Delaware Cheese Company Pleads Guilty to Food Adulteration Charge
U.S. District Court Also Issues Permanent Injunction Against Company and Two Principals
Roos Foods Inc., a Delaware company, pleaded guilty to a misdemeanor violation of the Federal Food, Drug and Cosmetic Act (FDCA), in the U.S. District Court for the District of Delaware, the Department of Justice announced today. U.S. Magistrate Judge Sherry R. Fallon accepted the company’s guilty plea and sentenced Roos Foods to pay a fine of $100,000.
In addition to the company’s guilty plea, Roos, and its principals, Ana A. Roos and Virginia Mejia, agreed to a consent decree of permanent injunction. The consent decree of permanent injunction was entered by U.S. District Court Judge Richard G. Andrews on Jan. 26.
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 criminal information filed on Jan. 22. A civil complaint along with the proposed consent decree was also filed on that same date. The criminal charge and civil complaint allege that Roos distributed cheese connected to a 2014 outbreak of Listeria monocytogenes (L. mono).
“The Department of Justice will use all of the tools available to us – criminal and civil – 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. “We will continue to work aggressively with the Food and Drug Administration (FDA) to combat and deter conduct leading to the distribution of adulterated food to consumers.”
“The criminal and civil cases demonstrate the need for the government to protect consumers from adulterated food,” said U.S. Attorney Charles M. Oberly III for the District of Delaware. “Manufacturers of our nation’s food supplies, such as Roos, 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 alleged 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. 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 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 alleged 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, the 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.
“Consumers rely on the FDA to help ensure that their food is safe and wholesome,” said Deputy Commissioner Howard Sklamberg of FDA’s Global Regulatory Operations and Policy. “When companies put themselves above the law and produce food that puts the public's health at risk, we will see that they are brought to justice.”
The civil complaint alleged that Roos Foods and the 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.
As part of the consent decree, defendants represented to the court that, at the time of entry of the consent decree, they were not engaged in receiving, preparing, processing, packing, holding, or distributing any type of food at or from any location. The permanent injunction requires the defendants to notify the FDA if they intend to resume such operations. In addition, the defendants must take a series of safety related steps under the permanent injunction before they can resume such operations.
Principal Deputy Assistant Attorney General Mizer and U.S. Attorney Oberly commended the investigative efforts of the FDA’s Office of Criminal Investigation. 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 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.
For more information about the Consumer Protection Branch, visit its website at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of Delaware, visit its website at https://www.justice.gov/usao-de.