FDA Extends Deadline for Front-of-Package Label Comments

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.

2026-20730, Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction

The FDA fixed a previous announcement about pulling approval for 16 generic drug applications. Three drugs from Navinta LLC—ribavirin solution, fosaprepitant powder, and nicardipine capsules—won't lose approval because Navinta asked to keep them active. This means those three drugs stay on the market, while the other 13 still had their approvals withdrawn as planned back in July 2026.

Previous: 2025-08194, Security Zone; Upper Mississippi River, Saint Louis, MO

The Coast Guard wants to create a permanent no-go zone on the Upper Mississippi River near Jefferson Barracks in Saint Louis, MO. Boats and people can’t enter or stop there unless they get special permission. This keeps the military base safe from any sneaky or dangerous actions, and they’re asking for your thoughts before making it official.

Next: 2025-08157, Negotiated Rulemaking Committee; Negotiator Nominations and Schedule of Committee Meetings

We're setting up a special team to help create new rules for Federal Student Aid programs. This team will include people from groups that care a lot about these rules, and we're asking for nominations to join. If you're involved in student aid, this could affect you, and the process will shape how aid works in the future.