FDA Roundup: November 21, 2023

FDA News Release

• For Immediate Release: November 21, 2023

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

• Today, the FDA issued a safety communication to provide additional information about the voluntary recall of SoClean2 and SoClean3 equipment used to clean, sanitize, or disinfect CPAP devices and accessories. This SoClean device recall includes new instructions for device use, including the importance of using a hose and mask adapter provided by the company. This voluntary recall is intended to help reduce potential health risks related to exposure to ozone gas after the use of SoClean2 or SoClean3 equipment.
• Today, the FDA issued a Center for Drug Evaluation and Research (CDER) alert warning consumers to not purchase or use any Neptune’s Fix products, or any other product with tianeptine -- a potentially dangerous substance that is not FDA-approved for any medical use. The FDA has received severe adverse event reports after use of Neptune‘s Fix products, including seizures and loss of consciousness leading to hospitalization. Neptune’s Fix labels state the product contains tianeptine, but may contain other harmful ingredients not listed on the label.  
• Today, the FDA announced it will host a jointly sponsored virtual public meeting with the Duke-Margolis Center for Health Policy titled, “Advancing Drug Development for the Prevention of Preterm Birth” Jan. 23 and 24, 2024. The meeting will bring together stakeholders to help generate ideas and discussion related to overcoming the challenges of developing and studying products to prevent preterm birth. For more information and to register for this meeting, please visit Duke-Margolis Center for Health Policy’s website. For further information on submitting comments for the meeting , please visit Advancing Drug Development for the Prevention of Spontaneous Preterm Birth; Public Workshop; Request for Comments.
• Today, the FDA published the “Direct-to-Consumer Prescription Drug Advertisements:  Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule.” The final rule establishes standards to implement the statutory requirement that certain direct-to-consumer human prescription drug television and radio ads present the drug’s major side effects and contraindications, known as the “major statement,” in a clear, conspicuous, and neutral manner.
  
  The standards under the rule include: The information uses consumer-friendly language and terms that are easily understandable. The audio information in the major statement is at least as understandable as the audio information in the rest of the ad. In ads in TV format, the information is presented concurrently using both audio and text (dual modality); to achieve dual modality, (1) Either the text displays the verbatim key terms or phrases from the corresponding audio, or the text displays the verbatim complete transcript of the corresponding audio; and (2) The text is displayed for a sufficient duration to allow it to be read easily. (For purposes of this standard, the duration is considered sufficient if the text display begins at the same time and ends at approximately the same time as the corresponding audio.) In ads in TV format, the information in text is formatted so the information can be read easily. The ad does not include audio or visual elements when the major statement is presented that can interfere with understanding the major statement.
• On Monday, the FDA issued a Letter to Health Care Providers alerting providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps or patient-controlled analgesia (PCA) pumps. The use of Cardinal Health Monoject syringes with syringe pumps or PCA pumps may result in infusion pump performance issues including overdose, underdose, delay in therapy, and delays in occlusion alarms.
• On Monday, the FDA’s Center for Veterinary Medicine published a Perspectives with CVM blog post, CVM Antimicrobial Stewardship in FY 2023 and Beyond, in recognition of 2023 World Antimicrobial Awareness Week (November 18-24). The post highlights what CVM is doing to address antimicrobial resistance and preserve the effectiveness of these critical and life-saving drugs.
• On Monday, the FDA issued an Outbreak Advisory on an outbreak investigation of Listeria monocytogenes linked to peaches, plums, and nectarines (stone fruit). Federal and state partners have continued to investigate the outbreak as new matching cases have been identified over the past several years. As of November 17, 11 people infected with the outbreak strain of Listeria have been reported from seven states. Samples from sick people were collected from August 22, 2018, to August 16, 2023. In response to this investigation, HMC Farms has voluntarily recalled peaches, plums, and nectarines sold in retail stores from May 1, 2022 through November 15, 2022 and from May 1, 2023 through November 15, 2023. 
• On Friday, the Interagency Food Safety Analytics Collaboration’s – a collaboration between the FDA, CDC, and the USDA Food Safety and Inspection Service (FSIS) – published its newest annual report, “Foodborne illness source attribution estimates for Salmonella, Escherichia coli O157, and Listeria monocytogenes – United States, 2021.”
• On Friday, the FDA issued an Outbreak Advisory on an outbreak investigation of Salmonella Sundsvall in cantaloupes. Consumers, restaurants, and retailers should not eat, sell, or serve recalled cantaloupe and products containing cantaloupe. Three brands have issued recalls. The FDA and CDC in collaboration with Canadian and U.S. state and local partners, are investigating an outbreak of Salmonella Sundsvall infections. The  FDA recommends that consumers, restaurants, and retailers should not eat, sell, or serve recalled cantaloupe. The investigation is ongoing to determine whether additional products are linked to illnesses. The FDA will update this advisory should additional consumer safety information become available.
• On Friday, the FDA approved Bonqat (pregabalin oral solution) for the alleviation of acute anxiety and fear associated with transportation and veterinary visits in cats. The drug is administered orally approximately 1.5 hours before the start of the transportation or veterinary visit and can be given on two consecutive days. Bonqat is the first FDA-approved animal drug containing pregabalin.