Over the past year and a half, Jeni’s Splendid Ice Cream has struggled with food safety issues, specifically the presence of Listeria monocytogenes (L. monocytogenes) in its production facility. Despite taking extensive precautions, a Food and Drug Administration (FDA) warning letter released today indicates that eradication efforts have failed.
In the letter dated August 9, 2016, the FDA writes that the presence of L. monocytogenes was yet again found in the production facility. The FDA also noted two “significant” violations of Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food regulation. The inspections took place in January and February 2016.
L. monocytogenes samples were found in two locations, a drop from an April 2015 inspection which found the bacteria in 20 locations within the facility. Unlike the 2015 samples, which were found on equipment used in food production, this round of inspections only found L. monocytogenes in non-food contact areas (specifically a drain and floor).
According to the Centers for Disease Control and Prevention, consuming food contaminated with L. monocytogenes can cause the infection Listeriosis. Although healthy individuals will generally only suffer from short-term symptoms from the infection, it can have serious and sometimes fatal effects in children, elderly individuals, pregnant women and people with weakened immune systems.
Inspectors conducted Whole Genome Sequencing (WGS) analysis on the samples and were able to link current strains of L. monocytogenes to the April 2015 strains.
“The evidence demonstrates that L. monocytogenes has maintained its presence within your production facility since 2015,” the FDA Letter states. “The recurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility. These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility.”
Jeni’s has taken numerous steps to update its facilities, change its production methods and beef up sanitation practices. In April 2015 after L. monocytogenes was found in finished product, the brand issued a recall of all of its products and shut down its production facility and scoop shops.
The brand was lauded for its openness with consumers, and provided regular updates on its company blog. In one such update, CEO John Lowe noted that the company had hired a dairy processing cleaning expert and wrote that, “We want to provide an update on what we have done, what we have learned and what we are doing to ensure this never happens again.”
Jeni’s resumed making ice cream in May 2015. In June 2015 the company’s ice cream shops yet again had to close due to the presence of listeria in the production facility. At the time Lowe noted, “While we would most certainly prefer that Listeria never enter our facility, we do take solace in the fact that our protocols and testing have worked: we found the Listeria before it got into ice cream we served.”
The company also hired a director of food safety and changed its production flow so that ice cream is no longer made on site. Instead the company produces flavor bases and ships them to a co-packer to be finished.
“In looking at this letter, the typical reasons the FDA would send a warning letter, either because they felt there was unsafe product out in the market and the company elected not to do a recall or the responses were inadequate, don’t seem to be apparent in this particular situation,” Justin Prochnow, an attorney at Greenberg Traurig, LLP who handles civil litigation and regulatory filings for food and beverage companies, told NOSH. “The FDA acknowledged the corrective actions and there wasn’t particular product that had been identified as contaminated. So it is a little puzzling as to why the FDA decided that a warning letter was necessary in this situation.”
Jeni’s did not respond to requests for comment by press time. This post will be updated with any comments from the brand.