same deadly flu-like condition which prompted the FDA to take L-Tryptophan off the market in 1989.
Notwithstanding its public ban and import alert on L-Tryptophan, the FDA today allows Ajinomoto U.S.A. the right to import from Japan human-use L- Tryptophan. Distributed from the Ajinomoto in Raleigh, North Carolina, the L- Tryptophan is then sold to, and through, a network of compounding pharmacies across the United States. Purchased by individuals only under a physician's order, L-Tryptophan emerges here as a new prescription drug in the serotonin marketplace; one hundred 500 mg. capsules cost about $75.00, approximately five times more than if they were sold as a dietary supplement.
Since the FDA holds the political mandate and power of a public regulatory agency established ostensibly, to protect people from raw corporate interests in drug production and distribution, the actions of the FDA in concert with Ajinomoto U.S.A. are illuminating. 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 of the FDA L-Tryptophan policy is revealed.
During and after the 1989 EMS outbreak, the FDA did not totally ban the use of L- Tryptophan in humans---then, as today, the FDA has granted the pharmaceutical industry the protected right to use L-Tryptophan in hospital settings. Manufactured by Abbott Laboratories, the amino acid injectable solutions Aminosyn and Aminosyn II contain as much as 200 mg. of L-Tryptophan. (Moreover, L-Tryptophan has never been removed from baby food produced and sold within the United States.) While the FDA has banned the public sale and use of safe, non-contaminated, dietary supplements L-Tryptophan for people, the United States Department of Agriculture still sanctions the legal sale and use of non-contaminated L-Tryptophan for animals. Today, as in the past, feed grade L-Tryptophan continues to be used as a nutritional and bulk feed additive by the commercial hog and chicken farming industry. Additionally, L- Tryptophan is now available for use by veterinarians in caring for horses and pets.
Outside of the United States, in countries such as Canada, the Netherlands, Germany, England, and others, L-Tryptophan is widely used. Nowhere, have any serious or widespread health problems have occurred.
At bottom, the FDA public ban of safe, non-contaminated L-Tryptophan is uneven, expensive, and biased in favor of the pharmaceutical industry. The FDA proscription effectively awards billions of dollars in profits to pharmaceutical companies and their suppliers in the same proportion as it adds billions of unnecessary dollars to the nation's already bloated health care expenditures.
On June 15, 1993, the FDA Dietary Supplement Task Force published a report on the work it had been doing in the area of developing FDA policy around nutritional supplements. On page two, the report admits, "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."
In this case, the FDA has succeeded in carrying out its stated policy goal. With competition from publicly available L-Tryptophan removed, the rapidly expanding market in prescription serotonin drugs---now among them L-Tryptophan itself---contains no major "disincentives" for the massive accumulation of pharmaceutical industry profits.
It is now time for appropriate congressional committees to review openly and aggressively the entire matter of L-Tryptophan. This will provide a needed forum where political, corporate, and scientific issues of the FDA L- Tryptophan regulatory policy may be addressed. There exists ample precedent for such hearings: in the 1980's and early 1990's, for example, such investigations uncovered favoritism in the approval of generic drugs and the bribery of FDA officials.
The story of L-Tryptophan illustrates a sad perverse picture of the politics and priorities of public health in America: A safe, dietary-supplement serotonin producer is publicly unavailable to people, while daily fed to animals by corporate agribusiness. A patent is approved to use L-Tryptophan to cure the very condition the FDA claims it caused. And, while publicly exclaiming that L-Tryptophan is a dangerous and untested drug, the FDA more quietly, allows human-use L-Tryptophan to be imported, and then marketed and sold by the pharmaceutical industry.
To allow the FDA ban of L-Tryptophan to continue unreviewed and univestigated condemns millions of Americans to unnecessary financial expenditures and needless suffering.
Are you Dean Manders,or do you have his email address or know anyone who does? I have a ton of info on this subject. The patent he is discussing on L-tryptophan for the cure of eosinophilia myalgia syndrome is held by Dr.Christopher Caston of Spartenburg S.C. and info about his patent was published in two peer reviewed medical journals at the exact same time the FDA banned l-tryptophan. I have a transcript of the entire FDA run hearing on Dietary Supplements which took place in the Masur Auditorium of NIH on August 29th 1990 in which the FDA was shamelessly parading eosinophilia myalgia victims up to the microphone for propaganda purposes, in order to have them denounce the dietary supplement industry over the Showa Denko contaminated tryptophan.
(Showa Denko is a PHARMACEUTICAL company, and a really bad actor at that- they once BLEW UP part of their plant to thwart a Japanese government inspection which would have proved that they were responsible for contaminating a river in Japan with mercury, causing untold misery and suffering- kids born with birth defects, etc, ad nauseum. The contaminated l-tryptophan was caused by using genetic engineering to crank up a strain of bacteria used in the fermentation process that the amino acid is generated through. They wanted to make the stuff FASTER than their competitors, and tossed GMPs out the window.
At NIH these poor people were being plugged full of prednisone, and other highly dangerous drugs, which did NOTHING to alleviate their condition, while a patented, peer reviewed nutritional protocol including l-tryptophan existed, to the FDA's knowledge, but the FDA and NIH did not let these patients at NIH hospital have it, because they wanted to use them as political pawns. I can document everything I'm saying here because I testified at that hearing and exposed the whole charade, and I have the official government transcript of my testimony, along with the proof of everything I said, stored in multiple locations in case they ever burn my house down. You are right, there should be a congressional investigation- but there never will be unless we CRUSH congress with faxes about this. Anyone want to?
The FDA can't even regulate the quality of imported FOOD grade wheat gluten which has killed thousands of animals across the USA and now they want to take on the task of regulating the vitamins, herbal supplements and massage oils that have been around for decades.