FDA Clocks Extra Patent Time for Heart Drug TRYVIO

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.

2026-16939, 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.

2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate

The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.

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.

Previous: 2026-01571, Call for Information and Nominations for Central California Outer Continental Shelf Oil and Gas Lease Sales Proposed in the 11th National Outer Continental Shelf Oil and Gas Leasing Program

The government is asking companies and the public for ideas and nominations about possible oil and gas lease sales off Central California’s coast. They want to learn about the environment, history, and local concerns before making any decisions. If you want to share your thoughts or nominate areas, you have until February 26, 2026, so don’t miss out!

Next: 2026-01574, Determination of Regulatory Review Period for Purposes of Patent Extension; Symplicity Spyral Renal Denervation System

The FDA has officially set the review period for the Symplicity Spyral Renal Denervation System, a medical device used to treat high blood pressure. This means the company can apply to extend its patent, giving them more time to protect their invention and potentially earn more money. If you want to share your thoughts, you have until March 30, 2026, to send in comments.