FDA and CFSAN on Issuing Guidance Documents Concerning COVID-19

The Food and Drug Administration (FDA) published a Notice that set forth the process that it and the Center for Food Safety and Applied Nutrition (CFSAN) will use in expediting the availability of guidance documents concerning the ongoing COVID-19 public health emergency. It will include essential recommendations and policies and will eliminate requisite notice and comment before the agency finalizes a guidance document. The FDA explains in their Notice that they will continue to work within their established good guidance practices and aim to “rapidly disseminate essential Agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders.” The FDA intends to use the following procedures:

1. The FDA anticipates that it will issue COVID-19-related guidance documents for immediate implementation without prior public comment. Although the guidance documents will be implemented without prior comment, the FDA will solicit and review comments, and revise the guidance documents, as appropriate.
2. A Notice of Availability (NOA) will not be published in the Federal Register for each COVID-19-related guidance document. Rather, the FDA intends to publish periodically a consolidated NOA. This will provide instructions to the public on submitting comments on the guidance documents, including the docket number(s) associated with each guidance document, information on how to view the dockets, and instructions for those interested in obtaining a copy of a the document.
3. COVID-19-related guidance documents will be made publicly available online at the FDA website under Coronavirus Disease 2019 (COVID-19) and at Search for FDA Guidance Documents.   
4. The FDA also intends to establish one docket for each Center or Office that may issue COVID-19-related guidance documents. The docket for CFSAN at regulations.gov will be FDA-2020-D-1139.
5. To date, the following guidance documents have been published relative to the food industry:
   1. Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic, available here.
   2. Guidance for Industry: Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency, available here.

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OFW Law is monitoring for updates to these documents and will review them upon release. If you have questions or would like more information, please reach out to us at OFW Law or visit our website for continuing updates at OFWLaw.com.