United States, October 2025 — In a significant move aimed at enhancing safety and transparency in feminine hygiene products, the U.S. Food and Drug Administration (FDA) has released a draft guidance document titled “Menstrual Products – Performance Testing and Labeling Recommendations.” This guidance outlines key updates affecting manufacturers of tampons, pads, and menstrual cups, with implications across product design, testing, and labeling practices.
Caution : Please note that the FDA’s draft guidance titled “Menstrual Products – Performance Testing and Labeling Recommendations.” (October 2025) is intended for comment purposes only and is not for implementation at this stage.
PURPOSE OF THE FDA MENSTRUAL PRODUCT GUIDANCE
This draft provides updated recommendations for:
- Performance testing of menstrual products
- Detailed labeling (including ingredient disclosure)
- 510(k) submission content (for non-exempt devices)
- Biocompatibility, microbiological testing, and risk assessment
It reflects current best practices, scientific literature, and congressional interest in improving transparency and safety, especially regarding toxic shock syndrome (TSS) and potential contaminants like metals in tampons.
SCOPE OF THE GUIDANCE
The document applies to:
- Tampons (scented and unscented, Class II devices – 510(k) required)
- Pads (scented, unscented, reusable, intralabial – mostly 510(k) exempt)
- Menstrual Cups (Class II, but 510(k) exempt)
It covers devices regulated under:
21 CFR 884.5425, 884.5435, 884.5460, 884.5470, 884.5400 and explicitly references applicable product codes and class designations.
IMPACT ON MANUFACTURERS
1. New Testing Requirements
Manufacturers must meet expanded performance testing expectations:
- Biocompatibility Testing
Based on ISO 10993 series standards
Includes cytotoxicity, irritation, sensitization, systemic toxicity, and more
Applies to all components, including coatings and additives
b. Microbiological Assessment (Tampons & Menstrual Cups)
Evaluate impact on vaginal microflora
Conduct testing for TSST-1 production using standardized or alternative methods like:
Tampon sac method
Syringe method
Shake flask method
All with strain-specific S. aureus and ELISA quantification
c. Non-Clinical Bench Testing
- Syngyna test (mandatory for tampon absorbency per 21 CFR 801.430(f))
- String strength, fiber shedding, integrity over 8-hour simulated use
d. Clinical Performance Testing (in some cases)
- Required for new tech or high-risk absorbency levels (>15g)
- Assess irritation, allergy, residual fiber, and TSS-related risks
PREDICATE DEVICE COMPARISON FOR 510(K)
For new products requiring a 510(k) premarket notification, the FDA now expects more structured predicate comparisons, including:
- Tabular comparisons of materials, absorbency, design, and indications
- Justification of changes made from existing marketed devices
Modifications such as new materials, increased absorbency levels, or intended use changes may also trigger the need for a new 510(k) submission.
Takeaway: Manufacturers must anticipate regulatory hurdles for even minor product modifications.
WHAT TRIGGERS A NEW 510(K) MENSTRUAL PRODUCTS?
The FDA has clarified scenarios where a new 510(k) must be filed:
- Changes to materials or additives
- Absorbency modifications (especially >18g range)
- Altered intended use or patient population
- New shapes or sizes that may affect effectiveness or safety
WHY THIS MATTERS NOW
The guidance responds to increasing public and scientific scrutiny over chemical exposures, reusable product safety, and transparency in menstrual product labeling. With reusable menstrual cups and alternative hygiene products growing in popularity, the FDA aims to provide a consistent framework to protect consumer health.
WHAT PROMPTED THIS GUIDANCE (RECENT DEVELOPMENTS)
1. Congressional Requests (2022 & 2023)
- U.S. House Appropriations Committees asked FDA to:
- Expand coverage to menstrual cups
- Ensure ingredient disclosure
- Address contaminants like metals
- Expand coverage to menstrual cups
2. 2024 Metal Study
- A 2024 study detected metals in tampons
- Although toxicological risks weren’t established, FDA commissioned a systematic literature review (SLR)
- The SLR (completed Dec 5, 2024) didn’t find conclusive safety concerns, but raised awareness
3. QSR Alignment
- The Quality System Regulation (21 CFR Part 820) is being amended (effective Feb 2026) to incorporate ISO 13485
- This guidance aligns pre-submission expectations accordingly
WHAT SHOULD MANUFACTURERS DO?
- Review product classification: Ensure correct FDA device class and submission pathway.
- Update testing protocols: Incorporate required biocompatibility, microbiological, and absorbency testing.
- Revise labeling: Add complete ingredient tables and risk disclosures.
- Prepare new 510(k) submissions: For any significant product updates.
Align quality systems: Begin transition to ISO 13485 compliance before February 2026.
📅 WHAT’S NEXT?
This is currently a draft guidance—FDA is accepting comments from industry stakeholders before finalization. Manufacturers are encouraged to review and submit feedback to shape the final version.