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YOUR SOURCE ON FOOD LITIGATION AND REGULATION

In an order issued on July 20, Judge Raag Singhal of the US District Court for the Southern District of Florida dismissed a class action lawsuit that claimed Burger King Corporation’s advertising deceived customers by making a “presumption” that its plant-based “Impossible Whopper” patties would be cooked on different grills than those used to cook meats. Williams v. Burger King Corp., Case No. 1:19-cv-24755 (S.D. Fla. July 20, 2020).

Harvard Law School’s Animal Law & Policy Clinic (Clinic) submitted a petition on June 9 to the USDA’s Food Safety and Inspection Service (FSIS), urging it to adopt a labeling approach for the emerging category of cell-based meat and poultry that “does not overly restrict speech and that respects the First Amendment.”[1] In its response of July 23, FSIS indicates that it considers the document a request for future rulemaking.[2]

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.

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.

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.

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.

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).

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.