YOUR SOURCE ON FOOD LITIGATION AND REGULATION

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 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:

FDA released a consumer update stating that it supports industry’s effort to toss expiration dating terms on foods, such as “use before,” “sell by,” and “expires on,” for the more neutral date phrase “best if used by.”

Recent scientific advancements have revolutionized the way food and agricultural products are being grown, sold, and regulated. These advancements raise new regulatory issues and create unique challenges for companies in the industry. A rapidly growing population, combined with tremendous attention from investors, means animal cell-culture derived products are poised for entry into the global marketplace within 5 to 10 years.

FDA partner Bob Hibbert explored this topic in a webinar titled “Opportunities in Food and Agricultural Tech” as part of the 2019 Morgan Lewis Technology May-rathon. The Technology May-rathon, now in its ninth year, is a series of tailored webinars and in-person events designed to share tech-related current issues, trends, and developments.

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As promised and on time, the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) issued an agreement on March 7 describing in some detail the division of responsibility between the two agencies over the emerging and much-talked-about category of human food produced using cell culture technology derived from cell lines of USDA-amenable species of meat and poultry. The document contains no real surprises and, as is often the case with such materials, tends to raise as many questions as it answers. Nonetheless, it provides the clearest delineation to date on the particulars of just how the safety, suitability, and marketing of such products is to be overseen by the two agencies.

With a focus upon the emerging cell-cultured meat industry, there has been considerable recent discussion about the significance of jurisdictional differences at the federal level between the US Department of Agriculture and the US Food and Drug Administration. But what now appear to be moving on a parallel track are various recently enacted laws or proposed legislation at the state level designed to impose new labeling requirements and/or restrictions for meat-alternative products, both cell- and plant-based, generally designed to restrict access to traditional terminology such as “ground beef” on such products' labels.

The pending and still tentative resolution of jurisdictional issues between the US Department of Agriculture (USDA) and the Food and Drug Administration (FDA) surrounding cell-cultured meat and poultry products should address one of the three core regulatory issues confronting this emerging industry. Assuming that it holds, a resolution will establish an overarching role for FDA in the broad assessment of the technology in order to ensure that it is safe. Once the foods themselves enter the production stage, ongoing inspection authority and related jurisdiction will revert to the USDA through the Food Safety and Inspection Service (FSIS) if the cell-cultured items in question replicate the traditional meat and poultry items that currently fall within that agency’s jurisdiction.

As readers are undoubtedly aware, the Centers for Disease Control (CDC) issued a Food Safety Alert (Alert) on November 20 due to a multistate outbreak of E. coli-related infections linked to romaine lettuce. The CDC alert associated the product with 32 illnesses and 13 hospitalizations. Further, it advised consumers not to consume any romaine lettuce and advised retailers and restaurants not to serve or sell it. By rendering such products unsellable, the alert raised immediate questions concerning the identity of parties forced to bear the risk of loss. The issue has been addressed by the US Department of Agriculture’s (USDA) Perishable Agricultural Commodities Act (PACA) Division through FDA Advisory Alert on Romaine Lettuce and the PACA (PACA Announcement).