No food may leave the facility for sale or distribution
March 30, 2017
- 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).
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.
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.
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.
- FDA Form 483 (Inspectional Observations) for Dixie Dew Products, Inc.
- Suspension of Food Facility Registration Order
- FDA Investigates Multistate Outbreak of E. coli O157:H7 Infections Linked to SoyNut Butter