FDA investigates potential health risks of heavy metals in tampons

The U.S. Food and Drug Administration (FDA) is currently assessing the potential health risks posed by heavy metals, including lead and arsenic, found in tampons. This examination was prompted by the publication of a pilot study in July, which detected the presence of these metals in both organic and non-organic tampons. Although the levels of the metals found were minimal, the U.S. Environmental Protection Agency (EPA) maintains that no amount of lead exposure is considered safe.

The study, however, did not investigate whether these metals are released from tampons during use, nor did it assess whether the metals could be absorbed through the vaginal lining or enter the bloodstream. In response, the FDA has initiated an independent literature review and launched its own laboratory study to explore the presence of metals in tampons.

The FDA’s internal research will aim to measure the number of metals that could potentially be released from tampons under conditions that mimic normal use. This will help the agency conduct a comprehensive risk assessment based on the worst-case scenario of exposure. The results of both the literature review and the lab study will be made publicly available after they undergo peer review.

The organization also noted that all tampons currently cleared by the agency have already been evaluated according to guidelines outlined in the document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) and have met FDA premarket requirements. The agency reiterated its commitment to monitoring these products throughout their lifecycle as part of its regulatory oversight of medical devices.