Fear of The Unknown: Recent Study Suggests Need for FDA to Conduct More Research and Implement Regulations on Menstrual Product Manufacturing.

By: Payton Colace, JHBL Staff Member

Introduction:

    Concerns developed this past summer over the protection of the female body, specifically, the safety of menstrual care products.[1]  Worries arose following publication of the UC Berkeley School of Public Health study examining the contents of tampons and other feminine hygiene products produced by popular brands, which revealed toxic chemicals in the items.[2]  The reports sparked a public outcry and a demand for stricter regulations to ensure that companies use safe materials and identify them on product labels.[3]

    The Food and Drug Administration (hereinafter FDA) classifies tampons as medical devices, determining their safety in terms of functioning and efficiency.[4]  This functioning requirement, however, does not extend to the contents of tampons and does not include a required test of tampons for chemical contaminants.[5]  The FDA only recommends that tampons do not contain pesticide residue or dioxin; other materials are acceptable.[6]  Thus, due to a lack of disclosure requirements, companies can construct products using whatever materials they choose, granting already powerful corporations even more authority to do as they please.[7]  This study helped reveal the issues caused by a lack of regulations and expressed concern over the possible side effects of these products.[8]

Background:

    Over the course of a women’s reproductive years, she uses about 7,400 tampons, a quantity that merits deeper analysis of the health effects of the products on the body.[9]  This study aimed to identify what makes up these tampons and the implications for consumer safety.[10]  UC Berkeley School of Public Health headed this study with multiple schools across the country including Columbia and Michigan State University.[11]  Surprisingly, this study is the first of its kind and evaluated toxins and metals within popular brands of tampons.[12]  The study examined thirty different tampons, which all contained sixteen different chemicals including arsenic, lead, and cadmium.[13]  Experts do not yet know how environmental factors affect the introduction of metals and toxins into the products, or if the chemicals enter the items during the manufacturing process for odor control, pigment, or as antibacterial agents.[14]  Along with analyzing the various chemicals that make up these products, the study revealed a lack of substantive knowledge about the long-term effects of exposure to these agents.[15]  The use of chemicals within tampons is especially concerning, as tampons come into contact with the most sensitive and absorbent tissue in the body.[16]  The vaginal epithelium has a higher potential for chemical absorption compared to skin, resulting in system-wide exposure.[17]  Exposure to these chemicals increases possibility of heart disease, dementia, infertility, diabetes and cancer.[18]  The presence of such dangerous substances in common feminine hygiene products calls into question the need for stricter regulations of the manufacturing of tampons.[19]

    The role of the FDA in regulating tampons is minimal.[20]  Since tampons are medical devices, questionable materials can be used in the creation of these products.[21]  The FDA does not require companies that manufacture tampons to disclose ingredients used in the development of feminine hygiene products.[22]  Warnings about a possible infection known as Toxic Shock Syndrome, as well as information about absorbency, are the only labels that must appear on tampon boxes.[23]  Companies also do not need to conduct chemical testing on their products, contributing to the ongoing mystery of the formula used to make tampons.[24]  The FDA requires companies to submit pre-market notifications demonstrating that their products are safe and effective, but these reports are not readily available.[25] Companies, therefore, possess significant discretion to selectively reveal information about products, as the FDA does not hold them accountable.[26]

    Although FDA regulations are quite relaxed, various states are implementing mandatory regulations and disclosures for menstrual products.[27]  In 2021, New York became the first state to enact a menstrual product disclosure law requiring companies to list all intentionally added ingredients on packaging.[28]  At least six other states introduced legislation to address safety and disclosure of ingredients in these products.[29]  Additionally, California governor Gavin Newsom signed a similar law that took effect this year; however, the law still grants protection over trade secrets, raising another issue.[30]  Laws about trade secrets protect companies rather than consumers.[31]  These laws keep details about fragrances in pads and tampons confidential so competitors cannot copy the formulas.[32]  All of the ingredients in fragrances, therefore, are not disclosed, which poses significant health risks as fragrances negatively affects the body.[33]

Analysis

    The UC Berkeley School of Public Health study is another example of the lack of proper regulation by the FDA, representing another regression in women’s health.  Once again, minimal research on women’s health issues and the improper regulations perpetuate this harmful standard.[34]  As helpful as the study is in providing an indication of the damaging chemicals women introduce into their bodies through pad and tampon usage, much more research is needed on the safety of feminine hygiene products.[35]  A significant portion of women use tampons, and these common products should not pose potential harmful effects on the body.  The long-term effects of exposure to chemicals in feminine hygiene products is unknown, along with the method by which these chemicals enter the products.[36]  Obvious concerns center around the use of lead, which is known to negatively affect neurological, reproductive, and developmental health.[37]  Even minimal lead exposure can affect the body in harmful ways.[38]  The main initiative is continuous research and development of these products.[39]  By continuing to research the development process of these products, society can understand their effects and how to change the products to be healthier for consumers.[40]  Once the products are used by consumers, however, data that supports the impact of these products on the body and how they could be improved is no longer available.[41]  The government must no longer allow powerful companies to construct their products with harmful ingredients without any consequences.  The UC Berkeley study provokes these needed discussions and demonstrates that additional research is required to ensure the safety of all women using necessary menstrual products.[42]

Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.  

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[1] See Chantelle Lee, Do You Really Need to Ditch Your Tampons Over Safety Concerns, Time (Aug. 2, 2024, 4:40 PM), https://time.com/7007220/tampon-safety-metals/ [https://perma.cc/3URR-5ZHS] (providing breakdown on impact of study on public).

[2] See generally Jenni A. Shearston et al., Tampons as a Source of Exposure to Metal(loid)s, 190 Env’t Int’l 1 (June 22, 2024) (outlining contents of study and important takeaways).

[3] See Lee, supra note 1.

[4] See Rachel Treisman, A Study Found Toxic Metals in Popular Tampon Brans. Here’s What Experts Advise, NPR (July 11, 2024, 4:07 PM), https://www.npr.org/2024/07/11/nx-s1-5036484/tampons-heavy-metals-study [https://perma.cc/ALV3-2FRX] (explaining various experts’ advice on outcome of study).

[5] See id.

[6] See Menstrual Care Products and Toxic Chemicals, Campaign for Safe Chem., https://www.safecosmetics.org/resources/health-science/menstrual-care-products/ [https://perma.cc/745H-J8NA] (last visited Sept. 18, 2024) (addressing what effects various chemicals uncovered in tampons has on female body).  The FDA says that tampons are safe, and that they do not contain dangerous levels of dioxin.  Id.  However, even trace levels of dioxins are concerning because these chemicals have been linked to cancer, hormone disruption, and endometriosis.  Id.  These effects can happen with very low exposure levels of dioxin, and the science shows that our bodies are already above the “safe” limits.  Id.

[7] See Erica Zurek, Federal Rules Don’t Require Period Product Ingredients on Packaging Labels. States are Stepping In, CBS News Health Watch (Apr. 27, 2023, 5:00 AM), https://www.cbsnews.com/news/menstrual-pads-tampons-fda-ingredients-labels/ [https://perma.cc/H4QF-24TH] (emphasizing lack of federal regulation and introducing states initiatives).

[8] See Shearston et al., supra note 2.

[9] See id. (determining importance of more research needed to assess dangers).  Tampons being a product so widely used, putting a number for how much one uses throughout their life helps to visualize and understand just how large of an impact there is.  Id.

[10] See id.

[11] See id.

[12] See Elise Proulx, First Study to Measure Toxic Metals in Tampons Shows Arsenic and Lead, Among Other Contaminants, Berkeley Pub. Health (July 12, 2024, 11:46 AM), https://publichealth.berkeley.edu/news-media/research-highlights/first-study-to-measure-toxic-metals-in-tampons-shows-arsenic-and-lead [https://perma.cc/TD3F-YDBT] (breaking down study results and explaining what remains unclear).

[13] See Helena Oliviero & Ariel Hart, Lead and Other Toxic Metals Found in Tampons, Study Finds, Atlanta  J. Const. (July 11, 2024), https://www.ajc.com/news/health-news/study-finds-lead-arsenic-and-other-metals-in-tampons-used-by-millions-of-women-in-the-us/IFNT55LVOJBYDC4QWGSJHJ6GLY/ [https://perma.cc/KCF5-KLWS] (providing risks of exposure and specific chemicals within products).

[14] See Proulx, supra note 12 (highlighting inability to pinpoint exactly how these metals show up in tampons).  Metals could make their way into tampons several ways:  Cotton material absorbing metals is one of the many ways that metals can make their way into tampons.  Id.  The cotton material could have absorbed the metals from water, air, soil, through a nearby contaminant (for example, if a cotton field was near a lead smelter), or some might be added intentionally during manufacturing as part of a pigment, whitener, antibacterial agent, or some other process in the factory producing the products.  Id.

[15] See id.; see also Shearston, supra note 2, at 2 (detailing concerns with presence and exposure of metals in tampons).

[16] See Menstrual Care Products and Toxic Chemicals, supra note 6 (indicating harmful chemicals and concern due to nature of tampon contact with female anatomy).  Chemicals used include dioxin, pesticides and fragrances.  Id.  The discovery of pesticides within tampons stems from cotton.  Id.   According to Pesticide Action Network, farmers are forced to use some of the most hazardous pesticides on their cotton fields, and the World Health Organization has classified many cotton pesticides as “extremely or highly hazardous.  Id.   These pesticides have been linked to infertility, neurological dysfunction, and developmental defects.  Id.

[17] See Shearston, supra note 2, at 2 (explaining process of absorbing contents of tampon).  The vagina has a highly permeable and vascularized mucosal membrane and contains rugae, or small folds, resulting in an increased surface area.  Id.  This allows for efficient absorption, for example, vaginal administration of the medications propranolol and misoprostol results in greater bioavailability than oral or buccal administration.  Id.  Vaginally absorbed chemicals do not undergo first-pass metabolism and detoxification via the liver and directly enter systemic circulation.  Id.  Critical evidence for systemic exposure to toxins with tampon use is provided by the toxic shock syndrome outbreak of the early 1980s.  Id.

[18] See Hannah Singleton, A New Study Found Toxic Metals in Tampons- Should You Still Use Them?, health (July 23, 2024), https://www.health.com/tampons-contain-toxic-metals-study-8679104 [https://perma.cc/2EWD-R3G6] (addressing research results and specific health conditions that arise from exposure).

[19] See Oliviero & Hart, supra note 13.

[20] See Treisman, supra note 4 (highlighting both minimal and ineffective issues within FDA regulations).  The FDA classifies tampons as medical devices and regulates their safety.  Id.  However, there is no requirement to test tampons for chemical contaminants, and the FDA only recommends that tampons not contain pesticide residue or dioxin.  Id.

[21] See Zurek, supra note 7.

[22] See Jasmine Wang, The Mystery of Tampon Regulation, Regul. Rev. (Sept. 2, 2021), https://www.theregreview.org/2021/09/02/wang-mystery-tampon-regulation/ [https://perma.cc/9W3C-H268] (discussing current FDA regulations and how causing speculation remains minimal).

[23] See id.  The FDA currently regulates tampons as Class II medical devices, a classification that applies to devices with moderate to high risks.  Id.  The agency requires tampon manufacturers to submit safety evaluations, which include a detailed description of the product’s composition and absorbency, risk assessments, and safety test results.  Id.

[24] See id.  The FDA only recommends, rather than mandates, that tampon manufacturers inform consumers of the presence of chemicals in their products.  Id.  Although some feminine hygiene companies voluntarily list basic ingredients on their product packaging, consumer health advocates urge all companies to provide more detailed information about the chemicals contained in tampons.  Id.

[25] See Food & Drug Admin., Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) – Guidance for Industry and FDA Staff, (July 27, 2005) (outlining information on FDA premarket notification process).

[26] See Wang, supra note 22 (criticizing mystery of tampons through minimal regulations by FDA).  Health advocates argue that FDA’s optional requirements for ingredient disclosure for Class II medical devices do not go far enough to encourage increased ingredient transparency from tampon manufacturers.  Id.

[27] See Zurek, supra note 7 (presenting first few states encouraging and passing stricter regulation).

[28] See id. (examining New York’s steps in regulation).  New York’s law requires companies to disclose all intentionally added ingredients no matter how much is used, with no trade secret protections for fragrances.  Id.  Though it applies only to products sold in that state, similar detailed labeling is appearing elsewhere.  Id.

[29] See id.

[30] See id. (distinguishing California’s approach from New York creating another obstacle to regulations).

[31] See Zurek, supra note 7.

[32] See Menstrual Care Products and Toxic Chemicals, supra note 6 (discussing harmful effects of protecting trade secrets).  Because these fragrance formulas are considered trade secrets, companies have no obligation to say what’s in them.  Id.  We know from product testing that fragrance may contain any number of harmful chemicals, including allergens, sensitizers, phthalates which are linked to hormone disruption and can affect development and fertility, neurotoxins, and synthetic musk’s which can also disrupt hormones.  Id.

[33] See Id.

[34] See Shearston et al., supra note 2, at 7-8 (referring to study being first of its kind to examine contents of tampons).  Future research is necessary to replicate findings and determine whether metals can leach out of tampons and cross the vaginal epithelium into systemic circulation.  Id.  These findings point towards the need for regulations requiring the testing of metals in tampons by manufacturers.  Id.

[35] See generally id., supra note 2 (noting necessity of further studies regarding metal exposure in tampons).

[36] See Lee, supra note 1 (addressing many questions still unanswered).  The article emphasizes the hysteria that has come from the study due to the confusion on what the long-term effects and how much exposure women are facing indicating the additional need for more research and understanding.  Id.

[37] See Shearston et al., supra note 2, at 5 (presenting scientific data on chemical exposure long-term effect).

[38] See id. (determining lead content and even small exposure impacts body).  Concerningly, lead was found in all the tested tampons.  Id.  There is no safe exposure level to lead; any proportion of lead that may leach out of a tampon and reach systemic circulation might contribute to negative health outcomes.  Id.  Lead is stored in bones, where it replaces Calcium, and can be retained in the body for decades.  Id.

[39] See Lee, supra note 1 (developing opinion of what contents of study reveal).  Due to lack of answers available to ease the public’s fear, it is apparent that we need to know a lot more about what is present in these menstrual products and conduct necessary test so we can understand if there are things that could be impacting our health.  Id.

[40] See id.

[41] See Singleton, supra note 18 (pointing to lack in support and research).  Whether or not this has negative health implications, experts say the discovery highlights a significant gap in the oversight of menstrual products.  Id.  Experts claim this space has been neglected and consumers deserve to know that products they use regularly are safe and free from harmful substances drawing attention to the need for increased scrutiny of menstrual products.  Id.

[42] See generally Shearston et al., supra note 2.