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  5. FDA Roundup: March 8, 2022
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FDA News Release

FDA Roundup: March 8, 2022

For Immediate Release:

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 signing of a domestic mutual reliance partnership agreement with the Minnesota Department of Agriculture – the first such agreement to include both human and animal food. The work will focus on establishing key metrics, data and information sharing, and official establishment inventory reconciliation and maintenance.
  • On March 7, a consent decree of permanent injunction was signed by a judge requiring Salud Natural Entrepreneur, Inc. of Illinois not to engage in any distribution operations until it completes corrective actions to ensure the company is in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company distributed adulterated and misbranded 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 responsible for the sale of mislabeled dietary supplements and for unlawful claims to cure, treat, and mitigate diseases, as this can be potentially harmful to consumers.
  • On March 7,  the FDA announced a low-risk determination for the marketing of products from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns. The IGA results in the equivalent genotype (genetic make-up) and short-hair coat trait seen in some conventionally bred cattle, known as “slick” coat. This is the FDA’s first low-risk determination for enforcement discretion for an IGA in an animal for food use.
  • COVID-19 testing updates: 
    • As of today, 420 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests and 45 antigen tests. There are 70 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, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 868 revisions to EUA authorizations.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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