- The Food and Drug Administration last Thursday named Dixie Dew Products Inc. of Erlanger, KY as the manufacturer of soy paste contaminated with E. coli, according to Food Safety News. The paste appeared in soy nut butter products sold under the SoyNut Butter Company’s I.M. Healthy brand.
- The FDA also noted that it suspended Dixie Dew’s food facility registration on March 28, meaning no products can leave the facility until the agency deems the manufacturer has made necessary changes to its operations.
- Although SoyNut Butter initiated a recall more than two weeks ago, the Food and Drug Administration refused to name the contract manufacturer responsible for making the contaminated soy paste, citing a federal law that prohibits the agency from revealing “confidential corporate information.”
According to documents reviewed by Food Safety News, Food and Drug Administration officials first tried to gain access to Dixie Dew’s manufacturing facilities on March 3. Company officials turned them away, so the FDA issued a demand that required the manufacturer to turn over facility records and to allow inspectors access.
Inside, the inspectors recorded broken temperature controls, a fly and larva infestation, liquid dripping from the ceiling and onto production areas and food making equipment stored on dirty floors. They also heard testimony from supervisors who said production machines hadn’t been cleaned since 2015, and that some equipment had been broken for 15 years.
The outbreak linked to contaminated soy paste made by Dixie Dew has so far sickened 29 people in twelve states. SoyNut Butter Co., which used the paste in its I.M. Healthy soy nut butters and some granola products, issued a recall shortly after the inspection, and has expanded it twice. The products were distributed at retail stores, schools and daycare centers, but the FDA didn’t publicize which locations sold and distributed the products. Likewise, the agency didn’t name Dixie Dew as the manufacturer of the tainted soy paste until its hand was forced by Seattle law firm Marler Clark, which named the company in a civil action lawsuit.
Other food safety agencies, like the Food Safety and Inspection Service, name retailers and manufacturers in their recall notices. So why not the FDA? The agency says its following a law that bars it from revealing trade secrets. Publicizing sales and distribution information could indeed be bad for business, but critics say the FDA’s interpretation of the law is obtuse, and that in the case of public safety, business concerns should take a back seat. According to Richard Raymond, who fought for increased recall transparency as undersecretary of agriculture for food safety under President George W. Bush, said the FDA has bowed to pressure from the food industry.
“I suspect they don’t want that fight themselves,” he recently told The Washington Post.
Meanwhile, consumers are kept in the dark, and can only hope a company will be diligent enough to notify them if they purchased tainted product. Retailers and manufacturers certainly don’t want their products to sicken anyone, but any lack of disclosure on their part can harm their company's image at a time when consumers are demanding increased transparency. It also poses a danger to public health.
But it is curious how conditions at Dixie Dew were allowed to get so bad and stay that way for so long. Food safety has undergone massive changes in the last several years. Inspectors were already paying closer attention to plant conditions after the salmonella outbreak that killed nine and ended in long jail terms for executives at the Peanut Corporation of America plant and the massive listeria outbreak that led to many new testing protocols at Blue Bell. If Dixie Dew was on the FDA's radar, it's unclear why it was not revisited.
And the Food Safety Modernization Act, which is currently rolling out throughout the industry, requires rigorous testing and quality controls. While Dixie Dew may not have had to abide by FSMA's preventive controls regulations yet because of its size, the manufacturer still should have been starting to work toward compliance with the new law — which uses guidelines so strict that products are often recalled even before anyone gets sick.