Good afternoon! The FDA Intergovernmental Affairs (IGA) team would like to bring to your attention the following announcements the Agency made during the week of March 6, 2022. If you have any questions on the below announcements, please reach out to us at IGA@fda.hhs.gov. 

Intergovernmental Affairs

Weekly Digest for the Week of Mar. 6, 2022

FDA Warnings and Recalls

• FDA, along with CDC and state and local partners, continue to investigate consumer complaints and/or reports of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility. All of the ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI facility. FDA first announced the investigation on February 17, 2022. The Salmonella Newport illness previously included in this investigation of complaints and illnesses has been removed. In the early stages of this investigation, FDA included all consumer complaints of illness with exposure to products from the Sturgis, MI, facility. After further investigation, the FDA has determined that there is not enough information to definitively link this illness to powdered infant formula. CDC confirmed that this single Salmonella illness is not linked to an outbreak. The FDA and CDC are continuing to monitor for Salmonella cases and consumer complaints that may be related to this incident. FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. To provide clarity about which products are included in the Abbott Nutrition recall, FDA is publishing a full list of recalled brands that have been included in the initial and expanded recall. Recalled products should no longer be available for sale, but if consumers have these products in their homes, they should check the lot code on the bottom of the package to determine if it is included in the recall. FDA is also providing additional information for parents and caregivers of infants receiving medical specialty infant formula and individuals using certain medical foods. You can find additional information and product images here.
• On March 10, 2022, FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate. Read more by clicking here.

• FDA and CDC, in collaboration with state and local partners, investigated a multistate outbreak of Listeria monocytogenes infections during December 2021 - February 2022. As of March 8, 2022, this outbreak has ended. The product is past expiration and should no longer be available to consumers. Therefore, there are no recommendations for consumers, retailers, or suppliers. As a part of routine sampling, the Michigan Department of Agriculture and Rural Development (MDARD) collected a product sample of Fresh Express Sweet Hearts salad mix with a Use-By-Date of December 8, 2021 for testing. The sample tested positive for Listeria monocytogenes and subsequent whole genome sequencing (WGS) analysis determined that the Listeria monocytogenes present in the samples matches the strain that has caused illnesses in this outbreak. In response to the sample results and the ongoing outbreak investigation, Fresh Express voluntarily ceased production at the Streamwood, IL, facility and initiated a recall of certain varieties of its branded and private label salad products produced at the company’s Streamwood, Illinois facility. You can read additional details here.

• As part of the FDA’s effort to protect consumers, on March 7, 2022, the agency issued a warning letter jointly with the Federal Trade Commission to Viraldine, LLC  for selling unapproved products with fraudulent COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.

• Testing updates:  
  • As of today, 421 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 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 875 revisions to EUA authorizations
  • Update: The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd.

COVID-19 Updates

• On March 4, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius.  This extension was granted following a thorough review of data submitted by Janssen, now applying to all refrigerated vials of Janssen COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions.  A copy of the concurrence letter is posted on FDA’s website.

Foods

• On March 11, 2022, FDA issued guidance on its intent not to enforce certain provisions of five rules that implement FDA Food Safety Modernization Act (FSMA). As the Agency began implementation of these rules, FDA received questions and comments from stakeholders regarding specific provisions. In certain situations, FDA has determined it is appropriate to take time to consider options, including rulemaking, to address concerns raised by stakeholders, while continuing to protect public health. You can find more details here.
• On March 7, 2022, 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 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. 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.

Cross-Cutting

• On March 8, 2022, 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. The agreement and more information can be found here.

Tobacco

• On March 11, 2022, FDA issued a modified risk granted order authorizing Philip Morris Products S.A. (PMPSA) to market the IQOS 3 System Holder and Charger.  This reduced exposure information is the same as the information previously authorized by FDA in July 2020 for an earlier version of the device.  Today’s action follows FDA’s review of a new modified risk tobacco product (MRTP) application submitted by the company for the IQOS 3 System Holder and Charger.  For more details on the exposure claim for IQOS 3 System Holder and Charger, click here.

• On March 7, 2022, FDA’s posted to its web site the recent webinar about the agency’s plans to advance two tobacco product standards—one to prohibit menthol as a characterizing flavor in cigarettes and another to prohibit characterizing flavors, except tobacco, in cigars.  To view the webinar, click here.

Devices

• On March 8, 2022, FDA alerted medical device users and manufacturers about a cybersecurity vulnerability identified for the Axeda agent and Axeda Desktop Server. The agent and desktop server are used in numerous medical devices across several medical device manufacturers and all versions of Axeda agent and Axeda Desktop Server are affected. On March 8, 2022, the Cybersecurity and Infrastructure Security Agency (CISA) published an advisory, ICSA-22-067-01, on these vulnerabilities. The Axeda agent and Axeda Desktop Server are web-based technologies that allow one or more people to securely view and operate the same remote desktop, through the Internet. The Axeda agent and desktop server are owned and supported by the computer software company, PTC. Successful exploitation of this vulnerability could allow an unauthorized attacker to take full control of the host operating system, resulting in full system access, remote code execution, read/change configuration, file system read access, log information access, and a denial-of-service condition. For more details, please click here.
• The Agency will host a webinar for stakeholders to share information and answer questions about the final guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies, on March 22, 2022, 1:00 PM - 2:00 PM (ET). Registration is not required and dial-in information can be found here.

Drugs and Biologics

• On March 10, 2022, FDA announced the availability of the revised draft guidance “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs” as part of the Drug Supply Chain Security Act. The guidance clarifies the minimum recommended components of robust verification systems for the determination, quarantine, and investigation of suspect products, as well as the quarantine, notification, and disposition of illegitimate products. The guidance also outlines the revisions that were made in response to comments received from stakeholders. Interested stakeholders are encouraged to submit comments on this revised draft guidance.
• More information can be found at these links:
  • Drug Supply Chain Security Act (DSCSA)
  • Drug Supply Chain Security Act Law and Policies

Veterinary Food and Medicine

• On March 7, 2022, FDA announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). The IGA results in the equivalent genotype (genetic make-up) and short-hair coat trait seen in some conventionally bred cattle, known as a “slick” coat. This is the FDA’s first low-risk determination for enforcement discretion for an IGA in an animal for food use. “Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “It also demonstrates our ability to identify low-risk IGAs that don’t raise concerns about safety, when used for food production. We expect that our decision will encourage other developers to bring animal biotechnology products forward for the FDA’s risk determination in this rapidly developing field, paving the way for animals containing low-risk IGAs to more efficiently reach the marketplace.” Click here to read more.