YOUR SOURCE ON FOOD LITIGATION AND REGULATION

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.

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.

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).

In an article authored for Law360, Morgan Lewis partner Robert Hibbert and associate Ryan Michael Fournier cover several food and beverage policy trends to watch this year. A few areas that stand out include CBD products, online food delivery companies, and plant-based meats; state actions on food safety and animal welfare standards; and the rise in food safety plan violations.

Read the full Law360 article >>

In a late November ruling, Judge Christina Snyder of the US District Court for the Central District of California denied a motion for a preliminary injunction filed by the North American Meat Institute (NAMI), which sought to enjoin enforcement of the California measure known as the Prevention of Cruelty to Farm Animals Act, or Proposition 12. N. Am. Meat Inst. v. Becerra et al., Dkt. No. 19-08569 (C.D. Cal. Oct. 4, 2019).

Approved by voter referendum in 2018, Proposition 12 places specific minimum-size requirements on the coops and cages used to contain egg-laying hens, breeding pigs, and veal calves. It will effectively ban all businesses from selling in California any food products derived from animals not raised in compliance with these requirements.

FDA issued a final rule on October 28 that revises the type size requirement for front-of-pack (FOP) calorie labeling for food sold from glass-front vending machines. This new rule amends FDA’s 2014 final rule, which requires vending machine operators that own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines.

The 2014 final rule requires calorie labeling to be clear, conspicuous, and easily read on the article of food while in the vending machine, in a type size at least 50% of the size of the largest printed matter on the label. Following objections due to technical challenges faced by industry, FDA revised the type size requirement to reduce the regulatory burden on and increase flexibility for industry while ensuring that calorie information remains visible to consumers.

Morgan Lewis partner and FDA practice leader Kathleen Sanzo recently authored an article about the regulatory landscape and marketing implications for cannabidiol (CBD) products. In the Food Safety Magazine article, Kathy discusses the current regulatory status of CBD products and the continued legal uncertainty around the marketing of products containing CBD, including dietary supplements, foods, and alcohol. She also discusses recent FDA enforcement actions against CBD products and includes risk mitigation considerations for companies marketing dietary supplements, foods, or alcohol products containing CBD. Such considerations include

  • ingredient specifications,
  • labels for finished products,
  • product claims,
  • warning statements,
  • guarantees,
  • indemnification, and
  • insurance.

Read the full Food Safety Magazine article >>