Next Steps:

It is likely over the coming weeks that the following will be happening or are even happening now:

  • Criminal Investigation of Dixie Dew and perhaps I.M. Healthy
  • Additional Illnesses
  • Additional Civil Lawsuits – both illness victims and commercial recall claims
  • Bankruptcy of one or both of Dixie Dew and I.M Healthy
  • Onsite visits of Dixie Dew
  • Retailers being added as defendants to the Civil Lawsuits

Outbreak Update:

The I.M. Healthy brand Soy Nut Butter paste outbreak includes at least 29 confirmed with infections from the outbreak strain of E. coli O157:H7 across 12 states.

While the most recent illness began March 13, the CDC cautioned that additional people who became ill after March 7 might not yet be included in the case count because of the two to three weeks needed for lab confirmation and reporting. Illnesses started on Jan. 4.

Of the 29 victims, 24 are younger than 18 years old. Victims’ ages range from 1 to 57, with a median age of 8 years old. A dozen of the victims have had symptoms so severe they required hospitalization. Nine victims developed hemolytic uremic syndrome (HUS).

Public health officials have interviewed 28 of the victims — or their parents — and 21 of them reported either eating I.M. Healthy brand SoyNut Butter in the week before becoming ill at home; at a facility that served I.M. Healthy brand SoyNut Butter; or at childcare centers that served I.M. Healthy brand SoyNut Butter and I.M. Healthy brand granola coated with SoyNut Butter.

FDA Investigation:  

The FDA also has finally named and shut down the manufacturer of soy nut butter implicated in an ongoing nationwide E. coli outbreak, noting that records and employees at Dixie Dew Products Inc. revealed food safety violations going back at least 15 years.

Documents released Thursday show the FDA was investigating Dixie Dew Products production facility in Erlanger, KY, from at least March 3 in relation to the E. coli outbreak. The federal agency did not publicly name the company as the manufacturer until Thursday evening, two days after notifying Dixie Dew president Robert Carl that his food facility registration was suspended.

In an accompanying report known as a Form 483, FDA inspectors detailed filthy conditions at the Dixie Dew plant. They documented:

  • broken temperature control equipment;
  • liquid dripping from the roof in production areas;
  • an infestation of flies and larva;
  • food production tools stored on dirty, wet floors;
  • and statements from supervisors about equipment being broken for 15 years, soy paste production machines not having been cleaned since 2015, and no hot water in hand-washing sinks for two years.

“We issued the suspension of registration on Tuesday, but they had a due process period of time in which they could request a hearing — even though the suspension order was effective immediately — hence the delay in announcing,” an FDA spokeswoman said Thursday evening.

FDA officials have repeatedly cited a clause in federal law that prohibits the agency from revealing “confidential corporate information” (CCI) such as transactions between food ingredient suppliers and food manufacturers.

The SoyNut Butter Co. of Glenview, IL, had also kept secret the name of its soy paste supplier, referring to it only as a “contract manufacturer” in recent notices on the SoyNut Butter website. However, at some point Wednesday the most recent post on the SoyNut Butter website, dated March 9, was changed to say “our contract manufacturer Dixie Dew Products.”

“On March 3, 2017, Dixie Dew refused to allow FDA investigators access to the facility’s environmental sampling and production records; the FDA subsequently issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act. After receiving the Demand for Records, Dixie Dew provided FDA investigators with the necessary records,” according to FDA’s suspension notice.

“At the close of the inspection, the FDA provided Dixie Dew with a list of the investigators’ inspectional observations — Form FDA 483 — noting objectionable conditions seen during the inspection. Dixie Dew responded to the report in writing with a list of actions the firm has taken to correct the conditions; however, FDA found the corrective actions were not adequate to fully address the risks that were identified, and issued the Suspension Order to prevent further illnesses from occurring.

Specific problems noted in the suspension order and Form 483 included (blanks reflect redacted information):

  • investigators observed grossly insanitary conditions that cause your firm’s soy nut butter products to be adulterated;
  • 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 previous production runs.
  • firm does not routinely wash and sanitize smaller pipes, pipe fittings, gaskets, seals, “or the rubber _____ plug” when broken down following a production run;
  • firm does not conduct a kill step for SoyNut Butter product remaining in your firm’s mixing kettle leftover from a production run;
  • plant Manager stated, up to _____ may remain in the kettle overnight or weekend prior to resuming production. You and your Plant Manager stated the kettle is shut off when product remains in the kettle overnight and/or over the weekend;
  • plant manager and maintenance supervisor reported your _____ machine, used for fine mixing of the SoyNut Butter and ________, routinely shuts off during processing. Your Plant Manager stated this occurs one to two times per day and, this problem has persisted for approximately 15 years despite repeated maintenance intended to correct the problem;
  • firm monitors the SoyNut ______ with a ______ thermometer, but plant manager stated he has never verified the accuracy of this instrument;
  • you and your plant manager report, your temperature probe and chart recorder, initially engineered to verify and record _____ of product in the large mixing kettle, is not functioning properly and has not been used for well over a year.

FDA inspectors also noted problems with Dixie Dew’s food safety testing program, noting the company’s “failure to perform microbial testing where necessary to identify possible food contamination.” Inspectors found the testing materials on hand at Dixie Dew had expired in July 2016 and October 2015.

Problems in the Dixie Dew quality control lab were described in detail by FDA inspectors.

“An apparent fly infestation in your firm’s Quality Control and Product Development Laboratory was observed on 3/13/2017. Small apparent flies and fly larvae, too numerous to count, were inside an unplugged chest freezer,” according to the 483 report.

“A sealed blue plastic bag was inside the freezer and according to your plant manager, contained an egg product that became rotten when power was disconnected. The small apparent flies were observed along the laboratory counters and flying throughout the laboratory.”

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of E. coli outbreaks and hemolytic uremic syndrome (HUS). The E. coli lawyers of Marler Clark have represented thousands of victims of E. coli and other foodborne illness infections and have recovered over $600 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our E. coli lawyers have litigated E. coli and HUS cases stemming from outbreaks traced to ground beef, raw milk, lettuce, spinach, sprouts, and other food products.  The law firm has brought E. coli lawsuits against such companies as Jack in the Box, Dole, ConAgra, Cargill, and Jimmy John’s.  We have proudly represented such victims as Brianne Kiner, Stephanie Smith and Linda Rivera.

If you or a family member became ill with an E. coli infection or HUS after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark E. coli attorneys for a free case evaluation.