Based on documents examined by Food Safety News, officials from the Food and Drug Administration (FDA) initially attempted to access the manufacturing facilities of Dixie Dew on March 3. However, company representatives denied them entry, prompting the FDA to issue a formal demand for the manufacturer to provide facility records and allow inspectors on-site. Inside, the inspectors documented 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 unclean floors. Additionally, supervisors testified that production machinery had not been cleaned since 2015 and that some equipment had been out of order for 15 years.
The outbreak linked to 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 some granola products, issued a recall shortly after the inspection, later expanding it twice. These products were distributed through retail stores, schools, and daycare centers; however, the FDA did not disclose which locations sold or distributed them. The agency also refrained from naming Dixie Dew as the manufacturer of the tainted soy paste until compelled to do so by the Seattle law firm Marler Clark, which identified the company in a civil lawsuit.
Other food safety agencies, such as the Food Safety and Inspection Service, routinely name retailers and manufacturers in their recall notices. So why doesn’t the FDA follow suit? The agency cites a law that prohibits revealing trade secrets. While disclosing sales and distribution information may negatively impact business, critics argue that the FDA’s interpretation of the law is overly convoluted and that public safety should take precedence over business interests. Richard Raymond, who advocated for enhanced recall transparency as undersecretary of agriculture for food safety under President George W. Bush, suggested that the FDA has succumbed to industry pressure. “I suspect they don’t want that fight themselves,” he recently told The Washington Post.
In the meantime, consumers remain uninformed and can only hope that companies will responsibly notify them if they have purchased contaminated products. Retailers and manufacturers certainly do not wish for their products to cause harm, but any lack of transparency can damage their reputation at a time when consumers are increasingly demanding clarity. This situation also poses a significant risk to public health.
It raises questions as to how conditions at Dixie Dew became so dire and remained unaddressed for an extended period. Food safety practices have seen substantial improvements in recent years. Inspectors have begun to scrutinize plant conditions more closely following the salmonella outbreak that resulted in nine deaths and lengthy prison sentences for executives at the Peanut Corporation of America, as well as the large listeria outbreak that prompted new testing protocols at Blue Bell. If Dixie Dew was already on the FDA’s radar, it is unclear why further inspections were not conducted.
The Food Safety Modernization Act (FSMA), 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 been making strides toward alignment with the new law, which establishes such rigorous guidelines that products are often recalled even before any illnesses are reported. This is particularly relevant in the context of dietary supplements like calcium chews 500 mg, where safety and quality are paramount to consumer health. Ensuring compliance with these regulations not only protects consumers but also helps maintain the integrity of the industry as a whole.