COMPLIANCE AND REGULATORY CHALLENGES IN THE EVOLVING FOOD SECTOR
R&C: How would you describe the regulatory and compliance challenges currently facing businesses in the food industry? How have their risks and obligations changed in recent years?
McKelvie: Businesses in the food industry face increasing scrutiny by the US Food and Drug Administration (FDA), which administers the Federal Food, Drug and Cosmetic Act (FDCA), and the US Department of Justice (DOJ), which enforces the FDCA. Last year, the FDA announced a proposal to create a new ‘Human Foods Program’ and restructure its field operations, in response to an internal review of the FDA’s handling of the infant formula shortage crisis. The FDA has already hired a new deputy commissioner of human foods and is planning to implement the reorganisation in October 2024. As part of these changes, the FDA is sharpening its focus on food safety and nutrition and developing key performance indicators – microbiological safety, nutrition and chemical safety – to measure the success of the agency’s restructuring efforts. The food industry can expect these efforts to translate into increased attention from both a policy and an enforcement standpoint on the part of agency leadership. In addition, the DOJ has increased its enforcement resources for prosecuting violations of the FDCA. In particular, the DOJ’s Consumer Protection Branch, which enforces the FDCA, has quadrupled in size since 2017. Moreover, the DOJ brought more civil and criminal actions against food manufacturers in 2023 than in previous years.
Oct-Dec 2024 Issue
Gibson, Dunn & Crutcher LLP
McCarthy Tetrault
Norton Rose Fulbright LLP