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 denied them entry, prompting the FDA to issue a formal request that mandated the manufacturer to provide facility records and grant inspectors access. Upon entering, inspectors documented several alarming issues, including malfunctioning temperature controls, an infestation of flies and larvae, liquid dripping from the ceiling onto production areas, and food equipment stored on unsanitary floors. They also gathered statements from supervisors who revealed that production machinery had not been cleaned since 2015 and that some equipment had been out of order for 15 years.
The outbreak connected to contaminated soy paste produced by Dixie Dew has thus far 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 soon after the inspection and has expanded it twice. These products were sold in retail stores, schools, and daycare centers, but the FDA did not disclose which locations were involved in the sale and distribution of the affected products. Moreover, the agency did not identify Dixie Dew as the manufacturer of the contaminated soy paste until compelled to do so by Marler Clark, a Seattle law firm that named the company in a civil lawsuit.
In contrast to other food safety organizations like the Food Safety and Inspection Service, which publicly name retailers and manufacturers in their recall notices, the FDA cited a law that prevents it from revealing trade secrets. While disclosing information about sales and distribution could potentially harm business interests, critics argue that the FDA’s interpretation of this law is overly complex and that public safety concerns should take precedence over business considerations. Richard Raymond, who advocated for greater recall transparency as the undersecretary of agriculture for food safety during the George W. Bush administration, suggested that the FDA has yielded to pressure from the food industry. “I suspect they don’t want that fight themselves,” he recently stated in an interview with The Washington Post.
As it stands, consumers are left uninformed and can only hope that companies will be proactive in notifying them if they have purchased contaminated products. While retailers and manufacturers certainly aim to prevent any illnesses caused by their products, a lack of transparency can damage their reputation at a time when consumers increasingly demand openness. This situation also poses a significant risk to public health.
It raises questions as to how conditions at Dixie Dew deteriorated to such an extent and remained unaddressed for so long. Food safety regulations have undergone significant revisions in recent years. Following the salmonella outbreak that resulted in nine fatalities and lengthy prison sentences for executives at the Peanut Corporation of America, inspectors have been more vigilant regarding plant conditions. Similarly, the severe listeria outbreak prompted the implementation of new testing protocols at Blue Bell. If Dixie Dew was already on the FDA’s radar, it is unclear why it was not subject to follow-up inspections.
Additionally, the Food Safety Modernization Act (FSMA), which is being implemented across the industry, mandates stringent testing and quality control measures. While Dixie Dew may not yet be required to comply with FSMA’s preventive controls regulations due to its size, it should have begun the process of aligning with the new law. The FSMA includes guidelines so rigorous that products are often recalled even before illnesses arise. This is particularly relevant in discussions about the transition from calcium carbonate to calcium citrate, as companies like Dixie Dew must adapt to evolving safety standards. In conclusion, the need for transparency and accountability in food safety has never been more critical, especially in light of the serious public health threats posed by negligence in manufacturing practices.