# 2025-19948: FDA Shares Draft Guidelines for Testing Tampons Pads and Cups

2025-19948, Menstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-17, effective Submit either electronic or written comments on the draft guidance by January 16, 2026. (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-19948
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-19948
- Title: Menstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 51371
- Published: 2025-11-17
- Effective: Submit either electronic or written comments on the draft guidance by January 16, 2026.
- Comments close: 2026-01-16
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Shares Draft Guidelines for Testing Tampons Pads and Cups

## 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The FDA just dropped draft guidance to help makers of tampons, pads, and menstrual cups test and label their products better.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!

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Menstrual Products-- Performance Testing and Labeling Recommendations." This draft guidance document provides recommendations for performance testing, labeling, and information for inclusion in premarket notification (510(k)) submissions, when necessary, for certain menstrual products. The recommendations in this guidance apply to tampons, pads, and menstrual cups used to absorb or collect menstrual fluid or other vaginal discharge. The recommendations reflect updated review practices and are intended to promote consistency and transparency in product labeling and testing for manufacturers of these devices. This draft guidance is not final nor is it for implementation at this time.

## Effects PRIA read

- Ingredient Disclosure on Outer Labels: benefit, low. 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: benefit, low. 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.
- Tampon Testing for TSS and Microflora: benefit, medium. 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, 2…
- Menstrual Cups Included in Guidance: benefit, low. 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: benefit, low. 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 Januar…

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## Sources
- [2025-19948 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/17/2025-19948/menstrual-products-performance-testing-and-labeling-recommendations-draft-guidance-for-industry-and)
- [2025-19948 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-17/pdf/2025-19948.pdf)

## Related
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- [Next: 2025-19949, Combined Notice of Filings #1](https://policyrisk.com/federal-register/2025-19949)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-19948 (as of 2026-06-08).