FDA Roundup: August 8, 2023

FDA News Release

• For Immediate Release: August 08, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA announced it is issuing a direct final rule to complete administrative actions that reflect the agency’s June 2015 final determination that the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe (GRAS). In the 2015 final determination, the FDA indicated that there were outdated references to PHOs in regulations that the FDA would address separately. The FDA’s actions regarding PHOs address artificial sources of trans fat, however trans fat will not be completely removed from the food supply because it occurs naturally in meat and dairy products and is present at very low levels in other edible oils.
• Today, the FDA issued a draft guidance, “QTc Information in Human Prescription Drug and Biological Product Labeling,” intended to assist applicants with incorporating QTc interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological products. This guidance provides recommendations to help ensure that clinically relevant information on QTc interval prolongation is included in and distributed appropriately across sections of labeling, in accordance with regulatory requirements for the content and format of human prescription drug labeling. Comments should be submitted by October 7, 2023, to ensure the FDA reviews them prior to work on the final version of the guidance.