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FDA Highlights Recent Actions and Communications

On December 17, 2024, the U.S. Food and Drug Administration (FDA) released a summary detailing several significant developments within the agency.

Warning Letters Issued for GLP-1 Products

The FDA has issued four warning letters to companies for marketing unapproved GLP-1 products, which include semaglutide, tirzepatide, and retatrutide. The companies receiving these letters include:

• - Xcel Peptides
• - Swisschems
• - Summit Research
• - Prime Peptides

Additionally, a warning letter was dispatched to Veronvy for offering misbranded oral GLP-1 products that falsely claim FDA approval. This action emphasizes the FDA's ongoing commitment to regulating the market for GLP-1 medications to ensure patient safety and drug efficacy.

New EU Import Regulations for Honey

In line with its regulatory oversight, the FDA announced the adoption of new EU requirements for importing apiculture products, effective November 29, 2024. This regulation mandates that all entities importing honey, beeswax, royal jelly, propolis, and pollen into the EU must register with the EU's Trade Control and Expert System (TRACES). Exporters are required to undergo an assessment by the USDA AMS before applying for registration. Those entities wishing to be included on the export list should apply by December 23, 2024, with the FDA committed to updating the list regularly.

Veterinary Medicine Updates

Moreover, on the same day, the FDA's Center for Veterinary Medicine provided information regarding adverse events reported in dogs treated with Librela (bedinvetmab injection). The adverse effects including ataxia, seizures, and other neurologic signs were analyzed, with some reports indicating serious outcomes, including death. Vets were alerted to take necessary precautions when treating dogs with this product.

Safety Communication on Pacemakers

The FDA also issued a crucial safety communication regarding Boston Scientific Accolade pacemaker devices, urging patients and caregivers to consider early replacement due to a manufacturing issue that could lead to the device entering Safety Mode, which hampers its ability to regulate heart rhythms. Boston Scientific recalled a subset of Accolade devices underlining the need for immediate replacement to avoid potential health risks.

Food Safety Webinar Series

In an effort to promote food safety, the FDA has partnered with Stop Foodborne Illness to continue their webinar series dedicated to exploring food safety culture. The series comprises seven webinars, with the first scheduled for January 29, 2025, focusing on building a stronger understanding of food safety practices.

Criminal Investigations Highlighted

The FDA also detailed a significant case from the Office of Criminal Investigations involving a doctor implicated in tampering with IV bags at Baylor Surgicare in North Dallas, TX. This case highlights the agency's commitment to safeguarding public health through strict law enforcement.

Drug Safety Updates

In a move to bolster drug safety, the FDA updated a prior Drug Safety Communication regarding Veozah (fezolinetant), which now includes a Boxed Warning due to a known risk of serious liver injury. This measure underscores the FDA's proactive approach to addressing potential safety concerns related to pharmaceuticals.

Recent Approvals

On a positive note, the FDA approved Unloxcyt (cosibelimab-ipdl), a new treatment for adults suffering from advanced cutaneous squamous cell carcinoma, providing hope for patients who are not candidates for curative surgery. Furthermore, Crenessity (crinecerfont) received approval as a therapy alongside glucocorticoids for managing androgen levels in patients with congenital adrenal hyperplasia, a rare genetic condition.

Accountability in Opioid Crisis

Lastly, significant developments arose from the FDA’s collaboration with the Department of Justice concerning McKinsey & Company’s involvement with Purdue Pharma, revealing the firm’s misguidance that exacerbated the opioid crisis. This resolution has led to McKinsey agreeing to a $650 million settlement and implementing new compliance measures, marking a critical step toward accountability in the healthcare industry.

In conclusion, the FDA's recent actions reflect its determination to ensure public health safety, regulate drug approval effectively, and hold companies accountable to their obligations. These updates provide essential insights for healthcare professionals, consumers, and regulatory bodies across the United States.