November 22, 1999
FDA Reports Internet Rumors About Asbestos,
Dioxin and Rayon in Feminine Hygiene Products are Unfounded
Washington, DC (SafetyAlerts) - Recently some
allegations were being spread over the Internet alleging that some tampons are
contaminated by asbestos and dioxin during manufacture, and that rayon fibers cause toxic
shock syndrome (TSS). According to the Food and Drug Administration (FDA), the
available scientific evidence does not support these rumors. The following
information was provided by the FDA and may help answer some concerns.
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Dioxin and Rayon Concerns
Toxic Shock Syndrome (TSS)
Keeping Your Risk of TSS Low
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.
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Dioxin and Rayon
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
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.
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Toxic Shock Syndrome
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 that,
when related to menstruation, occurs most frequently in young women aged 15 to 24, usually
in association with tampon use. Different bacterial toxins may cause TSS, depending
on the situation, but most often streptococci and staphylococci are responsible.
Although scientists have recognized an association
between TSS and tampon use, the exact connection remains unclear.
The number of confirmed menstrually-related TSS
cases peaked in 1980 at 814, with 38 deaths. At that time, the national Centers for
Disease Control found that 71 percent of women who developed the condition had been using
Rely, a brand of highly absorbent tampons that had recently come on the market. These
tampons were removed from the market, and the Food and Drug Administration and tampon
manufacturers developed product labeling to help women avoid the life-threatening
The incidence of menstrually-related TSS was
reduced to 470, with 13 deaths, in 1981 and has continued to fall steadily since then.
TSS was first identified as a distinct disease in
1978 and also affects people who don't use tampons. It occurs in children, men, and
non-menstruating women, most frequently in connection with wounds. Though scientists know
there is a relationship between the development of TSS and the use of tampons, especially
high-absorbency tampons, the exact connection remains unclear.
Scientists think that in order for the disease to
develop, bacteria called Staphylococcus aureus must be present. These bacteria release one
or more toxins (poisons) into the bloodstream. S. aureus bacteria commonly live in body
areas such as the nose, skin or vagina and usually cause no problem. But the bacteria also
can lead to serious infection after a deep wound or surgery or, for reasons not fully
understood, during tampon use.
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Keeping Your Risk of
If you've ever had TSS, get medical advice before
You can reduce your risk of TSS by not using
tampons or by alternating between tampons and pads. Whether the benefits of using
tampons--particularly high-absorbency ones--are worth the increased risk of TSS is an
Because the TSS risk increases with tampon
absorbency, if you use tampons, you should use products with the lowest absorbency that
meets your needs. There's usually less need for high absorbency at the end of a menstrual
period. You can find what's best for you by experimenting with different sizes and
different brands, beginning with the least absorbent.
To help women compare absorbency from brand to
brand, FDA requires that manufacturers use a standard test to measure absorbency and that
the absorbency be stated on the label using standard terminology. When shopping for
tampons, look on the packages for the following absorbency terms and ranges and then
compare brands before you make your selection.
|If the package says:
||The absorbency range is:
||6 grams and under
||6 to 9 grams
||9 to 12 grams
|Super Plus Absorbency
||12 to 15 grams
It also helps to:
- Follow the manufacturer's instructions.
- Store tampons in a clean, dry place.
- Wash hands with soap and water before and after
inserting or removing a tampon.
- Try a less absorbent variety if a tampon is
irritating or difficult to remove.
FDA also requires manufacturers to give
information about TSS on the tampon box or in a package insert. This information must
include a warning about the association between TSS and high-absorbency tampons. You can
stay up-to-date on TSS by reading the package information when you buy tampons and asking
about TSS when you get a medical checkup.
Symptoms may not appear until the first few days
after the end of your period. Be sure to explain to your doctor what your symptoms are,
when your period began, and whether you've ever had TSS before. If you use tampons,
mention what absorbency you use.
TSS symptoms appear quickly and are often severe.
Not all cases are exactly alike, and you may not have all the symptoms. You may have
aching muscles, bloodshot eyes, or a sore throat, making it seem like the flu. The
sunburn-like rash may not develop until you're very ill; it may go unnoticed if it's only
on a small area. Later, the skin on your palms and soles may flake or peel. A first
episode may be so mild that you don't connect the symptoms with TSS, but the next time,
the symptoms may be severe. Once you've had TSS, you're more likely to get it than someone
who never has had it.
Deaths, though rare, tend to happen during the
first week of illness. The danger lies in a sudden drop in blood pressure, which could
lead to shock if not treated in time.
TSS is usually treated with antibiotics, and drugs
to lower temperature, and large amounts of fluids and electrolytes (essential body
chemicals) to raise lowered blood pressure. Blood and other specimens from the body are
analyzed in a laboratory to identify bacteria. Antibiotics are given to help prevent
recurrence. Patients often are hospitalized, and severe cases require intensive care. With
proper treatment, patients generally recover within three weeks.
While TSS is rare, it's an important health
concern for menstruating women, and especially young women. Knowing how to prevent it and
recognizing its symptoms can do much to reduce its dangers and continue to keep its
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