- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Jan. 5, the FDA published a new, interactive public data dashboard that allows anyone to view historical data from the Reportable Food Registry (RFR), an essential tool that the food industry uses to alert the FDA of 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 state and local partners better determine when to issue health alerts, take steps to remove harmful food from the market and target enforcement efforts, such as sampling assignments.
- On Jan. 6, the FDA issued an outbreak advisory, as the agency is working in collaboration with the CDC, state and local partners to investigate illnesses in a multistate outbreak of E. coli O157:H7. According to the CDC, as of Jan. 6, 10 people infected with the outbreak strain of E. coli O157:H7 have been reported from four states. Consumer purchase data indicate that seven people purchased Nature’s Basket Power Greens or Simple Truth Organic Power Greens at grocery stores before becoming sick. Based on those purchase dates, the latest “best if used by” date is estimated to be Dec. 20, 2021. These two salad blends consist of organic spinach, mizuna, kale and chard; both brands were manufactured by the same processor. At this time, the available evidence does not indicate that there are implicated products currently on the market. Although this product is past expiration and should no longer be available for purchase, if consumers froze Nature’s Basket or Simple Truth Power Greens salad blend with a “Best if Used By” date through Dec. 20, 2021, they should discard it. This is an ongoing investigation and additional information will be provided as it becomes available.
- On Jan. 6, the FDA issued an announcement that the agency will hold two virtual public meetings on the recently released proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” The purpose of the public meetings is to discuss the proposed rule, which was issued under the FDA Food Safety Modernization Act. These public meetings are intended to facilitate and support the public’s evaluation and commenting process on the proposed rule.
- Today, the FDA added organ preservation solutions (product codes KDL and KDN) to the device shortage list. The presence of a device type on the shortage list does not necessarily indicate that patient care has been affected. There may be certain facilities that may not be able to perform transplants 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 availability of these products to affected facilities and minimize any impact on patients. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time. The FDA will update the lists as the COVID-19 public health emergency continues to evolve.
- 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, 87 antibody and other immune response tests and 43 antigen tests. There are 69 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 13 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 24 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 751 revisions to EUA authorizations.
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.