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Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA announced the agency’s Total Diet Study (TDS) Report: Fiscal Years 2018-2020 Elements Data and associated data tables. The TDS is an essential tool that helps the FDA prioritize food safety and nutrition efforts. This report is our first in a series on FY2018-FY2020 TDS data and summarizes our most recent data on nutrients and toxic elements from the agency’s on-going survey of the U.S. Food Supply.
- Today, the FDA issued a safety communication advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. Testing samples not taken from a lesion may lead to false test results.
- On Thursday, the FDA announced the availability of educational resources for parents and caregivers with questions about using the hundreds of millions of bottles worth of imported infant formula headed to the U.S.
- On Thursday, the FDA updated the SARS-CoV-2 Viral Mutations: Impact on and COVID-19 Tests web page to include information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages or variants.
- On Wednesday, the FDA provided updates on its continued implementation of a new law to regulate non-tobacco nicotine products, including issuing its first two warning letters to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization. The agency also announced it has issued 107 warning letters to retailers in the last two weeks for illegally selling non-tobacco nicotine products to underage purchasers.
- On Tuesday, the FDA announced its recognition of six accreditation bodies under the Laboratory Accreditation for Analyses of Foods (LAAF) program. Under the LAAF program, these accreditation bodies may accredit laboratories to the standards established in the LAAF final rule. Laboratories may now apply to the recognized accreditation bodies to participate in the LAAF program. The LAAF final rule, issued by the FDA on December 3, 2021, establishes the LAAF program and outlines eligibility requirements for accreditation bodies and laboratories that wish to participate in the program. The LAAF final rule also describes the procedures for how the FDA will manage and oversee the program.
- On Tuesday, the FDA authorized another over-the-counter (OTC) at-home COVID-19 antigen test. The Genabio COVID-19 Rapid Self-Test is an OTC COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used as a single test for people with COVID-19 symptoms and as a serial test for people with or without symptoms, meaning the test is done two times over three days, with at least 24 hours and no more than 48 hours between tests. The test can be used for people age 14 years or older with a self-collected nasal swab sample and age 2 years or older when an adult collects the nasal swab sample.
- On Tuesday, the FDA authorized another over-the-counter (OTC) at-home COVID-19 antigen test. The Watmind Speedy Swab Rapid COVID-19 Antigen Self-Test is an OTC COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used as a serial test for people with or without symptoms, meaning the test is done two times over three days, with at least 24 hours and no more than 48 hours between tests. The test can be used for people age 14 years or older with a self-collected nasal swab sample and age 2 years or older when an adult collects the nasal swab sample.
- On Tuesday, the FDA authorized for marketing the Apollo Endoscopic Sleeve Gastroplasty (ESG) and Revise systems, the first FDA-authorized systems for endoscopic sleeve gastroplasty, a minimally invasive procedure to facilitate weight loss. In the procedure, a suturing device and camera are passed down the throat (esophagus) to the stomach and used to place permanent stitches (sutures) inside the stomach to reduce the stomach’s volume. It is intended for adults with obesity (BMI 30-50 kg/m2) who have not been able to lose weight or maintain weight loss through more conservative measures such as diet and exercise.
- COVID-19 testing updates:
- As of today, 441 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 304 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 28 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1029 revisions to EUA authorizations.
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