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How come L-Tryptophan still not available OTC in the USA?
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phantom309
Platinum Member
BJ's are illegal in several states.
BaliBabyDoc
Lifer
Turkey is an excellent source but it blunts the pharmacological properties of L-tryptophan. Virtually all amino acids have pharmacological effects if given in high enough doses (1-5g). They lose their pharmacological effects when consumed with other amino acids b/c they compete for absorption in the small intestine. The best method for taking any single amino acid is to consume it on an empty stomach.
As for L-tryptophan's ban . . . the FDA has the most entrenched institutional memory of any agency of the government. They remember absolutely every time they've been burned b/c usually people die horrible deaths or develop permanent deformities. I believe all batches of bad L-tryptophan were traced back to a single Japanese company. Many biotechs use microorganisms (typically bacteria) to produce products. Obviously, the only people selling semi-dormant to active bacteria are yogurt makers and US beef/poultry producers. Accordingly, companies employ multiple filtration systems to insure clean products. This particular company decided to use the oldest trick in the book when it comes to saving money . . . cut corners. They removed a stage of the filtration process . . . which resulted in fatalities.
Although the etiology of the problem was identified, L-tryptophan is sold throughout the world, and many single amino acids are produced by essentially the same process . . . L-tryptophan will NEVER come off the list of banned substances. You can certainly acquire it from foreign producers but it will never see counterspace as an OTC product.
that's a good question...this guy seems to make a valid point
link 1
link 2
It is worth noting that there is NO possibility of this problem occurring with the amino acid tryptophan, which the FDA banned after a single contaminated batch was sold. Unlike other such occurrences, they never let tryptophan back on the market, under the absurd false pretense that this essential amino acid ITSELF is dangerous. This assault on the free market left people with obesity, insomnia, and many other problems looking for something -- ANYTHING -- to fill the gap. Thus, it was this ridiculous regulatory action led to the introduction of 5-HTP.
5-HTP is sold legally and is potentially more dangerous
The FDA's scientifically indefensible ban of the essential amino acid, L-tryptophan, has led to supplement companies selling 5-HTP in its place. There is some concern that 5-HTP could be converted to serotonin in the blood instead of the brain, possibly causing heart problems. This is not a problem with L-tryptophan, but thanks to the FDA, it is hard to obtain this safe amino acid anymore.
----
Tryptophan (TRIP-toe-fan)
An essential amino acid that is converted into serotonin and niacin. It is useful in the treatment of obesity, insomnia, and depression. Tryptophan is converted into 5-Hydroxytryptophan (5-HTP), which is converted into serotonin (5-HT).
link 1
link 2
It is worth noting that there is NO possibility of this problem occurring with the amino acid tryptophan, which the FDA banned after a single contaminated batch was sold. Unlike other such occurrences, they never let tryptophan back on the market, under the absurd false pretense that this essential amino acid ITSELF is dangerous. This assault on the free market left people with obesity, insomnia, and many other problems looking for something -- ANYTHING -- to fill the gap. Thus, it was this ridiculous regulatory action led to the introduction of 5-HTP.
5-HTP is sold legally and is potentially more dangerous
The FDA's scientifically indefensible ban of the essential amino acid, L-tryptophan, has led to supplement companies selling 5-HTP in its place. There is some concern that 5-HTP could be converted to serotonin in the blood instead of the brain, possibly causing heart problems. This is not a problem with L-tryptophan, but thanks to the FDA, it is hard to obtain this safe amino acid anymore.
----
Tryptophan (TRIP-toe-fan)
An essential amino acid that is converted into serotonin and niacin. It is useful in the treatment of obesity, insomnia, and depression. Tryptophan is converted into 5-Hydroxytryptophan (5-HTP), which is converted into serotonin (5-HT).
Daaavo
Platinum Member
The FDA Ban of L-Tryptophan: Politics, Profits and Prozac
© Dean Wolfe Manders, Ph.D., All Rights Reserved
----------
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 unecessary 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?
© Dean Wolfe Manders, Ph.D., All Rights Reserved
----------
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 unecessary 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?
Chalk it up any way you want to, folks.. there is no reason for marijuana to be against the law. Period.
The impairment argument doesen't fly. Many over the counter medications fsck you up more than cannabis. That's why they tell you not to drive or operate machinery on the box.
I'm all for DUI laws against cannabis when it becomes legal. Have no problem with that whatsoever, you shouldn't be driving while stoned. Period.
The impairment argument doesen't fly. Many over the counter medications fsck you up more than cannabis. That's why they tell you not to drive or operate machinery on the box.
I'm all for DUI laws against cannabis when it becomes legal. Have no problem with that whatsoever, you shouldn't be driving while stoned. Period.
Actually, there is. Cannabis is not native to the Americas. It was imported by sea-faring travelers who, after months of sailing, needed to repair their sails, make new rope, make or repair clothing, create more lamp oil, etc...nothing could compare to cannibis for providing all of these needs that allowed them to get home. And it only took 3 months to grow a sativa harvest.
Back when marijuana was still legal, few white people in America knew that you could smoke it or eat it and get high. However, during the Industrial Revolution, congressional lobbyists for new industries known as "chemical" and "textiles" knew their companies would not succeed if there were natural ways of doing what their synthetic products could produce...and doing it at reduced costs, which would all but negate them ever getting off the ground. That's right: the government itself didn't step in to outlaw marijuana, it was industry.
Think about it: would you prefer crop rotation with marijuana, or use a completely unnatural way to fertilize your farm? Would you prefer high-quality paper that lasts for centuries, and not greatly polute ground water while making it, or do you really like using all that bleach for paper than won't last more than 60 years years before it disentigrates? How about the strongest natural rope known to man?
BTW, I once heard about ten years ago that one acre of Sativa converts just as much CO2 into oxygen as 10 acres of old-growth forest.
It's indica they should worry about. Sativa only gives you a headache...but it's still illegal, simply because it contains THC, albeit in trace amounts.
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