Company Petitions FDA for New Food Additive Use

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.

2026-16420, Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce." This guidance supersedes a previous guidance, entitled "Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables," issued in 2008, and is a final guidance to the draft guidance for industry entitled "Guide to Minimize Food Safety Hazards of Fresh-Cut Produce" issued in 2018. The guidance is intended to help manufacturers or processors of ready-to-eat fresh-cut produce that is not a low-moisture food comply with applicable requirements in our regulations on current good manufacturing practices for hazard analysis and risk-based preventive controls for human food.

2026-16353, Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. GDUFA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to assess and collect fees to support human generic drug activities. The current legislative authority for GDUFA expires at the end of September 2027. At that time, new legislation will be required for FDA to continue to assess and collect generic drug user fees for future fiscal years. The FD&C Act directs FDA, following negotiations with the regulated industry and periodic consultations with other stakeholders, to present recommendations for reauthorization of the GDUFA program to the relevant Congressional committees, publish the recommendations in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.

2026-16248, Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that OZOBAX (baclofen) oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

Previous: 2026-12826, Defense Federal Acquisition Regulation Supplement: Certification Requirement for Military Recruitment Advertising (DFARS Case 2024-D022)

This new rule affects companies that create ads to help the military find recruits. They now have to prove their ads meet certain standards before getting contracts. This change starts soon and helps make sure military recruitment ads are clear and honest, with no extra costs expected.

Next: 2026-12861, Rescinding the Equity Assistance Center Program Regulations

The government is officially ending the rules for the Equity Assistance Center Program, which helped schools promote fairness and fight discrimination. This change affects schools and organizations that used these centers, and it means the program won’t have new regulations or funding moving forward. The update is effective right away, so everyone should get ready for a new way of supporting equity in education.