*Melissa Bosley
I. Introduction
Over the past eleven years, research has demonstrated there are known harmful materials in tampons,[1] but no research exists to determine what negative health effects these materials have on menstruators’ bodies.[2] Fifty-two to eighty-six percent of menstruators are exposed to dangerous materials,[3] and even though tampon users face prolonged exposure to the materials over the course of their lives,[4] the Food and Drug Administration (FDA) does not require testing of tampons for those harmful materials and does not ensure the safety of tampon users.[5]
II. Scientific Studies & Discovery of Dangerous Materials
A 2014 study by STAT Analysis Corporation shows that menstrual pads emit toxic chemicals.[6] The United States Department of Health and Human Services, among other agencies, recognizes these chemicals as carcinogens linked to cancer and reproductive and developmental harm.[7] Chemicals in tampons include titanium dioxide and polyethylene glycols which could pose a health risk to menstruators because of the prolonged exposure tampon users have to tampons over the course of their lives.[8] In August 2024, researchers published findings that show tampons from over a dozen popular tampon brands have measurable amounts of heavy metals, including lead and arsenic.[9] Heavy metals can cause negative health effects,[10] with potential to impact the cardiovascular, nervous, and endocrine systems and cause damage to the liver, kidneys, and brain.[11] The presence of heavy metals also shows a significant risk of harming maternal health and fetal development.[12]
Harmful elements such as carcinogens, heavy metals, and other toxins can make their way into tampons by a number of means.[13] The studies from 2014 and 2024 show that tampon materials are vulnerable to contamination from water, air, or soil during production, and manufacturers may intentionally introduce metals for odor control, pigment, or as an antibacterial agent.[14] In addition, tampon manufacturers use cotton that is treated with pesticides, and “cotton plants can absorb heavy metals, fertilizers, sewage, and other irritants from treated agricultural soil.”[15] The researchers who conducted the 2024 study emphasize that menstruators’ bodies could absorb the metals and other toxins found in menstrual products, but more research is needed to determine their effects.[16]
The lack of regulation for menstrual products likely causes unknown harms to the menstruating community because the Federal government requires little to no premarket testing of tampons.[17] “Tampons are of particular concern as a potential source of exposure to chemicals, including metals, because the skin of the vagina has a higher potential for chemical absorption than skin elsewhere on the body.”[18] Health and science journalist Catherine Roberts expressed surprise that a product designed for “the most sensitive part of people’s bodies . . . is both so little researched and so little regulated.”[19]
III. FDA Regulations
The FDA regulates all medical devices and places them into three grades: Classes I, II, and III.[20] Class I devices receive the least oversight; Class III devices receive the most.[21] Class III devices typically require[22] more rigorous premarket approval than Class II devices,[23] that entails a thorough application[24] including “mandatory additional testing, such as ‘microbiological, toxicological, immunological, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests . . . .”[25]
The FDA regulates tampons as Class II medical devices.[26] Although the FDA categorizes tampons in Class II, they are subject to a premarket approval process referred to as a 510(k) review.[27] The FDA requires full premarket approval for only some devices,[28] even some Class III devices are not subject to the full premarket approval.[29] If the device is not subject to the full premarket approval, the FDA requires manufacturers , , to submit a 510(k) to the FDA.[30] The 510(k) review does not entail the same level of testing required for full premarket approval.[31] The purpose of the 510(k) premarket review is for the manufacturer to demonstrate to the FDA that “the device to be marketed is as safe and effective, that is, substantially equivalent to a legally marketed device . . . .”[32] The FDA’s issued guidance for 510(k) review for tampons instructs manufacturers to test for some identified risks (i.e., adverse tissue reaction, vaginal injury, vaginal infection, and toxic shock syndrome); however, the guidance makes no mention of the harmful materials discovered through independent research.[33]
In December 2024, the FDA responded to the 2024 study and commissioned an “independent, systematic, literature review and initiated a laboratory study on metals in tampons materials.”[34] The FDA stated that all evidence indicated tampons could be considered safe but acknowledged the limitations of literature available for review.[35] Based on the current testing practices alone, menstruators are in the dark about what health risks they face when using tampons.[36]
Megan Fallon of Elon University School of Law recommends the FDA elevate tampons from Class II to Class III devices, and that the FDA require tampons to pass full premarket approval rather than the less regulated 510(k) approval process.[37] While the core of Fallon’s argument is that the FDA needs to require more testing to keep menstruators safe,[38] upgrading a device’s classification alone does not ensure adequate testing is done.[39] Even if the FDA upgrades tampons to Class III, the FDA must also update their guidance for manufacturers and mandate testing to determine the effects of harmful materials identified in the independent research studies.[40]
IV. Conclusion
Although two studies conducted ten years apart show there are known harmful contaminants in tampons,[41] the FDA provides little oversight to protect consumers.[42] Researchers from the 2024 study call for further testing on tampons to protect menstruators,[43] and the FDA advises that tampons are safe to use despite their limited knowledge and commissioning new ongoing studies.[44] In light of the research done, menstruators may suffer health consequences for years to come, and unless the FDA requires manufacturers to test tampons for these harmful elements, menstruators cannot know what those health consequences are .[45]
*Melissa Bosley is a second-year, evening student at the University of Baltimore School of Law, where she is a Staff Editor of the Law Review and a UB LEADs mentor. Melissa received her undergraduate degree in Legal Studies from Stevenson University and then began working full time as an estates & trusts paralegal in 2019. She currently works as the Executive Paralegal at Jim Rutledge Esq LLC in Bel Air, Maryland.
[1] Rachel Treisman, A Study Found Toxic Metals in Popular Tampon Brands. Here’s What Experts Advise, NPR (July 11, 2024), https://www.npr.org/2024/07/11/nx-s1-5036484/tampons-heavy-metals-study.
[2] See Jenni A. Shearston et al., Tampons as a Source of Exposure to Metal(loid)s, Env’t Int’l, Aug. 2024 at 1, 1 https://www.sciencedirect.com/science/article/pii/S0160412024004355.
[3] Id.
[4] Id.
[5] Megan Fallon, Reckless Regulation: The Frightening Truth Behind Feminine Hygiene Products, 16 Elon L. Rev. 315 (2024).
[6] Always Pads Testing Results, Women’s Voices for the Earth, https://womensvoices.org/menstrual-care-products/detox-the-box/always-pads-testing-results/ (last visited January 18, 2025).
[7] Id.
[8] See Fallon, supra note 5, at 344–46.
[9] Treisman, supra note 1.
[10] Id.
[11] Id.
[12] Id.
[13] Id.
[14] Id.
[15] Fallon, supra note 5, at 343.
[16] See id. at 318.
[17] See id.
[18] Elise Proulx, First Study to Measure Toxic Metals in Tampons Shows Arsenic and Lead, Among Other Contaminants, Berkley Pub. Health (July 3, 2024), https://publichealth.berkeley.edu/news-media/research-highlights/first-study-to-measure-toxic-metals-in-tampons-shows-arsenic-and-lead.
[19] Treisman, supra note 1.
[20] See Fallon, supra note 5, at 327–28.
[21] Id.
[22] See Ctr. for Devices and Radiological Health,Guidance for Industry and FDA Staff Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (July 27, 2005) (showing that tampons are subject to a 510(k) premarket approval process); see also Medtronic v. Lohr, 518 U.S. 470, 479 (1996) (stating that a 510(k) requires about 20 hours of review compared to a full FDA premarket approval (PMA) process that takes 1,200 hours of review.)
[23] See Fallon, supra note 5, at 330.
[24] Id.
[25] Id. at 334.
[26] Id. at 324.
[27] See Ctr. for Devices and Radiological Health, supra note 21.
[28] U.S. Food and Drug Admin. Premarket Notification 510(k) (Aug. 22, 2024) https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k.
[29] Id.
[30] Id.
[31] See id.; Fallon, supra note 5, at 330.
[32] U.S. Food and Drug Admin., supra note 28 (emphasis added).
[33] Fallon, supra note 5, at 351.
[34] U.S. Food & Drug Admin., Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology (Dec. 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.
[35] Id.
[36] Ctr. for Devices and Radiological Health, supra note 22.
[37] Fallon, supra note 5, at 351.
[38] See Fallon, supra note 5, at 353–54.
[39] Medtronic v. Lohr, 518 U.S. 470, 479 (1996) (clarifying that even some Class III devices are given approval through the 510(k) process).
[40] See Always Pads Testing Results, supra note 6; see also Shearston et al., supra note 2, at 1.
[41] Shearston et al., supra note 2, at 1; Fallon, supra note 5, at 316–17.
[42] Fallon, supra note 5, at 344, 351.
[43] Treisman, supra note 1.
[44] U.S. Food & Drug Admin., supra note 34.
[45] See supra text accompanying notes 34–40.
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