The FDA has launched a study to examine the potential toxicity of metals that can be found within tampons—a regulated medical device, from the agency’s point of view.
Researchers will conduct their own experiments to measure the amounts of metals that may leech out of tampons and enter the body, and explore the potential health effects of those chemicals.
The agency said it will also review previously published scientific evidence. Earlier this year, a study published in the journal Environment International tested 14 tampon brands collected worldwide and measured the concentrations of 16 different metals. They found different amounts of lead, for which there is no safe exposure level, as well as arsenic, mercury, zinc and cadmium, among others.
“Although toxic metals are ubiquitous and we are exposed to low levels at any given time, our study clearly shows that metals are also present in menstrual products and that women might be at higher risk for exposure using these products,” the study’s co-author, Kathrin Schilling, an assistant professor at the Columbia University Mailman School of Public Health, said in a July statement.
Those results led members of the congressional Democratic Women’s Caucus to send a letter to the FDA and Commissioner Robert Califf last week. The lawmakers urged the agency to review its safety standards for tampons, according to a report from NPR.
Under FDA regulations, tampons are considered a Class II medical device, or one carrying a moderate patient risk, and they require a 510(k) clearance to be sold in the U.S. market. Most menstrual pads, by comparison, land within the lower-risk Class I category.
The researchers in the July study said the absorbent cotton material of tampons could potentially capture metals found within the air, water and soil, or that the chemicals could be added during the manufacturing process.
Metals such as lead have been linked to increased risks of dementia, infertility, diabetes and cancer, and they can damage the liver, kidneys and brain. In their paper, the researchers said additional studies would be needed to explore exactly how much can find their way into human tissue.
“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,” the agency said in its announcement. “The FDA will communicate its findings from the literature review and lab testing publicly when they are available and have been peer-reviewed. The FDA will also continue monitoring these devices as part of its total product lifecycle approach to medical devices.”