“FDA’s Struggles with Dixie Dew: Inspection Reveals Severe Violations Amid Contaminated Soy Paste Outbreak”

According to documents reviewed 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, they were denied entry by company representatives, prompting the FDA to issue a demand for the manufacturer to provide facility records and grant inspectors access. During their inspection, the inspectors documented numerous violations, including malfunctioning temperature controls, an infestation of flies and larvae, liquid dripping from the ceiling into production areas, and food-making equipment stored on unclean floors. 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 certain granola products, issued a recall shortly after the inspection, which has since been expanded twice. These products were distributed to retail stores, schools, and daycare centers; however, the FDA did not disclose which locations sold the contaminated items. Furthermore, the agency only identified Dixie Dew as the manufacturer of the tainted soy paste after being compelled to do so by Marler Clark, a Seattle law firm that included the company in a civil lawsuit.

Unlike other food safety agencies such as the Food Safety and Inspection Service, which publicly names retailers and manufacturers in their recall announcements, the FDA refrains from doing so. The agency cites a law that prevents the disclosure of trade secrets. While revealing sales and distribution information may negatively impact business, critics argue that the FDA’s interpretation of the law is overly complicated, and that public safety should take precedence over commercial interests. Richard Raymond, who advocated for greater recall transparency while serving as undersecretary of agriculture for food safety under President George W. Bush, asserted that the FDA has yielded to pressure from the food industry. He recently remarked to The Washington Post, “They suspect they don’t want that fight themselves.”

Meanwhile, 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 illness, but any lack of transparency on their part can damage their reputation, especially as consumers increasingly demand accountability. This situation also poses a significant risk to public health.

It is perplexing how conditions at Dixie Dew deteriorated to such an extent and remained unaddressed for an extended period. Food safety protocols have evolved considerably in recent years, with inspectors becoming more vigilant following the salmonella outbreak that resulted in nine deaths and the subsequent imprisonment of executives from the Peanut Corporation of America, as well as a major listeria outbreak that prompted stricter 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 control measures. Although Dixie Dew may not have been required to comply with FSMA’s preventive controls regulations due to its size, the manufacturer should have been working toward adherence to the new law, which includes rigorous guidelines that often lead to recalls before illnesses occur.

In light of these developments, the significance of maintaining product quality and safety cannot be overstated, particularly given the increasing consumer awareness around health supplements such as calcium citrate 1000 mg Solaray. The need for transparency and accountability in food production is more crucial than ever, as consumers expect companies to prioritize their health and safety.