FDA Roundup: May 2, 2023

FDA News Release

• For Immediate Release: May 02, 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 published a Conversations with Experts QA that focuses on the importance of the agency’s engagement with international organizations, including World Health Organization, the Food and Agriculture Organization of the United Nations, the World Trade Organization’s Standards and Trade Development Facility, and the Asia Pacific Economic Cooperation’s Food Safety Cooperation Forum, among others. In the conversation, the authors discuss the objectives of the collaboration and how collectively it supports the FDA mission and strengthens the global food safety system.
• On Monday, the FDA warned consumers to not purchase or use Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy. These products are inhalants and primarily contain ammonia. Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction. The FDA has received reports of adverse events such as shortness of breath, seizures, migraines, vomiting, diarrhea, and fainting from consumers after using the Nose Slap or Soul Slap products. These products may have been purchased online through the Nose Slap website. On April 24, 2023, FDA issued a warning letter to Nose Slap LLC for marketing these unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act. These products have not been demonstrated to be safe or effective for their intended uses. Failure of the company to promptly correct violations may result in legal action without further notice, including, without limitation, product seizure and injunction.
• On Monday, the FDA released its third video on the topic of cybersecurity for medical devices. This new video, Tips for Health Care Facilities: Cybersecurity Incident Preparedness and Response, features Dr. Mark Jarrett, Chief Quality Officer from Northwell Health, with the key focus on how to prepare for a cybersecurity event and how to help ensure patient safety during a prolonged cybersecurity event. The video also points viewers to supplementary materials on the FDA website to help health care facilities plan.
• On Monday, the FDA approved the xT CDx (Tempus Labs Inc.), a next generation sequencing (NGS)-based companion diagnostic (CDx) that detects certain mutations in RAS genes in tumor samples of colorectal cancer patients to aid in the identification of patients who may be eligible for targeted treatment therapies with cetuximab or panitumumab. If Tempus xT CDx does not detect a mutation (presumed to be RAS mutation-negative), then panitumumab or cetuximab may be appropriate treatment options. In addition, the xT CDx can be used to detect the presence of somatic variants in 648 different genes using DNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue specimens and matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms. 
• Test results are generated using information from several databases including information derived from the FDA-recognized Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB), a tumor mutation database that contains detailed information regarding specific alterations in cancer genes. This is the latest example of the FDA’s ongoing commitment to advance access to diagnostic testing that has reasonable assurance of safety and effectiveness and is intended to aid health care professionals in making more informed decisions for patients.
• On Friday, the FDA published a Consumer Update warning consumers the agency reviewed several incidents of serious adverse events associated with the use of Apetamin, which is being marketed illegally for weight gain and figure augmentation. Although, the FDA restricted importation of Apetamin, the product continues to find its way into the U.S. market, often via online marketing and in some retail stores, and is being is heavily promoted and sold online.
• On Wednesday, the FDA published a Consumer Update warning consumers that the agency continues to receive adverse event reports related to selective androgen receptor modulators, commonly called SARMs. Social media posts by influencers and sellers of SARMs contribute to the availability and promotion of these dangerous products.
• On Monday, April 24, the FDA issued an emergency use authorization (EUA) for the Status COVID-19 Antigen Rapid Test for Home Use (manufactured by Princeton BioMeditech Corp.). Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The test can be used for serial testing for symptomatic people within the first 5 days of symptom onset or for people who do not have symptoms, and shows results in 15 minutes. This test should always be repeated if a negative result is found - at least 2 times over 3 days with at least 48 hours between tests if the person has symptoms, or at least 3 times over 5 days with at least 48 hours between tests if the person does not have symptoms. The test can be used for people ages 14 years or older with a self-collected nasal swab sample and ages 2 years or older when an adult collects the nasal swab sample.
• COVID-19 testing updates: 
  • As of today, 446 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 83 antibody and other immune response tests, 62 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 29 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
  • The FDA has authorized 47 antigen tests and seven molecular tests for serial screening programs. The FDA has also authorized 1358 revisions to EUA authorizations.