FDA Literature Review on July 2024 Tampon Study- No Safety Concerns Found
January 6, 2025
In response to the July 2024 tampon study reporting that tampons contain trace amounts of metals, the FDA has commissioned a comprehensive literature review to better understand the available data on tampon safety.
The FDA has released its findings and cleared tampons as a safe menstrual product. The FDA stated there are no safety concerns associated with tampon use and contaminant exposure.
BAHP supports the FDA’s further research on the safety of tampons in real world use and the agency’s ongoing commitment to public health.
BAHP member companies are committed to the safety and quality of their tampon products and to providing accurate and useful information regarding the ingredients in menstrual products.
As part of continuing efforts to assess the safety of tampons, in September 2024, the FDA commissioned an independent, systematic, literature review and initiated a laboratory study on metals in tampon materials. The literature review is now complete, and the FDA is sharing the report.
Although limitations were identified in the literature review, as is common, the findings did not identify safety concerns associated with tampon use and contaminant exposure. The FDA continues to recommend FDA-cleared tampons as a safe option for use as a menstrual product.
The Literature Review
The purpose of the literature review was to determine the available evidence on contaminants in tampons and their related health effects. It included nine published articles that evaluated a variety of different contaminants in tampons, including metals, phthalates, parabens, bisphenols, volatile organic compounds (VOCs), dioxins, and triclocarban.
There are limitations related to the methods used in the studies that were reviewed. In addition, none of the studies reviewed address how much, if any, of the contaminants identified are released from the tampon or absorbed through the vagina. Although limited, the available evidence continues to support the FDA’s conclusion that tampons remain a safe menstrual product option.
Additional Study
The FDA’s internal bench laboratory study, already underway, intends to determine if metals from tampon materials are released or absorbed in the body. Specifically, the study will measure the amount of metals that may be released from tampon materials under conditions that more closely mimic normal use. The FDA will share findings from the laboratory testing when they are complete and have been peer reviewed.
The ongoing laboratory study will better enable the FDA to complete a risk assessment of metals contained in tampon materials, based on a worst-case scenario of metal exposure.
FDA Actions
The FDA committed to further evaluating the safety of tampons because an outside study published in 2024 found low levels of metals in tampons during laboratory testing. While that study reported metals in some tampons, it did not test whether metals are released from tampons when used or whether they were absorbed into the vaginal lining or getting into the bloodstream.
Regulatory Background
Before tampons can be legally sold in the U.S., they must meet FDA requirements for safety and effectiveness. Manufacturers must test tampons and the materials the tampon is made of before, during, and after manufacturing. Also, before tampons are allowed onto the market, manufacturers must perform biocompatibility and other safety testing. The FDA reviews the results of the testing prior to market authorization.
Any tampon currently cleared by the FDA has been evaluated as described in the guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) and was determined to meet FDA premarket performance requirements.
The FDA will also continue monitoring these devices as part of its total product lifecycle approach to medical devices.
For inquiries, please contact:
BAHP Deputy Director, Gia Komst (gia@bahp.com)
