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.
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.
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 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,
- indemnification, and
FDA announced on October 24 that it does not intend to take enforcement action against manufacturers in the first six months following the January 1, 2020, deadline to update Nutrition Facts labels on food packaging. The enforcement discretion extension follows the May 2018 compliance date delay, which extended the compliance dates for manufacturers with $10 million or more in annual food sales from July 26, 2018, to January 1, 2020, while compliance dates for manufacturers with less than $10 million in annual food sales moved from July 26, 2019, to January 1, 2021.
The US Department of Agriculture (USDA) issued a Notice of Availability and Request for Public Comment on a new guideline addressing multi-component food kits that contain meat or poultry items (Meal Kit Guideline). The Meal Kit Guideline provides industry with information on how to label a multi-component food kit that contains meat or poultry and whether it would need to be prepared under FSIS inspection.
The major takeaways include the following: