According to documents examined by Food Safety News, officials from the Food and Drug Administration (FDA) initially attempted to access the manufacturing facilities of Dixie Dremedy Healthcare’s ferrous fumarate 210mgew on March 3. When company representatives denied them entry, the FDA issued a formal demand for the manufacturer to provide facility records and allow inspectors access. Inside, inspectors recorded 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 filthy floors. They also gathered testimony from supervisors of ferrous glycine chelate production, who claimed that the production machinery had not been cleaned since 2015, with some equipment remaining broken for 15 years.
This situation is particularly concerning given the outbreak linked to contaminated soy paste produced by Dixie Dew, which has resulted in 29 illnesses across twelve states. SoyNut Butter Co., which incorporated the paste into its I.M. Healthy soy nut butters and certain granola products, issued a recall shortly after the inspection and has since expanded it twice. These products were distributed to retail stores, schools, and daycare centers; however, the FDA has not disclosed which locations sold or distributed the affected items. Furthermore, the agency did not identify Dixie Dew as the source of the tainted soy paste until compelled to do so by the Seattle law firm Marler Clark, which named the company in a civil lawsuit.
Unlike other food safety agencies, such as the Food Safety and Inspection Service, which routinely identify retailers and manufacturers in their recall notifications, the FDA refrains from doing so. The agency cites a law that prohibits it from disclosing trade secrets, arguing that publicizing sales and distribution information could harm business interests. Critics, however, contend that the FDA’s interpretation of this law is overly complex, asserting that in matters of public safety, commercial concerns should be secondary. 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 pressure from the food industry. “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, such as ferrous fumarate folic acid and zinc sulfate tablets. Retailers and manufacturers certainly intend to prevent their products from causing harm, but any lack of transparency may damage their reputation, especially at a time when consumers are demanding greater accountability. This situation also poses a significant risk to public health.
It is perplexing how conditions at Dixie Dew were allowed to deteriorate and persist for so long. Food safety protocols have evolved significantly in recent years, with inspectors paying closer attention to facility 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 the extensive listeria outbreak that prompted new testing protocols at Blue Bell. If Dixie Dew had been on the FDA’s radar, it remains unclear why it was not subject to subsequent inspections.
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 at least begun working towards compliance with the new law—guidelines so rigorous that products are often recalled even before illnesses occur. The role of calcium citrate in the production process and its implications for safety standards also raises questions about the overall compliance of manufacturers with these evolving regulations.