According to documents analyzed by Food Safety News, officials from the Food and Drug Administration (FDA) initially attempted to access Dixie Dew’s manufacturing facilities on March 3. When company representatives denied them entry, the FDA issued a formal request demanding the manufacturer provide facility records and grant inspectors access. During their inspection, the inspectors noted numerous alarming conditions, including malfunctioning temperature controls, an infestation of flies and larvae, liquid dripping from the ceiling onto production areas, and food-making equipment stored on dirty floors. They also received statements from supervisors indicating that production machinery hadn’t been cleaned since 2015, with some equipment out of service for 15 years.
The outbreak associated with contaminated soy paste produced by Dixie Dew has resulted in illnesses for 29 individuals across twelve states. SoyNut Butter Co., which incorporated the paste into its I.M. Healthy soy nut butters and certain granola products, initiated a recall shortly following the inspection and has expanded it twice. These products were distributed to retail stores, schools, and daycare centers, yet the FDA did not disclose which locations sold and distributed the tainted goods. Furthermore, the agency refrained from identifying Dixie Dew as the source of the contaminated soy paste until compelled by Seattle law firm Marler Clark, which included the company in a civil lawsuit.
Other food safety agencies, such as the Food Safety and Inspection Service, typically identify retailers and manufacturers in their recall announcements. So why does the FDA not follow suit? The agency asserts that it is adhering to a law which prohibits 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 and that, in matters concerning public safety, commercial considerations should be secondary. Richard Raymond, who advocated for greater recall transparency while serving as undersecretary of agriculture for food safety during President George W. Bush’s administration, suggested that the FDA has yielded to pressure from the food industry. “I suspect they don’t want that fight themselves,” he recently told The Washington Post.
As it stands, consumers remain uninformed and must rely on companies to adequately notify them if they have purchased contaminated products. Retailers and manufacturers certainly do not wish for their products to cause illness; however, a lack of transparency on their part can damage their reputation at a time when consumers are increasingly demanding openness. This situation also poses a significant risk to public health.
It is perplexing how the conditions at Dixie Dew could deteriorate to such an extent and remain unaddressed for an extended period. Food safety standards have evolved substantially in recent years, with inspectors placing increased scrutiny on facility conditions following the salmonella outbreak that resulted in nine fatalities and lengthy prison sentences for executives at the Peanut Corporation of America, as well as a massive listeria outbreak that prompted new testing protocols at Blue Bell. If Dixie Dew was already on the FDA’s radar, it remains unclear why it was not subject to further inspections.
Additionally, the Food Safety Modernization Act (FSMA), which is currently being implemented across the industry, mandates rigorous testing and quality controls. Although Dixie Dew may not yet be required to comply with FSMA’s preventive control regulations due to its size, the manufacturer should have been working towards alignment with the new law, which establishes stringent guidelines that often lead to product recalls even before illnesses occur. Interestingly, calcium carbonate and citrate, often used as food additives, highlight the importance of strict quality control and transparency in food manufacturing. In light of these developments, the presence of calcium carbonate and citrate in products should be closely monitored to ensure safety and compliance with food safety regulations.