According to documents examined by Food Safety News, officials from the Food and Drug Administration (FDA) initially sought access to Dixie Dew’s manufacturing facilities on March 3. Company representatives denied them entry, prompting the FDA to issue a formal demand requiring the manufacturer to provide facility records and grant inspectors access. Upon inspection, the FDA team discovered numerous violations, 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 also testified that production machinery had not been cleaned since 2015 and that some equipment had been out of order for 15 years. The outbreak associated with contaminated soy paste produced by Dixie Dew has resulted in illnesses for 29 individuals across twelve states. SoyNut Butter Co., which incorporated the paste into its I.M. Healthy soy nut butters and various granola products, promptly issued a recall that has since been expanded twice. These products were distributed to retail outlets, schools, and daycare centers, yet 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 the Seattle law firm Marler Clark, which included the company in a civil lawsuit.
In contrast to the FDA, other food safety agencies like the Food Safety and Inspection Service routinely disclose the names of retailers and manufacturers in their recall notifications. Why doesn’t the FDA do the same? The agency cites a law that restricts it from disclosing trade secrets. While revealing sales and distribution details might harm business interests, critics argue that the FDA’s interpretation of the law is overly convoluted, and in matters of public safety, commercial concerns should take a secondary role. Richard Raymond, who advocated for enhanced recall transparency during his tenure as undersecretary of agriculture for food safety under President George W. Bush, suggested that the FDA has yielded to pressures from the food industry. “I suspect they don’t want that fight themselves,” he recently told The Washington Post.
Meanwhile, consumers remain uninformed and can only hope that companies will responsibly notify them if they have purchased contaminated products. While retailers and manufacturers certainly do not intend for their products to cause harm, any lack of transparency can jeopardize their reputation at a time when customers are increasingly demanding openness. This situation also poses significant risks to public health.
It is perplexing how conditions at Dixie Dew could deteriorate so severely and remain unaddressed for an extended period. Food safety protocols have evolved dramatically in recent years, with inspectors 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 led to 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.
Additionally, 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 control regulations due to its size, the manufacturer should have been taking steps toward compliance with the new law—guidelines that are so rigorous that products are often recalled even before illnesses occur. This is particularly relevant for manufacturers of products such as bariatric calcium citrate, which necessitate strict adherence to safety standards. As the industry evolves, it is crucial for all companies, including those producing bariatric calcium citrate, to prioritize compliance and transparency to safeguard public health.