January 22, 2016 - A criminal information was filed today in the U.S. District Court for the District of Delaware against Roos Foods Inc., charging the company with the distribution of adulterated cheese in interstate commerce, the Department of Justice announced today. The company has signed a plea agreement in which it has agreed to plead guilty to a misdemeanor violation of the federal Food, Drug and Cosmetic Act (FDCA). In addition to the company’s agreement to plead guilty, Roos, and its principals, Ana A. Roos and Virginia Mejia, have agreed to a proposed consent decree of permanent injunction.
Roos Foods distributed several varieties of ready-to-eat cheese, including ricotta, queso fresco and fresh cheese curd and sold and distributed its products to wholesale customers in Maryland, New Jersey, Virginia and Washington D.C., according to the information. A civil complaint along with the proposed consent decree was also filed in the U.S. District Court for the District of Delaware. The criminal charge and civil complaint allege that Roos distributed cheese in interstate commerce connected to an outbreak of Listeria monocytogenes (L. mono) in early 2014.
“We must work to ensure that the food we buy is free from dangerous bacteria and is safe to eat,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work aggressively to combat and deter conduct leading to the distribution of adulterated food to consumers.”
“It is cases like this that demonstrate the need for government regulations concerning food safety, ” said U.S. Attorney Charles M. Oberly III for the District of Delaware. “Fortunately, there were no serious or permanent injuries as a result of the marketing of contaminated cheese. Manufacturers of our nation’s food supplies must comply with the law and when violators are found they should expect to be prosecuted and, if necessary, put out of business.”
The criminal information alleges that on Feb. 21, 2014, the Centers for Disease Control and Prevention (CDC) reported that a total of eight people (five adults and three newborns) in Maryland and California were infected with L. mono and according to the CDC, several of the Maryland patients reported having eaten soft or semi-soft cheeses in the month before becoming ill.
L. mono is the bacterium that causes the disease listeriosis. Listeriosis is most commonly contracted by eating food contaminated with L. mono. Listeriosis can be serious, even fatal, for high-risk groups such as unborn babies, newborns and those with impaired immune systems.
Unlike many other foodborne microbes, L. mono bacteria are capable of adapting and growing even at refrigerator temperatures. Thus, the presence of L. mono in ready-to-eat foods is a particularly significant public health risk.
As alleged in the information, following a report that L. mono had been isolated from cheese manufactured by Roos Foods, the U.S. Food and Drug Administration (FDA) inspected the firm’s Kenton, Delaware, facility and established that ready-to-eat cheese products were adulterated in that they had been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. As alleged, FDA found numerous failures to implement effective monitoring and sanitation controls in accordance with current Good Manufacturing Practices.
The information alleges that the FDA inspection revealed significant sanitation deficiencies, such as widespread roof leaks in the manufacturing area, including over open manufacturing equipment; rust flakes on the manufacturing equipment from corroded roof trusses and metal roofing; un-cleanable surfaces on walls, floors and ceilings and product residue on equipment that had purportedly been cleaned. In addition, as alleged in the information, FDA collected environmental samples and found L. mono on 12 surfaces in the facility.
On March 11, 2014, FDA suspended the food facility registration of Roos Foods after determining there was a reasonable probability that food manufactured, processed, packed, or held by Roos Foods would cause serious adverse health consequences or death to humans. A company without a food facility registration cannot distribute any food products. Roos Foods has not reopened.
“The FDA will not tolerate food companies that fail to provide adequate safeguards and place the public health at risk by producing and shipping contaminated products,” said FDA’s Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg, J.D. “We will continue to work with the Department of Justice to use the full force of our justice system against those that place profits over the health and safety of American consumers.”
The civil complaint alleges that Roos Foods and two individual defendants violated the FDCA by, among other things, introducing or delivering for introduction into interstate commerce articles of food that were adulterated in that the food was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. The proposed consent decree of permanent injunction requires the defendants to cease receiving, preparing, processing, packing, holding and distributing all food products unless and until the defendants bring their operations into compliance with the FDCA and its implementing regulations.
The criminal case is being prosecuted by Trial Attorney Heide L. Herrmann of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorneys Jennifer Welsh and Edmond Falgowski of the District of Delaware. They were assisted by Associate Chief Counsel Laura Pawloski of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services. The case was investigated by the FDA’s Office of Criminal Investigations.
The government is represented in the civil case by Trial Attorney Megan Englehart of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney Patricia Hannigan of the District of Delaware, with the assistance of Associate Chief Counsel Shannon M. Singleton of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services.
A criminal information is merely an allegation and every defendant is presumed innocent until proven guilty beyond a reasonable doubt.
A civil complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.
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