28.10.2024.
Following widespread attention surrounding research on tampons as a potential source of metal(loid) exposure, the US Food and Drug Administration (FDA) announced on September 10th that it has commissioned an independent literature review and initiated an internal laboratory study to evaluate the presence of metals in tampons.
A study by a group of researchers published in Environment International reported the following:
- 16 metal(loid)s were evaluated in different kinds of tampons.
- Several toxic metals, including lead, were detected.
- Tampon use is a potential source of exposure to metals in menstruating people.
- The highest concentration was found for zinc (geometric mean = 52,000 ng/g)
- A geometric mean lead concentration of 120 ng/g was found in our samples.
FDA statement:
The FDA is aware of concerns about tampon safety after a 2024 study found metals in tampons during laboratory testing. We want the public to know that before tampons can be legally sold in the U.S., they must meet FDA requirements for safety and effectiveness.
Manufacturers must test the product and its component materials before, during, and after manufacturing. Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.
While the study found metals in some tampons, 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.
The FDA has therefore commissioned an independent literature review and initiated an internal bench laboratory study to evaluate metals in tampons. The comprehensive review of the published literature will 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.
The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use. These initiatives will enable the FDA to complete a risk assessment of metals contained in tampons, based on a worst-case scenario of metal exposure.
The FDA will communicate our findings from the literature review and lab testing publicly when they are available and have been peer reviewed. The FDA will also continue monitoring these devices as part of its total product lifecycle approach to medical devices.
Any tampon currently cleared by the FDA has been evaluated as described in the guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) and was determined to meet FDA premarket requirements.
The Consumer Healthcare Products Association (CHPA) response:
The Consumer Healthcare Products Association (CHPA) released the following statement in response to a recent study published in Environment International regarding the presence of metals in certain tampon products. The study did not assess the risk of metal exposure to tampon users.
Consumer trust is a responsibility CHPA member companies take very seriously, and their commitment to ensuring consumer safety remains the top priority.
Our members strictly adhere to Current Good Manufacturing Practices (CGMPs) outlined in the Federal Food, Drug and Cosmetic Act (FDCA) and abide by all regulations, guidelines, and procedures set forth by the U.S. Food and Drug Administration (FDA).
Consumer healthcare products are rigorously tested to meet these strict regulatory standards. Before tampons can be legally marketed in the United States, they must undergo FDA’s review process. Manufacturers are required to submit data, including results evaluating the safety of the materials used to make the tampons and applicators, demonstrating that they can be safely used in or on the human body.
This study did not assess if any metals are released from tampons in real world use conditions and did not document any health risks to tampon users.
FDA stated that it has commissioned an independent literature review and an internal laboratory study and will share peer-reviewed data when available. CHPA is supportive of continued research to help ensure the safe use of these products.
SOURCE
FDA.GOV
SCIENCEDIRECT.COM
CHPA.ORG
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