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Updates
2011 - 2013
Caution: Current L-Tryptophan Contacts
Tryptophan
is now once again legally sold in many forms. NEMSN reports current
contacts from people telling us of adverse reactions which they
attribute to L-Tryptophan supplements, to 5-HTP supplements (which are
chemically similar to L-T), to other L-Tryptophan-containing products,
etc. Our Medical Advisory Panel has been monitoring the situation and
has asked to be informed if any new cases come along. If you know of
anyone who has become sick from taking a product containing
L-Tryptophan or 5-HTP, tell them to save the product and contact NEMSN.
December 2012
The
medical journal Case Reports in Rheumatology has just published an
article entitled "Severe Eosinophilic Syndrome Associated with the Use
of Probiotic Supplements: A New Entity?" by four doctors in
Philadelphia (F.A. Mendoza, S. Purohit, L. Kenyon, S.A. Jimenez). The
abstract of this article, which details two current cases of an
EMS-like illness from probiotic supplements, can be found at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3521401/
Quoting from this medical research article:
"Prior experience in unveiling the etiology of the eosinophilic
syndromes has shown that a high index of suspicion is required. The
description of these two cases may allow the recognition of similar
cases and remind the medical community that the widespread use of
agents seemingly considered to be beneficial and free of side effects
may occasionally have serious consequences."
November 2011
The medical journal Arthritis & Rheumatism has just
published an article that details a new 2009 case of EMS from current
L-tryptophan. The article, "Post-epidemic eosinophilia-myalgia syndrome
associated with L-tryptophan", is found in Arthritis & Rheumatism,
Volume 63, Issue 11, pages 3633-3639, November 2011.
The abstract, posted in October 2011, can be found online at http://onlinelibrary.wiley.com/doi/10.1002/art.30514/abstract
2011
Warning from National Institutes of
Health: 5-HTP supplements may cause EMS
http://www.nlm.nih.gov/medlineplus/druginfo/natural/794.html
Excerpt from this NIH Webline Plus webpage, last updated 2011:
5-HTP (5-Hydroxytryptophan) is a chemical by-product of the protein
building block L-tryptophan. It is also produced commercially from the
seeds of an African plant (Griffonia simplicifolia). Don’t use 5-HTP
until more is known. 5-HTP might be UNSAFE. Some people who have taken
it have come down with eosinophilia-myalgia syndrome (EMS), a serious
condition involving extreme muscle tenderness (myalgia) and blood
abnormalities (eosinophilia). Some people think the EMS might be caused by an accidental ingredient (contaminant) in some 5-HTP
products. But there is not enough scientific evidence to know if EMS is
caused by 5-HTP, a contaminant, or some other factor. Until more is
known, avoid taking 5-HTP.
L-Tryptophan Is Now Legal In The US Again
It’s easy to buy tryptophan again in the U.S. You can get L-tryptophan
(L-T) and L-5-hydroxytryptophan (a related compound commonly known as
5-HTP) legally on many U.S.-based websites, where you’ll read
persuasive ads about the products’ benefits as well as glowing
testimonials from users about how L-T and 5-HTP have improved their
lives. In 1990 the FDA banned the sale of tryptophan in the United
States in order to prevent further loss of human life and health due to
EMS. How did it happen that the supplement is all over the place again?
Back in the early 1990s there was a movement supported by supplement
manufacturers and distributors and signed on to by users, to prevent
government from regulating vitamins, minerals, amino acids, herbs and
other food supplements. Consumers feared that too much government
regulation would result in supplements becoming more expensive and even
unavailable except by prescription. The indignant cry was that it was
the people’s right, not government’s right, to decide what we could and
couldn’t take.
Congress seemed to agree, and obliged by passing the 1994 Dietary
Health Supplement Education Act (DHSEA), which President Clinton signed
into law. This law greatly weakened the FDA’s ability to regulate
dietary supplements. You can download a copy of the DHSEA at http://thomas.loc.gov/cgi-bin/query/z?c103:S.784:
(choose #6).
In January 2001 the Federal Food and Drug Administration published its
own statement on DHSEA entitled the Overview of Dietary Supplements (http://www.cfsan.fda.gov/~dms/ds-oview.html).
This FDA document states that before DSHEA was passed, “dietary
supplements were subject to the same regulatory requirements as were
other foods. This new law, which amended the Federal Food, Drug, and
Cosmetic Act, created a new regulatory framework for the safety and
labeling of dietary supplements.”
Under DSHEA, the manufacturer itself or the distributor of supplements
“is responsible for determining that the dietary supplements it
manufactures or distributes are safe. This means that dietary
supplements do not need approval from FDA before they are marketed.”
The FDA neither sets nor enforces any safety standards. And unless the
product contains a “new ingredient”, meaning one that was not marketed
before 1994, the manufacturer or distributor does not have to provide
the FDA with any information about the safety or efficacy of the
product. Manufacturers are not required to be registered with the FDA
and they need no approval to sell their supplements.
The FDA’s Overview of Dietary Supplements further states,
“manufacturers and distributors of dietary supplements are not
currently required by law to record, investigate or forward to FDA any
reports they receive of injuries or illnesses that may be related to
the use of their products.” And companies are not required “to disclose
to FDA or consumers the information they have about the safety or
purported benefits of their dietary supplement products.”
The document goes on to say that the agency’s efforts to “monitor the
marketplace for potential illegal products (that is, products
that may be unsafe or make false or misleading claims)” include
“inspections of dietary supplement manufacturers and distributors, the
Internet, consumer and trade complaints, occasional laboratory analyses
of selected products, and adverse events associated with the use of
supplements that are reported to the agency.” However it also notes
that the FDA has “limited resources” to carry out this monitoring.
In February 2001, about a month after the FDA’s Overview of Dietary
Supplements came out, the agency issued another document, its Position
Paper on L-tryptophan, 5–HTP, and EMS. The full text can be found at
http://www.cfsan.fda.gov/~dms/ds-tryp1.html.
This Position Paper recaps the 1989 epidemic of EMS associated with
L-tryptophan use, with 37 deaths and over 1500 reported cases. It
acknowledges the serious nature of EMS and that “the true incidence of
the disorder is thought to be much higher.”
The report states the FDA is not sure that all cases of EMS came solely
from an impurity in Showa Denko’s product:
“. . . many people who consumed Showa Denko L-tryptophan did not
develop EMS and cases of EMS and a related disease, eosinophilic
fasciitis, have occurred prior to and after the 1989 epidemic. EMS and
related disorders are also reported to be associated with exposure to
L-5-hydroxytryptophan, which is not made in the same manner as
L-tryptophan (e.g., via fermentation processes). Based on these
observations, FDA concluded that other brands of L-tryptophan, or
L-tryptophan itself, regardless of the levels or presence of
impurities, could not be eliminated as causal or contributing to the
development of EMS. . . . Consequently, FDA cannot determine that oral
dosage forms of L-tryptophan and related compounds such as
L-5-hydroxytryptophan can be safely used as dietary supplements.”
The paper goes on to state current policy:
“Although FDA continues to enunciate its concern about the safety of
dietary supplements containing L-tryptophan and related compounds such
as L-5-hydroxytryptophan, this does not mean that FDA prohibits the
marketing of dietary supplements that contain L-tryptophan. . . .
[Under DSHEA] the manufacturer is responsible for ensuring that its
products are safe. A firm is not required to obtain premarket review or
approval from the FDA of its products before marketing them as dietary
supplements. Moreover, a firm is not required to submit scientific
evidence to FDA of the safety of its products or ingredients. . . .”
and so on.
That’s how it happened that Americans are legally buying and ingesting
tryptophan today. One has to wonder though, in light of the number of
lives lost and ruined by tryptophan use and in light of the FDA’s own
admission that it can’t determine if tryptophan supplement usage itself
is safe, whether more couldn’t be done by the agency to protect human
life and health. If tryptophan is not to be banned entirely, couldn’t
the unsuspecting user at least be warned of potential disaster?
by Lois Vierk in 2006
elveevee@aol.com
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