FDA to conduct independent review, lab study evaluating metals in tampons

Key takeaways:

• FDA will initiate a literature review and lab study to evaluate metals in tampons sold in the U.S.
• The announcement comes after a study suggested tampon samples tested positive for toxic metals.

The FDA announced it has commissioned an independent literature review and internal bench laboratory study to evaluate metals in tampons after a recent study suggested tampons sold in the U.S. tested for the presence of toxic metals.

In its announcement, the agency noted any tampons sold in the U.S. must meet safety requirements, adding that manufacturers must test the product and its component materials before, during and after manufacturing.

“The FDA is aware of concerns about tampon safety after a 2024 study found metals in tampons during laboratory testing,” the agency stated. “We want the public to know that before tampons can be legally sold in the U.S., they must meet FDA requirements for safety and effectiveness.”

As Healio previously reported, researchers with the Sustainability and Health Equity Lab at University of California Berkeley School of Public Health confirmed the presence of toxic metals, including lead, cadmium and arsenic, in each of 60 tampon samples tested, though they cautioned more studies are needed on whether the detected metals can leach into the body. The researchers evaluated the concentrations of 16 metal(loid)s in 30 tampons from 14 tampon brands and 18 product lines, purchased from September 2022 to March 2023, and compared the concentrations by tampon characteristics. The study did not name the specific brands that were tested.

In the study, researchers detected “measurable concentrations” of all 16 metals assessed, including elevated mean concentrations of lead (geometric mean, 120 ng/g), cadmium (geometric mean, 6.74 ng/g) and arsenic (geometric mean, 2.56 ng/g).

In the announcement, FDA noted that while the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining and getting into the bloodstream during tampon use.

“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,” FDA stated. “The FDA’s laboratory 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 worst-case scenario of metal exposure.”

The agency said it will communicate the findings from the literature review and lab testing publicly once these 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,” the agency said in the release.