FDA Asks: Should States Skip Federal Health Rules?
Published Date: 9/21/2026
Notice
Summary
The FDA wants your thoughts on how states ask for permission to skip certain federal rules about health products. This affects state governments and could change how they report info to the FDA. You’ve got until November 20, 2026, to share your comments—no cost involved, just your voice!
No Economic Impacts Identified for this Document
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.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
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.
2026-20727, Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
The FDA is officially classifying home test kits that detect non-viral germs causing sexually transmitted infections as Class II devices, meaning they have special safety rules but fewer hurdles than the strictest category. This change, effective October 9, 2026, helps make these tests safer and easier to get, benefiting patients and innovators alike. If you make or use these home test kits, this update means better access and clear safety standards without extra costs or delays.
Previous / Next Documents
Previous: 2026-19281, Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The FDA wants your thoughts on keeping the rules for telling them about imported food before it arrives. This affects food importers who must keep sharing info to keep our food safe. You’ve got until November 20, 2026, to send in your comments—no cost changes, just a chance to help shape the process!
Next: 2026-19283, Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
The FDA wants your thoughts on how they collect info for temporary marketing permits, which help companies get products to market quickly. This affects businesses applying for these permits and aims to keep the process smooth without extra costs or delays. You’ve got until November 20, 2026, to share your comments and help shape the rules!