From a Reactive to a Proactive FDA Risk Assessment in Tampon Regulation
Leigha Whitridge*
Introduction
The consumption of personal care products, cosmetics, and cleaning products exposes Americans to a wide variety of potentially harmful chemicals on a daily basis.[1] Recently, people are asking the question we often do not pause to consider: what is in this?[2] We can all imagine the list of ingredients on the back of an unassuming product like a bag of chips, a stick of deodorant, or a bottle of household cleaner. We do not know what many of these ingredients are or even how to pronounce them. The Food and Drug Administration (FDA) regulates products that reach the hands and homes of consumers,[3] but a closer look into what substances products contain is needed.
This consumer skepticism should apply to menstrual products, especially considering recent data.[4] In June of 2024, researchers at the University of California Berkeley conducted a study regarding the presence of certain chemicals and heavy metals in tampons,[5] which has stirred discussion regarding tampon regulation.[6] The study found the presence of numerous toxic substances, including lead, within tampons.[7] Even more surprising than these findings is that this study is the first of its kind.[8]
This Note argues that before a tampon can be marketed and placed on store shelves, the risk assessment within the rules and guidelines governing tampon manufacturing and marketing should be expanded to include testing for the presence of lead and, in the event that lead is present, adequate warnings. Additionally, by expanding regulations, the FDA could address issues associated with the 510(k)-clearance process and incentivize tampon manufacturers to innovate safer products. Part I explains the history of tampons and current tampon regulation under the FDA. Part II discusses the findings of and reactions to the UC Berkeley study. Part III argues for expanding the FDA’s risk assessments to include potential lead exposure through tampon use and recommends mandatory warning labels.
I. Tampons and Current FDA Regulation
A. Tampons
Menstruation, the shedding of the uterine lining, begins a woman’s menstrual cycle.[9] The menstrual cycle “prepares [a woman’s] body for possible pregnancy.”[10] A woman’s hormone production heavily influences her menstrual cycle, which may vary each cycle.[11] The menstrual cycle is composed of four phases, each of which performs a particular function in a woman’s reproductive cycle.[12] Menstrual bleeding occurs every twenty-one to thirty-five days and lasts roughly between two to seven days.[13]
A tampon is “a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual . . . discharge [commonly referred to as a period].”[14] Tampons existed in Egyptian society, and, historically, women used sponges or wool. [15] Tampons were not popular in the United States until the 1930s.[16] In the 1980s, tampons became associated with Toxic Shock Syndrome (TSS), a potentially fatal illness.[17] Today, tampons range in size and level of absorbency, including light, regular, super, and plus.[18] Over the course of a lifetime, women spend about 2,372 days (roughly six and a half years) menstruating and use up to 11,000 tampons during this time.[19]
B. The FDA Framework
The Federal Food, Drug, and Cosmetic Act (FFDCA) grants the FDA authority to create and enforce rules regulating a wide range of products, including food, drugs, and cosmetics.[20] The FDA’s mission is to “[protect] the public health by ensuring the safety, efficacy, and security of human . . . medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”[21] The agency’s mission also includes “[speeding] innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products . . . to maintain and improve their health.”[22] In order to enforce the FFDCA and carry out its mission, the FDA promulgates rules that are legally enforceable and treated as law.[23] Furthermore, the FDA creates guidances in order to inform industry, the public, and its own staff of the agency’s thoughts on product regulation.[24] These guidelines aide industries in complying with rules and explore topics such as device design, testing, manufacturing, and inspections.[25]
The FDA regulates medical devices.[26] The agency categorizes medical devices into three classes (in order of low to high risk of user harm: I, II, and III).[27] Medical devices are cleared either through a Premarket Approval (PMA) or a 510(k) Premarket Notification.[28] Class III medical devices must undergo the PMA process, which is more burdensome than the 510(k) comparative process.[29] In the PMA process, manufacturers must demonstrate “reasonable assurance that the device is safe and effective.”[30] The 510(k) process consists of traditional and abbreviated 510(k) applications.[31] The abbreviated 510(k) process is meant to “streamline and expedite” the review process.[32] Through this process, manufacturers demonstrate substantial equivalence to a “predicate device,” which is a previously cleared device.[33] Substantial equivalence is defined as “having the same intended use and the same technological characteristics as a predicate device, or different technological characteristics that do not raise different questions of safety or effectiveness.”[34] To show “substantial equivalence,” manufacturers provide information that shows their medical device has the same intended use and the same technological characteristics as the predicate device.[35] After the FDA “finds a device substantially equivalent to the predicate” device, the device may be cleared for the market.[36] Under the 510(k) process, “premarket inspections of how devices were manufactured are generally not required . . . postmarket studies are not required by FDA as a condition of clearance; and . . . FDA has limited authority to rescind or withdraw clearance if a 510(k) device is found to be unsafe or ineffective.”[37] As a result of the comparative nature of the 510(k) process, manufacturers are not required to include clinical studies or to demonstrate independent safety or effectiveness of the product.[38]
C. Tampon Regulation
Tampons are Class II medical devices and subject to few rules, but nowhere do the rules mention testing for or disclosing the presence of lead.[39] Class II medical devices represent medical devices that pose a “moderate to high risk” of user harm.[40] Currently, tampon manufactures must include labels that clearly alert consumers to the risk of TSS, as well as the tampons absorbency level.[41] Before a tampon is marketed, the device must meet 510(k) Premarket Notification requirements and performance standards.[42]
The FDA states that before marketing a device, tampon manufacturers should meet these 510(k) requirements to comply with the FFDCA and receive FDA clearance based on “substantial equivalence.”[43] If the manufacturer meets the “substantial equivalence” standard, the FDA may clear the product to be sold.[44] Tampon manufacturers may use the traditional 510(k) clearance route or the abbreviated 510(k) process.[45] The abbreviated 510(k) process allows tampon manufacturers to submit a summary report “in lieu of detailed information about testing of the device.”[46] The summary report includes a description of the device, design, a risk assessment, and a description of tests used.[47] Tampon manufacturers also must submit information required for a traditional 510(k) submission.[48] These informational requirements are embodied in the FDA’s rules and include the following:
The device name . . .. The [device] class . . .. Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use … [and] a statement indicating the device is similar to and/or different from other products of comparable type in commercial distribution, accompanied by data to support the statement. This information may include an identification of similar products, materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.[49]
The Guidance for Industry and FDA Staff Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (Menstrual Tampon Guidelines) assists tampon manufacturers in meeting 510(k) submission requirements.[50] Concerning biocompatibility testing, The Menstrual Tampon Guidelines direct manufacturers to another FDA guidance: the Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing (ISO Guidelines).[51] Notably, the Menstrual Tampon Guideline’s chemical concerns focus on pesticide residue, and the guidance states that “[if] identical materials are used in a predicate device with the same type and duration of user contact, you may identify the predicate device in lieu of providing biocompatibility testing in your submission.”[52] The FDA created the ISO Guidelines to “assist industry in preparing . . . Premarket Notifications (510(k)s) . . . requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response.”[53] Manufacturers approach biocompatibility testing within “the framework of a risk management process” and complete a risk-benefit assessment that identifies potential risks, compiles available information, and addresses missing information.[54] Potential risks of any medical device include “chemical toxicity, unacceptable biological response to physical characteristics of the device, and aspects of manufacturing and processing that could alter the physicochemical characteristics of the device, which could lead to changes in the biocompatibility response.”[55] After potential risks are identified, the manufacturer submits a risk assessment for the FDA’s review.[56]
D. Concerns with the 510(k) Clearance Process
A risk-based clearance pathway allows the FDA to devote resources to investigating higher-risk medical devices.[57] However, the lack of clinical data in 510(k) applications may impede confirming the safety of new devices.[58] If a predicate device is later found to be unsafe, a device cleared based on comparison to the deficient device may likely be unsafe as well.[59] Over time, slight differences between predicate and new devices may aggregate, resulting in a device that is substantially different from the original predicate device and possibly unsafe.[60] The Institute of Medicine issued a report in 2011 that pointed out some of these weaknesses in the 510(k) clearance process and posed a new regulatory system for medical devices.[61] The FDA did not adopt these proposed amendments, but eventually the agency encouraged manufacturers to provide “real-world evidence” during market clearance.[62] Post-market regulations have also been introduced to compensate for these weaknesses, but the “substantial equivalence” standard still guides the 510(k) clearance process.[63] While high risk medical devices are more likely to be recalled than a medical device cleared through the 510(k) process, the vast majority of recalls are for medical devices cleared through the 510(k) process.[64] The sheer number of medical devices cleared through the 510(k) process raises public safety concerns.[65]
Congress and the FDA encourage the “least burdensome approach” to risk assessment, which includes the abbreviated 510(k) pathway.[66] This approach allows manufacturers to provide “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.”[67] The 510(k) premarket notification applications for tampons appear to be fairly bare bones.[68] Additionally, the Menstrual Tampon Guidelines, per the least burdensome approach, do not require clinical studies.[69] When clinical studies are involved, they revolve around irritation, allergies, effects on vaginal microflora, abrasions, ulcerations, lacerations, and residual fiber retention, not the presence of lead.[70]
A tension exists between ensuring accessibility of tampons in a large market and prioritizing the safety of products.[71] The term “period poverty” refers to the inability to obtain menstrual products and a lack of education regarding menstruation.[72] Women in low-income households, unhoused women, and women in college are disproportionately affected by period poverty.[73] While many women struggle to afford menstrual products, an increased cost of tampon production due to expanded regulations may exacerbate this issue.[74] The FDA’s “least burdensome” approach and attempts to “streamline and expediate” marketing medical devices through the 510(k) clearance process are virtuous efforts. Balance must be kept in perspective while researchers and legislatures move forward with proposed recommendations to address toxic substances found within tampons.
II. The UC Berkeley Study and Safety Concerns with Lead
A. Findings from the UC Berkeley Study
The UC Berkeley study tested thirty tampons, ranging in materials used.[75] The study included both organic and non-organic tampons.[76] The researchers omitted brand names of products included in the study but noted they were popular.[77] Heavy metals (including, but not limited to, lead, arsenic, chromium, nickel, barium, cadmium, mercury, and vanadium) were present in tested tampons.[78] The majority of women who menstruate (fifty-two to eighty-six percent) use tampons, making this a pressing issue.[79] The study found that women may use more than 7,400 tampons during their lifetime, which is a conservative estimate considering other findings.[80] The study acknowledges its limitations, including the small sample size and inability to explore differences in “absorbency, lot number, brand, or manufacturer.”[81] The study did not address vaginal absorbency or the ability of metals to leach into the body’s systematic circulation through the lining of the vagina.[82] Researchers concluded that more standardization may be necessary during tampon production.[83]
B. Lead and Effects of Exposure
Lead is one of the most notable metals found in the UC Berkeley study and was present in all tampons tested.[84] The presence of lead in tampons is concerning since lead has known negative health effects and previous research has concluded that there is no safe level of exposure to lead.[85] Additionally, lead may be stored within bones for decades.[86] According to the UC Berkely study, even minimal exposure to lead “can result in neurobehavioral impacts in adults and children, including decreased cognitive function such as impaired attention, memory, and learning ability.”[87] Lead exposure in adults can also cause high blood pressure, joint pain, memory and focus deficiencies, and miscarriage, premature birth, stillbirth, or harm to a woman’s reproductive health.[88] In general, heavy metal exposure has also been linked with infertility.[89] The UC Berkeley study also raises matter for concern considering some women begin using menstrual products in adolescence.[90] Most women begin their menstrual cycle between the ages of ten to fifteen.[91] Children also absorb more lead when exposed, and exposure may negatively affect a child’s cardiovascular and reproductive systems, decrease kidney function, and increase blood pressure.[92]
C. Responses to the UC Berkeley Study
Following the study, members of Congress called for greater research and standards in tampon regulation.[93] The FDA promptly announced and published its research initiatives.[94] The FDA’s report included a literature review of nine articles discussing the presence of certain medals and substances in tampons.[95] The agency admitted to “regulatory science gaps and challenges” and “[a] need for tools/methods . . . that facilitate and improve consistency of toxicological risk assessments for medical devices” and adequate “guidelines for evaluating biocompatibility of medical devices . . ..”[96] Despite the FDA’s lack of understanding of a “worst-case scenario of metal exposure” during tampon use, it deems previously marketed tampons as safe.[97]
Not everyone found cause for alarm following the UC Berkeley study.[98] The American College of Medical Toxicology (ACMT) found that the study may promote unnecessary panic.[99] The ACMT noted that in order to understand health effects of tampon use, “we would need to understand how the dose delivered [through tampon use] compares to the doses where adverse effects are expected to occur.”[100] The report used estimates to conclude that it’s unlikely the amount of lead absorbed from a tampon would be harmful.[101] Nevertheless, the report still recommended further research to “understand whether absorbed doses of metals . . . approach harmful concentrations.”[102] Another hesitant reaction claimed that the study was inflammatory and exposure to metals through a single, light absorbency tampon appears to be “negligible.”[103] The UC Berkeley researchers characterized this argument as “misleading,” “premature,” and “unjustified” [104] for the following reasons:
(1) Light absorbency tampons are not commonly used. [Larger absorbency ranges] are more common. (2) Menstruators who use tampons typically use 3–4 a day, ranging from 2 to . . . 18 . . . (3) No safe level of [lead] exposure exists no matter the route of exposure. (4) Chemical absorption has been shown to be more efficient via the vaginal route compared to the oral route of exposure. In particular, unlike the oral exposure route, chemicals absorbed vaginally bypass first-pass metabolism by the liver and directly enter systemic circulation . . . [Concluding there is] negligible risk based on exposure to a single light tampon is scientifically unsupported.[105]
The UC Berkeley study simply emphasized the need for continuing research.[106] It cannot be said that the potential lead exposure is “negligible,” nor can it be said that the potential lead exposure is currently harming tampon users.[107] However, it can be said that tampon use is a potential source of lead exposure throughout a woman’s lifetime.[108] We cannot do nothing with this information simply because the full picture is not clear. A potential risk is a risk, nonetheless.
III. Solutions
A. Updating the Rules and Guidelines
i. Updating Risk Factors Within the Guidelines
First, relevant guidelines should include lead exposure as a risk associated with tampon use. Manufacturers should be advised to address this risk during the clearance process. The Menstrual Tampon Guidelines contain a chart listing risks associated with tampon use, as well as corresponding mitigation strategies.[109] These risks include adverse vaginal injury, vaginal infection, TSS, and adverse tissue reaction.[110] Labeling is a recommended mitigation strategy for all identified risks in the table.[111] Other concerns associated with tampons include chemical residues, absorbency ranges, the growth of bacteria that may cause TSS, irritation, allergies, effects on vaginal microflora, abrasions, ulcerations, lacerations and residual fiber retention.[112] However, the presence of lead is not identified anywhere within the Menstrual Tampon Guidelines or in the table of identified risks.[113] Lead exposure should be included in this chart of identified risks, and labeling warnings should be the corresponding mitigation strategy.
Additionally, the ISO Guidelines state that unnecessary testing may be avoided considering available literature, clinical experiences, animal study experiences, consensus standards, and comparison to previously cleared devices. [114] Similar to the gaps identified in the 510(k) clearance process, a comparative analysis to previously marketed devices provides manufacturers with a pathway to conclude that biocompatibility has been properly addressed without independent clinical studies or source material testing for the presence of lead.[115] Since lead is naturally occurring in soil or may be added to tampons during the manufacturing process, the lead content in source material used in a new device may differ substantially from a predicate device.[116] Therefore, comparing a new device to a previously marketed device may not establish the absence of lead in the new device. In order to ensure the safety of tampons and alert consumers of the presence of lead, if needed, comparison to a predicate device should not be considered in a risk-based analysis of biocompatibility.
ii. New Legally Binding Warnings
Although the guidelines appear robust, they are not legally binding.[117] The FDA should mandate lead disclosures in the event lead is discovered within a tampon, describing the possible presence of lead and stating that lead is associated with negative health effects. This would provide women with a bare minimum understanding of possible lead exposure from tampon use.
A more informed decision may result in women purchasing alternative menstrual products rather than blindly purchasing products that may contain lead. This would offer greater decision-making power to women who suffer from reproductive conditions with unknown etymologies, those who want to avoid lead exposure, and those who want to control what substances enter their body. This proposed change incentivizes innovation. Requiring tampon manufacturers to disclose the presence of lead in their products would create a need in the market for a “lead-free” tampon and incentivize other manufacturers to create a novel tampon. If women gravitate towards other menstrual products, this may also place pressure on tampon manufacturers to improve the quality of tampons and produce lead-free products. In turn, the FDA would further its mission of accelerating the innovation of medical devices to protect the public health.[118]
B. More Proactive Risk Assessment is Needed
i. Recalling the History of Menstrual TSS
A more proactive approach to risk is at the heart of this Note. In the face of the unknown, the FDA should not wait to find out the possible ramifications of lead exposure through tampon use before requiring manufacturers to inform consumers of what they are purchasing. While there are arguments that exposure to lead through tampon use may not be harmful,[119] the unknown health effects of lead exposure through tampon use presents a risk in itself.[120] The sphere of women’s health is full of unknowns and a lack of research.[121] Some health conditions that women suffer from, including endometriosis, uterine fibrosis, and ovarian cancers do not have known causes.[122] The uncertainty surrounding these etymologies and the unknown absorbency of vaginal and uterine tissues are strong reasons to create rules giving women an informed decision when purchasing menstrual products. While burdensome approaches like complete disclosure of every chemical or ingredient within tampons may not be possible, the FDA’s “least burdensome approach,” should not be the attitude towards this facet of tampon regulation.
This is not the first time that tampon use has been under scrutiny.[123] TSS emerged in the 1970s, but awareness of the illness grew in the 1980s.[124] The illness presents as a multitude of symptoms, including “high fever, sunburn-like rash, desquamation, hypotension, and abnormalities in multiple organ systems.”[125] In the context of menstruation, a bacteria, staphylococcus aureus, grows within a tampon, “cross[es] the vaginal epithelium, enter[s] systemic circulation,” and causes illness.[126] In the 1980s, studies determined that the overwhelming majority of TSS cases began during menstruation, and TSS was associated with continuous use of tampons and use of high absorbency tampons.[127] By the end of 1980, thirty-eight of the 772 women who suffered from menstrual TSS lost their lives.[128] In 1982, the FDA required manufacturers to produce labels warning consumers of TSS risks, pointing to the FFDCA, which calls for regulators to “prevent harm, even if the regulator is less than certain that harm is otherwise inevitable.” [129] These requirements did not include standardized absorbency ranges.[130] The terms “super” or “regular” varied between brands, so women were unable to compare absorbency ranges between brands.[131] In 1987, the CDC published a study that established a positive correlation between tampon absorbency size and the risk of TSS.[132] On August 20, 1987, the Public Citizen Health Research Group (Public Citizen) petitioned for the FDA to timely address the lack of industry-wide standardized absorbency ranges.[133] The FDA responded with proposed regulations to standardize absorbency ranges between brands.[134] While a rule was proposed, the FDA received comments and made amendments.[135] In 1989, Public Citizen filed suit, seeking rules to be enacted at once while the FDA was taking “unreasonable delay” in enacting “long-needed regulations.”[136] On August 28, 1989, the court granted Public Citizen declaratory and injunctive relief, ordering the FDA to enact a rule within two months.[137] The presiding judge characterized the FDA as “lethargic” and noted the agency’s failure in executing its mission to protect the health of the public.[138] A final rule was issued effectuated on March 1, 1990.[139] These labeling requirements alerted women of absorbency levels and terms identifying the level of absorbency indicated the same level of absorbency across brands.[140]
The history of TSS illustrates that warnings labels do prove useful. By 1990, the number of TSS cases decreased dramatically.[141] And in 2018, cases continued to decrease to a rate of 1 per 100,000 women.[142] The decrease in cases is linked to the production of lower absorbency tampons and the FDA’s new labeling requirements.[143] Tampon packaging now describes the cardinal warning signs and symptoms of TSS, how to prevent TSS, and what to do if the illness presents.[144] Public awareness and prevention of menstrual TSS are also contributory factors in the drastic decrease in TSS cases.[145] After the delay in rules requiring TSS labeling, people have asked if harm could have been avoided.[146] We should not ask the same question.
ii. Potential Challenges for Future Litigation
Another reason to include warning labels and shift the burden of weighing risk onto consumers is that potential litigation surrounding tampon use may be difficult on manufacturers and plaintiffs. It may be costly for manufacturers to pay plaintiffs if lead exposure through tampon use is clearly linked with harm. This may lead to the increase costs of tampons, exacerbating period poverty.[147] On the flip side, future plaintiffs may face difficulties establishing harm specifically linked with tampon use. Class action lawsuits require certification of a class.[148] In order for a class to be certified, the plaintiffs in the potential class must demonstrate that the disputed issue is common to the class and that the class’s claims or defenses are “typical” to the class.[149] A range of injuries suffered would not likely be considered “typical.” The inability to prove the cause of certain conditions, like endometriosis, and the lack of available research in this area could provide a defense against claims alleging that lead exposure through the use of tampons caused injury.[150] Additionally, because there is an array of tampon brands, it may be difficult to find a class of women that have used the same, singular brand of tampon throughout their lifetimes.
Willis-Albrigo and Wright v. The Procter & Gamble Co. highlights potential weaknesses in future plaintiffs’ claims.[151] The plaintiffs there brought their case soon after the UC Berkeley study was published.[152] They claimed that defendant Procter & Gamble’s failure to disclose that its products contained lead, violated state law, and should result in economic damages since the plaintiffs would not have purchased the tampons had they known the tampons contained lead.[153] The defendant highlighted that the plaintiffs were unable to prove that lead leeches from tampons into the body and asked the court to “give no weight” to claims that tampon use was unsafe.[154] The defendants also pointed out that the plaintiffs’ injuries must be “actual and imminent, not conjectural or hypothetical.”[155] This kind of challenging litigation may be avoided if women are able to judge risk for themselves.
Conclusion
In order to uphold its mission of providing safe, effective, and innovative products that do not harm the public health, the FDA should require manufacturers to warn women of the presence of lead, a material known to be unsafe,[156] in a product they use over a lifetime. Despite the less-than perfect knowledge surrounding the potential risks of lead exposure through tampon use and the lack of research regarding vaginal and uterine absorbency, there is conclusive research about lead.[157] This conclusive data should be reason enough to warn women of potential exposure, rather than waiting to see what happens. The benefits of a risk-based approach allows the FDA to devote resources and attention to high-risk medical devices, quickly clear lower-risk medical devices, and ease production burdens on manufacturers.[158] These benefits are precisely why this Note focuses narrowly on the presence of lead in tampons and suggests labeling requirements. Lead warning labels would address safety concerns over the current “substantial equivalence” standard used in the regulation of tampons while keeping in mind those who are affected by period poverty.
Concern over possible lead exposure through tampon use is not frivolous, dramatic, nor is it unnecessary. The lack of awareness of the “worst-case scenario of metal exposure” should not be a reason to continue marketing these medical devices under a system that does not address the risk of lead exposure. This lack of awareness should drive more robust labeling. The unknown is a risk in itself that women should be aware of. Beyond potential health risks, this Note hints at informed decision-making. A proactive approach to risk assessment would shift the burden of risk assessment to consumers. Women, provided with more information through labels, would be the ultimate weighers of risk. Women should be decision makers in preventing possible exposure of their bodies to lead, especially considering that there are unavoidable avenues of lead exposure.[159] The FDA has identified some risks to weigh,[160] but beyond that, determining who is weighing the risks is just as important. And in order to weigh the risks of lead exposure, women must first be informed of the potential exposure through tampon use and that lead is associated with negative health effects.
* J.D. Expected 2026, University of Kentucky J. David Rosenberg College of Law; BA Economics, minor in English 2022, University of Alabama. I would like to thank Professor Shavonnie Carthens for her guidance while writing this Note, as well as the Senior Staff Editors who helped edit this piece. Finally, I would like thank Ben, my supportive fiancé.
[1] Potentially Toxic Chemicals in Personal Care Products, N.Y. Health Found. (June 4, 2018), https://nyhealthfoundation.org/resource/fact-sheet-potentially-toxic-chemicals-in-personal-care-products [https://perma.cc/BM7N-2CBK].
[2] Gary Drenik, Beyond the Label— Consumers Want the Truth About Product Ingredients, Forbes (July 18, 2024, 10:00 AM), https://www.forbes.com/sites/garydrenik/2024/07/18/beyond-the-label--consumers-want-the-truth-about-product-ingredients/ [https://perma.cc/8CNW-CV3V ] (discussing the “better-for-you trend” present on social media platforms); see, e.g., Adrienne Crezo, Red 3: FDA Finally Bans Cancer-Causing Food Dye, Ctr. for Sci. in the Pub. Int. (Jan. 15, 2025), https://www.cspinet.org/cspi-news/red-3-fda-finally-bans-cancer-causing-food-dye [https://perma.cc/4NH5-EMHM].
[3] What Does FDA Regulate?, U.S. Food and Drug Admin. (Mar. 29, 2024), https://www.fda.gov/about-fda/what-we-do/what-does-fda-regulate [https://perma.cc/C65Y-S6CM].
[4] See generally Jenni A. Shearston, Kristen Upson, Milo Gordon, Vivian Do, Olica Balac, Khue Nguyen, Beizhan Yan, Marianthi-Anna Kioumourtzoglou & Kathrin Schilling, Tampons as a Source of Exposure to Metal(loid)s, Env’t Int’l, Aug. 2024, at 1 (discussing the discovery of heavy metal within tampons).
[5] Id. at 2.
[6] This note focuses specifically on the presence of lead within tampons. For reactions to the UC Berkeley study and discussions on proposed legislation that focus on complete disclosure of all tampon ingredients and additives, see Pamela Mejia & Jeannie Mancheno, Congress, Intensifies Tampon Safety Efforts and FDA Takes Steps to Respond, Mintz (Sept. 25, 2024), https://www.mintz.com/insights-center/viewpoints/2146/2024-09-25-congress-intensifies-tampon-safety-efforts-and-fda-takes [https://perma.cc/UJE6-XTCL]; Judith Beck & Charlotte Oram, Tampons: Looking Beyond Toxic Shock, Sci. for the People, Sept.–Oct. 1981, at 12; Rebekah Ninan, Legal Responses to the Potential Dangers of Menstrual Products, The Petrie-Flom Ctr. (Nov. 4, 2024), https://petrieflom.law.harvard.edu/2024/11/04/legal-responses-to-the-potential-dangers-of-menstrual-products [https://perma.cc/98HS-C648]; Erica Zurek, Federal Rules Don’t Require Period Product Ingredients on Packaging Labels. States are Stepping In, CBS News (Apr. 27, 2023, 5:00 AM), https://www.cbsnews.com/news/menstrual-pads-tampons-fda-ingredients-labels [https://perma.cc/2LQ9-L4Z4].
[7] Shearson et al., supra note 4, at 5.
[8] Id. at 2.
[9] Menstrual Cycle, Cleaveland Clinic (Dec. 9, 2022), https://my.clevelandclinic.org/health/articles/10132-menstrual-cycle [https://perma.cc/H8ZJ-PD8B].
[10] Id.
[11] See Megan Fallon, Reckless Regulation: The Frightening Truth Behind Feminine Hygiene Products, 16 Elon L.R. 315, 317–20 (2024); Jessica E. McLaughlin, Menstrual Cycle, Merck Manual (July 2025), https://www.merckmanuals.com/home/women-s-health-issues/biology-of-the-female-reproductive-system/menstrual-cycle [https://perma.cc/46E7-3ME5].
[12] The Menstrual Cycle, Better Health Channel, https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/menstrual-cycle# [https://perma.cc/JQD5-UAD5].
[13] Menstrual Cycle: What’s Normal, What’s Not, Mayo Clinic (Apr. 22, 2023), https://www.mayoclinic.org/healthy-lifestyle/womens-health/in-depth/menstrual-cycle/art-20047186 [https://perma.cc/8AEM-Z8JD].
[14] 21 C.F.R. § 884.5470(a) (2025).
[15] Fallon, supra note 11, at 319; Rainey Horwitz, Menstrual Tampon, Ariz. State Univ. (May 25, 2020), https://embryo.asu.edu/pages/menstrual-tampon [https://perma.cc/UQ9Z-JABP]; Alice S. Weissfeld, The History of Tampons: from Ancient Times to an FDA-Regulated Medical Device, 32 Clin. Microbiology Newsl. 73, 73 (2010).
[16] Elianna Spitzer, What’s in Your Tampon? Increasing Transparency in Menstrual Products, 48 Seattle Univ. L. Rev. 229, 234 (2024).
[17] Id. at 236; see infra, Part III.B.i.
[18] Fallon, supra note 11, at 320; Tracee Cornforth, What Light, Regular, Super and Other Tampon Absorbencies Mean: Ratings Helps You Select the Safest Tampon Option, verywellhealth (June 29, 2023), https://www.verywellhealth.com/what-do-tampon-absorbency-ratings-mean-2721890 [https://perma.cc/94PR-P5YW].
[19] Menstruation Facts and Figures, Absorbent Hygiene Prod. Mfr. Ass’n., https://www.ahpma.co.uk/menstruation_facts_and_figures [https://perma.cc/2P38-5F9F]; Jasmine Wang, The Mystery of Tampon Regulation, The Regul. Rev. (Sept. 2, 2021), https://www.theregreview.org/2021/09/02/wang-mystery-tampon-regulation [https://perma.cc/KTU6-99EW].
[20] U.S. Food and Drug Admin., supra note 3; 21 U.S.C. §371(a).
[21] What We Do, U.S. Food and Drug Admin. (Nov. 21, 2023), https://www.fda.gov/about-fda/what-we-do#mission [https://perma.cc/G5LJ-5LBH].
[22] Id.
[23] FDA Rules and Regulations, U.S. Food and Drug Admin. (Apr. 9, 2024), https://www.fda.gov/regulatory-information/fda-rules-and-regulations [https://perma.cc/CZ38-FKPY].
[24] Guidances, U.S. Food and Drug Admin. (Jan. 17, 2025), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidances#:~:text=In%20general%2C%20FDA's%20guidance%20documents,or%20statutory%20requirements%20are%20cited [https://perma.cc/R64V-LZCS].
[25] Background: FDA Good Guidance Practices, U.S. Food and Drug Admin. (Dec. 17, 2024), https://www.fda.gov/regulatory-information/guidances/background-fda-good-guidance-practices [https://perma.cc/J94A-NVRS].
[26] Overview of Device Regulation, U.S. Food and Drug Admin. (Jan. 31, 2024), https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation [https://perma.cc/F3SY-6A7A].
[27] Judith A. Johnson, Cong. Rsch. Serv., R42130, FDA Regulation of Medical Devices 20–21 (2012); Amanda K. Sarata, Cong, Rsch. Serv., IN12441, FDA Regulation of Tampons 1 (2024).
[28] Johnson, supra note 27, at 4.
[29] Id.; Jonathan R. Dubin, Stephen D. Simon, Kirsten Norrell, Jacob Perera, Jacob Gowen & Akin Cil, Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008–2017, 4 JAMA Network, May 6, 2021, at 1, 2.
[30] Johnson, supra note 27, at 4; see Sarata supra note 27, at 1; see Regulatory Controls, U.S. Food and Drug Admin. (Mar. 27, 2018), https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls [https://perma.cc/9X3T-GLUA].
[31] Johnson, supra note 27, at 9.
[32] Id. at 10.
[33] Id. at 4.
[34] Sarata, supra note 27, at 2.
[35] Johnson, supra note 27, at 4.
[36] See id. at 9.
[37] Id. at 10.
[38] Id. at 9; Dubin et al., supra note 29, at 2.
[39] See 21 C.F.R. § 884.5470 (2025); Mejia & Mancheno, supra note 6; Sarata, supra note 27, at 1; The Facts on Tampons—and How to Use Them Safely, U.S. Food and Drug Admin. (Jan. 31, 2025), https://www.fda.gov/consumers/consumer-updates/facts-tampons-and-how-use-them-safely [https://perma.cc/5N37-TAEB].
[40] Regulatory Controls, U.S. Food and Drug Admin. (Mar. 27, 2018), https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls [https://perma.cc/4JX5-M77A]. Class II medical devices pose a higher risk of harm compared with Class I medical devices, and a lower risk of harm compared with Class III medical devices. Class II medical devices are subject to general and special controls.
[41] 21 C.F.R. § 801.430 (2025); see infra Section III.B.i.
[42] Sarata, supra note 27, at 1; see 21 C.F.R. § 801.430 (2025); U.S. Food and Drug Admin., Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (2005).
[43] Sarata, supra note 27, at 2.
[44] Id. at 1–2.
[45] Id. at 2.
[46] Id.
[47] Id.
[48] Johnson, supra note 27, at 20.
[49] 21 C.F.R. § 807.87(a)–(f) (2025).
[50] See U.S. Food and Drug Admin., supra note 42.
[51] See id. at 11.
[52] Id.
[53] U.S. Food and Drug Admin., Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process” 1 (2023).
[54] Id. at 6.
[55] Id.
[56] Id.; see Sarata, supra note 27, at 2.
[57] Johnathan J. Darrow, Jerry Avorn & Aaron S. Kesselheim, FDA Regulation and Approval of Medical Devices: 1976–2020, 326 JAMA Network 420, at 427 (2021).
[58] Id. at 428.
[59] Id.
[60] Id.
[61] Id.
[62] Id.
[63] Id.; Dubin, supra note 29, at 2.
[64] Dubin, supra note 29, at 5–6.
[65] Id. at 8.
[66] U.S. Food and Drug Admin., The Least Burdensome Provisions: Concept and Principles 4 (2019).
[67] Id.
[68] See, e.g., 510(k) Premarket Notification, U.S. Food and Drug Admin. (Oct. 27, 2025), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&Center=&Panel=&ProductCode=&KNumber=&Applicant=&DeviceName=unscented%20tampon&Type=&ThirdPartyReviewed=&ClinicalTrials=&Decision=&DecisionDateFrom=&DecisionDateTo=03%2F02%2F2025&IVDProducts=&Redact510K=&CombinationProducts=&ZNumber=&PAGENUM=500 [https://perma.cc/J8EP-BCQE] (providing a database of traditional and abbreviated releasable 510(k) applications from tampon manufacturers).
[69] U.S. Food and Drug Admin., supra note 42, at 12.
[70] Id.
[71] See Medical Device Safety and the 510(k) Clearance Process, U.S. Food and Drug Admin. (Sept. 6, 2023), https://www.fda.gov/medical-devices/510k-clearances/medical-device-safety-and-510k-clearance-process [https://perma.cc/3JLZ-UWQK].
[72] Katie Krumperman, Period Poverty in the United States, Ballard Brief (Feb. 2023), https://ballardbrief.byu.edu/issue-briefs/period-poverty-in-the-united-states [https://perma.cc/VR6H-TY6J].
[73] Id.
[74] See id.
[75] Shearston et al., supra note 4, at 2.
[76] Id.
[77] Id.
[78] Id. at 5.
[79] Id. at 1; Fallon, supra note 11, at 317.
[80] Shearston et al., supra note 4, at 1; see Wang, supra note 19.
[81] Shearston et al., supra note 4, at 7.
[82] Id.
[83] Jenni A. Shearston, Kristen Upson, Milo Gordon, Vivian Do, Olgica Balac, Khue Nguyen, Beizhan Yan, Marianthi-Anna Kioumourtzoglou & Kathrin Schilling, Communicating Risk in the Face of Data Gaps: Toxic Metals in Tampons, 194 Env’t Int’l, Dec. 1, 2024, at 1.
[84] Shearston et al., supra note 4, at 5.
[85] See id.; Lead in Food and Foodwares, U.S. Food and Drug Admin. (Jan. 6, 2025), https://www.fda.gov/food/environmental-contaminants-food/lead-food-and-foodwares [https://perma.cc/7MCS-73ZS]; Lead Poisoning, World Health Org. (Sept. 27, 2024), https://www.who.int/news-room/fact-sheets/detail/lead-poisoning-and-health [https://perma.cc/8EKZ-KX44].
[86] Shearston et al., supra note 4, at 5.
[87] Id.
[88] Lead Poisoning, Mayo Clinic (Jan. 21, 2022), https://www.mayoclinic.org/diseases-conditions/lead-poisoning/symptoms-causes/syc-20354717 [https://perma.cc/X98Z-HGZH]; About Lead and Other Heavy Metals and Reproductive Health, Ctr. for Disease Control (Feb. 14, 2024), https://www.cdc.gov/niosh/reproductive-health/prevention/lead-metals.html#:~:text=Working%20with%20lead%20or%20other,affect%20a%20baby's%20developing%20brain [https://perma.cc/HC2J-8QER].
[89] Jie Lin, Xiaoyan Lin, Jiahui Qiu, Xiumi You & Jinbang Xu, Association Between Heavy Metal Exposure and Infertility Among American Women Aged 20–44 Years: A Cross-Sectional Analysis from 2013 to 2018 NHANES Data, 11 Frontiers Pub. Health, Feb. 13, 2023, at 1, 5.
[90] Fallon, supra note 11, at 317. See Talking to Your Child About Periods, Nemours KidsHealth (Oct. 2018), https://kidshealth.org/en/parents/talk-about-menstruation.html [https://perma.cc/5PG2-HVB9].
[91] Talking to Your Child About Periods, supra note 90.
[92] Lead Poisoning, Ctr. For Disease Control (Apr. 10, 2024), https://www.cdc.gov/lead-prevention/symptoms-complications/index.html [https://perma.cc/8MSX-5XF4]; What are Some of the Health Effects of Lead?, U.S. Env’t Prot. Agency (Jan. 13, 2025), https://www.epa.gov/lead/what-are-some-health-effects-lead [https://perma.cc/GRB9-W3CS].
[93] Mejia & Mancheno, supra note 6.
[94] Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology, U.S. Food and Drug Admin. (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.
[95] Id.
[96] Id.
[97] Id.
[98] See Mattais Öberg, Assessing the Risk of Toxic Metals in Tampons: Legitimate Concern or Misleading Alarm?, 192 Env’t Int’l, Oct. 9, 2024, at 1; Mehruba Anwar Parris, Maryann Mazer-Amirshahi, Diane P. Calello & Andrew I. Stolback, ACMT Position Statement: No Evidence that Tampons Cause Metal Poisoning, 21 J. Med. Toxicology 106, 107 (Dec. 27, 2024).
[99] Parris et al., supra note 98, at 107.
[100] Id. at 106.
[101] Id. at 106–07.
[102] Id. at 107.
[103] Öberg, supra note 98, at 1; see also Shearston et at., supra note 83, at 1.
[104] Shearston et al., supra note 83.
[105] Id.
[106] Id.
[107] See id.
[108] See Shearston et at., supra note 4, at 2.
[109] U.S. Food and Drug Admin., supra note 42, at 9.
[110] Id.
[111] Id.
[112] Id. at 10–12.
[113] Mejia & Mancheno, supra note 6, at 2; see id.
[114] U.S. Food and Drug Admin., supra note 42, at 12.
[115] Id. at 11.
[116] See Shearston et al., supra note 4, at 6; Lead in Soil, U.S. Env’t. Prot. Agency (Aug. 2020), https://www.epa.gov/sites/default/files/2020-10/documents/lead-in-soil-aug2020.pdf [https://perma.cc/A3Z3-RXTX].
[117] U.S. Food and Drug Admin., supra note 42, at 1; see also Erica Seiguer & John J. Smith, Perception and Process at the Food and Drug Administration: Obligations and Trade-Offs in Rules and Guidances, 60 Food and Drug L. J. 17, 20 (2005).
[118] What We Do, supra note 21.
[119] See Öberg, supra note 98; Shearston et al., supra note 83; Parris et al., supra note 98.
[120] See Shearston et al., supra note 83.
[121] World Economic Forum, 5 Conditions That Highlight the Women’s Health Gap, Gavi (May 6, 2024), https://www.gavi.org/vaccineswork/5-conditions-highlight-womens-health-gap [https://perma.cc/Z9YT-YV9G]; Women’s Health: Why is the Health of at Least Half the Global Population So Often Overlooked?, World Economic Forum (Jan. 2, 2023), https://www.weforum.org/stories/2023/01/women-health-gap-davos-2023 [https://perma.cc/5BSE-EEDK]; Matthew D. Baird, Melanie A. Zaber, Annie Chen, Andrew W. Dick, Chloe E. Bird, Molly Waymouth, Grace Gahlon, Denise D. Quigley, Hamad Al-Ibrahim & Lori Frank, Rsch. Funding for Women’s Health: Modeling Societal Impact 5 (Oct. 11, 2021).
[122] Endometriosis, Cleveland Clinic (Oct. 26, 2025), https://my.clevelandclinic.org/health/diseases/10857-endometriosis#symptoms-and-causes [https://perma.cc/MZ5Y-Q5X4]; Common Reproductive Health Concerns for Women, Ctr. for Disease Control (May 15, 2024), https://www.cdc.gov/reproductive-health/women-health/common-concerns.html [https://perma.cc/2YGP-3VAM]; Ovarian Cancer, NHS Inform (Feb. 21, 2025), https://www.nhsinform.scot/illnesses-and-conditions/cancer/cancer-types-in-adults/ovarian-cancer/#:~:text=What%20causes%20ovarian%20cancer%3F,breast%20cancer%20in%20the%20past [https://perma.cc/YZ84-9B3V].
[123] See Jamie M. Kohen, The History of the Regulation of Menstrual Tampons 16–20 (Apr. 6, 2001) (unpublished third year student paper), https://dash.harvard.edu/server/api/core/bitstreams/7312037c-acc7-6bd4-e053-0100007fdf3b/content [https://perma.cc/MW5R-APLM].
[124] Patrick M. Schlievert & Catherine C. Davis, Device-Associated Menstrual Toxic Shock Syndrome, 33 Clin. Microbiology Rev., May 27, 2020, at 1, 2–3.
[125] Historical Perspectives Reduced Incidence of Menstrual Toxic-Shock Syndrome—United States, 1980-1990, Ctr. For Disease Control (June 29, 1990), https://www.cdc.gov/mmwr/preview/mmwrhtml/00001651.htm [https://perma.cc/E86E-H7NN].
[126] Schlievert & Davis, supra note 124, at 1; Spitzer, supra note 16, at 236.
[127] Kohen, supra note 123, at 6; Historical Perspectives Reduced Incidence of Menstrual Toxic-Shock Syndrome—United States, 1980-1990, supra note 125.
[128] Historical Perspectives Reduced Incidence of Menstrual Toxic-Shock Syndrome—United States, 1980-1990, supra note 125.
[129] Kohen, supra note 123, at 10 (quoting Ethyl Corp. v. EPA, 541 F.2d 1, 25 (D.C. Cir. 1976)).
[130] Id. at 10–12.
[131] Id. at 12.
[132] Id. at 15–16.
[133] Id. at 16–17.
[134] Id. at 17–18.
[135] Id.
[136] Id. at 20.
[137] Id.
[138] Id.
[139] Id. at 23.
[140] Id. at 22-23.
[141] Id. at 34; see Historical Perspectives Reduced Incidence of Menstrual Toxic-Shock Syndrome—United States, 1980-1990, supra note 125.
[142] Fallon, supra note 10, at 324; see also Kohen, supra note 123, at 34.
[143] Kohen, supra note 123, at 34.
[144] See id.
[145] Id.
[146] Beck & Oram, supra note 6, at 12.
[147] See Krumperman, supra note 72.
[148] Fed. R. Civ. P. 23.
[149] Id.
[150] See, e.g., Defendant’s Notice of Motion and Motion to Dismiss at 4, Willis-Albrigo and Wright v. The Procter & Gamble Co. (S.D. Cal. 2024) (No. 3:24-cv-01416-GPC-SBC) (dismissed).
[151] See id.
[152] Id.
[153] Id. at 4–5.
[154] Id. at 15–16.
[155] Id. at 24 (citing Davidson v. Kimberly-Clark Corp., 889 F.3d 956, 967 (9th Cir. 2018)).
[156] Lead Poisoning, supra note 85.
[157] See id.; Shearston et al., supra note 4.
[158] Don Sherratt, Taking a Risk-Based Approach to Medical Device Design, Med. Device Diagnostic & Indus. (Sept. 1, 1999), https://www.mddionline.com/design-engineering/taking-a-risk-based-approach-to-medical-device-design# [https://perma.cc/C4K5-L8VN]; Darrow et al., supra note 57, at 427.
[159] See Lead Poisoning, supra note 85. While tampons are a surprising avenue of heavy metal exposure, most people are exposed to low levels of certain metals through food, air, and water. For example, arsenic is in avocados, mercury is present in fish, and certain types of chromium may actually be used as a supplement. Avocado Pits: Start or Stop Eating?, Health Scis. Acad. https://thehealthsciencesacademy.org/health-tips/avocado-pits-start-stop-eating [https://perma.cc/AZ43-3N8L]; FDA/EPA 2004 Advice of What You Need to Know About Mercury in Fish and Shellfish, U.S. Food and Drug Admin. (Mar. 2004), https://www.fda.gov/food/environmental-contaminants-food/fdaepa-2004-advice-what-you-need-know-about-mercury-fish-and-shellfish [https://perma.cc/P65D-T2C5]; Chromium, Nat’l Inst. Health (June 2, 2022), https://ods.od.nih.gov/factsheets/Chromium-HealthProfessional [https://perma.cc/N4X5-XEP2].
[160] See U.S. Food and Drug Admin., supra note 42, at 9.