FDA announced this week that it will examine the potential harm to women of heavy metals exposure such as lead, cadmium and arsenic found in tampons, following the results of a July pilot study, growing consumer concern over product safety, ingredient transparency, and potential health risks associated with tampon use. FDA stated that while the July study identified only the presence of heavy metals, “the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use.”
Various advocacy groups and individuals have long called for greater scrutiny of feminine hygiene products, raising alarms over issues like toxic shock syndrome (TSS), chemicals in tampon fibers, and the lack of clear labeling regarding ingredients.
Some investigative reports and independent studies have suggested that tampons might contain trace amounts of harmful substances, such as dioxins or other chemical byproducts, potentially linked to long-term health effects. Although these claims are far from universally accepted, they’ve sparked enough conversation for the FDA to launch a formal investigation. Accordingly, FDA announced that it has commissioned an independent literature review and has initiated an internal bench laboratory study to evaluate metals in tampons to further evaluate the presence of chemicals in tampons and associated health effects of these chemicals.
FDA reminded consumers that before being legally sold in the U.S., tampons, as Class II medical devices, must meet FDA requirements for safety and effectiveness, including manufacturer testing of both the product and component materials, before, during and after manufacturing. This includes FDA’s evaluation of tampon absorbency, strength and integrity, and whether tampons enhance the growth of certain harmful bacteria or change normal bacteria levels. FDA also clarified that prior to FDA’s marketing authorization of tampons via a 510(k) premarket notification, manufacturers are required to complete biocompatibility testing.
What This Means for the Regulated Industry
For tampon manufacturers and the broader feminine hygiene industry, this investigation is no small matter. The FDA has the authority to issue warning letters, mandate product recalls, or even introduce new regulations depending on what it finds. So, what’s at stake?
- Increased Regulatory Oversight: If the FDA concludes that current manufacturing processes or product standards are inadequate, the industry could face tighter regulations. This might include more stringent testing requirements, expanded ingredient disclosures, or changes to how products are classified and marketed.
- Reformulation Challenges: Should the FDA identify problematic chemicals or materials in tampons, manufacturers may need to reformulate their products—an expensive and time-consuming process. This could especially impact smaller companies with less financial flexibility to quickly pivot.
- Potential Market Shifts: The industry is already seeing a shift toward more “natural” and “organic” products, as consumers become increasingly concerned with what they’re using. If the FDA’s findings validate some of these concerns, this could accelerate the demand for more eco-friendly or chemical-free alternatives, reshaping the market landscape.
What Manufacturers Should be Doing
Unsurprisingly, tampon manufacturers should be on high alert. This includes cooperating with FDA’s investigation, ramping up internal safety audits, reformulating certain products to meet the growing demand for “clean” tampons, and investing in research to preemptively address any potential issues the FDA might uncover. This may also include issuing public statements to re-assure customers of product safety, as substantiated.
The Bottom Line
The FDA’s investigation into tampons is a wake-up call for the industry and a sign that consumer advocacy is driving real change. Whether this leads to new regulations, product recalls, or simply more transparent labeling, one thing is clear: the feminine hygiene industry is in the spotlight, and manufacturers will need to tread carefully.
For more information on FDA’s regulation of tampons, feminine hygiene products, or other medical devices, please contact us at info@garg-law.com.
