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).
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.
Sonic Drive-In reached a $4.3 million settlement on October 10 with its customers over the chain’s data security breach in 2017 that exposed customer credit and debit card information at 325 Sonic Drive-In locations. The attack followed a pattern familiar in the retail and restaurant context, where hackers infect the point-of-sale system with malware that copied and transmitted the information from consumers payments cards when used to make a purchase. Plaintiffs filed several class action lawsuits for violations of state consumer protection laws and data breach notification statutes, along with various common law causes of action. The lawsuits were consolidated into a multidistrict litigation proceeding in the Northern District of Ohio in early 2018.
In recent months, questions about the potential future marketing of what will be termed herein “cell-cultured meat” (CCM) have moved outside the confines of biotech laboratories and tech funders’ boardrooms and caught the attention of both regulators and a much broader segment within the general public. As the regulatory future of such products starts to come into focus, debates and discussions have been generated within the food industry over three interlocking issues:
- Jurisdiction: What federal agency should be responsible for overseeing such products?
- Oversight: How should such products be regulated?
- Labeling: How are they to be identified to the consumer?
As always, if you have any questions, please do not hesitate to contact us.
The Food and Drug Administration (FDA) held a public meeting July 12 on “Foods Produced Using Animal Cell Culture Technology” to give the public an opportunity to provide comments on federal regulation of the future production of foods using animal cell culture technology. While a thorough account of the all-day meeting is beyond the scope of this article, we wanted to share with you our main takeaways from the meeting, which can be lumped into three categories: jurisdiction, regulatory oversight, and labeling.
The US Department of Agriculture issued a proposed rule requiring that foods containing bioengineered (i.e., genetically modified organisms or “GMO”) ingredients display a food label to indicate to consumers that it is a “bioengineered food.” The proposed rule is far-reaching and, if adopted, would impact labeling obligations for a substantial percentage of food products offered for sale in the United States. This includes, but is not limited to, raw produce, seafood, dietary supplements, and most prepared foods, such as breads, cereals, non-meat canned and frozen foods, snacks, desserts, and drinks. As explained in greater detail in the preamble, it also applies to some of the meat, poultry, and egg products independently regulated by the USDA, but only if an ingredient regulated by the US Food and Drug Administration (FDA) predominates. Read the full LawFlash.
Since our last post, more than 41 comments have been submitted in response to the US Cattlemen’s Association’s petition (USCA Petition) requesting that the USDA FSIS exclude from the statutory definitions of “meat” and “beef” those products that are not “derived from animals born, raised, and harvested in the traditional manner.” Such excluded products would presumably include plant-based products that resemble the appearance and taste of beef products and cell-cultured meat (CCM). While an exhaustive analysis of the submitted comments is beyond the scope of this article, we would like to highlight two comments we found interesting. We also would also like to highlight a separate but related approach taken by Rep. Rosa DeLauro (D-Connecticut), to understand how best to regulate these innovative food products.
In a petition (USCA Petition) submitted to the Food Safety and Inspection Service (FSIS) on February 9, the US Cattlemen’s Association requests that FSIS exclude from the statutory definitions of “meat” and “beef” those products that are not “derived from animals born, raised, and harvested in the traditional manner.” Such excluded products would presumably include plant-based products that resemble the appearance and taste of beef products and cell-cultured meat (CCM)—meat grown in a cell culture instead of culled from an animal (jointly, Alternative Products). The USCA Petition presents the following assertions to support such exclusions:
- Alternative Products, it maintains, do not meet the common dictionary or statutory/regulatory definitions of “meat,” “beef,” and related terms because the definitions contemplate products derived naturally from animals.
- The marketing of Alternative Products is potentially misleading because consumers would reasonably expect products labeled as “meat” and “beef” to be derived from animals slaughtered in the traditional manner.