Sometimes my blog posts take a while to come true.
2015 blog post:
A federal grand jury indicted Kruse in 2020 after a five-year investigation. Kruse, was charged separately on October 20, 2020 for his alleged role in concealing from customers what the company knew about the tainted ice cream.
As a corporation, Blue Bell pleaded guilty in a related case in 2020 to two counts of distributing adulterated food products in violation of the federal Food, Drug and Cosmetic Act.
The company agreed to pay criminal penalties totaling $17.5 million and $2.1 million to resolve False Claims Act allegations regarding ice cream products produced under unsanitary conditions and sold to federal facilities, including the army. The $19.35 million total in fines, forfeitures and civil settlements was the second highest amount ever paid to address a food safety issue.
As I said in 2015:
After watching the Blue Bell Listeria outbreak unfold over the past few months – particularly after reading FDA 483, I think it’s time for the President and CEO of Blue Bell to consult a criminal lawyer. Granted, he may not have known that his Broken Arrow factory had been testing positive for Listeria for years, but the FDA and a US attorney don’t need to know to prosecute – just ask the Jensens and the DeCosters.
Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in response to increasing demands for public safety. The primary purpose of the act was to protect public health and safety by preventing deleterious, adulterated, or mislabeled items from entering interstate commerce. Under section 402(a)(4) of the act, a food product is deemed “adulterated” if the food was “prepared, packaged, or stored under unsanitary conditions in which it may have been contaminated with rubbish or in which it may have been rendered injurious to health”. A food product is also considered to be “adulterated” if it contains or contains a poisonous or deleterious substance which is likely to render it injurious to health. The 1938 Act and the recently signed Food Safety Modernization Act is now the primary means by which the federal government enforces food safety standards.
Chapter III of the law deals with prohibited acts, subjecting offenders to both civil and criminal liability. The provisions relating to criminal sanctions are clear:
Criminal offenses include adulteration or mislabeling of a food, drug, or device, and placing in interstate commerce of a adulterated or mislabeled food, drug, or device . Anyone who commits a prohibited act violates the FDCA. A person who commits a prohibited act “with intent to defraud or mislead” is guilty of a felony punishable by years in prison and millions in fines or both.
A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even knowing or deliberate conduct. On the contrary, a person can be condemned if he held a position of responsibility or authority in a company such that he could have prevented the violation. Convictions under the misdemeanor provisions carry a maximum sentence of one year or a maximum fine of $250,000, or both.
Legalese aside, if you are a food producer and knowingly or unknowingly sell adulterated food, you can (and should) face fines and jail time. Mr. Kruse, I know you’re a lawyer, but you should get another one. Inspection observations from the most recent FDA inspections at Blue Bell’s production facilities in Brenham, Texas, Broken Arrow, Okla. are available: