McGill Journal of Law and Health

By Raiha Shareef

For many menstruators, tampons are more than just a convenience—they are a lifeline, enabling menstruators to work, attend school, and enjoy their physical activity without interruption. Whether it’s running a marathon or sitting in a boardroom, tampons provide the essential protection needed to maintain one’s daily routine during menstruation. Unfortunately, in July, an alarming headline hit the news: a UC Berkeley study revealed that every major tampon brand contains traces of arsenic and lead. This news sent shockwaves through the public, as any amount of arsenic is considered harmful to the human body. As many menstruators panicked, throwing out their tampons to avoid toxins, with some switching to menstrual cups, I could not help but wonder: how did we get here? How could dangerous substances allegedly make their way into tampons, a product on which millions of menstruators in Canada rely monthly? In this blog, I dive into the Food and Drug Act (FDA), which governs tampon manufacturing and labelling in Canada. I will explain why tampons are currently classified as Class II medical devices and why it is critical to reclassify tampons as a higher-risk medical device. 

FDA and its interpretation of tampons 

In Canada, the Food and Drug Act (FDA) regulates the safety and quality of food, drugs, and medical devices to protect public health. Under the FDA, Tampons are considered medical devices. Medical devices are categorized into four classes based on the level of risk they pose to consumers, with Class I representing the lowest risk, such as simple external use products like bandages, and Class IV as the highest, including more invasive products like pacemakers. Tampons are currently classified as Class II, which designates devices that pose moderate risk. This classification implies that while tampons must meet certain safety standards for manufacturing and labelling, they undergo less stringent testing and regulation compared to higher-risk products like surgical instruments or implants. 

Applications to license Class II medical devices in Canada must contain the attestation of the senior official of the manufacturer that the product follows the safety and effectiveness requirements under sections 10-20 of the FDA Medical Device Regulations. Section 32(2)(a) of the FDA Medical Device Regulations states that manufacturers must also demonstrate the medical conditions, purposes, and uses for which the device is manufactured. However, unlike higher-class devices, Class II devices are not subject to extensive clinical trials or pre-market approval. Only medical devices ranked as Class III and IV require an extensive description of the materials  used in its manufacturing and packaging and a summary of the studies on which the manufacturer relies to ensure that the device meets the applicable requirements for a medical device in such a class.  

Is there a gap in the FDA classification system? 

According to Rule 2(3) of the FDA‘s classification for medical devices, any product that is intended to be absorbed by the body for at least 30 consecutive days is deemed Class III. While tampons only remain in the body for 4-8 hours at a time, obstetrician-gynecologists like Dr. Eboni January underscore that the mucous in the vagina and vulva, the main points of contact for a tampon, are highly absorbent. This high absorbency makes it crucial that the materials in tampons be proven safe, yet the UC Berkeley study revealing the amount of lead and arsenic in tampons is the first study to investigate the presence of metals in tampons. The dearth of research on the presence of harmful chemicals in menstrual products is largely due to the fact that Class II medical devices do not require extensive clinical trials to be marketed. Dr. Shruthi Mahaligaiah from the Chan School of Public Health advocates for a change to the FDA system in the US, one that creates stricter regulation for tampons to accurately monitor the presence of toxins in these essential products. The Menstrual Product Disclosure Law legislated in New York in 2019 requires companies to clearly list all intentionally added ingredients on packaging. A coalition of reproductive health advocates studying the effects of this law found it easier to identify toxins in tampons, highlighting the need for broader adoption of this legislation. The effectiveness of this legislation shows the importance of similar adoption in Canada. 

Exceptions to the medical device classes are not uncommon in the FDA scheme. According to Rule 2(4) for invasive devices, any device that is intended to prevent the transmission of infectious agents during sexual activities or reducing the risk thereof are classified as Class III. According to s.32.4(i), this means that any non-latex condom would undergo the rigorous clinical testing and full disclosure of all materials in manufacturing. It is odd that tampons are not held to as high of standards as is for externally applied devices like condoms. Studies have shown that local treatment to penile skin is ineffective, while the vagina is an effective method to absorb contraceptives. These studies highlight the higher absorbency of vaginas, yet tampons are not regulated to the extent that condoms are today.  

Silencing the conversation – stigmatizing menstruation has its harmful effects in health law 

Period stigma has long contributed to a significant lack of research and innovation in menstrual products, leaving critical gaps in understanding their safety and effectiveness. According to a 2021 report from Plan International, periods are a taboo topic, creating a culture that avoids speaking openly about menstruation. The lack of conversation on menstrual health has led to not prioritizing research in menstrual health, perpetuating outdated product designs and limited regulatory oversight. The reluctance to prioritize menstrual health issues has allowed products like tampons to be inadequately studied, despite their widespread use. This is largely the reason for the delayed recognition of health concerns, such as the presence of harmful substances in tampons. 

Conclusion 

The recent discovery of arsenic in tampons has exposed alarming gaps in the regulation and safety of menstrual products. Despite their use for invasive purposes and the potential for harmful absorption, tampons stay classified as Class II medical devices, subject to less rigorous testing than other products like condoms. This does not mean that it is time to toss out all your tampons. As worrisome as this new development is, this is only the first study to test for metalloids in tampons, and we do not fully understand the health risks that accompany the use and absorption of these substances. This new discovery underscores not only how menstrual health has been overlooked systematically for far too long but also how period stigma has compounded the issue of underfunding in menstrual health research. By reclassifying tampons to a higher-class medical device, we can ensure they undergo stricter scrutiny. Requiring clinical studies on tampon materials and packaging would go a long way in safeguarding the health of millions of menstruators. It is time to prioritize menstrual health and push for stronger FDA regulations that protect consumers from hidden dangers. 

About the author 

Raiha Shareef is the Executive Online Editor of the McGill Journal of Law and Health. She holds a Bachelor of Arts in Psychology from the University of Regina and is currently in her second year of the B.C.L./J.D. program at McGill University’s Faculty of Law. Raiha’s interests include reproductive justice, housing advocacy, and transformative gender equity. Prior to her legal studies, Raiha partnered with Plan International Canada as a Youth Ambassador advocating for international gender equality policies. She later became the Youth Spokesperson for P&G Always’ Menstrual Hygiene Day campaign, educating Canadians across the country on menstruation. Raiha aspires to create inclusive communities through the power of collaborative grassroots initiatives and academia.