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Updated February 22, 1999
FDA regulates the safety and effectiveness of medical devices, including tampons. Recently it has come to the agencyís 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 evidence does not support these rumors. The following information will help answer concerns.
Unfounded rumors on the Internet suggest that U.S tampon manufacturers add asbestos to their products to promote excessive menstrual bleeding in order to sell more tampons. Asbestos is not an ingredient or even a trace contaminant in any brand of tampon manufactured in the U.S. FDA has received no evidence of asbestos in tampons or any reports regarding increased menstrual bleeding following tampon use.
The design and materials for all tampons sold in the U.S. are reviewed and must be cleared by the FDA before marketing. Asbestos is not, and never has been, associated with the fibers used in making tampons. Manufacturing sites for tampons are subject to inspection to assure that good manufacturing practices are being followed. If asbestos were to contaminate any tampon product as a result of tampering, it would be a crime. Anyone having knowledge of tampon tampering is urged to notify FDA or a law enforcement officer. Thus far, we have received no reports of tampering.
Dioxin and Rayon Concerns
There are also allegations that some tampons contain the chemical dioxin. Tampons 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. Described below are the bleaching methods for purifying wood pulp used to produce rayon raw material for tampons:
Cellulose used in U.S. tampons is now produced using elemental chlorine-free bleaching processes that produce no dioxin. The Environmental Protection Agency (EPA) regulates wood pulp producers to ensure that dioxin-free methods are used because dioxin is an environmental pollutant.
While the methods used for manufacturing tampons today are considered to be dioxin-free processes, dioxin is an environmental pollutant, and it is possible for trace amounts to be introduced through environmental sources such as air, water, or ground before the wood pulp or cotton is processed.
Even tampons made in the past contained little or no dioxin. Several years ago, FDA asked the major tampon manufacturers to test their products for dioxin using an analytical method approved by the EPA. The data showed that dioxin levels in rayon ranged from non-detectable to 1 part in 3 trillion, far below the threshold that EPA believes puts consumers at risk of cancer. FDA has determined that dioxin at this extremely low level does not pose a health risk.
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. 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, frequently in connection with wounds. The number of reported TSS cases has decreased significantly in recent years. In 1997, only five confirmed menstrually- related TSS cases were reported, compared with a high of 814 cases in 1980 [according to data from the Centers for Disease Control and Prevention (CDC)]. Though scientists recognize an association between TSS incidence 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. However, rayon tampons do not appear to have a higher risk of TSS than cotton tampons of similar absorbency.
Vaginal dryness and ulcerations may occur when the tampon used is too absorbent for the amount of menstrual flow. 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. More information is available about this topic on the web at: www.fda.gov/opacom/catalog/ots_tss.html
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