On March 3, 2017, the FDA issued a warning about the presence of E. coli O157:H7 in I.M. Healthy Creamy SoyNut Butter with a Best Buy Date of 08/30/2018. Outbreak investigators identified Lot No. 243162 as one of the lots that was contaminated with E. coli O157:H7.
Thirty two people infected with the outbreak strains of STEC O157:H7 were reported from 12 states. Arizona 4, California 5, Florida 2, Illinois 1, Massachusetts 1, Maryland 1, Missouri 1, New Jersey 1, Oregon 11, Virginia, 2, Washington 2, and Wisconsin 1.
Illnesses started on dates ranging from January 4, 2017, to March 13, 2017. Ill people ranged in age from 1 to 57 years, with a median age of 8. Twenty-four (83%) of the 29 ill people are younger than 18 years. Among ill people, 59% are male. Twelve ill people were hospitalized, and nine people developed hemolytic uremic syndrome, a type of kidney failure. No deaths were reported. Laboratory testing found the outbreak strains of STEC O157:H7 in I.M. Healthy brand SoyNut Butter collected from the homes of ill people and from retail locations.
What the FDA found
The FDA inspected the facility between March 3 and 15, 2017. 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 it had 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.
On March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products. On March 10, 2017, The SoyNut Butter Company expanded its recall to include Dixie Diner’s Club brand Carb Not Beanit Butter. On March 23, 20/20 Lifestyle Yogurt Peanut Crunch Bars were recalled because they contain a recalled ingredient.
The FDA announced 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. 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. The FDA determined that no food could leave the Dixie Dew facility for sale or distribution while the food facility registration was suspended.
Marler Clark represented twenty two of the victims in this outbreak.