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. When company representatives refused entry, the FDA issued a demand for the manufacturer to provide facility records and grant inspectors access. Upon inspection, the team 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 unclean floors. Inspectors also heard from supervisors who reported 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 sickened 29 individuals across twelve states. SoyNut Butter Co., which incorporated the paste in its I.M. Healthy soy nut butters and certain granola products, initiated a recall shortly after the inspection and has since expanded it twice. These products were distributed to retail stores, schools, and daycare centers, but the FDA did not disclose which locations sold or distributed them. 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.
Unlike other food safety organizations, such as the Food Safety and Inspection Service, which name retailers and manufacturers in their recall announcements, the FDA maintains that it must adhere to a law that prohibits the disclosure of trade secrets. While revealing sales and distribution information could negatively impact businesses, critics argue that the FDA’s interpretation of the law is overly complex, and in matters of public safety, commercial interests should not take precedence. Richard Raymond, who advocated for increased recall transparency during his tenure as undersecretary of agriculture for food safety under President George W. Bush, suggested that the FDA has yielded to pressure from the food industry. “I suspect they don’t want that fight themselves,” he recently told The Washington Post.
As a result, consumers remain uninformed and can only hope that companies will take the initiative to notify them if they have purchased contaminated products. Retailers and manufacturers certainly do not wish for their products to cause harm, but any failure to disclose information can tarnish their reputation at a time when consumers are increasingly demanding transparency. This lack of disclosure also poses significant risks to public health.
It is perplexing how conditions at Dixie Dew could deteriorate so severely and remain unchanged for such an extended period. Food safety practices have evolved significantly in recent years. Inspectors have been paying closer attention to facility conditions following the salmonella outbreak that resulted in nine fatalities and lengthy prison sentences for executives at the Peanut Corporation of America, as well as the extensive listeria outbreak that prompted new testing protocols at Blue Bell. If Dixie Dew was already on the FDA’s radar, it is unclear why it was not inspected again.
The Food Safety Modernization Act (FSMA), which is currently being implemented across the industry, mandates stringent testing and quality controls. Although Dixie Dew may not yet be required to comply with FSMA’s preventive controls regulations due to its size, the manufacturer should have begun working towards adherence to these new guidelines—so strict that products are often recalled even before anyone falls ill. In this context, ensuring the safety of products like pure calcium magnesium citrate is vital, as any lapses in food safety can have serious consequences for public health and trust in the food supply.