FDA Changes Where Animal Food Additive Petitions Must Go

2026-20848, Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods

The FDA is changing food rules to allow salt substitutes in many standardized foods, helping companies make lower-sodium options. This move aims to cut heart disease risks by reducing sodium without changing how foods basically taste or look. The new rule kicks in December 14, 2026, and food makers have until November 12, 2026, to raise any concerns, with no big costs expected.

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.

Previous: 2026-22657, Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of Congestion

The FDA is officially classifying the external mechanical stimulator for congestion relief as a Class II device, meaning it now has special safety rules but fewer regulatory hurdles. This change helps patients get access to these devices faster and ensures they’re safe and effective. The new classification took effect on November 6, 2026, with the rules applying retroactively from December 4, 2023.

Next: 2026-22671, Air Plan Approval; California; Revised Format for Materials Incorporated by Reference

The EPA is updating how it formats certain California air quality rules to make them easier to read and find. This change affects six California air districts and won’t change any rules or costs—just the way the information is organized and shared with the public. The new format takes effect on November 6, 2026, making it simpler for everyone to access these important air plans.