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FDA Evaluates Contaminants, Including Metals, in Tampons Through Independent Literature Review

The U.S. Food and Drug Administration (FDA) has released findings from an independent review of published studies examining potential contaminants in tampons. This review, referred to as an independent systematic literature review, evaluated the safety of tampon use in relation to contaminant exposure. Despite identifying certain limitations in the studies reviewed—a common occurrence in such analyses—the findings did not reveal any safety concerns associated with tampon use. The FDA continues to recommend FDA-cleared tampons as a safe and reliable menstrual product.

What Are Vaginal Tampons?

Vaginal tampons are small, cylindrical products made from absorbent materials such as cotton or rayon. They are designed to be inserted into the vagina to collect menstrual blood before it leaves the body. Unlike external pads, tampons are worn internally, offering discreet and comfortable protection throughout the day.

Key Points About Vaginal Tampons:

  • Function: Absorb menstrual blood.
  • Material: Made primarily of cotton or rayon fibers.
  • Application: Inserted into the vagina, often with an applicator.
  • Usage Tips: Choose the appropriate size based on menstrual flow, ensure proper insertion, and change tampons regularly to prevent infection.

Purpose of the Literature Review

The review aimed to assess existing evidence on contaminants found in tampons and their potential health effects. Nine published articles were analyzed, focusing on a variety of contaminants, including:

  • Metals
  • Phthalates
  • Parabens
  • Bisphenols
  • Volatile Organic Compounds (VOCs)
  • Dioxins
  • Triclocarban

Key Findings:

While limitations were noted in the study methodologies, no evidence suggested that contaminants identified in tampons were released into the body or absorbed through the vaginal lining. Based on the available data, the FDA reaffirms that tampons remain a safe menstrual product option.

Additional Research Underway

The FDA is conducting its own laboratory study to assess whether metals present in tampon materials are released or absorbed by the body during normal use. This study is designed to simulate real-life conditions and will measure:

  • The amount of metals released from tampon materials.
  • Potential absorption of these metals into the body.

Once completed and peer-reviewed, the findings will contribute to a comprehensive risk assessment of metal exposure from tampons.

FDA Actions and Commitment to Safety

The FDA initiated further evaluations after an external study published in 2024 reported low levels of metals in tampons during laboratory testing. However, that study did not examine whether the metals were released during use or absorbed by the body. To address these gaps, the FDA is undertaking additional testing to provide a more accurate assessment of potential risks.

Regulatory Oversight for Tampons

Before tampons can be sold in the United States, they must comply with stringent FDA safety and effectiveness requirements. Manufacturers are obligated to:

  • Test tampon materials at various stages of production.
  • Conduct biocompatibility and other safety evaluations.
  • Submit these test results to the FDA for review prior to market authorization.
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 performance requirements.

All medical devices that contact the human body undergo biocompatibility safety assessments prior to market release. Pre-clinical research undertaken to address pre-market questions raised about the biocompatibility of medical devices is multidisciplinary and encompasses the use of biological evaluation and toxicological risk assessment technologies including novel in vitro, ex vivo/in vivo testing, and computational/in silico methodologies.


Contaminants in Vaginal Tampons: A Systematic Literature Review (SLR) 👇

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