UNPA / FDA issues two updates to COVID-19 policies and procedures

​Dear Colleagues,

Yesterday, FDA issued two memos of interest to the dietary supplement industry:

The first, a 14-page guidance document, "Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic," is an update to a 2012 guidance and outlines the agency's recommendations regarding postmarketing adverse event reporting when high employee absenteeism at the agency and industry while "reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase."

FDA believes this approach will make it possible for firms with reporting responsibilities to focus their limited resources on the following types of reports:

• Reports related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic
• Other reports indicated in this guidance
• Reports on products presenting special concerns as specified by FDA.

Download the guidance at:  https://www.fda.gov/media/72498/download

The second communication is a March 23 update, "Food Safety and the Coronavirus Disease 2019 (COVID-19)" that consists of three elements:

• Resources for industry
• Guidance to communicate FDA's intention to temporarily not enforce supplier verification onsite audit requirements for receiving facilities and importers under the FDA Food Safety Modernization Act (FSMA) in response to the global pandemic of COVID-19.
• A Q&A section that addresses manufacturing issues, such as social distancing within manufacturing facilities; the approved off-label use of quaternary ammonium sanitizer; the use of employee facemasks; what to do if an employee tests positive for COVID-19 and other issues.

Access the Q&A updates at:  https://www.fda.gov/food/food-safety-during-emergencies/food-safety-and-coronavirus-disease-2019-covid-19

With warm regards,
Frank