FDA-cleared tampons continue to be 'safe option' says FDA
FDA is investigating concerns of metal found in tampons
The FDA has announced initial results of a review of the safety of tampons, following a study last year by UC Berkeley and Columbia Uni that found small amounts of more than a dozen metals including lead and arsenic in 14 worldwide brands.
For its review, the FDA commissioned an independent literature review, looking at nine published articles that evaluated a variety of different contaminants in tampons.
It has now issued a statement to say that although the literature it examined had some limitations, the available evidence continues to support the FDA’s conclusion that tampons remain a safe menstrual product option.
It said:
“Before tampons can be legally sold in the U.S., they must meet FDA requirements for safety and effectiveness. Manufacturers must test tampons and the materials the tampon is made of before, during, and after manufacturing. Also, before tampons are allowed onto the market, manufacturers must perform biocompatibility and other safety testing. The FDA reviews the results of the testing prior to market authorization.”
Second part of review now underway
The FDA has also initiated an independent lab study on metals in tampon to determine if metals from tampon materials are released or absorbed in the body. Specifically, the study will measure the amount of metals that may be released from tampon materials under conditions that more closely mimic normal use.
This study will specifically address the findings of the initial UC Berkeley and Columbia from July 2024, which although identified metals in tampons, did not discover if metals leach out of tampons and cross into the body.
Metals have been found to increase the risk of dementia, infertility, diabetes, and cancer. They can damage the liver, kidneys, and brain, as well as the cardiovascular, nervous, and endocrine systems. In addition, metals can harm maternal health and fetal development.
Tampons are of particular concern as a potential source of exposure to chemicals, including metals, because the skin of the vagina has a higher potential for chemical absorption than skin elsewhere on the body and tampons are in place for extended periods of time - typically up to eight hours for each use.
As lead author Jenni A. Shearston said at the time:
“Despite this large potential for public health concern, very little research has been done to measure chemicals in tampons.”