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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.
Fresh Express Lettuce – 10 sick with 1 death in 8 states – 2021
Illnesses: As of Dec. 21, 2021, 10 people infected with the outbreak strain of Listeria monocytogenes have been reported from eight states: Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania and Virginia. Illnesses started on dates ranging from July 26, 2016 through Oct. 19, 2021. Sick people range in age from 44 to 95 years, with a median age of 80, and 60% are female. All 10 people have been hospitalized. One death has been reported from Pennsylvania. WGS showed that bacteria from sick people’s samples are closely related genetically. This means that people in this outbreak likely got sick from the same food.
Traceback and Recall: On Dec. 16, 2021, the Michigan Department of Agriculture identified the outbreak strain of Listeria in a bag of Fresh Express Sweet Hearts packaged salad. On December 20, 2021, Fresh Express recalled several brands of packaged salad products. The recall includes all Use-By Dates with product codes Z324 through Z350.
Dole Lettuce – 16 sick with 2 deaths in 13 states – 2021
Illnesses: As of Dec. 17, 2021, 16 people infected with the outbreak strain of Listeria monocytogenes have been reported from 13 states: Idaho, Iowa, Maryland, Michigan, Minnesota, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Utah and Wisconsin. Illnesses started on dates ranging from Aug. 16, 2014, to Oct. 17, 2021. Sick people range in age from 50 to 94 years, with a median age of 76, and 81% are female. Of 14 people with information available, 12 have been hospitalized. Two deaths have been reported from Michigan and Wisconsin. WGS showed that bacteria from sick people’s samples are closely related genetically. This suggests that people in this outbreak got sick from the same food.
Traceback and Recall: In October 2021, the Georgia Department of Agriculture identified the outbreak strain of Listeria in a Dole brand garden salad as part of a routine sampling program of food at grocery stores. As a result, Dole recalled some of their garden salad products that are now past their “best if used by” dates. This sampling was not part of this outbreak investigation, but WGS later showed that the Listeria bacteria in the garden salad were closely related to the outbreak strain. After CDC reopened this outbreak investigation, Michigan Department of Agriculture and Rural Development collected samples of packaged salads from retail stores for testing and identified the outbreak strain of Listeria in a Marketside brand package of shredded iceberg that was produced by Dole. On Dec. 22, 2021, Dole recalled all Dole-branded and private label packaged salads processed at the two facilities that produced the contaminated packaged salads.
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. Dole, Mr. Fresh Express, I might suggest a good lawyer.
Here are some recent cases where prosecutors brought criminal charges:
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Publisher's Platform: Could Dole and Fresh Express face criminal charges for Listeria outbreaks? – Food Safety News
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