YOUR SOURCE ON FOOD LITIGATION AND REGULATION
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.

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.
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.
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.
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.
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The US Food and Drug Administration issued a draft guidance document on September 6 stating it will allow use of the colony forming units (CFUs) unit of measure in the Supplement Facts panel. The draft guidance applies to what are colloquially known as “probiotics,” or dietary supplement products that contain a live microbial dietary ingredient.
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.
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.