FDA doesn't require manufacturers to disclose tampon ingredients
In the past few weeks, both P&G and Kimberly-Clark have published additional information on their websites
About 70% of all American women use tampons. On average, a woman will use between 11,000 and 16,000 tampons in her lifetime.
In fact, tampon-like devices have been used since ancient Rome, where women fashioned devices out of wool to absorb menstrual flow. Rolls of grass were used in parts of Africa, and Hawaiian women used ferns.
But what is actually in a modern-day tampon and pads?
Generally, tampons are blends of cotton and rayon, along with synthetic fibers, but each manufacturer’s products are different and considered proprietary.
Consumer groups in the United States have been wanting to know more since the 1980s. A growing environmental movement and awareness about toxic shock syndrome prompted women to ask what was in these products because manufacturers weren’t required to fully disclose what goes into a tampon or pad. That’s because they are regulated and approved as medical devices by the Food and Drug Administration and full disclosure is not required.
Democratic Rep. Carolyn Maloney of New York has introduced legislation nine times since 1997 that would require manufacturers to be more transparent and disclose the complete makeup of tampons, pads, and other feminine hygiene products. She wants companies to clearly label not only the fabrics used, but also any contaminants, fragrances, colorants, dyes and preservatives. Her bill directs the National Institutes of Health to look at the health effects of these products, because, she says, there is little research in this area.
But her bill has failed to move beyond the floor, every time.
Demands for more transparency
Last month, members of the consumer group Women’s Voices for the Earth dressed up as boxes of tampons and pads and protested in front of Procter & Gamble’s corporate headquarters. They held up signs that said, “My uterus loves accurate labels.”
According to market research group Euroshare, P&G is the largest manufacturers of feminine products, with 44% of the United States market share. Women’s Voices for the Earth wants manufacturers such as P&G to fully disclose what goes into tampons, sanitary pads and wipes.
“Our concerns of the care products … was out of the lack of ingredient disclosure,” said Alexandra Scranton, director of science and research for Women’s Voices for the Earth. The group has been leading a two-year campaign it calls “Detox the Box.”
When the group tested P&G’s Always pads, it found the sanitary napkins emitted chemicals, like styrene, chloroethane and chloroform. The World Health Organization classifies styrene as a carcinogen. And the EPA says short-term exposure to high concentrations of chloromethane can have neurological effects. The Centers for Disease Control and Prevention says high levels of exposure to chloroethane can result in lack of muscle coordination and unconsciousness.
However, all the levels are accpetable under federal regulations. In a statement, Women’s Voices for the Earth said, “While the levels of the toxic chemicals emitted by Always pads were relatively low, their presence warrants health concerns for women.”
Tonia Elrod, a P&G spokeswoman, said the company hasn’t seen the complete study, but pointed out that these are naturally occurring chemicals found in the ambient air, and that the study did not measure the composition in their product.
Tucker Helmes, executive director of the Center for Baby and Adult Hygiene Products, an industry trade group, said there should be no concern about these chemicals. “There is more styrene in strawberries than there is in the air sample they measured in this study,” said Helmes.
The U.S. Food and Drug Administration, which regulates the industry, reviews all designs and materials. In May, the organization addressed concerns, responding to Internet allegations, which alleged that tampons are contaminated by asbestos and dioxin, which can lead to toxic shock syndrome.
The agency said, “The available scientific evidence does not support these rumors.”
Manufacturers release more information
In the past few weeks, both P&G, maker of Always pads and Tampax tampons, and Kimberly-Clark, maker of Kotex tampons and pads, have published additional information on their websites.
But microbiologist Philip Tierno of the New York University School of Medicine said that’s not enough. “Even if they list some ingredients, they may not be listing all of them.”
Tierno was one of the scientists who helped discover the link between toxic shock syndrome and tampons in the 1980s. He connected TSS to the synthetic materials that were used in superabsorbent tampons at the time.
The FDA says those synthetic products are no longer used in tampons sold in the United States.
“Those fibers amplified the bacteria staph, if a toxigenic strain was present,” Tierno said. About 20% of people naturally have the bacteria staph. At the height of the TSS scare in 1980, there were 890 cases reported to the CDC.
According to voluntary reports to the CDC, the number of TSS cases since 1998 has varied between 138 to as low as 65 in 2012.
But Tierno said there are still products using viscose rayon, which he called “the best of the four bad ingredients.”
‘A lot of dioxin’
Rayon is a synthetic made from sawdust and a byproduct of it is dioxin, which the EPA says is likely carcinogenic. The FDA says that trace amounts of dioxin are not of concern for human health and that rayon tampons don’t have higher incidences of TSS.
“Sure, one tampon is trace,” said Tierno, “but consider the menstrual lifetime of a woman. They use approximately 12,000 tampons in a lifetime. That means 12,000 exposures of dioxin … five, six, seven times a day. That’s a lot of dioxin absorbed directly through the vagina. It goes directly into the blood.”
“Vaginal tissue isn’t like other skin. It’s covered in mucous membranes, it’s very permeable. It’s a direct route to your reproductive organs. We need to be really careful of these products,” said Scranton, of Women’s Voices for the Earth.
Bob Brand, spokesperson for Kimberly-Clark, said “Kimberly-Clark’s U by Kotex tampons are manufactured by a process that is both chlorine and dioxin-free. However, since dioxins can be found in the environment, Kimberly-Clark regularly tests for dioxins to ensure the safety of our products.” P&G said it also used a similar process.
And while companies are required to track their dioxin levels, neither company would offer to make those measurements public when asked.
‘Our products are safe’
“Our member companies take into consideration lifetime use of these products, the materials they are made from, and the body areas they contact as part of their rigorous safety assessments,” said Helmes of the industry trade group.
But what may be of greater concern, said both Tierno and Scranton, are ingredients like “superabsorbent foam,” found in pads, or “fragrance” that doesn’t list any other details.
“We want to know what ‘flexfoam’ is made of. Is it rayon or cotton or both? What are the ‘fiber finishes’?” asked Scranton.
“Every single product contained in a tampon has to be researched. We already know the fibers contain dozens (of chemicals), polyester contains hundreds of chemicals. It’s not just a fiber you put in the vaginal vault,” said Tierno.
And the concern is not just for TSS, they say, but for adverse and allergic reactions. The FDA does catalog such complaints. Since 2014, there have been 270 claims made about tampons, and 12 claims about pads.
The complaints allege everything from TSS to the products breaking apart to allergic reactions.
Elrod of Proctor & Gamble stated plainly, “Our products are safe. That’s the foundation of everything that we do. We’re working with university scientists, FDA. Women can use our products safely.”
Brand of Kimberly-Clark said “Nothing is of greater concern to Kimberly-Clark than the quality of our products and the well-being of the consumers who use them. ”
The FDA says women should choose a tampon with the minimum absorbency they need, and should consult their doctors.
The FDA requires manufacturers to provide labeling on packaging about the signs of TSS, and how to minimize risk.