Insights

The U.S. Food and Drug Administration (FDA) proposed a change to the Generally Recognized as Safe (GRAS) notification system for the first time in almost 30 years. The new proposed rule, unlike the current rule proposed in 1997 and finalized in 2016, makes GRAS notifications mandatory. The comment period for the proposed rule ends in only two months (December 9, 2026), and stakeholders should act promptly to submit comments before the deadline closes. Given the significance of the proposed changes for food manufacturers and suppliers, understanding the scope and implications of the rule is critical now — before it is finalized.

Despite other sweeping changes to the federal government under the Trump administration, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), passed under former President Biden, remains good law. Below, we report on recent trends in FDA’s implementation and enforcement of MoCRA in the early months of Trump’s presidency.

On December 20, 2024, the Federal Circuit affirmed a district court’s holding that five device patents had been improperly listed in the Orange Book by Teva Pharmaceuticals, Inc. as claiming a drug, and ordering that they be delisted.