According to documents reviewed by Food Safety News, officials from the Food and Drug Administration (FDA) first attempted to access Dixie Dew’s manufacturing facilities on March 3. When company representatives denied them entry, the FDA issued a demand requiring the manufacturer to submit facility records and allow inspectors access. Upon inspection, 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 unsanitary floors. Supervisors also testified that production machinery hadn’t been cleaned since 2015, and some equipment had been out of order for 15 years.
The outbreak associated with contaminated soy paste produced by Dixie Dew has, to date, resulted in 29 illnesses across twelve states. SoyNut Butter Co., which incorporated the paste into its I.M. Healthy soy nut butters and various 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, yet the FDA did not disclose which locations sold or distributed them. Additionally, the agency did not identify Dixie Dew as the manufacturer of the contaminated soy paste until pressured by the Seattle law firm Marler Clark, which included the company in a civil lawsuit.
Other food safety agencies, like the Food Safety and Inspection Service, typically name retailers and manufacturers in their recall notices. So why doesn’t the FDA do the same? The agency claims it is adhering to a law that prevents the disclosure of trade secrets. While publicizing sales and distribution information could potentially harm business interests, critics argue that the FDA’s interpretation of the law is convoluted, suggesting that public safety concerns should take precedence over commercial considerations. Richard Raymond, who advocated for improved recall transparency as undersecretary of agriculture for food safety under President George W. Bush, remarked that the FDA seems to have 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 be proactive in notifying them if they have purchased a contaminated product. 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 at a time when consumers demand greater accountability. Moreover, it poses a risk to public health.
It is perplexing how conditions at Dixie Dew could deteriorate so severely and persist for an extended period. Food safety has undergone significant changes in recent years, with inspectors paying closer attention to facility conditions following the salmonella outbreak that resulted in nine deaths and severe penalties for executives at the Peanut Corporation of America. Following this, a major listeria outbreak 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 it was not revisited.
The Food Safety Modernization Act (FSMA), which is currently being implemented throughout the industry, mandates stringent testing and quality controls. Although Dixie Dew may not yet be subject to FSMA’s preventive controls regulations due to its size, the manufacturer should have begun efforts to comply with the new law. This law includes stringent guidelines that often result in product recalls even before any illnesses occur.
In this context, consumers are left wondering: is calcium citrate safe? As public health concerns continue to rise, transparency in food production practices becomes increasingly critical. The expectation for companies to disclose potential risks, including those related to calcium citrate and other ingredients, is paramount in safeguarding consumer health.