FDA Shuts Down Source Of Contaminated Soy Butter That Sickened 26 Kids

Image courtesy of Connie Ma

Now that 29 people, 26 of whom are children, have been confirmed sick from E. coli in contaminated I.M. Healthy brand soy butter, at least we know which company actually made the recalled products. A Food and Drug Administration inspection of the facility earlier this month found insects, dirty and broken equipment, and general filth.

The FDA announced that it “suspend[ed] the food facility registration” of the manufacturer, Dixie Dew in Erlanger, KY. Since that means no products can leave the facility, translated from bureaucrat-ese, the plant has been effectively shut down.

Dixie Dew is a contract manufacturer and packager. It processes a wide variety of food products, including marinara sauce, dessert glaze toppings, meat glazes, and dry mixes.

“Though we produce many nationally known products, client confidentiality is of extreme importance to all parties and prevents us naming names,” the company says on its website.

Inspectors visited the plant at the beginning of March, and found that it skipped several steps normally taken to prevent pathogens from contaminating and growing in packaged food products.

For example, the FDA reported:

• The company doesn’t bother with a “kill step,” like cooking the product to a high temperature, when it leaves soy paste behind from a production batch overnight or over the weekend, then picks production back up the following work day.

• According to plant supervisors, one machine used for mixing has been malfunctioning, shutting off mid-cycle, for the last 15 years.

• Thermometers used during production were either malfunctioning or had never been checked to find out whether they were accurate.

• A “clear liquid,” identified as water from a leaking overhead pipe, dripped from the processing room ceiling and onto the soy paste processing equipment during the entire production run that the FDA observed.

• The inspectors observed floors, walls, and ceilings were covered in soy butter residue from previous batches of the product, and there was also standing water and “black and brown apparent filth” on the processing room floor.

• The processing equipment hadn’t been taken apart and sanitized since Dec. 2015.

• Mops used for bathrooms and processing facilities intermixed and in terrible shape.

• The plastic tote used to transport soy oil had “brown residue” and employees reported that it was never cleaned.

There’s a lot more in the full inspection report, which is very readable (except for the trade secret redactions) and may make you want to grind your own peanut or soy butter at home.

Bill Marler, an attorney who handles cases of food poisoning and the publisher of Food Safety News, told the publication that the inspection report seemed familiar. He noted that the conditions sound a lot like the Peanut Corporation of America plant, which produced Salmonella-contaminated peanut butter that was officially linked to 714 illnesses and nine deaths, though the total was most likely much higher. In that case, the former owner of the plant, his brother, and three other employees were sent to federal prison for their part in knowingly shipping peanut butter made under gross conditions.

“After reading the Form 483, I would recommend that the principals of Dixie Dew lawyer up with a good criminal defense counsel,” Marler told FSN, “because assuming the Trump Administration is as aggressive as the Obama Administration was with respect to investigation and prosecution under the Food, Drug and Cosmetic Act, they should be worried.”

No one knows yet how the current administration plans to treat cases of food contamination. We can only hope that the people running the relevant agencies believe that a company should be punished for manufacturing a product marketed for children with life-threatening allergies in a filth-encrusted room. The question will be whether they end up prosecuting the company principals personally for crimes.

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