FDA Launches Investigation Into Health Risks from Tampons with Heavy Metals

The U.S. Food and Drug Administration (FDA) has launched an investigation to determine whether women face potential health risks from toxic chemicals in tampons, following the release of a recent report that found elevated levels of heavy metals in a number of store bought tampon products.

Concerns about the safety of tampons with heavy metals emerged after a study was published in the August 2024 edition of the journal Environment International, indicating that 18 different store-bought tampon product lines contained 16 different metals, including lead, arsenic, cadmium and others.

Some of these metals found in the tampons are known human carcinogens, which raises serious health concerns about the risks they may pose if the toxic chemical elements are absorbed through vaginal tissues and get into the bloodstream. This could result in a host of potential side effects, including cancer, weakened immune systems, skin irritation, infertility and hormonal disruptions, as well as developmental problems, birth defects and developmental delays in fetuses.

It is unclear how heavy metals wound up in tampons, but they could have leached into the cotton fibers through soil exposure, pesticides, fertilizers, bleaching, industrial equipment, dyes, fragrances or even other environmental factors, such as air and water.

In response to rising questions raised by women about the health risks from using tampons with heavy metals, the FDA released a statement on September 10, indicating that the agency intends to do further research into the results of the study, to determine how prevalent the metals are and whether there may be adverse health effects for women from the presence of the toxic chemicals in tampons.

FDA Evaluating Presence of Heavy Metals in Tampons

Although the original report confirmed the presence of 16 heavy metals in tampons, the team of researchers from Columbia University, University of California Berkeley and Michigan State University indicated that further studies are required to determine if the metals actually leach out of the tampons and into the body’s circulatory system.

The FDA indicates that it has commissioned an independent review of available literature, as well as internal bench laboratory studies to evaluate the prevalence of tampons with heavy metals.

This review will allow the agency to gain a better understanding of the current data regarding the presence of heavy metals in tampons, as well as whether these chemicals are absorbed into a woman’s bloodstream and vaginal wall.

“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 said in its statement. “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.”

Following the risk assessment, the regulators intend to communicate their findings to the public, and continue monitoring tampons throughout the product lifecycle to see if there are any changes in the results.

The FDA also reminds consumers that all tampons currently available in the U.S. have already gone through biocompatibility testing before being brought to market, and must adhere to the FDA’s premarket requirements and guidance document: Menstrual Tampons and Pads: Information for Premarket Notification Submissions.