FDA Rolls Back Lab Test Regulations After Court Vacatur

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: 2025-18238, Acceleration of Effectiveness of Registration Statements of Issuers With Certain Mandatory Arbitration Provisions

If a company’s registration statement includes a rule that investors must use arbitration to settle disputes, the SEC won’t slow down approving it. Instead, they’ll focus on whether the company clearly explains this arbitration rule in their paperwork. This means companies with these arbitration clauses can get their registrations approved just as fast as others, as long as they’re upfront about it.

Next: 2025-18243, Airspace Designations; Incorporation by Reference Amendments

The FAA is updating its official airspace rules by adding some new changes to a key order, effective September 15, 2025. This affects pilots and air traffic controllers by keeping airspace info fresh and accurate. No extra costs are expected, just smoother skies ahead!