The Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) have announced a memorandum of understanding (MOU) to help prevent potential disruptions to the food supply chain, particularly fruit and vegetable processing plants, resulting from the coronavirus (COVID-19) pandemic.

In a joint statement, USDA Under Secretary for Food Safety Mindy Brashears, Ph.D., and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas noted that the MOU is “an important preparedness effort” due to the upcoming peak harvesting seasons, when many fruits and vegetables grown across the United States are sent to FDA-regulated facilities to be frozen or canned.

Read More

Law clerk Angela Silva contributed to this post.

As restaurants and other retail food establishments begin to reopen around the country, trade associations and the US Food and Drug Administration (FDA) have both issued guidance for retail food establishments that provide direction, checklists, and best practices for reopening while the country emerges from the coronavirus (COVID-19) pandemic.

On April 22, the National Restaurant Association issued Reopening Guidance: A Guide for the Restaurant Industry and on May 8, FDA followed suit by issuing a detailed food safety checklist, Best Practices for Re-Opening Retail Food Establishments During the COVID-19 Pandemic.

Read More

As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively releasing new, and updating existing, policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the COVID-19 pandemic. FDA recently issued a final guidance providing the Accredited Third-Party Certification Program some flexibility. FSIS recently extended its policies for the labeling of products intended for food products going to retail through the end of July.

Read More

Law clerk Angela Silva contributed to this post.

The US Department of Agriculture Food Safety Inspection Service (FSIS) and US Food and Drug Administration (FDA) have released policy statements and temporary guidance providing flexibility on certain regulatory requirements during the pendency of the coronavirus (COVID-19) pandemic.

FSIS is exercising enforcement discretion for the labeling of products intended for food products going to retail. The scope of FDA’s enforcement discretion is broader, allowing flexibility with respect to both labeling and audits.

We’ve created the attached chart describing the modified requirement under each policy statement or guidance. It also includes the standard requirement for a point of reference.

We hope this will serve as a convenient resource, and we will provide additional amendments as future circumstances warrant.

See the chart >>

Law clerk Angela M. Silva contributed to this post.

The designation of the food industry as critical infrastructure in the context of the coronavirus (COVID-19) pandemic has led to necessary and sensible efforts to realign the federal regulatory landscape to facilitate this essential activity, without compromising the public interest.

From the perspective of FDA regulated companies, this has essentially involved a changed environment, where the agency has announced its willingness to step back, physically and otherwise, from many routine inspections and the enforcement of various pending labeling requirements. However, the meat, poultry, egg product, and catfish industries, overseen by USDA’s Food Safety and Inspection Service (FSIS), confront a different reality because statutory requirements of carcass-by-carcass and continuous inspections dictate daily interaction, often in close quarters, between the inspector and the inspected.

Read More

FDA representatives on March 18 initiated a conference call with representatives of the food industry to discuss public health and food safety issues related to the coronavirus (COVID-19) outbreak. The FDA was represented by Frank Yiannas (FDA Deputy Commissioner for Food Policy and Response), Michael Rogers (Assistant Commissioner for Human and Animal Foods), and Dr. Susan Mayne (Director of the Center for Food Safety and Applied Nutrition). Morgan Lewis lawyers Bob Hibbert and Ann Begley recently authored a LawFlash summarizing the conference call and the measures the FDA plans to take.

Read the full LawFlash on our website.

Law clerk Angela M. Silva contributed to this post.

The USDA’s Food Safety and Inspection Service (FSIS) updated two labeling guidelines involving animal raising claims in December. Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims (Animal-Raising Claims Guideline) discusses the current requirements for substantiating a variety of animal-raising claims (e.g., Raised without Antibiotics, Grass Fed, Raised Without the Use of Hormones). Labeling Guideline on Statements That Bioengineered or Genetically-Modified Ingredients or Animal Feed Were Not Used in Meat, Poultry, or Egg Products (Animal Ingredient/Feed Claims Guideline) specifically focuses on claims that state bioengineered or genetically modified ingredients or feed were not fed to animals being raised for human consumption (i.e., negative claims).

Read More

The Mexican Ministry of Economy and Federal Commission for the Protection Against Sanitary Risks approved a project on January 24 to modify the mandatory “Official Mexican Standard NOM-051-SCFI/SSA1-2010, General Labeling Specifications for Pre-packaged, Non-alcoholic Foodstuffs and Beverages” (NOM-051). The updated NOM-051 standards establish mandatory rules for all prepackaged, nonalcoholic foodstuffs and beverages sold in Mexico, regardless of their country of origin.

Among the key amendments established by NOM-051, relevant provisions include:

• Front of Label Warnings: In addition to the already existing nutritional information requirements for principal display panels, NOM-051 requires the inclusion of an additional frontal “stamp” warning aimed at preventing the risk of overconsuming "Critical Nutrients," which, when ingested in excess, are considered risk factors associated with chronic diseases. Such Critical Nutrients include added sugars, saturated fat, sodium, and other nutrients and ingredients determined by the Ministry of Health.

Read More

Marler Clark LLP filed a petition on behalf of several individuals and consumer groups on January 19, asking USDA’s Food Safety and Inspection Service (FSIS) to issue an interpretive rule declaring 31 salmonella strains as per se adulterants in meat and poultry products. These strains, which the petition refers to as the “Salmonella Outbreak Serotypes,” include four antibiotic-resistant strains—Salmonella hadar, heidelberg, newport, and typhimurium—as well as Salmonella dublin, enteritidis, and infantis. The petition seeks expedited review of its request on the grounds that these strains have been shown to be linked to foodborne illness outbreaks and/or product recalls and, as such, constitute an imminent threat to public health.

According to the petition, declaring these 31 strains as adulterants would promote the goals of the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act to protect public health by encouraging the meat and poultry industry to implement more effective safeguards and oversight measures. The petition relies heavily on its interpretation of precedent established following the 1993 Escherichia coli, when USDA declared Escherichia coli O157:H7 a per se adulterant in raw ground beef through interpretive rulemaking.

Read More

Whole genome sequencing (WGS) has become the technology of choice for FDA, the Centers for Disease Control and Prevention (CDC), and the USDA Food Safety and Inspection Service (FSIS) to help protect consumers from foodborne illness. It can reveal the complete DNA makeup of an organism, thus enabling the differentiation between organisms with a precision that other technologies do not allow. Agencies can use WGS to determine what illnesses are part of an outbreak or narrow down the specific ingredient in a multi-ingredient food responsible for an outbreak; identify the geographic areas from where a contaminated ingredient may have originated; differentiate sources of contamination, even within the same outbreak; and link illnesses to a processing facility even before the food product vector has been identified. See, e.g., FDA, Examples of How FDA Has Used Whole Genome Sequencing of Foodborne Pathogens For Regulatory Purposes (WGS Examples).

Read More