A publication of the Kentucky Center for Public Service Journalism

FDA shuts down Erlanger’s Dixie Dew Products amid E.Coli concerns related to I.M. Healthy SoyNut Butter

By Mark Hansel
NKyTribune managing editor

The U.S. Food and Drug Administration has shut down a food processing plant in Erlanger that has been linked to an ongoing E. coli outbreak.

On March 28, the FDA suspended the food facility registration of Dixie Dew Products, Inc. (Dixie Dew), because products manufactured in the facility may be contaminated.

Soy nut butter manufactured by Dixie Dew and sold under the brand name I.M. Healthy SoyNut Butter, has been implicated in an outbreak of ecoli , according to an FDA report.

The FDA’s investigation into the Dixie Dew plant located at 1360 Jamike Avenue, in Erlanger, identified 10 observed violations at the facility dating back several years.

Among the violations listed in the report of an inspection of the facility include the claim that, “a clear liquid substance was observed dripping intermittently from a hole in a ceiling tile in your firm’s Soy Butter Processing Room and landing on the Processing Room floor and splashing on food manufacturing equipment below.”

The report indicates the dripping persisted through the duration of a processing run and states plant employees identified the source as water leaking from a pipe that runs above the ceiling tiles.

The Dixie Dew website states the company manufactures a wide variety of products for the food industry, including caramel and chocolate sauces, fillings and toppings.

Dixie Dew was established in 1934 and had 18 full-time employees in 2016, according to the Kentucky Cabinet for Economic Development. The State website identifies Robert Carl as president/CEO of Dixie Dew Products.

The FDA report indicates that during a March 3, inspection, “Dixie Dew refused to allow FDA investigators access to the facility’s environmental sampling and production records.” The FDA then issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act, after which, Dixie Dew complied with the request.

The suspension of registration at Dixie Dew Products applies to the entire facility, but the FDA does not have any evidence at this time that other products are contaminated, or subject to recall.

In March, Congresswoman Rosa DeLauro, D-Conn., called for the FDA to reverse its policy of withholding the names and locations of stores and schools where recalled food products are sold. DeLauro said the agency has not responded to her letter, nor has it changed its policy.

The first two pages of the FDA report identifying 10 observed violations at Erlanger’s Dixie Dew Products. The report resulted in the facility’s suspension of registration, forcing the plant to shut down.  Click here to see the entire report (click on documents to enlarge).

Delauro released this statement regarding the contamination at the Dixie Dew plant:

“Dixie Dew’s gross negligence is sickening dozens of Americans and leaving thousands more at risk of falling seriously ill. With fifteen years of food safety violations, I am outraged that it took 29 Americans falling sick before the Dixie Dew plant closed,” said DeLauro. “Not only did Dixie Dew fail to take action to prevent contamination of its products, we do not even know all of the names and locations of where the recalled products were sold.

“While the FDA made the right decision in shutting down the Dixie Dew plant, the agency should take another step forward and reverse its policy of withholding the names and locations of stores and schools where recalled food products are sold,” continued DeLauro. “As we have seen with Dixie Dew, it is irresponsible and insufficient to rely on the good faith of food corporations to provide all the necessary recall information. Americans deserve to know these details to ensure their health and safety.”

The FDA reports that nine of those impacted by the E. coli outbreak have develop a potentially life-threatening complication, known as hemolytic uremic syndrome (HUS).

Symptoms of HUS include fever, abdominal pain, feeling very tired, decreased frequency of urination, small unexplained bruises or bleeding, and pallor. While most of those that contract HUS recover within a few weeks, the illness can cause permanent damage and even death.

Persons with HUS should be hospitalized because their kidneys may stop working or they could develop other serious problems such as hypertension, chronic kidney disease, and neurologic problems.

The FDA released this statement, which includes details and consumer and industry information regarding the facility:

“Dixie Dew’s gross negligence is sickening dozens of Americans and leaving thousands more at risk of falling seriously ill. With fifteen years of food safety violations, I am outraged that it took 29 Americans falling sick before the Dixie Dew plant closed. Not only did Dixie Dew fail to take action to prevent contamination of its products, we do not even know all of the names and locations of where the recalled products were sold,” Congresswoman Rosa DeLauro, D-Conn.

No food may leave the facility for sale or distribution

March 30, 2017

Fast Facts

  • On March 28, 2017, the FDA used authorities granted under the 2011 FDA Food Safety Modernization Act to suspend the food facility registration of Dixie Dew Products, Inc. (Dixie Dew) of Erlanger, Kentucky, because products manufactured in this facility may be contaminated.
  • Soy nut butter manufactured by Dixie Dew has been implicated in an outbreak of E. coli O157:H7.
  • The FDA’s decision to suspend the registration of Dixie Dew Products was prompted by the E. coli O157:H7 outbreak and the findings of FDA’s March 2017 inspection of Dixie Dew, which identified insanitary conditions that could lead to contamination with E. coli O157:H7 in finished products.
  • No food can leave the Dixie Dew facility for sale or distribution while the food facility registration is suspended.

What is the problem and what is being done about it?

On March 28, 2017, the FDA issued a Suspension of Food Facility Registration Order to Dixie Dew of Erlanger, Kentucky, after an inspection revealed insanitary conditions at the firm that could affect the safety of finished products.

The FDA inspected the facility between March 3 and 15, 2017. The inspection was conducted in response to an outbreak of E. coli O157:H7 in which many of those who became ill reported eating I.M Healthy SoyNut Butter products. The agency determined the soy nut butter in the products had been made by Dixie Dew, and identified Dixie Dew’s soy nut butter as the likely source of the outbreak. 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.

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 Suspension Order applies to the entire facility. While the order is in effect, no food product may leave the facility for sale or distribution. 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.

What are the symptoms of E. coli?

The symptoms of Shiga toxin-producing E. coli (STEC) from E. coli O157:H7 infections vary for each person but often include severe stomach cramps and bloody diarrhea. If there is fever, it is usually not very high (less than 101 degrees Fahrenheit/less than 38.5 degrees Celsius). Most people get better within 5–7 days. Some infections are very mild, but others are severe or even life-threatening.

Around 5–10 percent of those who are diagnosed with STEC infection develop a potentially life-threatening complication, known as hemolytic uremic syndrome (HUS).

Congresswoman Rosa DeLauro, D-Conn, has called for the FDA to release names and locations of stores and schools where recalled food products, such as those at the Dixie Dew facility in Erlanger, are sold (provided photo).

Symptoms of HUS include fever, abdominal pain, feeling very tired, decreased frequency of urination, small unexplained bruises or bleeding, and pallor. Most people with HUS recover within a few weeks, but some suffer permanent damage or die. People who experience these symptoms should seek emergency medical care immediately. Persons with HUS should be hospitalized because their kidneys may stop working (acute renal failure), but they may also develop other serious problems such as hypertension, chronic kidney disease, and neurologic problems.

Nine patients in the ongoing outbreak have developed HUS.

Who is at risk?

People of any age can become infected. Children under the age of 10 and the elderly are more likely than others to develop severe illness, including HUS, but even healthy older children and young adults can become seriously ill. In this particular outbreak, the age range of ill patients is between 1 and 57 years, with a median age of 8 years.

Consumer Advice

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.

Industry Advice

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 FDA report indicates the Dixie Dew facility in Erlanger will remain closed until the agency determines that adequate grounds do not exist to continue the suspension of registration.

Contact Mark Hansel at mark.hansel@nkytrib.com

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