FDA reports no contaminant exposure from tampon use

FDA reports no contaminant exposure from tampon use | Image Credit: © Tada Images - © Tada Images - stock.adobe.com.

A report detailing the safety of metals in tampon materials has been published by the FDA as part of its continued efforts to evaluate tampons’ safety.¹

The literature review was conducted to evaluate evidence about the contaminants in tampons and their health effects. Nine articles were included in the final analysis, with contaminants evaluated including phthalates, parabens, metals, volatile organic compounds (VOCs), bisphenols, triclocarban, and dioxins.¹

Limitations of the studies included not revealing how much of contaminants are released from the tampon or absorbed by the vagina. However, the current evidence supports the FDA’s stance that tampons are safe for use as menstrual products.¹

The articles were obtained through systematic searches of the Embase and Pubmed databases.² Data extraction was performed by 1 reviewer and included study design characteristics, population characteristics, descriptions of the intervention, outcome definitions, sample sizes, study design features, and results.

The 9 studies included 4 bench studies or laboratory experiments of vaginal tampons and 5 clinical studies of human samples. The largest sample size in the bench studies was 60 samples vs the largest clinical study sample size of 851 women. Participants of the clinical studies were aged a mean 23 to 34 years, and a majority were White.²

Reported comorbidities included obesity, smoking status, and body mass index. Tampon compositions included 100% cotton tampons, a blend of cotton and rayon, a blend of cotton, rayon, and viscose, a blend of cotton, rayon, polyester, and polypropylene, a blend of cotton, rayon, polyester, and polyethylene, and plastic tampons.²

In one of the studies evaluating VOC concentrations, tampon use was significantly associated with VOC in urine for 2-Butanone and methyl isobutyl ketone. This indicated significantly increased urine concentrations of VOCs from tampons vs pads and liners only.²

However, another study found no change in VOC levels from tampon use in the past month. Another study also found no association between tampon use and metal exposure based on adjusted linear regression models.²

Oxidative and inflammatory biomarker concentrations in blood samples were only reported in 1 study. This study found no statistically significant differences in any oxidative stress or inflammation biomarkers between the tampon and non-tampon groups, even after adjusting for covariates.²

Tampons must meet FDA safety and efficacy requirements before being sold in the United States.¹ This includes biocompatibility and other safety testing. The FDA will continue to evaluate the safety of tampons, including research in an ongoing study evaluating if metals from tampon materials are released or absorbed in the body.

Reference

1. Biocompatibility and toxicology program: research on medical devices, biocompatibility, and toxicology. US Food and Drug Administration. December 23, 2024. Accessed December 23, 2024. https://www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/biocompatibility-and-toxicology-program-research-medical-devices-biocompatibility-and-toxicology
2. Contaminants in vaginal tampons: A systematic literature review (SLR). International Consulting Associates. Accessed December 23, 2024. https://www.fda.gov/media/184682/download?attachment