FDA Investigates Heavy Metals in Tampons Following Pilot Study Findings
In a significant announcement on Tuesday, the U.S. Food and Drug Administration (FDA) revealed its plans to investigate potential risks associated with heavy metals, specifically lead and arsenic, present in tampons. This decision comes in the wake of a pilot study published in July, which detected these metals in both organic and nonorganic tampon brands. Although the study indicated that the detected levels were low, the U.S. Environmental Protection Agency (EPA) states there is no safe level of lead exposure.
The July study only confirmed the presence of the metals without testing whether these substances could be released during tampon use. The FDA, in its statement, emphasized, “It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use.” To address these concerns, the agency has commissioned an independent literature review and launched an internal laboratory study aimed at evaluating metals in tampons.
The FDA’s laboratory tests will simulate typical tampon usage to determine how much, if any, metals may be released into the body. The literature review will analyze existing research to assess the potential health impacts of such exposure.
“We want the public to know that before tampons can be legally sold in the U.S., they must meet FDA requirements for safety and effectiveness,” the FDA reiterated. The agency stated that manufacturers are required to test products along with their components throughout the manufacturing process.
Continuing on the safety protocols, the FDA explained that biocompatibility testing is conducted by the manufacturers as part of the safety assessment, which is then reviewed by the FDA prior to market authorization.
In support of this initiative, the Consumer Healthcare Product Association, a trade group, confirmed that its products undergo rigorous testing to comply with strict regulatory standards and expressed support for ongoing research to ensure safe product use. Meanwhile, the Center for Baby and Adult Hygiene Products, known as BAHP, also endorsed the FDA’s commitment to research on the safety of tampons during real-world use.
The pilot study assessed 30 tampons from 14 different brands, purchased from reputable online retailers and stores in the United States, the United Kingdom, and Greece. Conducting a blinded analysis, researchers were unaware of the brands being tested.
The study examined 16 types of heavy metals, including arsenic, cadmium, chromium, and lead, as stated by senior study author Kathrin Schilling, an assistant professor at Columbia University’s Mailman School of Public Health. “We found an average of 100 nanograms per gram of lead and 2 nanograms per gram of arsenic in the tampons,” Schilling reported. Notably, no detectable levels of chromium or mercury were found, which was perceived as a positive outcome.
Interestingly, findings indicated that organic tampons contained higher concentrations of arsenic, whereas nonorganic tampons had elevated levels of lead. Schilling noted that “the average lead concentration in tampons was about 10 times higher than the maximum levels currently allowed in drinking water,” while the arsenic levels were five times below the permitted limits for drinking water.
Schilling pointed out, “It’s important to note that arsenic shouldn’t be present in tampons at all, and we don’t yet understand the effects of vaginal exposure since it hasn’t been studied.” She further asserted that there is no safe level of lead exposure and highlighted the potential reproductive health concerns it poses for women.
Nonetheless, the American Chemistry Council, an industry association, commented that the mere presence of a chemical does not inherently indicate a risk or adverse effect. A spokesperson stressed, “As the Centers for Disease Control and Prevention emphasizes, ‘The measurement of an environmental chemical in a person’s blood or urine is a measure of exposure; it does not by itself mean that the chemical causes disease or an adverse effect.’”
Experts also warned that the permeability of vaginal tissue could pose significant concerns if heavy metals or harmful chemicals are found to leach into the body. Anna Pollack, an associate professor at George Mason University and co-author of a review assessing contaminants in menstrual products, stated, “I am most concerned with menstrual products that are used inside the body.” She, however, maintained that there is no need for alarm at this time: “I would just be aware of the issue and monitor any research that develops.”
Both tampon manufacturers and the FDA continue to advise against using tampons overnight or for periods longer than eight hours to reduce the risk of toxic shock syndrome, a serious bacterial infection that can result in severe health consequences if untreated. This precaution also applies to those worried about potential heavy metals or chemicals in menstrual products.
Experts recommend additional safety measures, such as washing hands before and after handling tampons, changing products every four to eight hours, and utilizing the lowest absorbency necessary. The FDA cautioned, “If you can wear one tampon up to eight hours without changing it, the absorbency may be too high.”
Signs of toxic shock syndrome, including high fever, dizziness, or a rash resembling sunburn, require immediate medical attention. Furthermore, the FDA urges individuals experiencing discomfort, pain, or unusual symptoms when using tampons to stop use and consult a healthcare provider.
