Analysis Law and Policy

‘Robin Danielson Act’ Would Mandate Independent Testing on Tampon Safety

Mary Emily O Hara

Almost no independent research has investigated the potential health impacts of long-term feminine hygiene product use. Studies have generally taken place through product manufacturers—who aren't required to release the results in full to the public.

Some feminine hygiene products, such as tampons and pads, are privately tested through their manufacturers before they receive the Food and Drug Administration (FDA) approval necessary for market entry. Others, like vaginal wipes and douches, require no specific safety testing at all. In both cases, critics say the process locks the public out of health risk information needed to make informed decisions about products they are using internally on a regular basis.

That’s why Rep. Carolyn Maloney (D-NY) has reintroduced the Robin Danielson Act, a bill named for a woman who died of Toxic Shock Syndrome (TSS) in 1998.

“We need more dedicated and substantial research to address unanswered health concerns regarding the safety of feminine hygiene products,” Maloney told Rewire. “American women spend well over $2 billion per year on feminine hygiene products, and the average woman will use over 16,800 tampons and pads over the course of her lifetime. Despite this large investment and high usage, there has been limited research on the potential health risks these products may pose to women.”

The legislation would require the National Institutes of Health (NIH) to allocate resources for independent research into the potential hazards posed by synthetic fibers and chemicals currently present in many of the feminine hygiene products on the market. It would also mandate research to confirm data submitted to the FDA by manufacturers. The results of all future independent studies would be submitted to Congress, the Environmental Protection Agency (EPA), and the Consumer Product Safety Commission as well as the FDA. These findings would also be available to the public.

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Maloney first introduced the Tampon Safety and Research Act in 1997, the year before Danielson died. The bill was re-named and has been brought before Congress a staggering nine times in total. Each time Maloney reintroduces the bill, it’s killed before it can get near a vote. It is currently in the Committee on Energy and Commerce.

A spokesperson for Maloney wasn’t able to comment on why the bill has been shot down so many times, but Chris Bobel, president of the Society for Menstrual Cycle Research, wrote in her 2010 book New Blood: Third-Wave Feminism and the Politics of Menstruation that the bill’s repeated failure could be “a result of activist inattention.” In Bobel’s interviews with feminine hygiene safety activists, she wrote, few seemed to set their sights on legislative action and instead focused on pressuring manufacturers through boycotts and other methods. With increasing public attention being paid to the policies surrounding hygiene products and alternatives to them, that may change—as might any congressional reluctance to engage with reproductive medical issues.

Regardless of activists’ strategy for approaching the topic, Bobel notes they are largely concerned about the health effects of feminine hygiene and menstrual products—especially because so few studies have been done using human subjects. According to everyone interviewed for this story, almost no independent research has investigated potential health impacts of long-term feminine hygiene product use, aside from the many studies on TSS. Bobel says anthropologists and other social scientists have frequently examined the culture around menstruation, but most medical research has centered on reacting to ongoing outbreaks of TSS rather than examining unknown outcomes.

And, health advocates point out, the research that has been done has taken place through product manufacturers. Part of the problem is that tampons and pads are considered “medical devices,” which means companies test them before submitting the results to the FDA as part of their pre-market approval (PMA) documents. PMAs—including testing results—are not readily available to consumers. Furthermore, the FDA does not require companies to list the ingredients on these products.

According to the FDA’s 2005 guidance, a tampon manufacturer submitting a PMA should test for potential health risks including adverse tissue reaction, vaginal injury, vaginal infection, and TSS. Preclinical toxicology and microbiology are “recommended” as well. Those submitting PMAs for pads should address adverse tissue reaction as well. Because so much of the testing data is kept secret, it’s unclear how strictly the FDA enforces the guidelines, much less what the actual results are.

“What’s clear is that there is so little data,” Bobel told Rewire. “We don’t have access to industry data that’s reported to the FDA because they aren’t obligated to release the results of their studies to the consumer. And that’s standard, but it means that consumers can’t make authentically informed choices. So there’s no transparency or accessibility.”

The FDA guidance also says nothing about long-term health effects relating to chemical leakage, which some scientists see as a potential problem concerning tampons in particular.

Philip Tierno, a microbiologist at New York University and author of The Secret Life of Germs, has been conducting independent research on TSS for years. TSS, caused by the bacteria Staphylococcus aureus, became epidemic around 1980. The health crisis was traced to the use of Proctor & Gamble’s Rely tampon, which was comprised of a synthetic blend encased in polyester. Tierno explained that the ingredient carboxymethylcellulose was primarily responsible for encouraging bacterial growth because of the way it “gelled” the liquids inside the vagina.

But toxic shock isn’t the only harm women face when it comes to feminine hygiene products, Tierno argues; it’s just the only disease that has been proven to be linked to them.

“There are many other leachables that come from fibers, and they leach out chemicals whether [the fibers are] organic or inorganic, and [they] clog the liver,” said Tierno. “If you have a woman who has no or low antibodies, not only are the leachables being absorbed, but other chemicals that come into play when the liver is clearing toxins.”

Many of the most toxic tampon ingredients—like the carboxymethylcellulose in Rely tampons—were banned in the 1980s after testing showed a direct connection between them and TSS. But Tierno says many products still include viscose rayon: the bleached wood pulp derivative that produces dioxins, the “leachable” about which he is most concerned. He believes that rayon and synthetics in general are responsible for ongoing cases of TSS, and that the disease can only be avoided by using all-cotton tampons or shunning their use altogether in favor of pads.

According to the EPA, most people have trace amounts (low parts per trillion) of dioxins in their systems. Dioxins are normally absorbed in these tiny amounts through food and water, and enters the environment through things like industrial waste processes and forest fires.

The EPA notes, however, that dioxins can be potentially harmful at moderately increased doses. “At body burden levels 10 times or less above those attributed to average background exposure, adverse non-cancer health effects have been observed both in animals and, to a more limited extent, in humans,” reads a posting about dioxin on the agency’s website. “In animals these effects include changes in hormone systems, alterations in fetal development, reduced reproductive capacity, and immunosuppression. Effects specifically observed in humans include changes in markers of early development and hormone levels. At much higher doses, dioxins can cause a serious skin disease in humans called chloracne.”

In a patient alert from 2013, the FDA stated that “trace amounts” of dioxins had been found in tampons on the market; manufacturers must also provide the FDA with test results of the dioxin levels in their products from independent laboratories. Though the FDA pointed out that the dioxin levels in these tampons were very low, Tierno told Rewire that no studies have ever examined the impacts of dioxin accumulation in the body over a lifetime.

“You have to do some research. There is no research taking place on things like dioxin except at the hands of the manufacturers [during the FDA’s pre-market approval requirements], which is like the fox taking care of the henhouse,” Tierno said. “They aren’t looking at long-term effects. We need data to be able to glean information that can serve as the basis for predicting what can occur.”

The overall lack of a push for research on these issues becomes more glaring when one compares the way feminine product safety is assessed to other products used regularly and internally, such as toothpaste.

For example, in December 2013, concerns about the presence of a chemical called triclosan in Colgate Toothpaste prompted the FDA to begin an ongoing review of its safety risks. The agency hasn’t concluded its study, but in the meantime the governor of Minnesota enacted a law banning triclosan, which has been shown to mimic hormones in animal testing, from all products sold in the state beginning in January 2017. Last year, the European Union voted to ban triclosan from three industrial product groups and is assessing its safety in hygiene products.

In the wake of the controversy, toothpaste manufacturers, such as Proctor & Gamble, which makes Crest, began labeling their oral care products as “100 percent triclosan free.” However, according to a 2013 research study from Women’s Voices for the Earth, several non-toothpaste products on the market—especially feminine wipes, washes, and sprays—could contain either triclosan or similar endocrine disruptors, as well as other ingredients that have been linked to endocrine disruption or other health problems. Yet there has been little focus on feminine hygiene products as sources of these chemicals, especially when contrasted with the widespread reaction to triclosan in toothpaste.

What’s more, because the FDA regards feminine wipes, washes, and douches as “cosmetics,” each product does not require specific testing to get the agency’s approval.

By mandating that the NIH support and fund research into any health risks stemming from all feminine hygiene products—including links between those products and common health conditions—the Robin Danielson Act seeks to close this research gap. It would also require studies examining products’ effect on reproduction: fetal and childhood development as impacted by regular feminine hygiene product use.

“The reality is menstrual health has been considered a taboo subject for far too long,” Maloney said. “It’s time that feminine hygiene products are researched so that we can ensure that complete and accurate information is being collected and made readily accessible. My legislation will give women the ability to make more informed decisions as they seek to lead healthy lives.”

CORRECTION: This article has been updated to clarify the confirmed ingredients found in feminine hygiene products.

Roundups Sexual Health

This Week in Sex: Birth Control on ‘Downton Abbey,’ and Not Much Sex in Japan

Martha Kempner

This week, the FDA warns of real Viagra in supposedly all natural supplements, a survey finds less than half of adults polled in Japan had sex in the last month, and we theorize about what method of contraception was available to the ladies of Downton Abbey.

This Week in Sex is a weekly summary of news and research related to sexual behavior, sexuality education, contraception, STIs, and more.

Real Viagra in “All Natural” Sexual Health Supplement

The Food and Drug Administration released a warning this week to anyone who has used or is considering using Happy Passengers, sold online as a “natural” alternative to Viagra. In laboratory tests the supplement was found to contain sildenafil, which is the active ingredient in Viagra and other drugs used to treat erectile dysfunction. Advertised on Amazon and other websites as “safe for men of all ages,” even men with high blood pressure, the supplement is anything but. In a press release, the FDA said:

This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

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This is far from the first time the FDA has found undeclared ingredients in sexual health supplements. In 2012, for example, the agency warned consumers about X-rock, a capsule that claimed to contain only herbal ingredients—including horny goat weed, ginggang root, and maca root. Lab tests found both sildenafil and hydroxythiohomosildenafil in the capsule.

The FDA warns that sexual health supplements, as well as products designed to facilitate weight loss and help in bodybuilding, are often inaccurately labeled as “all natural,” and that the agency cannot identify and test all products in these areas. Consumers, it says, should use caution when buying these products.

How Often Are the Japanese Getting It On?

A new report by the Japan Family Planning Association surveyed 3,000 adults in the country about their sexual health and behavior and found that almost half of the respondents had not had sex in the month prior to the survey.

Specifically, 48.3 percent of men said they had not had sex during that month, as did 50.1 percent of women. These numbers are about 5 percent higher than they were at the time of the last survey in 2012, which suggests the Japanese are having less sex.

The survey also asked participants why they were not having sex, and almost a quarter of women (23.8 percent) said they found sex bothersome. Married men, in contrast, blamed childbirth, with 15.7 percent saying they were no longer interested in sex after their wives gave birth. But it isn’t just older and/or married men who say they don’t really want sex; more than 20 percent of men between 25 and 29 expressed little interest in sex.

The study is worrisome to officials in Japan who are trying to increase the country’s sagging fertility rates. Population experts have been warning that if couples don’t have more children, there will only be 49.59 million Japanese by the year 2100 (there are currently 126.7 million people in the country, but a quarter of them are 65 or older). In one attempt to fix the situation, the government has told companies to insist staff leave work by 6 p.m., presumably to reduce tiredness and increase sex. According to the survey, however, getting off early is not enough—both men (21.3 percent) and women (17.8 percent) said they were too tired after work to do it.

Contraception Comes to Downton Abbey

I was surprised to learn that last week’s episode of Downton Abbey, the British period drama about an aristocratic family and their houseful of servants, included a reference to contraception—not because the show is so chaste (at its core, it’s a soap opera) but because women at that time had few birth control options and little access to those that did exist.

It is approximately 1923 on the show when Lady Mary sends her lady’s maid, Anna, to procure something that will prevent pregnancy. After the episode aired, Allyson Koerner at Bustle set out to determine what that something was. Condomsmade out of leather, paper, and animal intestines—have been around for hundreds of years, and they started being made out of rubber soon after Mr. Goodyear figured out vulcanization in 1883. But the episode seemed to suggest the method was for Mary and not her partner. According to Koerner, that would leave a sponge (either soaked in oil or a quinine sulfate); vaginal suppositories with cocoa butter, which were used between 1885 and 1960; a spermicide called Patentex, which was invented in 1906; or an early version of the cervical cap or diaphragm, which were first introduced in 1882.

Today’s women have far more choices, and our contraceptive methods are much more effective. What is striking, though, is how much easier it is for women of means around the world to access contraception now. In the episode, Mary left the illicit activity of procuring birth control up to her lady’s maid, and Anna was visibly scared that she’d be caught. Today, someone of Mary’s wealth could easily see a doctor for prescription methods or stop at a local drug store for an over-the-counter method, presumably without any embarrassment or shame.

Roundups Sexual Health

This Week in Sex: Condoms for Women, New Vibrating Underwear, and the ‘Fifty Shades’ Effect on Sex Toy Purchases

Martha Kempner

This week, design students want to revamp condom packaging to appeal to women, a sex toy company released new underwear, and sex researchers predict 2014 will mark the return of "vanilla" sex for couples—but we're not so sure we agree.

This Week in Sex is a weekly summary of news and research related to sexual behavior, sexuality education, contraception, STIs, and more.

Design Students Revamp Condom Packaging

Students at New York City’s School of Visual Arts are working to redesign condom packaging to make women feel more comfortable buying and carrying them. Mansi Gupta and three fellow students have come up with Mine products, which thus far include two different gender-neutral condom wrappers; one is a rectangular and one is circular, and both come in yellow, orange, or green, with a subtle white leaf design. With the tagline “There’s Nothing to Hide,” the line also includes a nifty night-table stand that allows women to store the condoms openly and proudly, and a caddy for holding condoms and tampons together.

The project is part of a course called “Design for Social Values,” which is conducted in partnership with the Centers for Disease Control and Prevention. Before settling on a line of products, the students surveyed more than 200 people and found that 77 percent were embarrassed to buy condoms and a full 60 percent believed that women who carry condoms are promiscuous. They set out to change this through design. Gupta explained to Fast Company, “We hope to encourage more women to buy condoms, thus adopting healthier sexual behaviors.”

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The products are not yet available commercially, but the students would like to partner with an existing condom company or manufacturer of feminine hygiene products to bring them to e-commerce outlets and drugstore shelves.

Bluetooth-Enabled Vibrating Underwear

Amid talk of new gadgets for your kitchen, media room, and home office at the 2014 Consumer Electronics Show in Las Vegas came this little tidbit: The sex toy company OhMiBod is releasing new underwear. How is that an electronic breakthrough, you ask? Well, the underwear is specially made to hold the blueMotion massager, a vibrator-shaped toy kind of like a pantyliner—or maybe an athletic cup—which can be controlled via Bluetooth, and an accompanying app available for iPhone and Android. Yep, as long as the two of you are within Bluetooth accessible range, your partner can control the vibrator in your underwear from his or her phone without anyone being the wiser. Cocktail parties just got a whole lot more interesting.

Brian Dunham, who founded OhMiBod with his wife Suki, said the two of them came up with the idea when they realized they were spending more time on their smartphones than being intimate. He told Mashable, “Technology can drive couples apart, but this is using technology and gadgets to bring them closer together.”

The gadget will be available in March for $129. The company is working on a future model that could be controlled from a further distance.

The “Fifty Shades of Grey Effect” May Be Waning, at Least in the Sex Toy Market

Fifty Shades of Grey, the just-short-of-pure-porn trilogy that seems to have been read by every suburban woman in the United States and Britain, made a huge splash when it hit bookshelves and e-readers a couple of years ago. Many have credited the books for a rise in curiosity around BDSM activities, such as tying up a partner or using a whip during sex play.

In 2012, the international sex toy company LELO released its 2012 Global Survey, noting that sales of certain toys had gone way—way up. That year, there was a 34 percent increase in sales of role-playing lingerie, 50 percent rise in sales of whips, 80 percent jump in sales of blindfolds, a 100 percent uptick in sales of handcuffs, and a 400 percent surge in sales of ben wa balls, which are featured in the book.

But, despite the fact that the movie version is set to come out later this year, the Fifty Shades phenomenon might be over. LELO released numbers showing that sales of products like whips and leashes plateaued at the end of 2013, and couples are instead investing in high-end vibrators and vibrating rings. Sales of these products spiked by 82 percent last year.

LELO is saying that this marks the return of “vanilla” sex, but maybe it just means people feel their toy chest is well-stocked for nights when they want to pretend to be Christian Grey and Anastasia Steele, and they now need some things that suit their many other moods.


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