Updated September 11, 2024 at 14:58 PM ET
The U.S. Food and Drug Administration will investigate the ingredients in tampons, after a study released earlier this summer found toxic metals in products from over a dozen popular brands.
The FDA posted a public notice to its website on Tuesday that it has commissioned two studies to evaluate metals in tampons, after growing calls from lawmakers concerned about their safety. The agency first confirmed the studies to NPR last week.
“These initiatives will enable the FDA to complete a risk assessment of metals contained in tampons, based on a worst-case scenario of metal exposure,” it said. “The FDA will also continue monitoring these devices as part of its total product lifecycle approach to medical devices.”
Safety concerns about tampons, and calls for stronger regulation, are not new. More than a dozen studies in recent years have evaluated the presence of various chemicals in widely used menstrual products, including a 2019 study that found higher concentrations of blood mercury in tampon users (which is cited in Thursday’s letter).
But they intensified in July after a first-of-its-kind study published in Environment International detected amounts of 16 heavy metals — including lead — in various tampons made by 14 common brands, which were not named.
Heavy metals have been linked to all sorts of negative health effects, from damaging the cardiovascular, nervous and endocrine systems to increasing cancer risks to harming maternal health and fetal development.
The study authors caution that more research is needed to determine to what extent the metals might “leach out of tampons” and into peoples’ bodies, and what health impacts they might have if so.
But they say more transparency is needed, too — especially considering millions of Americans spend so many hours with tampons inside their bodies. The study found that people who menstruate may use more than 7,400 tampons over their reproductive years.
“I think it's important that we ask for clear labeling on our products so that people can make informed decisions for themselves based on their own values and health priorities,” lead author Jenni Shearston, a postdoctoral scholar at the UC Berkeley School of Public Health, told NPR in July.
“And I think it's also important that we try to get better testing, especially of heavy metals like arsenic or lead in tampons so we can make sure everyone's safe.”
Since July, the FDA has defended the safety of tampons and emphasized the limitations of the study, pointing out it doesn’t answer questions about whether metals might leave the tampon and be absorbed by the body — nor what the potential health impacts of that would be.
Now, it has a plan to try to find out.
An agency spokesperson told NPR last week that the FDA is undertaking an independent literature review and an internal bench laboratory study to evaluate metals in tampons.
“The comprehensive review of the published literature will provide a better understanding of the data currently available regarding the presence of chemicals in tampons and, importantly, any associated health effects of those chemicals,” the agency said. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.”
The FDA says the findings will be shared publicly once they have been peer-reviewed.
The investigation follows pressure from women on Capitol Hill
Last Thursday, members of the Democratic Women’s Caucus wrote a letter to Commissioner Dr. Robert Califf, urging the FDA to “review and improve the current safety standards for tampons.”
“We urge the FDA to take swift action to ensure that women are safe from harmful and toxic substances in tampons,” they wrote. “We look forward to reviewing your plan to address these concerns and working with you on this issue.”
The letter, a copy of which was shared with NPR, was signed by Reps. Summer Lee of Pennsylvania, Grace Meng of New York and policy task force co-chairs Kathy Manning of North Carolina and Ayanna Pressley of Massachusetts. The Democratic Women’s Caucus includes all Democratic women in the U.S. House of Representatives.
An FDA spokesperson told NPR at the time that the agency "has received the letter and will respond directly to the Caucus."
Sen. Patty Murray, D-Wash., the chair of the Senate Appropriations Committee, also sent a letter to Califf of the FDA in late July, several weeks after the publication of the metals study.
“In light of this alarming reporting, I urge the U.S. Food and Drug Administration (FDA) to carefully examine these new findings and evaluate any necessary actions to ensure the safety of tampons and menstrual products,” Murray wrote.
Murray asked the FDA to respond in writing to six specific questions about what it currently does and plans to do to ensure the safety of period products, and to brief her staff on the “regulation and safety processes for tampons and menstrual products,” by specific dates in August.
Murray's office told NPR last week that the FDA has let the senator know "they take the issue of tampon safety seriously, and they are working on a more detailed response to her letter in addition to two related studies."
How tampons are currently regulated
The FDA regulates and classifies tampons as medical devices, so manufacturers are not required to disclose their ingredients on the label the way that other consumer products do, as the letter points out.
The FDA’s tampon guidance from 2005 doesn’t mandate that products be tested for chemical contaminants. And it recommends — but doesn’t require — that tampons “be free of” the highly toxic compound dioxin as well as “any pesticide and herbicide residues.”
Chemicals could get into tampons in a number of ways, from raw materials like cotton being contaminated by pollutants in the soil and water to manufacturers intentionally adding them as odor control or antimicrobial agents.
Tampons must meet FDA requirements for safety and effectiveness before they can be legally sold in the U.S.
The spokesperson said that process involves toxicity testing, which consists of identifying potentially harmful substances — "such as some metals" — and assessing the risk of those substances coming out of the product and being absorbed by the body during single as well as repeated use.
“As part of the FDA’s review, manufacturers submit data including the results of testing to evaluate the safety of the materials used to make tampons and applicators (if present); tampon absorbency, strength, and integrity; and whether tampons enhance the growth of certain harmful bacteria or change normal bacteria levels in the vagina,” the agency explained in an online fact sheet.
The Center for Baby and Adult Hygiene Products (BAHP), a North American trade association, defended the safety of its members’ menstrual products in a 2022 statement in which it said all absorbent hygiene products “undergo a thorough safety assessment beyond what is required by the applicable regulatory framework.”
It said any chemicals in menstrual products are “not intentionally added by the manufacturers,” saying such “impurities” may be present in the environment or “even made by the human body.”
“Our members routinely test their products with external labs for the presence of background substances and these reports affirm our products are safe and that women can use them with confidence,” it said.
The Consumer Healthcare Products Association released a statement last week saying its members abide by all FDA “regulations, guidelines and procedures” and, in light of the FDA’s studies, was expressing its support for “continued research to help ensure the safe use of these products.”
Some states are passing their own laws in the absence of federal requirements
Congress has tried unsuccessfully in the past to strengthen regulations on tampons and other menstrual products.
In 2022, Reps. Debbie Lesko, R.-Ariz., and Meng — one of the letter’s signatories — introduced the “Menstrual Products Right to Know Act,” which would have required the federal Food, Drug and Cosmetic Act to “treat menstrual products as misbranded if their labeling does not list each component of the product.”
The legislation was referred to a subcommittee and did not progress further.
In a report that same year, the House Appropriations Committee expressed concern about the “potential danger of fragrance ingredients used in menstrual products that are medical devices.
“These products are used frequently by consumers without knowledge of the presence of these ingredients, or understanding of their potential harms,” lawmakers wrote, noting that the FDA does not currently maintain a list of such ingredients.
The committee's report directed the agency to evaluate the fragrance ingredients in its existing records and “if necessary” compile a list. It also directs the FDA to determine at what concentrations it would recommend that manufacturers disclose the presence of such ingredients in their product labels.
The FDA spokesperson said the agency will continue working to update its existing guidance to include recommendations outlined in the report, and "looks forward to engaging with patients, health care providers, and others during a public comment period when those guidance updates are proposed."
In the meantime, some states are taking matters into their own hands.
In 2019, New York became the first to pass a law requiring manufacturers to contain a “plain and conspicuous” list of ingredients on the packaging for menstrual products. It took effect in 2021.
The nonprofit group Women's Voices for the Earth (WVE) conducted a field study on ingredient disclosures from late 2021 to early 2022 and found that the ingredients newly announced on period product labels included chemicals that can irritate skin, trigger allergic reactions, cause cancer and release microplastic particles into the environment.
“Numerous additives to period products are now being disclosed for the first time, indicating that chemical exposure from period products is much more complicated than previously assumed,” they wrote in a May 2022 report.
The group also noted that while compliance with New York law was imperfect — for example, some products described ingredients as “fragrance” or “adhesive” without including the actual chemical names — ingredient information appeared to be becoming more standard on menstrual product labels nationwide.
“We commonly found products in other states with ingredient disclosures on the package similar or identical to what is required in New York, affording period product users across the country the right to know what is in their products,” WVE added.
California followed suit in 2020, passing a law that requires period product manufacturers to disclose “intentionally added ingredients” both on labels and online starting in 2023. And last year, Nevada became the third state to require ingredient disclosure, with a law slated to take effect at the start of 2025.
In June, Vermont became the first state to ban so-called PFAS, or “forever chemicals,” from menstrual products; that law is poised to take effect in 2026.
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