FDA Shares Draft Guidelines for Testing Tampons Pads and Cups
Published Date: 11/17/2025
Notice
Summary
The FDA just dropped draft guidance to help makers of tampons, pads, and menstrual cups test and label their products better. This means clearer info and more consistent quality checks for these everyday essentials. Companies should check it out and send their feedback by January 16, 2026, before the rules get finalized—no costs or changes are official yet!
Analyzed Economic Effects
5 provisions identified: 5 benefits, 0 costs, 0 mixed.
Tampon Testing for TSS and Microflora
The draft guidance includes recommended test methods for evaluating tampons for Toxic Shock Syndrome (TSS) risk and effects on vaginal microflora, and clarifies non-clinical bench testing methods for tampons. These are recommendations in a draft FDA document with a comment deadline of January 16, 2026.
Ingredient Disclosure on Outer Labels
The FDA draft guidance recommends that manufacturers disclose ingredients, including fragrances and deodorants, on all menstrual product outer package labels. This is guidance (not final), and the Agency asked for comments by January 16, 2026.
Evaluation of Contaminants for Menstrual Products
The draft guidance recommends evaluating contaminants for all menstrual products (tampons, pads, and menstrual cups) as part of performance testing. The recommendations are for industry and are not final; FDA sought comments by January 16, 2026.
Menstrual Cups Included in Guidance
The draft guidance expands the scope of recommendations to include menstrual cups, in addition to tampons and pads, for performance testing and labeling. The draft is not final and FDA requested comments by January 16, 2026.
Support for Non-Animal Testing Options
FDA states it supports the '3Rs' (replace, reduce, refine animal use) and encourages manufacturers to consult FDA if they want to use non-animal testing methods; FDA will consider whether proposed alternative methods are equivalent. This is guidance (not final) and comments were requested by January 16, 2026.
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