FDA Regulation of Tampons (CRS Report for Congress)
| Release Date |
Oct. 11, 2024 |
| Report Number |
IN12441 |
| Report Type |
Insight |
| Authors |
Amanda K. Sarata |
| Source Agency |
Congressional Research Service |
Summary:
An August 2024 study led by researchers at Columbia University evaluated the concentration of 16
different metals in multiple brands of tampons and reported detecting measurable concentrations of all 16
metals. The authors concluded that using tampons may be a potential source of metal exposure, although
the study did not evaluate if the metals were released by the product or absorbed by the user. Research in
this area is limited.
In response, FDA has announced that it is undertaking a review of metals in tampons to help support its
regulation of these products. Specifically, FDA plans to commission an independent literature review to
learn more about data available regarding to what extent chemicals may be present in tampons, in
addition to possible health effects. The agency also plans a laboratory study of tampons in typical use
situations, to try to determine the extent to which metal may be released during normal use.
These findings have focused attention on FDA’s oversight of tampons, which are regulated as devices by
the agency. Specifically, questions have been raised about the sufficiency of labeling requirements for
these products (i.e., transparency around intentionally added ingredients in the product), as well as the
adequacy of premarket testing requirements for potential contaminants and elimination of those
contaminants. This Insight provides an overview of FDA’s current regulation of tampons.
