Tampons: FDA toxicological study finds negligible levels of toxic metals
Researchers at the US Food and Drug Administration (FDA) recently conducted a study in response to a 2024 study that raised safety concerns about metal toxicity from tampons; however, the study found that the potential leaching of metals from tampon usage in even the most conservative conditions was negligible.
Earlier this week, FDA announced results from a study published in the June edition of the journal Toxicological Sciences in which its scientists conducted a chemical characterization study with a toxicological risk assessment (TRA) to evaluate potential adverse health effects from toxic metal leaching from tampons.
“The levels of metals contained in, and released from 11 tampon products, which are legally marketed in the United States, were analyzed by inductively coupled plasma mass spectrometry (ICP-MS),” said FDA. “Levels of metals released were determined under exaggerated test conditions (50 C for 24 h in acidified water), considering the recommended use of tampons.”
The agency said it used the International Organization for Standardization’s ISO 10993 standard and FDA guidance to conduct a TRA that detected 19 metals, including trace amounts of ICH Class I metals: arsenic (As), cadmium (Cd), and lead (Pb). However, the margins of safety (MoS) of the metals detected were negligible from a toxicological perspective.
The study was conducted in response to earlier research conducted by scientists at several universities in New York and Michigan that was published in the journal Environment International in August 2024 that raised serious concerns about the potential for metals, such as lead, to leach from tampons under certain conditions. Those researchers reported finding measurable concentrations of all 16 metals assessed in their study. More specifically, they said they detected elevated levels of several toxic metals, including lead, cadmium, and arsenic. They also noted that concentrations of toxic metals differ depending on where they were bought, whether they were organic or non-organic, and whether they were store-brand or name-brand.
"Most metals differed by organic status; lead concentrations were higher in non-organic tampons while arsenic was higher in organic tampons," said the researchers. "No category had consistently lower concentrations of all or most metals."
FDA said more recent research, including a literature review it commissioned in 2024, and the latest study did not support the concerns raised by the study in Environment International. To follow up on the study and address the concerns raised, the agency conducted its own TRA study, using conservative exposure assumptions. It noted that the toxic metals identified in the Environment International study, such as arsenic, cadmium, and lead, were found in negligible amounts.
“Although metals can be present in tampons, only a proportion will become bioavailable based on our studies, and as a result, the TRA indicated that the levels of metals released from tampons are not expected to result in adverse health effects,” said FDA. “The calculated margins of safety values were 7 or greater, indicating a low toxicological concern, which is consistent with findings from an independent, systematic literature review.”
