After watching the Blue Bell Listeria Outbreak unfold over the last months – especially after reading the FDA’s 483’s, I think it is time for the President and CEO of Blue Bell to consult with criminal counsel. True, perhaps he did not know that his Broken Arrow Plant had Listeria positives going back over years, but knowledge is not necessary for the FDA and a US Attorney to prosecute – just ask the Jensens and DeCosters.
Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands. The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce. Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health. The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.
Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:
Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce. Any person who commits a prohibited act violates the FDCA. A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail 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 of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation. Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.
The legal jargon aside, if you are a producer of food and knowingly or not sell adulterated food, you can (and should) face fines and jail time. Mr. Kruse, I know you are a lawyer, but you should get another one.
The inspection observations of the most recent completed FDA inspections at the Blue Bell production facilities in Brenham, Texas, Broken Arrow, Okla., and Sylacauga, Ala. are available:
- Blue Bell Creameries Inc, Sylacauga, AL 483 Issued 04/30/15 (PDF – 1MB)
- Blue Bell Creameries, L.P. Brenham, TX, 483 Issued 05/01/15 (PDF – 1023KB)
- Blue Bell Creameries, LP, Broken Arrow, OK 483 Issued 04/23/15 (PDF – 2.6MB)
Listeria: Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Listeria outbreaks. The Listeria lawyers of Marler Clark have represented thousands of victims of Listeria and other foodborne illness outbreaks and have recovered over $600 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Our Listeria lawyers have litigated Listeria cases stemming from outbreaks traced to a variety of foods, such as caramel apples, cantaloupe, cheese, celery and milk.