The U.S. Food and Drug Administration requested a permanent injunction against a former Owings Mills-based ice cream company that filed for bankruptcy two months after Listeria was detected at one of its production lines during an unannounced inspection.
The FDA detected Listeria around one of Totally Cool Inc.’s production lines in late May 2024, and on June 21 directed the company to shut down all of its product lines. This forced the ice cream manufacturer to lay off 68 of its 71 employees and “suffer the loss of all revenue streams,” according to the bankruptcy filing in the U.S. Bankruptcy Court for the District of Maryland in June 2024.
The FDA filed the injunction Monday in the U.S. District Court of Maryland, stating it was “necessary to prevent future violations” despite the firm’s suspension order by the agency.
“Unless restrained by an order of this Court, nothing would prevent Defendants from resuming operations at a different facility in the future,” the injunction said. “Given defendants’ repeated violations, which resulted in the presence of a persistent strain of L. mono at the Facility, an injunction is necessary to prevent future violations.”
Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems, according to the FDA.
Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Other violations the FDA alleged at Totally Cool included “standing, pooled water and/or product debris on the facility’s production floor and excessive product material on equipment surfaces/framework and on floors, including in areas heavily trafficked by production staff and carts, thus facilitating the potential spread of environmental pathogens within and throughout the plant,” according to the injunction.
Irving Walker, an attorney representing Totally Cool in its Chapter 11 case, is perplexed by the FDA’s decision that it was necessary in the eyes of the FDA to file the injunction because the company had no intention of going back in business and had reached an agreement to sell its assets to a company called Chill Ice Cream Solutions LLS, a Delaware-based limited liability company.
As far as the investigation, Walker, who said he had known for months that the injunction was going to be filed, said a trace of Listeria was found on one of the company’s four production lines, which led to a complete recall of products sold and ending their ability to do business.
Totally Cool CEO Michael J. Uhlfelder filed Chapter 11 to ensure a fair “winding up of the company’s affairs” because he had significant assets, including insurance proceeds, and wanted to make sure that people owed money were paid as much as possible, Walker said.
However, Walker said the FDA suspended the sales process, directing that the equipment could not be sold without complying with the FDA’s request for additional information to confirm the equipment was clean and safe. In February, the FDA allowed the sale of the equipment, which allowed Totally Cool to close on the sale of its equipment to Chill Ice Cream Solutions LLC, according to Walker.
“For reasons I cannot explain, the FDA said they were going to file a complaint in order to enjoin Totally Cool from continuing in business without meeting a list of comprehensive FDA requirements for getting back in business,” Walker said. “Although Totally Cool had no intention of going into business and that the whole plan was to liquidate or sell the assets and distribute the proceeds to creditors and never go back in business, the FDA, with the U.S. The Attorney’s Office and Department of Justice involved, insisted on filing this complaint and having the consent decree to confirm this.”
Officials at Chill Ice Cream Solutions and a spokesperson for the FDA could not be reached for comment on Thursday.
Totally Cool manufactured and distributed its ice cream products throughout the U.S. under various brand names, including Friendly’s, Abilyn’s, Hershey’s Creamery Corp., Schwan’s/Yelloh!, Jeni’s, Cumberland Farms and ChipWich, according to court documents. Products were distributed nationwide and available in retail locations and direct delivery.
In its bankruptcy filing, Totally Cool estimated its assets fall between $500,000 and $1 million; its estimated liabilities are around $1 million to $10 million.
“As a layman, why the entry of the consent decree in these circumstances was necessary in the eyes of the FDA never made sense to me,” Walker said.
Have a news tip? Contact Todd Karpovich at tkarpovich@baltsun.com or on X as @ToddKarpovich