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The FDA just dropped draft guidance to help makers of tampons, pads, and menstrual cups test and label their products better.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The draft guidance includes recommended test methods for evaluating tampons for Toxic Shock Syndrome (TSS) risk and effects on vaginal microflora, and clarifies non-clinical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The FDA draft guidance recommends that manufacturers disclose ingredients, including fragrances and deodorants, on all menstrual product outer package labels.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The draft guidance recommends evaluating contaminants for all menstrual products (tampons, pads, and menstrual cups) as part of performance testing.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The draft guidance expands the scope of recommendations to include menstrual cups, in addition to tampons and pads, for performance testing and labeling.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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-19654, Naveed Aslam: Final Debarment Order
The FDA has permanently banned Dr. Naveed Aslam from working with any drug companies because he was convicted of a serious crime related to drug regulations. He didn’t respond to the FDA’s notice or ask for a hearing, so the ban started on September 25, 2026. Dr. Aslam can apply to end this ban anytime, but it won’t be easy or quick.
2026-19660, Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
The FDA is gearing up to renew the Biosimilar User Fee Act, which helps fund the review of biosimilar drug applications. This affects drug makers and the public by ensuring faster, smoother approval processes from 2028 to 2032. They’re hosting a public meeting on October 26, 2026, and want your comments by November 25, 2026, to shape the future of this important program.
Previous / Next Documents
Previous: 2025-19947, Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The FDA is sharing a draft guide to help medical device makers and staff understand new rules about Quality Management Systems starting February 2, 2026. These changes align U.S. rules with global standards, making it easier to prepare and share quality info in device marketing submissions. If you’re in the medical device world, get ready to update your paperwork and share your thoughts by January 16, 2026!
Next: 2025-19949, Combined Notice of Filings #1
The Federal Energy Regulatory Commission got a bunch of electric companies asking to update their rates and status. This affects many wind, solar, and energy storage projects across the country, with possible changes in how much customers pay or when projects operate. If you want to speak up, you’ve got until November 24, 2025, at 5 p.m. ET to comment!