By: Alex Barlow

In a scathing order dated March 27, 2017, the FDA suspended the registration of the Dixie Dew Products, Inc. (Dixie Dew) facility located in Erlanger, Kentucky.  The facility was identified as the sole manufacturing site for the SoyNut Butter products that have been recently voluntarily recalled by The SoyNut Butter Company of Glenview, Illinois due to contamination with E. coli O157:H7.  These products include all I.M. Healthy Soy Nut Butter products and I. M. Healthy Granola products. In addition, Dixie Diner’s Club brand Carb Not Beanit Butter and 20/20 Lifestyle Yogurt Peanut Crunch Bars have been recalled over concerns that these products may also be contaminated.  In Canada, SoLo GI brand energy bars are also recalled.

In an inspection that occurred between March 3, 2017 and March 15, 2017, the FDA found a cascade of insanitary conditions that appear to have contributed to the E. coli outbreak that has now resulted in 29 people confirmed to have been infected through positive testing and genetic matching with the rare strain of E. coli O157:H7.  Of these 29 people, most of whom are children, 9 have developed the additional the further complication of hemolytic uremic syndrome (HUS), a very serious and often life threatening condition.  In at least one case, the E. coli infection resulted in the victim falling into a coma and experiencing severe neurological complications.

The conditions observed by the FDA investigators were so severe that it characterized the Dixie Dew facility as “grossly insanitary” and that the soynut butter manufactured there had a “reasonable probability of causing severe health consequences or death.”  A partial list of the insanitary conditions discovered by the FDA includes:

  • Observing a clear liquid substance dripping from a hole in the ceiling in the SoyNut Butter processing room and splashing onto the food manufacturing equipment below.
  • Using mechanical forklifts both inside and outside the facility for waste disposal and other activities inside the production and packaging rooms, creating an avenue for pathogenic E. coli to be introduced from pest and rodent waste.
  • Failing to provide adequate handwashing facilities for employees that come into contact with the production equipment, including not having hot water in the sinks (for over 2 years) and not having functioning hand soap dispensers.
  • Observing that food contact services, floors, walls and ceilings in the soynut butter processing areas were covered with old soynut butter residue. The old soynut butter was seen on the blender, kettle and other production equipment used in the manufacturing process.  It was also found that the last full cleaning of the production room happened in approximately December of 2015, over a year before the suspected beginning of this outbreak.
  • Finding that the facility uses hot oil rather than detergents or sanitizers for periodic cleaning. However, there were no logs showing that the cleaning was actually taking place or how often.
  • Finding that machinery used in the manufacturing process often shut off due to amperage overload.
  • Finding that the thermometer on certain manufacturing equipment had never been verified for accuracy and that the temperature probe and chart recorder were not functioning properly. This is potentially very dangerous because maintaining proper temperature in manufacturing process is critical to killing off and/or preventing the growth of E. coli.  It appears that Dixie dew failed to maintain its equipment in such a way that it could verify that its “kill step” to ensure that E. coli could not survive in the end product actually achieved the required temperature.

Testing performed by the State of Maryland Department of Health and Mental Hygiene Lab showed that unopened jars of I.M. Healthy Soy Nut Butter were contaminated with very high levels of fecal coliforms which shows fecal contamination of the product.  Coliform bacteria, of which E. coli O157:H7 is one, are heat sensitive.  The E. coli contamination would have been eliminated from the food and none of the victims would have fallen ill if the kill step had been properly administered by Dixie Dew.  Further, had Dixie Dew or The SoyNut Butter Company performed adequate testing internally on the products, it likely would have prevented the adulterated product from reaching the consumers.  However, the buffer solution and culture plates utilized at the facility were expired at the time of the outbreak.  This calls into question not only their effectiveness, but the rigor with which the testing, if any, was performed.

Shockingly, even after having been presented with the inspection findings, Dixie Dew failed to take adequate steps to correct the identified issues.  While Dixie Dew did commit to repairing the leaking ceiling, labeling the forklifts on here they could be properly used, installing a new hot water heater and soap dispenser, retraining employees on hand washing and repairing certain aspects of the building, it failed to address a myriad of other important concerns.  It failed to properly document whether or not it sanitized the equipment used and how – merely stating that the equipment had been disassembled and cleaned.  It also failed to commit to calibrating the thermometer that is used to measure and verify its kill step.

While the FDA order and inspection report answer many questions about how this outbreak originated and the failures that led to it, it also raises many more questions.  For instance, why did Dixie Dew allow its facility to fall into such an insanitary state when it could clearly put the public at risk? And why did The SoyNut Butter Company employ such a facility to manufacture the products it was marketing across the country as a “healthy” alternative to peanut butter?  Did anyone actually inspect the facility to make sure it was safe and capable of making “healthy” food for the public to consume?  For how long did the management of Dixie Dew and The SoyNut Butter Company know about the conditions in the facility before the outbreak?  If they didn’t know, why not?

These questions will likely have to be answered during the discovery phase of the litigation currently pending in the State and Federal Courts of Illinois.  Dixie Dew was named as a Defendant in a case filed on March 31, 2017 in Illinois federal court by the law firm of Robins Cloud LLP.  And it will be added as a Defendant to two previously filed cases in Illinois State Court.  The plaintiffs and the public have much yet to discover about how this public health tragedy occurred.  Hopefully, it will inform us about what needs to be done to deter similar activity by food producers in the future.