FDA Roundup: May 05, 2023

FDA News Release

• For Immediate Release: May 05, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• On Thursday, the FDA issued a safety communication to warn consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.
• On Wednesday, the FDA published “Catching Up with Califf:” “Demystifying Cronobacter and Actions FDA is Taking to Keep the Food Supply Safe,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. Cronobacter is found naturally in the environment – for example, in our yards, kitchens, and living rooms. It can live on surfaces like kitchen counters, sinks, or also on food facility manufacturing equipment. We’re encouraging industry and public health partners to help us build a robust library of genetic data for Cronobacter that would be helpful to definitively link clinical samples to their source – i.e., certain foods or environments – and to identify repeat sources of clinical illnesses.
• On Tuesday, the U.S. Department of Justice announced the United States Marshals, acting with investigators from the FDA, seized nearly 250,000 bottles of liquid product containing kratom, 1.0 tank of liquid product containing kratom, more than 1,200 cartons of capsules containing kratom, and over 1000 kilograms of bulk powder kratom. The seized articles containing kratom were manufactured by Botanic Tonics, LLC of Broken Arrow, Oklahoma and are marketed under the brand name “Feel Free Plant Based Herbal Supplement.” The seized products are estimated to be worth more than $3 Million. The bulk kratom and articles containing kratom were seized after the U.S. Attorney’s Office in the Northern District of Oklahoma filed a civil forfeiture complaint on behalf of the FDA. The complaint alleges that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury. The complaint further states that dietary supplements containing kratom are adulterated under the Federal Food, Drug, and Cosmetic Act.
• On Tuesday, the FDA posted five additional deemed final orders, completing the process of posting 33 deemed final orders for 32 different monograph therapeutic categories and one for non-monograph conditions as part of over-the-counter (OTC) monograph reform under the CARES Act. All of the deemed final orders can be found on OTC Monographs@FDA. Monograph categories with deemed final orders posted today include first aid antiseptics, first aid antibiotics, laxatives, external analgesics, and anticaries drug products.
• COVID-19 testing updates: 
  • As of today, 447 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 83 antibody and other immune response tests, 63 antigen tests, and one diagnostic breath test. There are 78 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, 30 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
  • The FDA has authorized 48 antigen tests and seven molecular tests for serial screening programs. The FDA has also authorized 1361 revisions to EUA authorizations.