November 14, 2023 - FDA Roundup: November 14, 2023

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

• On Monday, the FDA updated the advisory for the Investigation of Elevated Lead Levels in Cinnamon Applesauce Pouches to include an expanded recall from WanaBana LLC to include Weis and Schnucks-brand cinnamon applesauce pouches. As of November 13, 2023, there have been 22 reports of illness potentially linked to recalled product submitted to the FDA. The FDA is continuing to evaluate incoming adverse reports of illnesses. The FDA’s investigation is ongoing to determine the source of lead contamination and whether additional products are linked to illnesses. The FDA will update this advisory as information becomes available.
• On Monday, the FDA issued a warning letter to Amazon.com, Inc. for the firm’s distribution of “Similasan Pink Eye Relief,” “The Goodbye Company Pink Eye,” “Can-C Eye Drops,” “Optique 1 Eye Drops,” “OcluMed Eye Drops,” “TRP Natural Eyes Floaters Relief” and “Manzanilla Sophia Chamomile Herbal Eye Drops” products. These products are not generally recognized as safe and effective for their claimed uses, including temporary relief of minor eye symptoms such as excessive watery (clear) discharge, sensation of grittiness, redness and burning, or pink eye. Therefore, these products are categorized as “new drugs” under the Federal Food, Drug & Cosmetic Act. Ophthalmic drug products are especially concerning from a public health perspective. Products intended for use in the eyes generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses. 

The FDA encourages consumers and health care professionals to report any adverse reactions to the agency’s MedWatch program.

• On Thursday, the FDA published a safety advisory about an investigation, in collaboration with the U.S. Centers for Disease Control (CDC) and state partners, into human cases of Salmonella Kiambu infection that are potentially associated with pet food made by Mid America Pet Food. Epidemiological data and advice from the CDC can be found in the CDC pet food safety alert.

Mid America Pet Food has voluntarily recalled all the pet food brands it manufactured with a best by date before 10/31/2024. This includes Victor, Eagle Mountain, Wayne Feeds and two varieties of Member’s Mark pet foods. These products include both dog and cat foods and were sold nationwide in retail stores and online. A full list of the recalled products can be found in the advisory. The investigation is ongoing, and the FDA will update this advisory as appropriate. 

• On Thursday, the FDA issued a Letter to Health Care Providers about labeling updates for Becton, Dickinson and Company (BD) surgical mesh products. The FDA is aware of increased use of surgical mesh products in breast surgery. The safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA. There are no surgical mesh products cleared or approved by FDA for use in breast surgery, including in augmentation or reconstruction.
• On Wednesday, the FDA approved fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. View full prescribing information for fruquintinib. 
• On Wednesday, the FDA authorized for marketing the Owlet Baby Care, Inc.’s Dream Sock, an over-the-counter device to monitor the pulse rate and oxygen saturation measurements for infants one to 18 months of age and between six to 30 pounds. This device is intended for use in a home environment and not intended for use with infants previously diagnosed with cardiovascular or respiratory conditions. The safety and effectiveness of this device for the detection or prevention of SIDS/SUID has not been established.
• On Tuesday, November 7, the FDA revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test. The FDA also approved the Agilent PD-L1 IHC 22C3 pharmDx as a companion diagnostic device to select patients with gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1). View full prescribing information for Keytruda.
• On Tuesday, November 7, the FDA issued a warning letter to Nic Nac Naturals, LLC for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and resemble a pack of mints. The manufacturer markets these tobacco products in a variety of mint and fruit flavors, all of which come in two nicotine strengths (3 milligrams or 6 milligrams). These products are of particular concern because of their resemblance to popular candies and the potential to cause severe nicotine toxicity or even death if accidentally ingested by young children. 
• On Tuesday. November 7, the FDA approved the ReCor Medical’s Paradise Ultrasound Renal Denervation System, the first breakthrough designated device intended to treat patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. The system delivers through a catheter ultrasound energy that heats and disrupts nerves surrounding kidney blood vessels. Reduced activity of these nerves results in blood pressure reduction. Hypertension affects approximately 45% of US adults and is linked to an increased risk of stroke, heart disease, and renal disease. Three clinical trials of the ReCor device showed that treatment with the Paradise System led to reduced blood pressure through 2 months after the procedure.

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