In response to the COVID-19 outbreak, the U.S. Food and Drug Administration (FDA) has announced it will begin requesting that importers send the agency records required under the Foreign Supplier Verification Programs (FSVP) rule electronically or through other prompt means to allow the agency to conduct FSVP inspections remotely during the public health emergency. 1 FSVP requires importers to perform certain risk-based activities to verify their foreign suppliers are producing food in accordance with U.S. food safety laws. FDA has been conducting its FSVP inspections by reviewing importers’ records at the importer’s place of business. However, FDA has the authority under the FSVP regulation to request that importers provide required records to the agency electronically or by other prompt means. Due to travel restrictions, social distancing, and other advisories associated with the COVID-19 pandemic, FDA has determined most routine onsite inspections are impractical to conduct at this time. Accordingly, FDA temporarily is shifting to conducting FSVP inspections remotely as practical until further notice.

FDA will begin conducting a limited number of remote inspections immediately and will prioritize inspections of FSVP importers for food from foreign suppliers whose onsite food facility or farm inspections have been postponed due to COVID-19. FDA also plans to continue conducting previously assigned routine and follow-up inspections remotely during the public health emergency. An FDA investigator will contact importers subject to the remote inspection and will explain the process and make the agency’s written request for records.

According to FDA, the agency may still choose to conduct an onsite FSVP inspection in rare situations. In those cases, an FDA investigator will make arrangements to conduct the inspection while practicing social distancing recommendations provided by the Centers for Disease Control and Prevention.

We will continue to monitor FDA’s response to COVID-19. Should you have any questions or if we can be of assistance with your COVID-19 response strategy, please contact us.


1 Constituent Update: FDA To Temporarily Conduct Remote Importer Inspections Under FSVP Due to COVID-19 (Apr. 3, 2020), available at https://bit.ly/2X81xte.

Today, FDA issued a new guidance document that provides retailers with some flexibility from labeling requirements for shell eggs in order to facilitate the distribution of eggs during the COVID-19 pandemic. This guidance provides a basis for retail food establishments to sell unlabeled cartons or flats of shell eggs during the public health emergency if the retailer meets certain requirements, detailed in this post.

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This post summarizes recent actions the U.S. Food and Drug Administration (FDA) has taken in response to the COVID-19 outbreak. First, FDA Deputy Commissioner for Food Policy and Response Frank Yiannas issued a food safety and supply public service announcement (PSA). The PSA states the U.S. food supply remains safe for both people and animals, and there is no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19. Deputy Commissioner Yiannas also reiterates that there currently are no nationwide shortages of food, despite local reports of shortages. Second, FDA has supplemented its food safety questions and answers guidance on COVID-19 to include Food and Beverage Issue Alliance (FBIA) suggested protocols among the resources available to industry for responding to COVID-19.

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This post summarizes recent actions the U.S. Food and Drug Administration (FDA) has taken in response to the COVID-19 outbreak. First, FDA has issued a temporary policy to provide flexibility to chain restaurants and similar retail food establishments currently required to provide nutrition information on menus and menu boards. In light of the need for many of these entities to change their business practices quickly (e.g., switching from dine-in to takeout only or making menu substitutions), FDA will not object to establishments that do not meet applicable menu labeling requirements. This temporary policy will remain in effect only for the duration of the COVID-19 public health emergency. Second, FDA has again updated its questions and answers guidance on COVID-19 with information on glove use by workers in food retail and processing during a pandemic.

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In response to two petitions, the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has announced that intends to conduct rulemaking to change its policy toward “Product of USA” claims for meat and poultry products, with an apparent objective of limiting the scope of products eligible for the claim.

Recently, FSIS announced that the Agency had completed its review of two Petitions submitted on behalf of the U.S. Cattlemen’s Association (USCA) (the USCA Petition) and the Organization for Competitive Markets (OCM) and American Grassfed Association (AGA) (the OCM/AGA Petition). The USCA, OCM, and AGA are national organizations representing the cattle industry, farmers and consumers in the agricultural markets, and grassfed meat producers, respectively. Both the USCA and OCM/AGA Petitions requested that FSIS amend its policy to limit voluntary “Product of USA” claims on beef products to only products made from cattle that have been born, raised, and slaughtered in the U.S. In response, FSIS concluded that its current labeling policy “may be causing confusion in the marketplace, particularly with respect to certain imported meat products” and indicated it would initiate a rulemaking to define voluntary “Product of USA” claims.” Although FSIS technically denied the Petitions, the promise of future rulemaking appears aimed at satisfying the Petitioners’ core requests.

This post briefly summarizes the petitions and FSIS’s planned rulemaking. FSIS has not yet issued a proposed rule and has not indicated when it plans to do so.

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This post summarizes recent actions the federal government has taken in response to the COVID-19 outbreak. First, the Department of Homeland Security’s (DHS’s) Cybersecurity & Infrastructure Security Agency (CISA) has updated its guidance identifying the types of food and agriculture sector workers who the agency suggests should be exempt from state and local shelter in place orders, curfews, and similar restrictions on movement. We previously summarized an earlier iteration of the guidance in our memo on March 20, 2020. Second, FDA supplemented its questions and answers guidance with additional material concerning food packaging, testing food processing facility environments for COVID-19, and flexibility for nutrition labeling of packaged food during the COVID-19 pandemic. The guidance continues to state that currently there is no evidence of food or food packaging being associated with transmission of COVID-19. Third, FDA’s Center for Veterinary Medicine (CVM) has issued a Fact Sheet on how unused human food may safely be used as animal food during the COVID-19 outbreak.

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As the novel coronavirus crisis continues to escalate, the demand for hygienic products such as hand sanitizer has dramatically increased. In response, many businesses, such as food and industrial and beverage alcohol manufacturers, are seeking to produce alcohol-based hand sanitizers using certain food grade materials, or to produce alcohol to be used in production of such sanitizers. In recent days, federal agencies such as the Food and Drug Administration (FDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have relaxed certain regulatory requirements for the production of alcohol-based hand sanitizers, in part, to respond to the call for food grade materials in such hand sanitizer products. This post provides a brief overview of the recently issued guidance, reflecting updates made to the FDA policies as of March 27 and to the TTB policies as of March 26.

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On March 27, 2020, the President signed into law the “Coronavirus Aid, Relief, and Economic Security Act,” or the CARES Act.  This is the third phase of federal legislation in response to the COVID-19 outbreak. The estimated $2 trillion package cuts across nearly every segment of the economy, widely affecting companies and consumers alike, and is part of the ongoing effort to address the fall-out from the novel coronavirus and COVID-19. This post highlights provisions of the CARES Act of the greatest interest to the food industry.

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The U.S. Food and Drug Administration (FDA) announced yesterday two policies to provide flexibility with respect to nutrition labeling requirements during the COVID-19 pandemic. First, the agency committed to work cooperatively with all manufacturers for the remainder of the year regarding the use of updated Nutrition and Supplement Facts labels and will not focus on enforcement actions during this time. FDA had previously announced this form of enforcement discretion for the first six months of implementation after the January 1, 2020 compliance date, which has now been extended until January 1, 2021.  Second, FDA also issued a new guidance document that details the conditions under which a restaurant or food manufacturer may sell packaged food labeled for foodservice use (i.e., without nutrition labeling) directly to consumers. We summarize this guidance in this post.

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The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) issued a Constituent Update announcing the Agency temporarily is exercising enforcement discretion to provide labeling flexibilities for redirecting to retail meat and poultry products originally intended for food service. Importantly, FSIS’s enforcement discretion applies only to food that already has been produced. FSIS continues to expect all food currently being produced to meet all requirements. This memorandum describes the circumstances under which products may be moved to retail with certain labeling deviations.

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