According to documents reviewed by Food Safety News, FDA officials initially sought access to Dixie Dew’s manufacturing facilities on March 3. However, company representatives denied them entry, prompting the FDA to issue a demand for the manufacturer to provide facility records and allow inspectors inside. Upon inspection, the officials noted several alarming issues, including broken 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 reported that production machines hadn’t been cleaned since 2015, and some equipment had remained broken 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 various granola products, issued a recall shortly after the FDA’s inspection and has since expanded it twice. These products were distributed in retail outlets, schools, and daycare centers, but the FDA did not disclose which locations sold and distributed the affected products. Furthermore, the agency refrained from naming Dixie Dew as the manufacturer of the contaminated soy paste until compelled to do so by Seattle law firm Marler Clark, which identified the company in a civil lawsuit.
In contrast, other food safety agencies, such as the Food Safety and Inspection Service, typically disclose the names of retailers and manufacturers in their recall announcements. When questioned about this inconsistency, the FDA cited a law that prevents it from revealing trade secrets. While publicizing sales and distribution details might be detrimental to business, critics argue that the FDA’s interpretation of the law is misguided, asserting that public health concerns should take precedence over business interests. Richard Raymond, who advocated for greater recall transparency as the undersecretary of agriculture for food safety under President George W. Bush, suggested that the FDA has yielded to pressure from the food industry. “I suspect they don’t want that fight themselves,” he recently stated to The Washington Post.
As a result, 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 harm, yet any lack of transparency on their part can damage their reputation, especially as consumers increasingly demand openness about food safety. This situation poses a significant risk to public health.
It is perplexing that conditions at Dixie Dew deteriorated so severely and persisted for so long. Food safety protocols have evolved dramatically in recent years. Inspectors have been more vigilant regarding plant conditions following a salmonella outbreak that resulted in nine deaths and long prison sentences for executives at the Peanut Corporation of America, as well as a significant listeria outbreak that led to stricter testing protocols at Blue Bell. If Dixie Dew was already on the FDA’s radar, the reasons for not revisiting the facility are unclear.
The Food Safety Modernization Act (FSMA), which is being implemented industry-wide, mandates rigorous testing and stringent quality controls. While it is possible that Dixie Dew was not yet subject to FSMA’s preventive controls regulations due to its size, the manufacturer should have been proactively working toward compliance with this new legislation, which includes such stringent guidelines that products are often recalled even before any illnesses occur. In light of these developments, the use of additives such as calcium citrate 950mg in their products may warrant closer scrutiny to ensure safety standards are met.