By Rita Rubin
WebMD Health News
Reviewed by Brunilda Nazario, MD
Nov. 2, 2015 -- A typical woman goes through more than 12,000 sanitary pads or tampons over the decades that she has her period.
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But is long-term use of sanitary protection safe?
Members of Congress and women's health advocacy groups have raised concerns about a lack of research into the safety of tampons, pads, and other feminine hygiene products such as douches.
"The reality is menstrual health has been considered a taboo subject for too long," Rep. Carolyn Maloney, D-NY, says in an email. "It's time that feminine hygiene products are thoroughly researched so that we can ensure that complete and accurate information is being collected and made readily accessible."
U.S. sales of tampons and sanitary pads totaled $3 billion last year, according to a report by Euromonitor International.
"There is no research that unequivocally declares these feminine hygiene products are safe, and independent studies by women's health organizations have found chemicals of concern like dioxin, carcinogens, and reproductive toxins in tampons and pads," Maloney wrote in April in an op-ed piece in The Guardian, a British newspaper.
Product makers and the FDA say sanitary and feminine hygiene products are safe, because they contain either no risky chemicals or only trace amounts. But Maloney and other women's health advocates argue that no one can be sure, because studies of their effects over a woman's lifetime haven't been done. Meanwhile, an official with the National Institutes of Health (NIH) says agency scientists are working with the EPA to look at chemicals of concern in personal care products such as tampons and pads.
Philip Tierno, Jr., PhD, a clinical professor of microbiology and pathology at the NYU School of Medicine, has long studied the microorganisms that live in the vagina and the workings of toxic shock syndrome, a rare, potentially fatal condition that is linked to the use of highly absorbent tampons.
"Women assume that the FDA or other bodies have looked at the matter, and, therefore, whatever product is on the market is safe," Tierno says. "And that's incorrect."
According to "Chem Fatale," a 2013 report published by Women's Voices for the Earth, a nonprofit advocacy group based in Missoula, MT, "chemicals of concern such as carcinogens, reproductive toxins, endocrine disruptors, and allergens are being used on, or even in, the extremely permeable mucous membranes of the vaginal area."
Such potentially hazardous ingredients include dioxins and pesticide residues in tampons and pads, and unknown fragrance chemicals and dyes in feminine hygiene products such as wipes and douches, according to the report. (In August, Women's Voices petitioned the FDA to ask that it prevent makers of feminine hygiene products from using dyes approved only for "externally applied" products, which are not supposed to be used on body surfaces covered by mucous membranes).
The group's stated goal is to "detox the box," or get rid of toxic chemicals from the products.
"We have so little research on how chemicals affect vaginal health," says Alexandra Scranton, author of "Chem Fatale." "The basic science just isn't there."
A recent study found that vaginal douches might increase women's exposure to phthalates, chemicals linked to a number of health problems, including developmental and behavioral issues in children exposed in the womb. The American College of Obstetricians and Gynecologists and other medical groups recommend against douching, because it has been linked to such problems as vaginal infections, pelvic inflammatory disease, and preterm birth.
"The main contribution of this work is showing that feminine care products can be a source of exposure to these synthetic chemicals into our bodies," says study researcher Ami Zota, ScD, assistant professor of environmental and occupational health at the George Washington University. She says more research is needed.
In late August, Maloney and six other members of Congress wrote NIH Director Francis Collins, MD, urging that the agency do research to "determine the extent to which the presence of dioxins, synthetic fibers, chlorine, and other contaminants in tampons and other feminine hygiene products pose any risk to women using these products."
Linda Birnbaum, PhD, director of the National Institute of Environmental Health Sciences and National Toxicology Program (NTP), acknowledges Maloney's and other women's concerns about the products, and cited a lack of information about what's actually in many of them.
"As you are well aware, manufacturers are not required to provide this information to consumers," Birnbaum wrote in a letter responding to Maloney's call for more research. "Tampons can contain a variety of potentially harmful chemicals and abrasive materials. Tampons treated with chlorine bleach can contain detectable levels of dioxins, which have been linked to a number of adverse health effects and diseases."
But Birnbaum wrote that two studies, published in 2002 and 2005, concluded that women are exposed to far higher levels of dioxins through what they eat and drink than through tampon use.
The NIH already is doing research related to the safety of personal care products, Birnbaum wrote. A study is collecting information about the use of personal care products to see how it might affect breast cancer risk and other health problems. And the toxicology program is conducting studies with the EPA "aimed at improving tools for assessing environmental exposures from personal care products, including feminine hygiene products," she wrote.
Procter & Gamble company spokeswoman Laura Dressman says in an email that "while ingredient information has been on our packaging and website for years, we recently updated the information along with a total refresh of our website." Tampax packages list ingredients, but Always packages do not, Dressman says. The company holds the biggest share of the U.S. sanitary protection market, according to Euromonitor International.
"For decades, our feminine care products have provided protection and comfort for women around the world, and that protection begins with safety," Dressman says. The company shares information about its feminine care products with independent experts, including medical consultants and university scientists, and the FDA, she says.
Devices and Cosmetics
The FDA considers tampons and pads medical devices, and classifies them based on the amount of risk they pose. The least risky are class I, while the most risky are class III. Tampons are class II devices, along with thermometers and blood pressure cuffs. Pads are I or II, generally depending on whether they have any fragrance.
The agency has issued "guidance" to tampon and pad makers on earning FDA approval. It recommends that manufacturers submit a list of materials used to make their products, such as chemicals, additives, and finishing agents, and an analysis of the risk of vaginal injury, tissue reactions, and infections, FDA spokeswoman Deborah Kotz says. But it's not required. The FDA also asks for -- but does not require -- testing to make sure the products don't cause reactions or help with the growth of bacteria, such as those that cause toxic shock syndrome, Kotz says.
The FDA regulates feminine hygiene products such as douches as either drugs or cosmetics, she says. Unlike medical devices, cosmetics are required to list ingredients on their labels. Kotz says the FDA has no plans to change how it regulates sanitary protection or feminine hygiene products.
To be on the safe side, Tierno recommends that women use pads, "which are far less of a problem," because they are not inserted. Or, he says, seek out tampons that are 100% organic cotton, made by small companies and typically available in health food stores.
Or you can buy handmade, washable cotton menstrual pads from one of thousands of sellers on Etsy, better-known for crafts and vintage items. Sellers promote them as being better for both the body and the planet.
SOURCES: Rep. Carolyn Maloney, D-NY.Ami Zota, ScD, assistant professor of environmental and occupational health, Milken Institute School of Public Health, George Washington University. Philip Tierno Jr., PhD, clinical professor of microbiology and pathology, NYU School of Medicine. Deborah Kotz, FDA spokeswoman. Laura Dressman, Procter & Gamble spokeswoman. Alexandra Scranton, MS, director of science and research, Women's Voices for the Earth. Women's Voices for the Earth: "Chem Fatale." Women's Voices for the Earth: "Women Move P&G To Reveal Ingredient Secrets." Euromonitor International: "Sanitary Protection in the US." Branch, F. Environmental Health, published online July 15, 2015. Department of Health and Human Services Office on Women's Health: "Douching." FDA: "Tampons and Asbestos, Dioxin, & Toxic Shock Syndrome." FDA: "Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)." Etsy.com.
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