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News!
Summer 2011
Caution:
Current L-Tryptophan Contacts
Tryptophan is legally back on the market in many forms. NEMSN reports that
recently several different people have contacted us and have told of adverse
reactions which they attribute to L-Tryptophan supplements, 5-HTP supplements
(which are chemically similar to L-T), or other L-Tryptophan-containing
products, since the beginning of this year. 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.
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
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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