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Tampons and Asbestos, Dioxin, &
Toxic Shock Syndrome
FDA regulates the safety and
effectiveness of medical devices,
including tampons. Recently it has
come to the agency's attention that
allegations about tampons are being
spread over the Internet. It is
alleged that tampons are
contaminated by asbestos and dioxin
during manufacture, and that rayon
fibers cause toxic shock syndrome (TSS).
The available scientific evidence
does not support these rumors. The
following information will help
answer concerns.
Asbestos Concerns
In the last six months, unfounded
rumors on the Internet have
suggested that U.S tampon
manufacturers add asbestos to their
products to promote excessive
menstrual bleeding in order to sell
more tampons. FDA has no evidence of
asbestos in tampons or any reports
regarding increased menstrual
bleeding following tampon use.
Before any tampon is marketed in the
U.S., FDA reviews its design and
materials. Asbestos is not an
ingredient in any U.S. brand of
tampon, nor is it associated with
the fibers used in making tampons.
Moreover, tampon manufacturing sites
are subject to inspection by FDA to
assure that good manufacturing
practices are being followed.
Therefore, these inspections would
likely identify any procedures that
would expose tampons products to
asbestos. If any tampon product was
contaminated with asbestos, it would
be as a result of tampering, which
is a crime. Thus far, FDA has
received no reports of tampering.
Anyone having knowledge of tampon
tampering is urged to notify FDA or
a law enforcement officer.
Dioxin and Rayon Concerns
There are also allegations that some
tampons contain toxic amounts of the
chemical dioxin. The term "dioxin"
or "dioxins" actually refers to a
number of related chemical
compounds. State-of-the art testing
of tampons and tampon materials that
can detect even trace amounts of
dioxin has shown that dioxin levels
are at or below the detectable
limit. No risk to health would be
expected from these trace amounts.
Tampons currently sold in the U.S.
are made of cotton, rayon, or blends
of rayon and cotton. Rayon is made
from cellulose fibers derived from
wood pulp. In this process the wood
pulp is bleached. At one time,
bleaching the wood pulp was a
potential source of trace amounts of
dioxin in tampons, but that
bleaching method is no longer used.
Rayon raw material used in U.S.
tampons is now produced using
elemental chlorine-free or totally
chlorine free bleaching processes.
These methods for purifying wood
pulp are described below:
Elemental chlorine-free bleaching
refers to methods that do not use
elemental chlorine gas to purify the
wood pulp. These methods include the
use of chlorine dioxide as the
bleaching agent as well as totally
chlorine-free processes. Some
elemental chlorine-free bleaching
processes can theoretically generate
dioxins at extremely low levels, and
dioxins are occasionally detected in
trace amounts in mill effluents and
pulp. In practice, however, this
method is considered to be dioxin
free.
Totally chlorine-free bleaching
refers to use of bleaching agents
that contain no chlorine. These
methods are also dioxin-free.
Totally chlorine-free methods
include, for example, use of
hydrogen peroxide as the bleaching
agent.
The Environmental Protection Agency
(EPA) has worked with wood pulp
producers to promote use of
dioxin-free methods because dioxin
is an environmental pollutant.
Because of decades of pollution,
dioxin can be found in the air,
water and ground. Therefore, while
the methods used for manufacturing
tampons today are considered to be
dioxin-free processes, traces of
dioxin may still be present in the
cotton or wood pulp raw materials
used to make tampons. Thus, there
may be trace amounts of dioxin
present from environmental sources
in cotton, rayon, or rayon/cotton
tampons.
When questions about dioxin arose a
number of years ago, FDA asked
tampon manufacturers to provide
information about their pulp
purification processes and the
potential for dioxin contamination.
Manufacturers of rayon tampons are
also asked to routinely monitor
dioxin levels in the raw material
used or the finished tampons.
Manufacturers have provided FDA with
test results of studies conducted at
independent laboratories, using the
most sensitive test methods
available. Dioxin monitoring is a
highly technical assay performed at
only a few independent expert
laboratories in the U.S. The
detectable limit of this assay is
currently approximately 0.1 to 1
parts per trillion of dioxin.
Using these tests, dioxin levels in
the rayon raw materials for tampons
are reported to be at or below the
detectable limit of the
state-of-the-art dioxin assay, i.e.,
approximately 0.1 to 1 parts per
trillion. FDA's risk assessment
indicates that this exposure is many
times less than normally present in
the body from other environmental
sources, so small that any risk of
adverse health effects is considered
negligible. A part per trillion is
about the same as one teaspoon in a
lake fifteen feet deep and a mile
square.
Toxic Shock Syndrome (TSS)
There are also allegations that
rayon in tampons causes TSS, and
dryness or ulcerations of vaginal
tissues.
TSS is a rare but potentially fatal
disease caused by a bacterial toxin.
(Different bacterial toxins may
cause TSS, depending on the
situation, but most often
streptococci and staphylococci are
responsible.) The number of reported
TSS cases has decreased
significantly in recent years.
Approximately half the cases of TSS
reported today are associated with
tampon use during menstruation,
usually in young women. TSS also
occurs in children, men, and
non-menstruating women. In 1997,
only five confirmed menstrually-related
TSS cases were reported, compared
with 814 cases in 1980 [according to
data from the Centers for Disease
Control and Prevention (CDC)].
Although scientists have recognized
an association between TSS and
tampon use, the exact connection
remains unclear. Research conducted
by the CDC suggested that use of
some high absorbency tampons
increased the risk of TSS in
menstruating women. A few specific
tampon designs and high absorbency
tampon materials were also found to
have some association with increased
risk of TSS. These products and
materials are no longer used in
tampons sold in the U.S. Tampons
made with rayon do not appear to
have a higher risk of TSS than
cotton tampons of similar
absorbency.
Vaginal dryness and ulcerations may
occur when women use tampons more
absorbent than needed for the amount
of their menstrual flow. Ulcerations
have also been reported in women
using tampons between menstrual
periods to try to control excessive
vaginal discharge or abnormal
bleeding. Women may avoid problems
by choosing a tampon with the
minimum absorbency needed to control
menstrual flow and using tampons
only during active menstruation.
To help women compare absorbency
from brand to brand, FDA requires
that manufacturers measure
absorbency using a standard method
and describe absorbency on the
package using standardized terms.
Thus, the terms "junior," "regular,"
"super," and "super plus," always
describe a specific range of tampon
absorbency regardless of the brand.
FDA requires manufacturers to give
information on the package labeling
about the signs of TSS and how to
minimize the risk. Women are
encouraged to read this information
before using tampons and to ask
about TSS when getting a medical
checkup
Content Courtesy : www.fda.gov
Note : Information herein is
provided for informational purposes
only and is not a substitute for
professional medical advice. You
should not use this information for
diagnosing or treating a medical or
health condition. If you have or
suspect you have a medical problem,
promptly contact your professional
healthcare provider. Please consult
your healthcare provider before
beginning any course of
supplementation or treatment.
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