FDA Roundup: July 26, 2024

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 Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to include initiation of treatment, up-dosing and maintenance in individuals ages 1 through 3 years with a confirmed diagnosis of peanut allergy to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Palforzia has been approved since January 2020 for initiation of treatment in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy with up-dosing and maintenance in individuals 4 years of age and older. Those who take Palforzia must continue to avoid peanuts in their diets.  A Risk Evaluation and Mitigation Strategy (REMS) is in place for Palforzia to mitigate the risk of anaphylaxis associated with Palforzia, which includes elements to assure safe use., which includes elements to assure safe use.
• Today the FDA released findings from a sampling assignment that collected and tested both domestic and imported fresh basil, cilantro, and parsley. The assignment sought to estimate the prevalence of Cyclospora cayetanensis, Salmonella spp., and Shiga toxin-producing Escherichia coli (STEC) in these herbs as part of the FDA’s ongoing effort to help proactively ensure food safety.
• Today, the FDA issued a Safety Alert, warning consumers not to use Optimized Plant Mediated Solutions (OPMS) Black Liquid Kratom..
• On Thursday, the FDA announced the issuance of warning letters to 80 brick and mortar retailers in 15 different states for selling unauthorized e-cigarette products popular with youth, including Elf Bar and Lost Mary. Additionally, the FDA also announced the filing of complaints for civil money penalties against eight other retailers who failed to take action after being previously warned about selling unauthorized e-cigarettes.take action after being previously warned about selling unauthorized e-cigarettes.
• On Thursday, the FDA issued a public health alert advising consumers to throw away and not buy the El Servidor brand ground cinnamon product listed in the alert due to it containing elevated levels of lead.
  “We appreciate the continued work of our state partners to help us monitor lead in ground cinnamon in the market,” said Jim Jones, Deputy Commissioner for Human Foods. “Reducing dietary exposure to lead and other heavy metals among babies and young children is one of the top priorities of the human foods program and something we will continue to work on through the Closer to Zero initiative.” 
• On Thursday, the FDA issued a Safety Alert advising restaurants and retailers not to serve or sell and consumers not to eat certain oysters from Recompense Cove, Freeport, Maine potentially contaminated with Campylobacter. 
• On Thursday, the FDA published the Digital Health Center of Excellence blog: A Lifecycle Management Approach toward Delivering Safe, Effective AI-enabled Health Care. The blog explores issues in the context of AI in health care settings. As global interest in AI in health care soars, it’s crucial to ensure the safety and effectiveness of AI-enabled medical devices, as well as their trustworthiness, fairness, and performance. The blog focuses on the potential of Lifecycle Management concepts to address the unique challenges of generative AI in health care, toward helping to ensure these systems meet real-world needs while managing their inherent risks across the software lifecycle.
• On Wednesday, the FDA published a Spotlight on CDER Science featuring CDER researcher conducted among adult asthma patients to determine how the similarity, proximity, and frequency of exposure to a disease awareness communication and prescription drug television advertisement impact consumer perception and understanding of the benefits and risks of a prescription drug. Consumers sometimes conflate the information in disease awareness communications with information presented in prescription drug promotional materials. Knowing which advertising features cause conflation is important because it offers an opportunity for pharmaceutical companies to consider these features when developing prescription drug advertising and disease awareness communications.  
• On Wednesday, the FDA announced the virtual Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A that will be held on August 7, 2024, from 2-3 p.m. EST. During this town hall, the FDA will discuss topics including bioburden, bacterial endotoxin, and packaging integrity testing for sterile medical devices. We will also host an open question and answer session. Please submit questions to MedicalDeviceSterilization@fda.hhs.gov by 4 p.m. EST on Wednesday, July 31, 2024. Registration is not required to attend.
• On Wednesday, the FDA posted a new web page dedicated exclusively to monitoring the research on microplastics and nanoplastics in the food supply, explaining what is known about their health effects, and describing ways in which the FDA is working to advance the science.
• On Tuesday, the FDA updated the advisory for illnesses linked to Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies to report additional illnesses. As of July 22, 2024, a total of 74 illnesses have been reported from 28 states. Sixty-two (62) of the 74 people have reported seeking medical care, 38 have been hospitalized, and there are two potentially associated deaths under investigation. All Diamond Shruumz-brand products have been recalled and should not be sold. Consumers should not purchase any Diamond Shruumz-brand products.

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