On April 22, 2015, the United States District Court for the Northern District of Illinois entered a consent decree of permanent injunction against Wholesome Soy Products Inc., of Chicago, Illinois, owner Julia Trinh, and manager Paul Trinh, following multiple findings of contaminated food and environmental samples by the U.S. Food and Drug Administration.
The consent decree prohibits Wholesome Soy Products from receiving, processing, manufacturing, preparing, packing, holding and distributing ready-to-eat mung bean and soybean sprouts. The company sold its products to wholesale distributors and retail stores in Illinois.
“It is FDA’s responsibility to ensure that appropriate action is taken when we conduct inspections and find results that could put consumers at risk,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “Agreeing to the consent decree is a first step in the right direction for this company.”
This action follows a multi-agency collaboration among the FDA, U.S. Department of Justice, the Centers for Disease Control and Prevention and the Illinois Department of Health.
In August 2014, during a routine inspection of the company, the FDA collected environmental and product samples that tested positive for Listeria monocytogenes (L. mono), a foodborne pathogen that can cause serious illness or even death in vulnerable groups including elderly adults and those with impaired immune systems (such as HIV/AIDS, cancer, diabetes, kidney disease and transplant patients). In pregnant women, L. mono can cause miscarriage, stillbirth and serious illness or death in newborn babies.
On Aug. 28, 2014, Wholesome Soy Products agreed to voluntarily recall and temporarily stop production of their sprout products. The company reported that they cleaned and sanitized their facility. They also hired an independent consultant to collect and test several samples that reportedly came back negative for L. mono. They resumed operations on Sept. 15, 2014, after making these corrections.
Later that month, the company was notified of an outbreak of human infections with a strain of L. monolinked to strains found in the samples previously collected by the FDA during its inspection of the company. According to the CDC, there were four cases in Illinois and one in Michigan. Of those five patients, all were hospitalized and two died.
The FDA began a follow-up inspection of Wholesome Soy Products in October 2014 to verify the effectiveness of the company’s corrective actions. Nine samples taken by FDA inspectors tested positive for L. mono. Due to these findings, the FDA concluded that sprouts could not be safely manufactured by the company in that environment.
In November 2014, the company agreed to voluntarily shut down operations, and the Illinois Department of Public Health oversaw the company’s voluntary destruction of their remaining inventory. The CDC closed its investigation in January 2015 and no further cases of illness in connection to the company have been reported.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.