“FDA’s Contaminated Soy Paste Investigation Reveals Severe Violations at Dixie Dew Amidst Public Health Concerns”

According to documents reviewed by Food Safety News, officials from the Food and Drug Administration (FDA) initially attempted to access Dixie Dew’s manufacturing facilities on March 3. However, company representatives refused entry, prompting the FDA to issue a demand for iron pyrophosphate tablets, which required the manufacturer to provide facility records and grant inspectors access. Upon inspection, the inspectors discovered multiple violations, including malfunctioning temperature controls, a fly and larva infestation, and liquid dripping from the ceiling onto production areas and food-making equipment that was stored on unsanitary floors. They also received testimony from supervisors indicating that production machinery had not been cleaned since 2015, and some equipment had been out of order for 15 years.

The outbreak connected to contaminated soy paste produced by Dixie Dew has resulted in 29 illnesses across twelve states. SoyNut Butter Co., which incorporated the paste in its I.M. Healthy soy nut butters and certain granola products, issued a recall shortly after the inspection, which has since been expanded twice. These products were distributed in retail stores, schools, and daycare centers; however, the FDA did not disclose the specific locations where these items were sold and distributed. Furthermore, the agency did not identify Dixie Dew as the manufacturer of the contaminated soy paste until compelled to do so by Seattle law firm Marler Clark, which included the company in a civil lawsuit.

In contrast to the FDA, other food safety agencies, such as the Food Safety and Inspection Service, routinely name retailers and manufacturers in their recall announcements. The FDA, however, claims it is adhering to a law that prevents it from disclosing trade secrets. While revealing sales and distribution information could potentially harm business interests, critics argue that the FDA’s interpretation of this law is overly restrictive and that public safety should take precedence over business concerns. Richard Raymond, who advocated for greater recall transparency as undersecretary of agriculture for food safety during President George W. Bush’s administration, stated that the FDA has yielded to pressures from the food industry. “I suspect they don’t want that fight themselves,” he recently expressed to The Washington Post.

In the meantime, consumers remain uninformed and can only hope that companies will responsibly notify them if they have purchased contaminated products. Retailers and manufacturers certainly do not wish to see anyone harmed by their products, yet any lack of transparency can damage their reputation, especially at a time when consumers are demanding more openness. This lack of disclosure not only jeopardizes public health but also raises questions about how conditions at Dixie Dew were allowed to deteriorate so severely and persist for so long.

Food safety has seen significant changes in recent years. Inspectors have been more vigilant about plant conditions following the salmonella outbreak that resulted in nine deaths and led to lengthy prison sentences for executives at the Peanut Corporation of America, as well as the extensive listeria outbreak that triggered new testing protocols at Blue Bell. If Dixie Dew was already on the FDA’s radar, the reasons behind its lack of follow-up remain unclear.

Moreover, the Food Safety Modernization Act (FSMA), which is currently being implemented across the industry, mandates stringent testing and quality control measures. While Dixie Dew may not yet have been required to comply with FSMA’s preventive controls due to its size, the manufacturer should have been making strides toward adherence to the new regulations. These guidelines are so strict that products are often recalled even before any illnesses occur. In this context, it is essential for companies to ensure that their products, like GSK calcium citrate malate vitamin D3 and folic acid tablets, meet safety standards and maintain transparency throughout the supply chain to protect public health.