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A U.S. District Court in Florida granted a motion for default judgment and a permanent injunction against the Genesis II Church of Health and Healing, Jonathan Grenon, and Jordan Grenon for violating federal law by distributing their product, “Miracle Mineral Solution,” an industrial bleach that the defendants claim is a cure for COVID-19 and other serious diseases. The order permanently prohibits the defendants from selling or distributing unapproved or misbranded products, such as Mineral Miracle Solution (MMS). The FDA has urged consumers not to purchase or use MMS, explaining that drinking MMS is the same as drinking bleach and can cause dangerous side effects, including severe vomiting, diarrhea, and life-threatening low-blood pressure. In May, the federal judge entered a preliminary injunction against the Genesis II Church of Health and Healing and four individual defendants associated with the entity.
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As part of the FDA’s effort to protect consumers, the agency issued warning letters to five companies for selling fraudulent COVID-19 products. There are currently no FDA-approved products to prevent or treat COVID-19. Read FDA warning letters to:
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The FDA is alerting clinical laboratory staff and healthcare providers of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found approximately three percent of results were false positive results. Read the FDA notice and fact sheet for healthcare providers.
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The U.S. Government Accountability Office (GAO) released a brief on Herd Immunity for COVID-19. The brief explains herd immunity and analyzes the opportunities and challenges for COVID-19 immunity. Read the GAO report.
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The U.S. FDA is warning consumers and healthcare providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. Read the FDA safety alert, including a list of products that have been found to contain methanol.
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CDC is offering a series of weekly one-hour web-on-demand videos that will provide an overview of vaccination principles, general best practices, immunization strategies, and specific information about vaccine-preventable diseases and the vaccines that prevent them. The series will start on July 1, 2020, and a new video will be released most Wednesdays through October 14, 2020. Please visit the Pink Book series page for the schedule and additional information. Continuing Education (CE) will be available for each event.
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Read about important NHSN updates in the June 2020 issue of the NHSN e-Newsletter. The newsletter includes information on NHSN COVID-19 activities, delay of the release of the Neonatal Component and Late Onset Sepsis and Meningitis Module, updates on the AUR module, and NHSN training updates.
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The FDA has updated the list of authorized ventilator, ventilator tubing connector, and ventilator accessory products that meet the criteria for the umbrella emergency use authorization (EUA) to expand availability of ventilators to treat COVID-19 patients. The umbrella EUA was issued in March 2020. Read the EUA and the updated Appendix B list of authorized products.
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The FDA sent a warning letter to Curativa Bay Corporation to cease sale of Advanced Hypochlorous Skin Spray, a topical hypochlorous acid-containing product which is intended to mitigate, prevent, treat, diagnose, or cure COVID-19. FDA reminds consumers that there are currently no FDA-approved products to prevent or treat COVID-19. Read the FDA warning letter.
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This week’s topic in the CMS Nursing Home Training Series is “PPE Strategies for COVID Care”. The webinar will be Thursday, June 25 at 4-5 pm ET. Register here.
