FDA Roundup: July 5, 2024

SILVER SPRING, Md., July 5, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Wednesday, the FDA updated the advisory for the investigation of Salmonella illnesses linked to cucumbers. The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of Salmonella Africana and Salmonella Braenderup infections with 449 illnesses in 31 states and the District of Columbia. While originally reported as two separate outbreaks, CDC and FDA combined these two outbreak investigations as they shared several similarities, including when and where illnesses occurred, the demographics of ill people, and the foods they reported eating before they became sick. Laboratory, epidemiological, and traceback data have determined that cucumbers from Bedner Growers, Inc., of Boynton Beach, Florida, are a likely source of illnesses in this outbreak; however, this grower does not account for all the illnesses in this outbreak. Bedner Growers, Inc.’s cucumber growing and harvesting season is over. There is no product from this farm on the market and likely no ongoing risk to the public.
On Tuesday, the FDA announced a public workshop entitled Food and Drug Administration/National Institutes of Health Joint Workshop: Developing Implanted Brain-Computer Interface Clinical Outcome Assessments to Demonstrate Benefit that will be held on Thursday, September 19 and Friday, September 20, 2024. The purpose of this public workshop is to discuss implanted brain-computer interface devices, to engage with stakeholders in the implanted brain-computer interface device ecosystem, and to discuss the development of clinical outcome assessments to evaluate the effectiveness of implanted brain-computer interfaces. The registration deadline is September 12, 2024. This is a hybrid workshop being held at the FDA’s White Oak Campus in Silver Spring, MD, and webcast.
On Tuesday, the FDA updated the advisory for the investigation of illnesses linked to Diamond Shruumz-brand products. As of July 1, 2024, a total of 48 illnesses have been reported from 24 states. Forty-six people have reported seeking medical care; twenty-seven have been hospitalized. There is one potentially associated death under investigation. Consumers should not eat, sell, or serve any flavor of Diamond Shruumz-brand Chocolate Bars, Cones, or Gummies.

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