YOUR SOURCE ON FOOD LITIGATION AND REGULATION

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.

The US Department of Agriculture (USDA), through its Agricultural Marketing Service (AMS) published its final rule (NBFDS Final Rule) on December 21 establishing a nationwide labeling disclosure requirement for foods containing bioengineered (BE) ingredients, defined as foods or substances that contain genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or be found in nature. While a more thorough analysis is still being conducted, here we provide a summary of the major topics addressed in the NBFDS Final Rule.

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).

On October 29, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that FDA is considering whether sesame should be disclosed on food labels as an allergen. Because sesame is not identified as a “major food allergen” under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the ingredient is not always required to be stated on the food label. Rather, in some cases, sesame can be listed generically as “spice,” “natural flavor,” “tahini,” or other nonspecific ingredient names, which can lead to consumer confusion and uncertainty.

The US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) issued a joint statement on November 16 indicating that both FDA and USDA will jointly oversee the production of cell-based food products derived from livestock and poultry. The proposed regulatory framework generally involves the FDA overseeing cell collection, cell banks, and cell growth/differentiation, and USDA overseeing the production and labeling of the food products following cell harvest. While it is encouraging to see the agencies working together to resolve this threshold question, it simply sets the stage for further evaluation of any number of challenging questions.

On November 6, the US Food and Drug Administration (FDA) announced that its final guidance on Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff (Mandatory Recall Guidance) is now available. The Mandatory Recall Guidance provides information on the implementation of the mandatory food recall provisions of the Food Safety Modernization Act (FSMA). The Mandatory Recall Guidance comes in the form of a Q&A on common topics about the FSMA’s mandatory recall provision.