FDA Summary: March 8, 2022

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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 signing of a National Mutual Trust Partnership Agreement with the Minnesota Department of Agriculture – the first such agreement to include both food and feed. Work will focus on establishing key indicators, sharing data and information, and reconciling and maintaining the official facility inventory.
  • On March 7, a permanent injunction consent decree was signed by a judge requiring that Salud Natural Entrepreneur, Inc. of Illinois not engage in any distribution transactions until it has completed the actions corrective actions to ensure the company is in compliance with the Federal Food, Drug, and Cosmetics Act (FD&C Act). The company distributed adulterated and mislabeled dietary supplements and unapproved new drugs that it claimed would cure, mitigate, treat or prevent diseases such as cancer, diabetes, high blood pressure and heart disease. The FDA will continue to hold manufacturers accountable for selling mislabeled dietary supplements and making illegal disease cure, treatment, and mitigation claims because it can be potentially harmful to consumers.
  • On March 7, the FDA announced a low-risk determination for marketing products from two genome-edited beef cattle and their offspring after determining that intentional genomic alteration (IGA) raised no safety concerns. The IGA gives the equivalent genotype (genetic makeup) and short coat trait seen in some conventionally bred cattle, known as “smooth” coat. This is the FDA’s first low-risk determination for the discretionary application of an IGA in a food animal.
  • COVID-19 testing updates:
    • To date, 420 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 290 molecular tests and sample collection devices, 85 antibody tests and other immune response tests and 45 antigen tests. There are 70 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, 14 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
    • The FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA also authorized 868 revisions to EUA clearances.

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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.


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