FDA Roundup: December 1, 2023

FDA News Release

• For Immediate Release: December 01, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  

• On Thursday, the FDA rolled out new tools and FAQs to continue to inform stakeholders about the Food Traceability Rule and help covered entities come into compliance. The Food Traceability Rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Foods subject to the final rule’s requirements appear on the Food Traceability List. 
• On Thursday, the FDA issued a safety communication to inform consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakages, particles in the syringes, and other problems) with syringes manufactured in China. The agency received information about quality issues associated with several Chinese manufacturers of syringes. As such, the FDA is concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance.  

The FDA is collecting and analyzing data to evaluate plastic syringes made in China that are used for injecting fluids into or withdrawing fluids from the body. The agency is also working with federal partners to further test syringes manufactured in China. The FDA plans to work with manufacturers to ensure adequate corrective actions are taken.

At this time, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes. At this time, while the FDA continues our evaluation, consider using syringes not manufactured in China, if possible. The FDA will keep the public informed as additional information becomes available. 

• On Thursday, the FDA updated the advisory of the Investigation of Elevated Lead Levels in Cinnamon Apple Puree Pouches. On Nov. 30, 2023, Austrofood, along with Wanabana USA, the distributor of WanaBana products in the United States, released a statement that reports that Wanabana has conducted a root cause investigation. Based on this investigation, the firm’s leading hypothesis to date is that the cinnamon is the source of the elevated lead levels in the recalled products. The statement released by Wanabana USA and Austrofood states that the cinnamon used to manufacture the recalled products was supplied by Negocios Asociados Mayoristas S.A., operating as Negasmart, a third-party distribution company located in Ecuador. The FDA is continuing to work with Ecuadorian authorities to investigate the source of the contamination and to determine if the cinnamon in the recalled products was used in other products or distributed as a raw ingredient to other countries. The FDA has confirmed that Negasmart does not import cinnamon directly into the U.S.  

The FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the FDA has no indication that this issue extends beyond these recalled products, but to further protect public health, FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination. As of Nov. 30, 2023, there have been no screening results that have tested positive for higher levels of lead. Separately, Austrofood CIA LDA’s apple cinnamon fruit puree pouch products exported to the U.S. were added to Import Alert 99-42, detention without physical examination of foods due to heavy metal (toxic element) contamination.  

• On Wednesday, the FDA published a Spotlight on CDER Science describing a series of simulations in which researchers in CDER and external collaborators studied how different factors may affect corticosteroid nasal deposition and, relatedly, nasal distribution. For these simulations, the researchers examined three groups of factors — spray characteristics, human factors, and nasal anatomy — to better understand how these affect drug delivery for generic nasal drugs. 
• On Wednesday, the FDA proposed to classify certain unclassified, wound dressings and liquid wound washes containing antimicrobials or other chemicals into three separate classification regulations:  
  • solid wound dressings 
  • wound dressings formulated as a gel, cream, or ointment; and 
  • liquid wound washes. 

The proposed classification for these wound dressings and liquid wound washes is intended to be split into two classifications:  

For class II, the FDA is proposing these devices be subject to special controls and premarket notification requirements, in addition to general controls. The FDA is proposing that manufacturers will need to demonstrate compliance with applicable special controls within six months after the effective date of the rule, when finalized.  

For class III, the FDA is proposing to require that manufacturers file a premarket approval application (PMA) in accordance with the timeframe as discussed in the accompanying proposed order.