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FDA launches tampon safety investigation after study finds toxic metals

Two months after a study led by UC Berkeley School of Public Health postdoctoral researcher Jenni Shearston reported that tampons used by millions of women can contain lead, arsenic, cadmium, and other chemicals, the Food and Drug Administration (FDA) has launched its own investigation into the potential hazard.

“The FDA is aware of concerns about tampon safety after a 2024 study found metals in tampons during laboratory testing,” the agency wrote on September 10, 2024. “The FDA has therefore commissioned an independent literature review and initiated an internal bench laboratory study to evaluate metals in tampons.”

Shearston said she was pleased that the FDA was following up. Shearston believes the report, which was primarily researched when she was a doctoral student at Columbia University, was the first of its kind. It was published in July online in Environment International.

“The FDA is taking it seriously,” she said. “I was really excited to see that.”

For their report, Shearston and her colleagues evaluated levels of 16 metals in 30 tampons across 14 different brands. The concentrations of metals, which included cadmium, manganese and arsenic, among others, varied by place of purchase (US vs. EU/UK); organic vs. non-organic, and store vs. name-brand.

Exposure to metals has been found to increase the risk of dementia, infertility, diabetes and cancer. Metals can damage the liver, kidneys, and brain, as well as the cardiovascular, nervous, and endocrine systems. Metals can also harm fetal development and maternal health.

The researchers reported that vaginal skin has a higher potential for chemical absorption than skin elsewhere on the body, making tampons a potentially hazardous source of exposure. They are currently testing how much of the metals can leach out of the tampons and into the body as well as determining the presence of any other chemicals in tampons.

The Environment International study quickly went viral, with dozens of news outlets calling Shearston and her colleagues from Michigan State University and Columbia University for comments.

Shortly after publication, Shearston and two colleagues were contacted by several congressional investigators, who requested additional details.

Separately, on July 29, Senator Patty Murray (D-WA), chairman of the appropriations committee, sent the FDA a letter urging the agency to examine the study and ensure that tampons, which women may use more than 7,400 of over a lifetime, are safe.

“I write today to express my deep concern about a new study which found that tampons from several popular brands often contain toxic metals, such as lead, arsenic, and cadmium,” Senator Murray wrote . “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.”

On September 5, the Democratic Women’s Caucus sent the agency a similar missive.

And on September 10, the FDA announced its two-part investigation. The agency will conduct a literature review, and then conduct an internal bench laboratory study to evaluate metals in tampons. The study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.

“These initiatives will enable the FDA to complete a risk assessment of metals contained in tampons, based on a worse-case scenario of metal exposure,” the agency wrote, adding that the investigation will be released to the public after peer review.

Shearston said she does not expect the agency’s literature review to turn up much, because there hasn’t been a lot of research on chemicals in menstrual products. Beyond that, while Shearston is pleased that the FDA will undertake its own leaching experiments, she hopes the current lack of knowledge about vaginal metal absorption doesn’t lead the agency to underestimate the potential risks.