FDA Roundup: February 3, 2023

News provided by

Feb 03, 2023, 17:50 ET

SILVER SPRING, Md., Feb. 3, 2023 /PRNewswire/ -- 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 in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease for conventional foods, provided that the qualified claim is appropriately worded so as not to mislead consumers and that other factors for the use of the claim are met.
On Thursday, the FDA alerted consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma's Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death. Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately.

The FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and state and local health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. The manufacturer initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears. FDA also placed the manufacturer on import alert for providing an inadequate response to a records request and current good manufacturing practice violations.
On Wednesday, the FDA authorized for marketing the RefleXion Medical Radiotherapy System (RMRS), which combines the functionality of an emission computed tomography detection system and a linear accelerator. This integrated functionality enables capabilities in addition to more common linear accelerator device indications for image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues. RMRS is also indicated for fluorodeoxyglucose (FDG) guided treatment for the precise delivery of FDG-guided radiation therapy, a type of Biology-guided Radiotherapy (BgRT). It is indicated for tumors in lung and bone with sufficient FDG metabolic activity, while minimizing the delivery of radiation to vital healthy tissue.
On Wednesday, the FDA revised the Letters of Authorization for two EUAs, Paxlovid and Lagevrio, to remove the requirement for positive test results to prescribe these products. The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. However, we recognize that, in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine that treatment with authorized therapeutics may be appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the product's authorization are met.

The latest information about COVID-19 therapeutics can be found on FDA's EUA webpage.
COVID-19 testing updates:

As of today, 443 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and one diagnostic breath test. There are 79 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, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
The FDA has authorized 44 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1221 revisions to EUA authorizations.

Additional Resources:

FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

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.

SOURCE U.S. Food and Drug Administration