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FDA Calls Jimmy John’s Controls for Receiving Produce ‘Inadequate’

A “freaky fast” company may want to slow down and reexamine its supply chain.

FDA posted a warning letter issued to Jimmy John’s Franchise LLC Feb. 25 for engaging in a pattern of receiving and selling adulterated fresh produce, specifically clover sprouts and cucumbers. FDA also posted a warning letter to Sprouts Unlimited Wholesale Foods for supplying sprouts to Jimmy John’s that sickened 22 people between Nov. and Dec. 2019, the most recent outbreak.

The pathogens associated with the outbreaks included Shiga toxin-producing Escherichia coli (STECs) and Salmonella enterica. STECs can cause serious illness, including diarrhea, often with bloody stools, according to FDA. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called hemolytic uremic syndrome (HUS), which most likely occurs in young children and the elderly. This condition can lead to kidney damage and death. Salmonella is a pathogenic bacterium that can cause serious, sometimes fatal, infections. These infections can be especially dangerous in young children.

The Iowa Department of Public Health reported as of Jan. 7, 2020, a total of 22 people from Iowa were infected with the outbreak strain of E. coli O103. The Iowa Department of Public Health interviewed 20 of the 22 case individuals, of which all of them reported eating at one or more of 15 Jimmy John’s restaurants. Of the 20 interviewees, 45% reported eating sprouts in the week before their illness.

The agency stated the proportion was significantly higher than results from a survey of healthy people in which 3.3% said they ate sprouts in the seven days before being interviewed.

A second E. coli outbreak was tracked in Idaho, Montana, Michigan, Utah, California, and Washington in Aug. 2014.

Nineteen people were infected with the outbreak strain of E. coli O121, with 16 reporting eating raw clover sprouts in the week before becoming ill. Additionally, FDA’s traceback investigation for 11 of the cases identified seven points of service as the likely locations of the exposure, with five being Jimmy John’s restaurants.

The third E. coli outbreak referenced by FDA developed in Colorado during Oct. 2013 and was linked to cucumbers. Of the eight ill people interviewed by Colorado Department of Public Health and Environment, all indicated they ate a sandwich with raw cucumbers at one of three Jimmy John’s restaurants in the Denver metro area. 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.

CDC reported that as of April 5, 2012, a total of 29 people from 11 states were infected with an outbreak strain of E. coli O26 in the fourth referenced outbreak. Of the 27 persons interviewed, 85% reported eating sprouts at one of six Jimmy John’s restaurants in the seven days preceding their illness.

The agency also reported a more recent salmonella outbreak when they discovered 10 people infected with Salmonella Montevideo in Illinois, Minnesota, and Wisconsin as of Feb. 28, 2018. Eight of the 10 people ate meals at Jimmy John’s restaurants in Illinois and Wisconsin the week before becoming sick, with all eight reporting eating raw sprouts on sandwiches from Jimmy John’s in Illinois and Wisconsin.

“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,” said FDA. “We acknowledge your parent company’s, Inspire Brands, decision in Dec. 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.”

Meanwhile, FDA inspected Sprouts Unlimited’s sprouting operation located in Marion, IA, between Dec. 31, 2019, and Jan. 9. FDA conducted the inspection after determining sprouts grown at the operation were linked by the Iowa Department of Inspections and Appeals, Department of Public Health, to an outbreak of STEC in Iowa.

FDA said during its inspections, investigators documented numerous serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation that may have resulted in the contamination of sprouts with human pathogens. Accordingly, the agency argued the company’s mung bean, red bean, alfalfa, clover, broccoli, onion, radish, pea, and lentil sprout products, and any combination thereof, were considered adulterated under the FD&C Act, in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or been rendered injurious to health.

Following the publication of the letters, Jimmy John’s removed the sprouts from the menu systemwide. “This removal was out of an abundance of caution and was not initiated by any known, immediate threat,” said Jimmy John’s president James North, reported USA Today (Feb. 25).