WASHINGTON – The United States filed a civil complaint against Freshy Foods, LLC of Elmwood, Louisiana, its co-owner and Chief Executive Officer Floyd D. James, and its co-owner and President Ida M. James (defendants) to stop them from manufacturing and distributing adulterated food in violation of federal law, the Department of Justice announced today.
According to the complaint, defendants prepare, manufacture, process, pack, label, hold, and distribute refrigerated, ready-to-eat (RTE) food, including sandwiches, wraps, salads, fruit cups, and snack cups. The complaint, filed in the U.S. District Court for the Eastern District of Louisiana, alleges that the RTE food that defendants prepare, manufacture and/or distribute is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby the food may have been contaminated with filth or rendered injurious to health. The allegations in the complaint apply to RTE food regulated by the U.S. Food and Drug Administration (FDA).
The Department filed the complaint at the request of the FDA.
“The Department of Justice is committed to ensuring that food manufacturers and distributors comply with laws designed to protect consumers,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice continues to work actively with the FDA to ensure that consumers are protected from potentially unsafe food.”
The complaint alleges that a July 2017 inspection by FDA of Freshy Foods’ facility established that RTE food that defendants prepare, manufacture and/or distribute is adulterated. Specifically, according to the complaint, FDA found evidence of a resident strain of Listeria monocytogenes (L. mono) in the facility. The complaint alleges that in addition to the July 2017 inspection, federal and state government agencies have found L. mono in Freshy Foods’ facility or in defendants’ RTE sandwiches on six separate occasions.
According to the complaint, the Florida Department of Agriculture and Consumer Services (FDACS) found L. mono in one of defendants’ sandwiches in 2013 and in another of defendants’ sandwiches in 2016. In addition, the complaint alleges that the U.S. Department of Agriculture (USDA) inspected Freshy Foods’ facility in June 2017, collected environmental subsamples from the facility, with three subsamples testing positive for L. mono.
The complaint states that FDA compared positive L. mono samples collected by FDA in July 2017, April 2017, and April 2016; by USDA in June 2017; and by FDACS in March 2016 and December 2013. According to the complaint, lab analysis identified a resident strain of L. mono, which has persisted in Freshy Foods’ facility since at least 2013, as well as a second, non-resident strain of L. mono at the facility.
As noted in the complaint, L. mono is one of several bacteria contained within the Listeria species. According to the complaint, L. mono can causes listeriosis, a disease commonly contracted by eating food contaminated with the bacterium. The complaint notes that Listeriosis can be serious, even fatal, for vulnerable groups such as newborns and those with impaired immune systems, and that the most serious forms of listeriosis can result in meningitis and septicemia.
The complaint alleges that defendants violated the Federal Food, Drug, and Cosmetic Act by causing adulterated food to be introduced into interstate commerce or delivered for introduction into interstate commerce. It also alleges that the defendants further violated the law by causing food to become adulterated while it was being held for sale after the shipment of one or more of its components in interstate commerce.
“Southeast Louisiana is famous for its delicious food and regardless of where it is ultimately consumed, food originating from our District should be safe,” said U.S. Attorney Duane A. Evans for the Eastern District of Louisiana. “This complaint furthers the Eastern District of Louisiana’s mission to protect and improve the quality of life for consumers both here and throughout the states where Freshy Foods, LLC’s products are distributed.”
“We have an obligation to make sure that foods are safe for people to consume. The conditions that this company was holding ready-to-eat food in were unacceptable,” said FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier. “FDA investigators repeatedly found Listeria monocytogenes at Freshy Food’s facility, and the company should stop operations until they can demonstrate to the FDA that their products are safe.”
The government is represented by Trial Attorney Kathryn Schmidt of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney K. Paige O’Hale of the U.S. Attorney’s Office for the Eastern District of Louisiana, with the assistance of Associate Chief Counsel for Enforcement Anna K. Thompson of the FDA, Office of General Counsel, and Department of Health and Human Services.
A 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.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Eastern District of Louisiana, visit its website at http://www.justice.gov/usao-edla.