The clock is ticking as far as the FDA is concerned when it comes to food safety at Jimmy John’s 2,800 restaurants. A warning posted today references five outbreaks associated with the chain. It demands specific details from the company president.
In the warning letter, dated Feb. 21, the Food and Drug Administration gave Jimmy John’s president Jim North the standard 15 days to provide information or explain why he can’t, about the 43-state network of restaurants. The problems outlined in the letter are violations of federal laws. The evidence, according to the warning, demonstrates that the corporation and restaurants engaged in a pattern of receiving and offering for sale adulterated fresh produce, specifically clover sprouts and cucumbers.
“Although you stated that corrective actions were implemented following the 2019 and 2012 outbreaks, you have not provided FDA with any information demonstrating long-term, sustainable corrections have been implemented throughout your organization to prevent this violation from recurring in the future,” according to the warning letter signed by William R. Weissinger, program division director for the Office of Human and Animal Foods in the FDA’s Division East 6.
“. . . Taken together, these outbreaks, which spanned over the past seven years and impacted no fewer than 17 states, demonstrate the corporate-wide supplier control mechanisms you have in place for receiving fresh produce are inadequate.”
The outbreaks involved Salmonella and E. coli.
In the warning, the FDA officials specifically discuss the chain’s use of fresh, raw sprouts and the dangers they pose. In a May 2012 meeting, at the request of the president of the chain, FDA officials pointed to the company’s situation with clover sprouts.
“During that meeting, you expressed that you would offer only clover sprouts, and to only source clover sprouts from (redacted by FDA) suppliers. Since that corrective action, your firm has been implicated in three additional sprout-related outbreaks. Documents from traceback investigations conducted by FDA, states and local partners demonstrate that in addition to (redacted by FDA) sprouts, Jimmy John’s restaurants are using multiple other sources of sprouts, the warning letter states.
“Although you stated that corrective actions were implemented following the 2019 and 2012 outbreaks, you have not provided FDA with any information demonstrating long-term, sustainable corrections have been implemented throughout your organization to prevent this violation from recurring in the future.”
The FDA wants the president of the Champaign, IL, fast-food chain to provide documentation of policies and procedures being used to meet requirements of the federal law involving the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. The agency also wants documentation that North has instituted controls to make sure restaurant operators are following the Produce Safety Rule of the Food Safety Modernization Act.
“The introduction or delivery for introduction into interstate commerce of food that is adulterated is a prohibited act. . . Further, receipt in interstate commerce of adulterated food is a prohibited act,” the warning letter states.
Outbreaks as reported by FDA
1. November to December 2019; an outbreak of human infections with E. coli O103 (STEC)
Iowa Department of Public Health reported that as of January 7, 2020, a total of 22 people from Iowa were infected with the outbreak strain of E. coli O103. Twenty of the 22 case individuals were interviewed by the Iowa Department of Public Health. Of the case individuals interviewed, 100 % reported eating at one or more of 15 Jimmy John’s restaurants. Of the 20 interviewed, 45% (9) reporting eating sprouts in the week before their illness. Iowa Department of Public Health states this proportion is significantly higher than results from a survey of healthy people in which 3.3% reported eating sprouts in the seven days before being interviewed.
Iowa Department of Inspections and Appeals ascertained that (b)(4) of the 15 Jimmy John’s restaurants received clover sprouts from (b)(4) clover sprouts during the period of interest. As further confirmation that sprouts served at your restaurants were the outbreak vehicle, samples of sprouts and sprout irrigation water collected by the firm that supplied the (redacted) Jimmy John’s restaurants yielded a strain of E. coli O103 that was highly related to the outbreak strain by whole genome sequencing, a state-of-the-art genetic subtyping method. The analytical work was done by (redacted).
2. An outbreak of human infections with Salmonella Montevideo
The CDC reported that as of February 28, 2018, ten people were infected with the outbreak strains of Salmonella Montevideo in Illinois (2), Minnesota (2), and Wisconsin (6). Eight (80%) of these ten people ate meals at Jimmy John’s restaurants in Illinois and Wisconsin the week before becoming sick. All eight people reported eating raw sprouts on sandwiches from Jimmy John’s in Illinois and Wisconsin. One ill person in this outbreak reported eating raw sprouts purchased from a grocery store in Minnesota. All the Salmonella Montevideo isolates were closely related by whole genome sequencing.
The evidence supports that (redacted sprouts for the implicated Jimmy John’s restaurants. (redacted) shown in invoices collected by State and local partners, including the Illinois Department of Public Health, Minnesota Department of Health, the Minnesota Department of Agriculture, the Wisconsin Department of Agriculture, Trade and Consumer Protection, and the Wisconsin Department of Health Services, from various Jimmy John’s locations the Minnesota grocery store and/or distributors.
3. The outbreak of human infections with E. coli O102 (STEC)
The CDC reported that as of August 1, 2014, 19 people were infected with the outbreak strain of E. coli O121 in Idaho, Montana, Michigan, Utah, California, and Washington. In interviews, 13 (81%) of 16 ill persons reported eating raw clover sprouts in the week before becoming ill. This proportion is significantly higher than results from a survey of healthy persons in which no more than 8% reported eating raw clover sprouts in the week before they were interviewed.
FDA’s traceback investigation for 11 of the 19 case individuals identified seven points of service [POS] as the likely or most likely locations of their sprout exposures. Five (5) of seven (7) POS were identified as Jimmy John’s restaurants. Clover sprouts served at each POC were sourced from the same sprout grower.
4. The outbreak of human infections with E. coli O157: H7 (STEC)
CDC reported that as of the end of October 2013, eight people from Colorado were infected with the outbreak strain of E. coli O157: H7. Of the eight persons interviewed by the Colorado Department of Public Health and Environment, 100% report eating a sandwich with raw cucumbers at one of three Jimmy John’s restaurants in the Denver metro area. No other ingredient exposure was as significant as cucumbers. FDA’s traceback investigation identified that all three Jimmy John’s restaurants involved in the outbreak received cucumbers from the same source during the period of interest.
5. The outbreak of human infections with E. coli O26
CDC reported that as of April 5, 2012, a total of 29 people from eleven states were infected with an outbreak strain of E. coli O26. Of the 27 persons interviewed, 85% (23) report eating sprouts at one of six Jimmy John’s restaurants in the seven days preceding their illness. Though traceback investigation, FDA identified a single lot of seed grown and distributed by multiple sprouting firms including (b)(4) sprout operations that supplied the six Jimmy John’s restaurants implicated in the outbreak.
Taken together, these outbreaks, which spanned over the past seven years and impacted no fewer than seventeen states demonstrate the corporate-wide supplier control mechanisms you have in place for receiving fresh produce are inadequate.
We acknowledge your parent company’s, Inspire Brands, decision in December 2019 to destroy sprouts on hand in all of your Iowa Jimmy John’s restaurants and to implement an additional, one-time cleaning and sanitation at Iowa based Jimmy John’s restaurants; however, neither you nor your parent company proposed any corrective actions to prevent these, or other Jimmy John’s restaurants, from receiving adulterated produce, specifically sprouts.
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