FDA Summary: July 15, 2022

0
For immediate release:

Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from 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 a critical tool that helps the FDA prioritize food safety and nutrition efforts. This report is the first in a series on FY2018-FY2020 TDS data and summarizes our most recent data on nutrients and toxic elements from the agency’s ongoing survey of the US food supply.
  • Today, the FDA issued a safety communication advising people to use swab specimens taken directly from a lesion (rash or growth) when testing for monkeypox virus. The FDA is not aware of any clinical data supporting the use of other specimen types, such as blood or saliva, for testing for monkeypox virus. Testing samples not taken from a lesion can lead to false test results.
  • On Thursday, the FDA announced the availability of educational resources for parents and caregivers with questions about the use of the hundreds of millions of bottles of imported infant formula destined for the United States.
  • 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 permitted for the identification and differentiation of specific mutations, lineages, or variants. of SARS-CoV-2.
  • On Wednesday, the FDA provided updates on its ongoing implementation of new legislation to regulate tobacco-free nicotine products, including sending its first two warning letters to manufacturers for the illegal marketing of tobacco-free nicotine e-liquid products without the required authorization. The agency also announced that it had sent 107 warning letters to retailers in the past two weeks for illegally selling non-tobacco nicotine products to underage buyers.
  • On Tuesday, the FDA announced the recognition of six accrediting bodies under the Laboratory for Food Analysis Accreditation (LAAF) program. Under the LAAF program, these accreditation bodies can accredit laboratories to the standards set out in the LAAF Final Rules. Laboratories can now apply to 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 the eligibility requirements for accrediting bodies and laboratories wishing to participate in the program. The LAAF Final Rule also outlines procedures for FDA management and oversight of the program.
  • On Tuesday, the FDA authorized another over-the-counter (OTC) home COVID-19 antigen test. The Genabio COVID-19 rapid self-test is an OTC COVID-19 antigen diagnostic test that displays results in 15 minutes. The test can be used as a single test for people with symptoms of COVID-19 and as a serial test for people with or without symptoms, meaning the test is done twice over three days, with at least 24 hours and not more than 48 hours. between tests. The test can be used for people aged 14 or older with a self-collected nasal swab sample and aged 2 or older when an adult collects the nasal swab sample.
  • On Tuesday, the FDA authorized another over-the-counter (OTC) home COVID-19 antigen test. The Watmind Speedy Swab Rapid COVID-19 Antigen Self-Test is an OTC COVID-19 antigen diagnostic test that displays results in 15 minutes. The test can be used as a serial test for people with or without symptoms, meaning the test is done twice over three days, with at least 24 hours and no more than 48 hours between tests. The test can be used for people aged 14 or older with a self-collected nasal swab sample and aged 2 or older when an adult collects the nasal swab sample.
  • On Tuesday, the FDA cleared the Apollo Endoscopic Sleeve Gastroplasty (ESG) and Revise systems for sale, the first FDA-cleared systems for endoscopic sleeve gastroplasty, a minimally invasive procedure to aid weight loss. During the procedure, a suture device and camera are passed down the throat (esophagus) to the stomach and used to place permanent stitches (sutures) inside the stomach to reduce stomach volume. It is intended for obese adults (BMI 30-50 kg/m2) who have failed to lose weight or maintain weight loss through more conservative measures such as diet and exercise .
  • COVID-19 testing updates:
    • To date, 441 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 304 molecular tests and sample collection devices, 85 antibody tests and other immune response tests, 51 antigen tests and 1 diagnostic breath test. There are 80 molecular clearances and 1 antibody clearance that can be used with home samples. There is 1 EUA for molecular prescription home testing, 2 EUA for antigen prescription home testing, 19 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
    • The FDA has authorized 28 antigen tests and 8 molecular tests for serial screening programs. The FDA also authorized 1029 revisions to EUA clearances.

Related information

###

Master key

The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.


Share.

Comments are closed.