Jimmy John’s Franchise, LLC – FDA Warning Letter, Feb 25, 2020

The FDA, CDC, and state partners investigated multiple foodborne illness outbreaks linked to Jimmy John's restaurants, detailing five incidents including a December 2019 E. coli O103 outbreak in Iowa. These outbreaks, spanning seven years and affecting over seventeen states, involved Shiga toxin-producing E. coli and Salmonella enterica, linked to clover sprouts and cucumbers. The FDA determined that Jimmy John's engaged in a pattern of receiving and selling adulterated fresh produce, rendering their products adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(1)]. The introduction and receipt of such adulterated food into interstate commerce are prohibited acts under Sections 301(a) and 301(c) [21 U.S.C. §§ 331(a), 331(c)]. The letter highlights inadequate corporate-wide supplier control mechanisms for fresh produce and a failure to implement long-term, sustainable corrective actions, despite previous outbreaks and commitments made in 2012. Jimmy John's is required to respond within fifteen working days, detailing and documenting specific steps to prevent the receipt and sale of adulterated food across all approximately 2,800 franchised restaurants, ensuring compliance with the Produce Safety Rule (21 CFR Part 112) and PC Rule (21 CFR Part 117). Failure to comply may result in enforcement actions like seizure or injunction.