The Food and Drug Administration concluded that tampons remain safe for use after conducting an independent literature review in response to a groundbreaking 2024 study that found toxic metals in popular tampon brands. The agency announced its findings on December 23, 2024, stating that despite identified limitations in available research, no safety concerns were associated with tampon use and contaminant exposure.
The controversy began in July 2024 when UC Berkeley postdoctoral researcher Jenni Shearston published a study in Environment International revealing that tampons from 14 different brands contained measurable concentrations of 16 metals, including lead, arsenic, and cadmium. The study tested 30 tampons and found metals present in all types, with concentrations varying by purchase location, organic versus non-organic classification, and brand type.
Congressional leaders quickly responded to the alarming findings. Senator Patty Murray, chairman of the appropriations committee, sent a letter to the FDA on July 29 urging the agency to examine the study and ensure tampon safety. The Democratic Women’s Caucus followed with a similar request on September 5, emphasizing concerns about products used by millions of women throughout their reproductive years.
The FDA commissioned International Consulting Associates to conduct a systematic literature review, which analyzed nine published studies evaluating various contaminants in tampons, including metals, phthalates, parabens, and volatile organic compounds. However, the review identified significant limitations in existing research, noting that none of the studies addressed how much, if any, of the identified contaminants are actually released from tampons or absorbed through vaginal tissue.
While the literature review provided reassurance about current tampon safety, the FDA acknowledged the need for more comprehensive research. The agency is continuing its internal bench laboratory study to determine if metals from tampon materials are released or absorbed in the body under conditions that more closely mimic normal use. This ongoing research will enable the FDA to complete a risk assessment based on worst-case metal exposure scenarios.
The original Berkeley study raised particular concerns because vaginal skin has higher potential for chemical absorption compared to skin elsewhere on the body. Researchers noted that 50-80% of menstruating individuals use tampons regularly for several hours at a time, potentially creating significant exposure opportunities. The study found that metals could enter tampons through various pathways, including absorption from contaminated water, air, or soil by cotton materials, or intentional addition during manufacturing processes.
Exposure to toxic metals has been linked to increased risks of dementia, infertility, diabetes, and cancer, according to health researchers. These substances can damage the liver, kidneys, and brain, as well as cardiovascular, nervous, and endocrine systems. The metals can also harm maternal health and fetal development, making the safety of menstrual products a critical public health concern.
The FDA emphasized that all tampons legally sold in the United States must meet safety and effectiveness requirements before market authorization. Manufacturers must conduct biocompatibility and safety testing before, during, and after production, with FDA review of all testing results prior to clearance. The agency continues monitoring these medical devices as part of its total product lifecycle approach to ensure ongoing safety and effectiveness for the millions of women who rely on these products monthly.