FDA to investigate presence of metals in tampons

Dive Brief:

The Food and Drug Administration said Tuesday it is studying the presence of metals in tampons to understand if there are health risks.
A study recently published in the journal Environment International identified tampon use as a potential source of exposure to metals in menstruating people, leading members of the Democratic Women’s Caucus to urge the FDA to address the safety concerns last week.
The FDA, which regulates tampons as medical devices, said the study did not assess whether metals are released, absorbed into the vaginal lining and enter the bloodstream. The agency is gathering more evidence to understand the worst-case scenario of metal exposure.

Dive Insight:

The Environment International study that raised the concerns tested 30 tampons, from 14 brands and 18 product lines, for 16 metals. The researchers found measurable concentrations of all 16 metals, including elevated levels of toxic materials such as lead and arsenic. Lead has no “safe” exposure level. The authors of the paper said further research is needed to show whether metals enter systemic circulation.

The study was published online in June, and a final version was made available in the journal on July 3.

Members of the Democratic Women’s Caucus cited the study in a letter to FDA Commissioner Robert Califf. The lawmakers urged the FDA to swiftly address safety concerns over the ingredients in tampons and the potential health impacts.

The FDA published a response on Tuesday, saying it is aware of the 2024 study and outlining existing measures that are in place to ensure the safety of tampons and other devices sold in the U.S. To assess if tampons are a health risk, the agency has commissioned an independent review of the literature and began an internal bench laboratory study.

Through the literature review, the FDA wants to better understand the data on the presence of chemicals in tampons and their health effects. The lawmakers cited two papers that may be relevant to the review. A study published in 2014 stated that tampons can cause tiny tears in the vagina, which could allow for chemicals to enter the body. The second paper, from 2019, showed concentrations of blood mercury were higher in tampon users.

The FDA said its laboratory study “will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.” The 2024 Environment International study put tampon samples in a microwave acid digestion system and used mass spectrometry to determine concentrations of the 16 metals.

“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. “The FDA will communicate our findings from the literature review and lab testing publicly when they are available and have been peer reviewed.”

Tampons sold in the U.S. are cleared under 510(k) guidance that the FDA published in 2005. The section of the guidance on health risks covers adverse tissue reactions, vaginal injuries, vaginal infection and toxic shock syndrome. There is no specific reference to metals or systemic circulation.

The regulation of women’s health medical devices has been a cause of controversy in recent years, with concerns about the safety of certain breast implants, the permanent contraceptive device Essure and urogynecologic surgical mesh putting the FDA’s oversight of these products in the spotlight.