FDA Wants Input on Tobacco Violations Reporting Form

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.

2026-19419, Sanjay Kumar: Final Debarment Order

Sanjay Kumar is banned for 5 years from importing any drugs into the U.S. because he was convicted of a serious crime involving fake goods. He didn’t respond to the FDA’s notice, so the ban starts on September 23, 2026. He can apply to end the ban anytime, but must follow special rules to keep info private.

2026-19349, Nonclinical Testing Terminology

The FDA wants to update its rules by swapping out the word “animal” tests for “nonclinical” tests to better reflect modern science. This change affects drug safety testing rules, encourages new testing methods that might use fewer animals, and doesn’t add any new costs or requirements. Anyone interested can comment on these changes until December 7, 2026.

Previous: 2026-12575, Foreign-Trade Zone (FTZ) 189; Authorization of Production Activity; Plascore, Incorporated; (Metal, Aramid Paper and Plastic Honeycomb); Zeeland, Michigan

Plascore, Incorporated in Zeeland, Michigan, got the green light to make metal, aramid paper, and plastic honeycomb products in Foreign-Trade Zone 189. This approval lasts two years and helps Plascore find a local supplier for aramid fiber. The move could speed up production and save money by using special trade zone benefits.

Next: 2026-12579, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity, Form FDA 3975

The FDA is asking for approval to keep using Form FDA 3975, which helps confirm who you are when you ask for your own records under the Freedom of Information Act or Privacy Act. If you want your personal info from the FDA but didn’t prove your identity well enough, this form steps in. Comments on this plan are open until July 23, 2026, and there’s no new cost for you—just a smoother way to get your info!