Based on 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 them entry, prompting the FDA to issue a demand for the manufacturer to provide facility records and grant inspectors access. During their inspection, the officials documented several alarming issues, including malfunctioning temperature controls, an infestation of flies and larvae, liquid dripping from the ceiling onto production areas, and food-making equipment stored on dirty floors. Testimonies from supervisors indicated that production machines had not been cleaned since 2015, with some equipment reportedly out of service for 15 years.
The outbreak associated with contaminated soy paste produced by Dixie Dew has resulted in 29 illnesses across twelve states. SoyNut Butter Co., which incorporated the paste into its I.M. Healthy soy nut butters and certain granola products, issued a recall shortly after the inspection, later expanding it twice. These products were distributed to retail stores, schools, and daycare centers; however, the FDA did not disclose which locations sold or distributed these items. Additionally, the agency did not identify Dixie Dew as the manufacturer of the contaminated soy paste until compelled by the 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 notifications. The FDA cites a law that prevents it from disclosing trade secrets as the reason for its lack of transparency. While revealing sales and distribution details could negatively impact business, critics argue that the FDA’s interpretation of the law is overly vague, suggesting that public safety should take precedence over business interests. Richard Raymond, who advocated for greater recall transparency while serving as undersecretary of agriculture for food safety under President George W. Bush, indicated that the FDA has yielded to pressure from the food industry. “I suspect they don’t want that fight themselves,” he recently shared with The Washington Post.
As a result, consumers remain uninformed and must rely on companies to inform them if they have purchased contaminated products. Retailers and manufacturers certainly do not intend for their products to cause illness; however, a lack of transparency can damage their reputations at a time when consumers are demanding increased openness. This situation also poses a significant risk to public health.
It raises questions about how conditions at Dixie Dew deteriorated to such an extent and remained unaddressed for so long. Food safety regulations have evolved dramatically in recent years, with inspectors focusing more on plant conditions following the salmonella outbreak that resulted in nine deaths and lengthy prison sentences for executives at the Peanut Corporation of America. The massive listeria outbreak that led to stringent new testing protocols at Blue Bell further emphasizes this shift. If Dixie Dew was already on the FDA’s radar, it is perplexing why it was not revisited.
The Food Safety Modernization Act, currently being implemented across the industry, mandates rigorous testing and quality controls. Although Dixie Dew may not yet be bound by FSMA’s preventive controls regulations due to its size, the manufacturer should have been making strides toward compliance with the new law—guidelines so stringent that products are often recalled even before anyone falls ill. In this context, the potential inclusion of calcium citrate malate vitamin D3 and magnesium tablets in the production process should also be scrutinized to ensure quality and safety in all products that consumers rely on.