On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A that intentional genomic alterations (IGAs) in animals would be regulated by FDA to “ensure that it is safe for the animal, safe for anyone that consumes food from the animal, and that it is effective, i.e., it does what the developer claims it will do.” The agency also explained that IGAs would be “subject to premarket oversight whether they are intended to be used for food or to produce pharmaceuticals or other useful products” (emphasis added), with the US Department of Agriculture (USDA) being responsible for the labeling of food from GM animals.
YOUR SOURCE ON FOOD LITIGATION AND REGULATION
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.
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.
The USDA’s Food Safety and Inspection Service (FSIS) updated two labeling guidelines involving animal raising claims in December. Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims (Animal-Raising Claims Guideline) discusses the current requirements for substantiating a variety of animal-raising claims (e.g., Raised without Antibiotics, Grass Fed, Raised Without the Use of Hormones).
Marler Clark LLP filed a petition on behalf of several individuals and consumer groups on January 19, asking USDA’s Food Safety and Inspection Service (FSIS) to issue an interpretive rule declaring 31 salmonella strains as per se adulterants in meat and poultry products.
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.
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.
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.
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.