FDA Seeks Ideas to Speed Up Cheaper Generic Drugs

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.

2026-16944, Gardenia Blue Interest Group; Filing of Color Additive Petition

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o Exponent, Inc., proposing that we amend our color additive regulations to expand the safe use of gardenia (genipin) blue in various foods at levels consistent with good manufacturing practice. The petition also proposes to lower the specification for arsenic in gardenia (genipin) blue.

2026-16939, GNT USA, LLC.; Filing of Color Additive Petition

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.

2026-16943, International Association of Color Manufacturers; Filing of Color Additive Petition

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the International Association of Color Manufacturers, proposing that we amend our color additive regulations to provide for the safe use of acetone as a solvent in the manufacture of carrot oil. The petition also proposes to add heavy metal limits and secondary names for carrot oil. FDA may also consider other changes to the regulation, as appropriate, during the course of our review.

Previous: 2025-08871, South Atlantic Fishery Management Council; Public Meeting

The South Atlantic Fishery Management Council is holding a big week of meetings to talk about managing snapper, grouper, mackerel, cobia, shrimp, and ocean habitats. Fishermen, seafood lovers, and coastal communities should pay attention because these talks could lead to new rules that affect fishing seasons and limits. The public can join in during a special comment session, so now’s the time to have your say!

Next: 2025-08873, Agency Information Collection Activities; Comment Request; Standard Job Corps Contractor Information Gathering; Correction

The Department of Labor fixed a mistake in a recent notice about collecting info from Job Corps contractors. They corrected the official control number to keep everything clear and on track. This update helps contractors and the public know the right details—no changes to timing or costs, just a quick fix!