“FDA’s Access Denied: Inspection Reveals Severe Violations at Dixie Dew 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 Dixie Dew’s manufacturing facilities 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 grant inspectors access. Once inside, inspectors documented numerous violations, including malfunctioning temperature controls, an infestation of flies and larvae, liquid leaking from the ceiling onto production areas, and food-making equipment stored on unsanitary floors. Supervisors testified 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 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, but the FDA did not disclose which locations sold or distributed them. Moreover, the agency only identified Dixie Dew as the manufacturer of the contaminated soy paste after being compelled to do so by the Seattle law firm Marler Clark, which named the company in a civil lawsuit.

Other food safety agencies, such as the Food Safety and Inspection Service, typically disclose the names of retailers and manufacturers in their recall notices. However, the FDA has refrained from doing so, citing a law that prohibits the disclosure of trade secrets. While revealing sales and distribution information could negatively impact business, critics argue that the FDA’s interpretation of the law is questionable, especially when public safety is at stake. Richard Raymond, who advocated for greater recall transparency as undersecretary of agriculture for food safety during the George W. Bush administration, suggested that the FDA has succumbed to industry pressure. “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 adequately notify them if they have purchased tainted products. Retailers and manufacturers certainly do not want their products to cause illness; however, any lack of transparency on their part can damage their reputation at a time when consumers are increasingly demanding disclosure. This situation also poses a significant risk to public health. It is perplexing how conditions at Dixie Dew could deteriorate so severely and remain unaddressed for such an extended period. Food safety protocols have evolved considerably in recent years, with inspectors taking a closer look at plant conditions in the aftermath of significant outbreaks, such as the salmonella outbreak that resulted in nine deaths and lengthy prison sentences for executives at the Peanut Corporation of America, as well as a massive listeria outbreak that led to the implementation of new testing protocols at Blue Bell. If Dixie Dew was already on the FDA’s radar, it remains unclear why the facility was not revisited.

The Food Safety Modernization Act (FSMA), which is currently being implemented across the industry, mandates stringent testing and quality controls. While Dixie Dew may not yet be required to comply with FSMA’s preventive controls due to its size, it should have begun working toward compliance with the new regulations, which are so stringent that products are often recalled even before any illnesses are reported. This lack of adherence to food safety standards is concerning, especially when considering that consumers rely on transparency from manufacturers. For instance, bariatric advantage calcium citrate chewable tablets 500mg exemplify the kind of product that consumers expect to be safe and properly regulated. The ongoing challenges in food safety highlight the urgent need for better compliance and communication in the industry to protect public health.