According to documents examined 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 formal request for the manufacturer to submit facility records and grant inspector access. Upon inspection, the inspectors noted several alarming conditions, including malfunctioning temperature controls, an infestation of flies and larvae, liquid dripping from the ceiling onto production areas, and food-making equipment stored on unsanitary floors. Supervisors testified that production machines had not been cleaned since 2015 and that some equipment had been 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 various granola products, issued a recall shortly after the FDA inspection, subsequently expanding it twice. These products were distributed to retail stores, schools, and daycare centers; however, the FDA did not disclose the specific locations where these products were sold. Furthermore, the agency did not identify Dixie Dew as the manufacturer of the contaminated soy paste until compelled to do so by the Seattle law firm Marler Clark, which included the company in a civil lawsuit.
Other food safety agencies, such as the Food Safety and Inspection Service, typically identify retailers and manufacturers in their recall announcements. So, why does the FDA refrain from doing the same? The agency cites a law that prohibits it from disclosing trade secrets. While publicizing sales and distribution information might negatively impact business, critics argue that the FDA’s interpretation of the law is overly complex, suggesting that public safety concerns should take precedence over business interests. Richard Raymond, who advocated for greater recall transparency as undersecretary of agriculture for food safety under President George W. Bush, commented that the FDA may be avoiding confrontation with the food industry. “I suspect they don’t want that fight themselves,” he recently told The Washington Post.
Meanwhile, consumers remain uninformed, relying on companies to alert them if they have purchased contaminated products. Retailers and manufacturers certainly do not want their products to cause illness, but a lack of transparency can damage their reputation, especially as consumers increasingly demand clearer information. This lack of disclosure also poses significant risks to public health.
It is puzzling how conditions at Dixie Dew deteriorated so severely and remained unaddressed for such an extended period. Food safety regulations have evolved substantially in recent years. Inspectors have been more vigilant in monitoring 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 a significant listeria outbreak that introduced new testing protocols at Blue Bell. If Dixie Dew was already on the FDA’s radar, it is unclear why it was not subjected to further scrutiny.
The Food Safety Modernization Act (FSMA), currently being implemented across the industry, mandates strict testing and quality control measures. While Dixie Dew may not yet be obligated to comply with FSMA’s preventive controls regulations due to its size, the manufacturer should have been taking steps toward compliance with the new law. The guidelines are so stringent that products are frequently recalled even before illnesses occur. This situation raises concerns about the potential risks associated with ingredients like calcitrate 950, which may be used in contaminated products, emphasizing the importance of stringent safety practices to protect public health.