The FDA has suspended the food facility registration of Dixie Dew Products, Inc. On March 28, 2017, the FDA used authorities granted under the 2011 FDA Food Safety Modernization Act to suspend that registration because products manufactured in that facility may be contaminated. Soy nut butter manufactured by Dixie Dew has been implicated in the I.M. Healthy SoyNut Butter E. coli O157:H7 HUS outbreak that has sickened at least 29 people in 12 states.
The FDA’s decision was prompted by that E. coli O157:H7 outbreak and the findings of the 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. The Suspension Order applies to the entire facility.
The government has determined that the soy nut butter in the recalled I.M. Healthy SoyNut Butter products had been made by Dixie Dew. On March 3, 2017, Dixie Dew refused to allow FDA investigators access to the facility’s environmental sampling and production records. So the FDA issued a Demand for Records under section 414 of the Federal Food, Drug, and Cosmetic Act. Dixie Dew then provided the government with the necessary records.
At the end of the inspection, FDA gave Dixie Dew a Form FDA 483, which is used when inspectors find objectionable conditions which “may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.” Dixie Dew then responded to that report in writing with a list of actions they took to correct conditions. But the FDA found that those actions were not adequate to address the risks that were identified.
The notice states that any brand owner of a product made by Dixie Dew should contact the Director of Compliance Branch at a FDA district office. The FDA is collecting and testing other products made by Dixie Dew.
All of the soy nut butter products made by Dixie Dew have been recalled. Those products include all I.M. Healthy SoyNut Butter products and Dixie Diner’s Club Carb Not Beanit Butter. In addition, Pro Sports Club of Bellevue, Washington is recalling 36,957 Yogurt Peanut Crunch Bars made with recalled Dixie Dew products.
If you purchased any of these products, do not eat them. Throw them away in a sealed package or take them back to the store where you bought them for a refund. Wash your hands well with soap and water after handling these products.
The symptoms of an E. coli O157:H7 infection include severe stomach and abdominal cramps and bloody diarrhea. About 5 to 10% of those diagnosed with this STEC infection develop hemolytic uremic syndrome (HUS), which causes kidney failure.
In this outbreak, nine of 29 people have developed HUS, for a rate of 31%. That very high rate is attributed, in part, to the age of the patients in this outbreak; the median age is 8. Children who are 5 and younger are more likely to develop HUS. The symptoms of HUS include little urine output, lethargy, pale skin, easy bruising, and bleeding from the nose or mouth.
Pritzker Hageman, America’s food safety law firm, successfully represents people harmed by adulterated food products in outbreaks throughout the United States. Its lawyers have won hundreds of millions of dollars for survivors of foodborne illness, including the largest verdict in American history for a person harmed by E. coli and hemolytic uremic syndrome. The firm also publishes the E-news site, Food Poisoning Bulletin (https://foodpoisoningbulletin.com/), a respected source for food safety news and information. Pritzker Hageman lawyers are regularly interviewed by major news outlets including the New York Times, CNN, and the Wall Street Journal. In addition, the firm represents people harmed by pathogenic microorganisms in Legionnaires‘ disease, surgical site infection and product liability cases.