On September 10, the Food and Drug Administration (FDA) Biocompatibility and Toxicology Program published a statement announcing its intention to commission an independent literature review and internal bench laboratory study to evaluate the presence of metals in menstrual tampons. This decision comes after the recent publication of a pilot study that found metal(loids)s in 30 tampons from 14 tampon brands. The study, which was published in the journal Environment International, found measurable concentrations of 16 different metals in the evaluated [unidentified] tampons. Notably, the study did not test whether the detected metals are released from the tampons when used and then subsequently absorbed into the vaginal lining. The small sample size of tampons tested (60 "sub-samples" from 30 different tampons) precluded a formal statistical analysis, which means that the authors could not make any statistically significant conclusions.
Scented and unscented tampons are class II medical devices regulated under 21 C.F.R. §§ 884.5460 and 5470, respectively, and can be sold only after FDA has cleared a premarket 510(k) notification. As part of the premarket review, FDA requires tampon manufacturers to conduct biocompatibility testing to assess the safety of tampon components and applicators; tampon absorbency, strength, and integrity; and whether tampons enhance the growth of certain harmful bacteria or change normal bacteria levels in the vagina.
Both the independent literature review and internal bench laboratory study are measures within FDA's authority to ensure the safety and efficacy of regulated medical devices. FDA monitors emerging scientific research regarding the possible negative health effects of marketed consumer goods and may take action if it considers there to be a potential safety issue. FDA maintains a running list of medical device safety communications related to specific products that are posted on its website here. FDA also conducts similar monitoring for other product classes under its jurisdiction. For example, FDA recently issued a final rule revoking the regulation that authorized the use of brominated vegetable oil (BVO), a food additive commonly used in citrus-flavored sodas, following studies commissioned by FDA finding that BVO consumption has potentially negative health effects. (Read our original and most recent update on our website.)
What's next?
Most immediately, FDA's stated objective for the laboratory study on tampons is to measure the "amount of metals that come out of tampons under conditions that more closely mimic normal use." The literature review will also "provide a better understanding of the data currently available regarding the presence of chemicals in tampons, and importantly, any associated health effects of those chemicals." FDA will communicate these findings publicly when they have been peer reviewed and will also use this information to perform a risk assessment of the chemicals contained in tampons, based on a "worst-case scenario of metal exposure."
If these results suggest the widespread presence of metals in tampons, it is possible the FDA may compel tampon manufacturers to engage in postmarket surveillance. Section 522 of the Food Drug & Cosmetics Act gives FDA the authority to require a manufacturer to conduct postmarket surveillance of a class II or class III device in certain instances, including in circumstances where the failure of a device would be reasonably likely to have serious adverse health consequences. This type of action may be warranted, for example, if tampons containing impurities, such as metals, are found to have the potential to cause toxic shock syndrome, a life-threatening illness.
Depending on the severity of the health threat, a recall may need to be considered. While recalls are usually initiated by the manufacturer on a voluntary basis, FDA can also order a recall under 21 U.S.C. § 360h if it determines that there is a "reasonable probability" that the device would cause "serious, adverse health consequences or death." In this case, FDA would then issue a cease distribution and notification order that requires the receiving company to immediately stop distribution, notify health professionals and device user facilities of the order, and instruct health professionals and device user facilities to cease use of the device.
Litigation alleging metals in tampons has already begun. In California, plaintiffs filed class action complaints asserting various causes of action under California consumer protection laws soon after publication of the study results (and before FDA's announcement). In July, one plaintiff law firm filed two different class actions against Proctor and Gamble and Kimberly-Clark in the Southern District of California targeting the labeling "#1 U.S. Gynecologist Recommended Tampon Brand," "Free of Perfume," "Free of Elemental Chlorine Bleaching," "Tampon Free of Dyes," and "Clinically Tested Gentle to Skin" on Tampax Pearl tampons (in the Proctor & Gamble case) and "no harsh ingredients," "elemental chlorine-free rayon," "made without fragrance," "gynecologist tested," and "BPA free" on Kotex Click tampons (in the Kimberly-Clark case). Both complaints allege these representations are misleading because of the presence of lead, according to their own independent lab testing but also in reliance on the Environmental International study as well as California's Proposition 65 Maximum Allowable Dose Level for lead. In August, another plaintiff followed suit by filing a class action against Proctor & Gamble in the Southern District of California, focusing on similar labeling on Tampax Pearl tampons and alleging deception because of the presence of lead in the tampons.
FDA's decision to commission a literature review and initiate a study to evaluate metals in tampons may impact the active litigation in a couple of ways. On one hand, it may inspire other class action plaintiffs or counsel to bring additional suits, including ones alleging personal injuries under product liability theories. On the other hand, the brands will challenge—and have begun challenging—existing complaints, under a theory of primary jurisdiction and potentially preemption, in addition to standard arguments under 12(b)(1) and 12(b)(6), seeking to dismiss or stay the litigation until FDA communicates its findings. Certainly, FDA's reassurance regarding the products' pre-market regulatory review and clearance in its announcement is an early indication that class action plaintiffs' claims may lack sufficient basis to support a plausible case for consumer deception based on the study and independent testing without further extrapolations to consumer use and exposure. The outcome of the FDA's literature review and study could either undermine or bolster the litigation generally, and weaken or strengthen the opinions of plaintiffs' expert witnesses in litigation.
Venable's Class Action, Product Liability, and FDA Regulatory practices, along with its consumer product and emerging contaminant teams, will be watching with interest and providing updates along the way.