FDA Summary: January 7, 2022

For immediate release:

Today, the United States Food and Drug Administration is providing an at-a-glance summary of the agency’s news:

  • On January 5, the FDA released a new interactive public data dashboard that allows anyone to view historical data from the Reportable Foods Registry (RFR), a vital tool used by the food industry to alert the FDA to ‘a dangerous food product. The new dashboard, which will be updated annually, makes it faster and easier to get better data from the RFR. The RFR program helps our national and local partners better determine when to issue health alerts, take action to remove harmful foods from the market, and target enforcement efforts, such as sampling missions.
  • On January 6, the FDA issued an outbreak advisory because the agency is working with the CDC, states, and local partners to investigate disease in an E. coli O157: H7 in several states. According to the CDC, as of Jan.6, 10 people infected with the epidemic strain of E. coli O157: H7 have been reported in four states. Consumer purchasing data indicates that seven people bought Nature’s Basket Power Greens or Simple Truth Organic Power Greens in grocery stores before they got sick. Based on these purchase dates, the latest “best if used before” date is estimated at December 20, 2021. These two salad mixes consist of organic spinach, mizuna, kale and chard; both brands were made by the same processor. At present, the available evidence does not indicate that there are currently any subject products on the market. While this product has expired and should no longer be available for purchase, if consumers have frozen Nature’s Basket or Simple Truth Power Greens salad mix with a “Best If Used By” date until December 20, 2021, they have to throw it away. This is an ongoing investigation and more information will be provided as it becomes available.
  • On January 6, the FDA announced that the agency would hold two virtual public meetings on the recently published proposed rule “Standards for the cultivation, harvesting, packaging and preservation of products intended for human consumption related to water. agricultural ”. The purpose of the public meetings is to discuss the proposed rule, which was issued under the FDA’s Food Safety Modernization Act. These public meetings are intended to facilitate and support the process of public assessment and comment on the proposed rule.
  • Today, the FDA has added organ preservation solutions (product codes KDL and KDN) to the list of missing devices. The presence of a device type on the shortage list does not necessarily indicate that patient care has been affected. Some establishments may not be able to transplant or process donor organs if they are unable to obtain these products. The FDA is working with manufacturers, distributors, organ procurement organizations, and government partners to support the availability of these products in affected facilities and to minimize any impact on patients. The list of missing devices reflects the categories of devices that the FDA has determined to be in short supply at this time. The FDA will update the lists as the COVID-19 public health emergency continues to evolve.
  • COVID-19 Testing Updates:
    • To date, 420 tests and specimen collection devices have been approved by the FDA under Emergency Use Authorizations (EUA). These include 290 molecular tests and specimen collection devices, 87 antibody tests and other immune response tests, and 43 antigen tests. There are 69 molecular clearances and one antibody clearance that can be used with home samples. There is one EUA for home molecular prescription testing, three EUAs for home antigen prescription testing, 13 EUAs for home over-the-counter (OTC) antigen testing, and three EUAs for OTC molecular testing. home.
    • The FDA has authorized 24 antigen tests and nine molecular tests for serial screening programs. The FDA has also cleared 751 reviews of EUA approvals.

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The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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