FDA Roundup: July 2, 2024

SILVER SPRING, Md., July 2, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

Today, the FDA approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease.

“Alzheimer’s disease is a devastating disease for the person diagnosed and their loved ones,” said Teresa Buracchio, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “The trial data demonstrated, convincingly, that Kisunla reduces the rate of cognitive and functional decline in patients in the mild cognitive impairment and mild dementia stages of Alzheimer’s disease. Today’s approval is evidence of the FDA’s commitment to helping more safe and effective drugs to treat Alzheimer’s disease become available.” 

Today, the FDA announced it is revoking the regulation authorizing the use of brominated vegetable oil (BVO) in food. Brominated vegetable oil (BVO) is a vegetable oil that is modified with bromine. The agency concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans. The rule is effective Aug. 2.

“Reassessing the safety of chemicals that have been previously authorized for use in or with foods, as new, relevant data become available, is a priority for the FDA. We are committed to conducting reassessments to ensure that our original determinations of safety have held up over time. The removal of the only authorized use of BVO from the food supply was based on a thorough review of current science and research findings that raised safety concerns. We will continue to monitor emerging evidence on the chemicals we have targeted for reassessment, and in cases such as this, where the science no longer supports continued authorized use, we will take action to protect public health,” says Jim Jones, Deputy Commissioner for Human Foods.

On Monday, the FDA’s Center for Devices and Radiological Health (CDRH) announced the continued expansion of the Total Product Life Cycle Advisory Program, which was launched in 2023 as a commitment under the Medical Device User Fee Amendments (MDUFA) V reauthorization to help spur faster development of high-quality, safe, effective, and innovative medical devices that are critical to meeting public health needs.

On Friday, the FDA’s Center for Veterinary Medicine made available two webinars for stakeholders interested in FDA regulation of intentional genomic alterations in animals. The webinars focus on two guidance documents: final Guidance for Industry #187A, “Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach,” and draft Guidance for Industry #187B, “Heritable Intentional Genomic Alterations in Animals: The Approval Process.” The webinars provide historical background on the guidances and walk through the details of what they cover. These and other webinars are available in the agency’s Animal Biotechnology Products Resource Center.

On Friday, the FDA updated the advisory for the Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies (June 2024) to include information about the Prophet Premium Blends, LLC, recall. The recall was initiated on 6/27/2024 for of all flavors of Diamond Shruumz-brand products.

Additional Resources: 

FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA 

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, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration