FDA Says Heavy Metals and Other Contaminants in Menstrual Products Are “Unlikely to Harm”

This week, an op-ed was published in The Conversation, discussing a lack of transparency regarding the materials used to manufacture tampons and other period products. Studies have shown the presence of endocrine disruptors in period products, including “phthalates, volatile organic compounds, parabens, environmental phenols, fragrance chemicals, dioxins, and dioxin-like compounds,” according to a 2024 study.

The study concludes, “Research gaps were identified, including the lack of studies on newer products such as menstrual underwear and cups/discs.” Poppy Taylor, PhD candidate and women’s health researcher for the University of Bristol’s Digital Footprints Lab wrote in her The Conversation piece that the UK regulates menstrual pads under the same regulation as candles. Despite the products being used internally, manufacturers don’t have to disclose the materials used during production.

The UN Environmental Programme released a report in 2021 regarding single-use menstrual products. The report states these products “can contain up to 90% plastic and are often individually wrapped.” The report estimates that 49 billion single-use menstrual products are used in the European Union each year and 19 billion in the United States.

A 2023 study published in Reproductive Toxicology found links between four common endocrine disruptors found in period products and endometriosis.

The World Health Organization (WHO) describes endometriosis as “a disease in which tissue similar to the lining of the uterus grows outside the uterus. It can cause severe pain in the pelvis and make it harder to get pregnant.” The WHO adds, “The cause of endometriosis is unknown. There is no known way to prevent endometriosis. There is no cure, but its symptoms can be treated with medicines or, in some cases, surgery.”

The study evaluated polychlorinated biphenyls (PCBs), dioxins (TCDD), bisphenol A (BPA) and its analogs, and phthalates. The researchers concluded, “The epidemiological and experimental data discussed in this review indicate that these four EDCs activate multiple intracellular signaling pathways associated with proinflammation, estrogen, progesterone, prostaglandins, cell survival, apoptosis, migration, invasion, and growth of endometriosis. The available information strongly indicates that environmental exposure to EDCs such as PCBs, dioxins, BPA, and phthalates individually or collectively contribute to the pathophysiology of endometriosis.”

A 2024 study estimates that 6.4% of women in America had endometriosis between 2011-2019. A 2021 study from the Indian Journal of Medical Research estimated the prevalence of endometriosis in developing countries to be 18%.

A 2024 study in Environment International tested tampons for 16 metals: arsenic, barium, calcium, cadmium, cobalt, chromium, copper, iron, manganese, mercury, nickel, lead, selenium, strontium, vanadium, and zinc. The researchers concluded, “We found measurable concentrations of all 16 metals assessed. We detected concentrations of several toxic metals, including elevated mean concentrations of lead (geometric mean [GM] = 120 ng/g), cadmium (GM = 6.74 ng/g), and arsenic (GM = 2.56 ng/g).”

American Scientist reported about the harmful effects of endocrine disruptors on menstruation. Author Kate Clancy wrote, “In the case of lead, much of it is stored in bone. Because bone turnover increases in pregnancy and because lead can pass through the placenta, fetuses can experience significant lead exposure if their mothers were previously exposed.”

Clancy further explains that researchers have only recently begun studying and measuring the “epigenetic effects of phthalates across the generations.” She adds, “Epigenetic effects have the potential to occur not only in, say, a prenatally exposed generation, but also in the unexposed offspring of the following generation: the grandchildren of the originally exposed parents.”

In September, the FDA began an investigation after studies found metals in period products. That report was released in December, 2024. The purpose was to evaluate the existing literature regarding contaminants in period products. In regards to health outcomes, the FDA concluded “The body of evidence that we identified demonstrated that it is unlikely that vaginal tampon use is associated with harmful health outcomes.”

The report adds that reported vaginal ulcerations “appear to be related to the daily tampon use, as they were resolved when tampon use was stopped…However, tampons are not designed for daily use outside the menstrual cycle. The patients in this study had other health conditions that likely led them to use tampons daily.”

The FDA report states that Shearston’s 2024 study that found lead, cadmium, and arsenic in “microwave-acid digested tampons” came back with numbers that were not statistically significant for blood metals. The report concludes, “Additional studies are needed to illuminate the relationships between vaginal tampon use and exposure to contaminants.”

In the United States, period products are regulated as medical devices and are approved based on the FDA’s analysis of manufacturer-provided data. It does not mandate testing for specific contaminants. The FDA’s 2005 guidance document only mentions dioxins and pesticide residues as contaminants of interest. It is recommended, not mandated, that manufacturers test for these contaminants.

Former New York Governor Andrew Cuomo signed a law in 2019 requiring menstrual products to contain an ingredient list. This law has been criticized for being too short and leaving open-ended questions. For example, the law only requires manufacturers to disclose ingredients that were intentionally added to the product. 

Disposable menstrual products have also been criticized for their environmental impact. The International Journal of Gynaecology & Obstetrics published an editorial in 2022. The authors wrote, “While in a landfill, disposable pads are estimated to take 500 to 800 years to break down, and materials such as plastic never truly biodegrade. This is of major concern given that each menstruator will use and dispose of between 5,000 and 15,000 pads and tampons in their lifetime.”

Poppy Taylor reported that in a survey, only 2.4% of 18-24-year-olds “were taught about sustainable alternatives to single-use tampons and menstrual pads.”