Fort Smith, AR – Duane (DAK) Kees, United States Attorney for the Western District of Arkansas, and Ned Sharpless, M.D., Food and Drug Administration (FDA) Acting Commissioner, announced today that J and L Grocery, LLC, of Alma, Arkansas, the company’s owner, James T. White, and its manager, Lori A. Layne were ordered Thursday to stop distributing food, drug products, medical devices, and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FC&C Act) and other requirements listed in a consent decree. The Honorable P.K. Holmes III entered the Consent Decree of Condemnation and Permanent Injunction in the United States District Court in Fort Smith.
According to court records, J and L Grocery, LLC (J and L Grocery) held FDA-regulated products under the insanitary conditions in which they may have become contaminated with filth, including widespread rodent, insect, and live animal infestation, in violation of federal law.
During the FDA’s inspection of J and L Grocery in September-October 2018, investigators observed multiple live and dead rodents, rodent nesting, live raccoons, live cats, a dead possum, animal feces, and urine-stained products in and around the company’s seven warehouses and sheds used to store food, medical products, and cosmetics. The FDA issued two Administrative Detention Orders at J and L Grocery, dated October 9 and 19, 2018. On November 7 and 8, 2018, the U.S. Marshals Service conducted a mass seizure of the company’s FDA-regulated human and animal food products, over-the-counter (OTC) drugs, cosmetic products, and medical devices.
The consent decree of condemnation and permanent injunction entered by the U.S. District Court requires J and L Grocery to cease operations until it completes corrective actions. Under the consent decree, J and L Grocery may not resume operations until it establishes and implements a comprehensive written sanitation control program and receives written authorization from the FDA that it appears to be in compliance with the FD&C Act, among other requirements. As part of the consent decree, the company agreed to destroy the seized products.
“U.S. consumers rely on the oversight and inspection efforts of the FDA to ensure that their foods and medical products are safe. We will not tolerate insanitary conditions at facilities—like J and L Grocery—that serve U.S. consumers. Product safety at all points in the supply chain must be a high priority, and distributors have a critical responsibility to ensure products are kept safe for Americans to consume or use,” said FDA Acting Commissioner Ned Sharpless, M.D. “When adulterated products make their way into the U.S. marketplace, it places consumers at risk. The FDA will continue our vigorous oversight and will take action to prevent the distribution of potentially contaminated products to the American people.”
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Assistant United States Attorney Mark W. Webb represented the United States in this case, with General Counsel Robert Charrow, Chief Counsel of the FDA Stacy Cline Amin, Deputy Chief Counsel Annamarie Kempic, and Associate Chief Counsel of the United States Department of Health and Human Services Seth I. Heller.
