The FDA 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.
Federal officials say they believe all of the potentially contaminated products made with soy paste from the Kentucky company have been recalled, but they are asking the food industry, foodservice operations, schools and consumers to double check the ingredients they have on hand.
The SoyNut Butter Co. recalled its I.M. Healthy brand products made with soy paste from Dixie Dew earlier this month after E. coli infections were linked to them with DNA analysis.
It expanded the recall to include Dixie Diner’s Carb Not Beanie Butter. On March 25 “Yogurt Peanut Crunch” protein bars, packaged under the 20/20 Life Styles brand, were recalled.
“All of the soy nut butter products manufactured by Dixie Dew have been recalled. Although the suspension of registration applies to the entire facility, FDA does not currently have evidence to indicate that any other products manufactured in the facility are contaminated or otherwise impacted and subject to recall,” according to the suspension notice.
“If you are the brand owner of a product manufactured by Dixie Dew, the FDA encourages you to contact the Director of Compliance Branch at your FDA district office to discuss your product(s). The FDA is currently collecting and testing other products manufactured by Dixie Dew.”
The suspension order applies to the entire facility. While the order is in effect, no food product may leave the facility for sale or distribution.
Just before the Food and Drug Administration went public Thursday evening with its action against Dixie Dew, other federal officials reported the E. coli outbreak linked to the so-called peanut butter substitute continues to grow.
More victims in more states
The soy paste outbreak includes at least 29 confirmed with infections from the outbreak strain of E. coli O157:H7 across 12 states, according to a Thursday afternoon update from the Centers for Disease Control and Prevention.
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), a type of kidney failure.
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 found filth, flies, maggots and more
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.”
Seattle attorney Bill Marler was the first to name Dixie Dew as the soy paste manufacturer in a civil action he filed on behalf of the parents of a sick child. He offered a bit of free advice to the Dixie Dew officers and owners Thursday evening after hearing about the FDA’s suspension action and inspection report.
“After reading the Form 483, I would recommend that the principles of Dixie Dew lawyer up with a good criminal defense council because assuming the Trump Administration is as aggressive as the Obama Administration was with respect to investigation and prosecution under the Food, Drug and Cosmetic Act, they should be worried,” Marler said.
The Seattle law firm Marler Clark is representing 15 of the victims in the outbreak and has filed four civil actions against SoyNut Butter Co and Dixie Dew Products in federal court.
Similarities between peanut butter, soy butter situations
Marler’s reference to criminal prosecutions comes a year after two peanut butter moguls began serving federal sentences for their actions related to a 2008-09 Salmonella outbreak that sickened hundreds and killed at least nine people.
Many of the details about the current E. coli outbreak and investigation of Dixie Dew Products mirror those of the outbreak traced to the Peanut Corporation of America. The CEO and a peanut broker — brothers Stewart Parnell, 61, and Michael Parnell, 57 — have been in federal prisons since February 2016. They are serving 28- and 20-year sentences, respectively.
The peanut butter production facility also had dirty equipment, a leaky roof and pathogens in its finished product. The company shipped product before receiving test results and lied and falsified documents about positive Salmonella results.
The U.S. Justice Department filed criminal charges against the Parnell brothers and others at the company, some of whom traded testimony against the Parnells in their plea agreements.
Meanwhile, back at Dixie Dew
Standing policy at the Department of Justice does not allow the department to comment on current investigations or even confirm them. Neither will the FDA comment on whether it is working with prosecutors. However, considering initial stonewalling by Dixie Dew officials when FDA investigators showed up March 3 and President Trump’s promises to pursue law and order government, criminal charges are not beyond the realm of possibility.
“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.
“The FDA will reinstate Dixie Dew’s food facility registration only when the agency determines that adequate grounds do not exist to continue the suspension of registration.”
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.”
For additional details on the outbreak and recalls, please see:
- Tainted soy butter spurs recalls one by one; FDA remains mum
- Civil suit does what FDA won’t — names soy nut butter maker
- I.M. Healthy SoyNut Butter outbreak reaches Portland school
- “Canada recalls I.M. Healthy products; no E. coli cases there yet”
- “Oregon confirms E. coli in SoyNut Butter from victims’ home”
- “UPDATE: SoyNut Butter Co. expands recall to all soy butters, granola”
- “Parents of 8-year-old E. coli victim sue SoyNut Butter Co.”
- “I.M. Healthy SoyNut Butter recall; E.coli hits kids”
- “UPDATE: Patients on both coasts ate ‘SoyNut Butter’ before becoming ill”
- “I.M. Healthy soy nut butter linked to E. coli outbreak”
- “CDC, states investigating foodborne sources in E. coli outbreak”
Editor’s note: Bill Marler is publisher of Food Safety News.
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