The E. coli O157:H7 outbreak linked to recalled I.M. Healthy SoyNut Butter products has sickened 29 people in 12 states, some very seriously. Nine of those people have developed hemolytic uremic syndrome, a type of kidney failure. And twelve patients have been hospitalized because they are so sick. The question many families are asking is: where did that pathogenic bacteria come from?
We now know the answer to that question. The FDA has shut down Dixie Dew Product’s food facility registration as of March 27, 2017. That company is located in Erlanger, Kentucky.
The FDA inspected the Dixie Dew facility between March 3 and March 15, 2017. During FDA’s inspection, the investigators “observed grossly insanitary conditions that cause your firm’s soy nut butter products to be adulterated within the meaning of section 402(a)(4} of the FD&C Act, in that the foods have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth and/or rendered injurious to health,” according to the letter.
In a letter sent to the President of that company, the government states, “FDA has determined that food manufactured, processed, packed, received, or held by your facility has a reasonable probability of causing serious adverse health consequences or death to humans, and that your facility created, caused, or was otherwise responsible for such reasonable probability. FDA is issuing this Order under section 41S{b)(1) of the FD&C Act, and the Order is effective immediately upon your receipt. While this Order is in effect, pursuant to section 41S{b)(4) of the FD&C Act, no person can import or export food into the United States from your facility, offer to import or export food into the United States from your facility, or otherwise introduce food from your facility into interstate or intrastate commerce in the United States.”
The letter continues, “food products manufactured at your Erlanger, Kentucky facility have been identified as the likely source of a multistate outbreak of pathogenic E. coli, leading to 10 hospitalizations and 7 cases of hemolytic uremic syndrome (HUS). Second, during a recent inspection of your facility, FDA documented that your firm was manufacturing, preparing, and holding ready-to-eat food products under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Third, although you have responded to the agency’s inspectional observations by taking a number of corrective actions, we do not believe your response to date is adequate to address the risks caused by your facility.”
During the inspections of the Dixie Dew plant, inspectors observed a clear liquid substance dripping intermittently from a hole in a ceiling tile in the Soy Butter processing room, which landed on the processing room floor and splashed onto food manufacturing equipment. Mechanical forklifts were operating inside and outside the building for waste disposal and throughout the facility, including the soy nut butter production and packaging rooms. The Plant Manager said those forklifts are never cleaned.
Areas that contain waste disposals are susceptible to pest and rodent harborage. Pests and rodents carry pathogenic E. coli bacteria. In addition, there was no control of employee food traffic in and out of the processing facility. Employees were moving to and from the waste disposal area outside of the facility, which could also be a potential source for bringing pathogenic E. coli into the building.
In addition, hand washing stations did not have hand soap or hot water. There was no hot water in the hand washing sink or the sink in the soy nut butter processing room and, according to the facility’s maintenance supervisor, the hot water tank for those sinks was “out of repair” for two years.
Inspectors noted that food contact surfaces, floors, walls, and ceilings in the soy nut butter processing and packaging rooms were heavily coated with soy nut butter build-up from the previous production runs. Old soy nut butter was observed on the blender and kettle. The firm told investigators that the last full clean of the soy nut butter production room was in December 2015. No cleaning logs were kept at the time of inspection and had not been maintained in several years.
The facility submitted its response to the Form 483, which FDA inspectors file after an inspection has found conditions that, in their judgment, may “constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.” The FDA’s review of Dixie Dew’s response found that the “firm has not taken sufficient corrective actions to give adequate assurance that products manufactured and distributed by your facility are not at risk for contamination with E. coli 0157:H7.”
No one knows what other companies may have received Dixie Dew products. The FDA is not naming the manufacturer or any companies that use those products. And the FDA is not naming the grocery store chains that sold the SoyNut Butter products in the first place. We have assembled a list of those stores that sold I.M. Healthy SoyNut Butter products based on recall notices posted on the store’s web sites.
Officials in Oregon and Arizona found the outbreak strain of E. coli O157:H7 bacteria in open containers of the I.M. Healthy SoyNut Butter taken from patient’s homes. And California public health officials found the outbreak strain of E. coli bacteria in an I.M. Healthy SoyNut Butter product purchased at a retail grocery store.
