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  5. FDA Roundup: August 8, 2023
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FDA News Release

FDA Roundup: August 8, 2023

For Immediate Release:

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 In the 2015 final determination, the FDA indicated that there were outdated references to PHOs in regulations that the FDA would address separately.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  • Today, the FDA issued a draft guidance, “QTc Information in Human Prescription Drug and Biological Product Labeling,” intended to assist applicants with incorporating QTc interval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.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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