FDA Investigates Heavy Metals in Tampons

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a statement that announced it commissioned an investigation to evaluate metals, such as lead and arsenic, in tampons.

The FDA’s actions follow concerns about tampon safety after a recent study found metals in tampons during laboratory testing. The small pilot study tested 16 metals in 30 tampons from 14 tampon brands and 18 product lines from major online retailers and stores in the U.S., United Kingdom and Greece.

The study found small amounts of heavy metals, such as arsenic and lead, in organic and nonorganic tampons. Lead concentrations were higher in nonorganic tampons while arsenic was higher in organic tampons. No safe level of exposure to lead exists, according to the U.S. Environmental Protection Agency. CNN reported the average lead concentration in tampons was about 10 times higher than the maximum levels currently allowed in drinking water.

While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. The study also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use

FDA’s comprehensive review of the pilot study 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. 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 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.

Before tampons can be legally sold in the U.S., they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing. Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.