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News!
NEMSN is asking you to support our organization by using
this search engine (instead of whatever you are using
now, like google.com for example)--please check out:
www.goodsearch.com
If you go to www.goodsearch.com instead of google or
other search engines, and select "National Eosinophilia
Myalgia Syndrome Network" as your designated charity,
this wonderful organization, because of its advertising
revenue, will donate one cent to NEMSN for each search
that you do! It is simple, it works easily and well.
A penny for a search may seem like not much, but if just
100 searches total, from all NEMSN supporters across the
country, are done in a day, it will mean a DOLLAR A DAY
for NEMSN! We are doing our best to be here for you,
please be here for NEMSN. And pass the word around to
anyone who is supportive.
The March 2008 Newsletter is available
on line as a PDF. To read it, click here.
March 2008 NEMSN Newsletter
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 read all eight pages of DHSEA at
http://www.fda.gov/opacom/laws/dshea.html.
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?
Lois Vierk
elveevee@aol.com
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Email List!
NEMSN Connections
This member only email service is now
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Please
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