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 manufacturer and sell adulterated food, you can (and should) face fines and jail time.

This Listeria outbreak is a mess. Illnesses began in January 2021 and are likely to be continuing. Listeria has been found on equipment in the the ice cream processing facility and in 16 of 17 flavors. Big Olaf first refused to recognize that it was the cause of the outbreak and refused to stop production and stop ice cream sales. According to the Florida Department of Agriculture and Consumer Services (FDACS):

“The results from product sampling taken from the Big Olaf production facility last week by FDACS found that 16 of the 17 flavors tested were positive for Listeria monocytogenes (L. mono). This includes Blueberry Cheesecake, Butter Pecan, Cherry Cordial, Chocolate, Chocolate Chip, Coconut, Coconut Almond Joy, Cookie Dough, Cookies & Cream, Kahlua Krunch, Mint Chip, Pistachio, Plantation Praline, Superman, Vanilla, and White Chocolate Raspberry. With these results, FDACS is currently issuing formal stop sales on the 16 products where L. mono was found, which were previously part of a voluntary recall. Our department continues to work closely with our state and federal partners on this investigation and enforcement of the stop sale.”

Please find linked here [dropbox.com] the results for the product samples that represent the 16 positive flavors. The one outstanding environmental sample [dropbox.com] noted previously has also come back positive, bringing the total positive environmental samples to 10, and I’m linking here [dropbox.com] to those results.

As of June 29, 2022, a total of 23 people infected with the outbreak strain of Listeria monocytogenes have been reported from 10 states. Of the 22 people with information, 20 sick people reported living in or traveling to Florida in the month before they got sick, although the significance of this is still under investigation. Illnesses started on dates ranging from January 24, 2021, through June 12, 2022.

The CDC reported that sick people range in age from less than 1 to 92 years, with a median age of 72, and 52% are male. Twenty-two people (96%) have been hospitalized. Five people got sick during their pregnancy, and one illness resulted in a fetal loss. One death has been reported from Illinois.

The Florida Department of Health, CDC, public health and regulatory officials in several other states, and the U.S. Food and Drug Administration (FDA) are collecting different types of data to investigate a multistate outbreak of Listeria monocytogenes infections. As a result of this investigation, Big Olaf Creamery in Sarasota, FL, is voluntarily contacting retail locations to recommend against selling their ice cream products. Consumers who have Big Olaf Creamery brand ice cream at home should throw away any remaining product.

Public health officials continue to interview people about the foods they ate in the month before they got sick. Of the 17 people interviewed, 14 (82%) reported eating ice cream. Among 13 people who remembered details about the type of ice cream they ate, six reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery.

On July 1, 2022, Big Olaf Creamery in Sarasota, FL, voluntarily began contacting retail locations to recommend against selling their ice cream products. Consumers who have Big Olaf Creamery brand ice cream at home should throw away any remaining product.

Public health officials continue to interview people about the foods they ate in the month before they got sick. Of the 17 people interviewed, 14 (82%) reported eating ice cream. Among 13 people who remembered details about the type of ice cream they ate, six reported eating Big Olaf Creamery brand ice cream or eating ice cream at locations that might have been supplied by Big Olaf Creamery.

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 $850 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 lettuce, polony, deli meat, cantaloupe, cheese, celery and milk.  

If you or a family member became ill with a Listeria infection after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark Listeria attorneys for a free case evaluation.