The warning letter, sent March 17, 2016, says Salmonella Enteritidis was found in the company’s Detailed Answers Chicken, 8 ounce raw chicken patties, and Salmonella Kentucky was found in Detailed Answers Chicken Formula, 2 pounder.
“FDA’s concerns with Salmonella-contaminated pet foods are two-fold: safety of the animals consuming the product and safety of the humans in the same household. It is more common to have human illnesses linked to contaminated pet food or treats than it is to have an animal illness. The association between human outbreaks of salmonellosis and Salmonella-contaminated pet foods is well established by the Centers for Disease Control and Prevention (CDC),” FDA’s letter said.
FDA says that, during inspections of Lystn’s facilities and contract manufacturer in September 2015, it confirmed that Lystn “manufactured, introduced and delivered for introduction into interstate commerce, a food that is adulterated, and as such is prohibited under section 301(a) of the Federal Food, Drug and Cosmetic Act.”
The letter continues: “In addition, your website makes mention to your reliance on cultured whey and montmorillonite, which are food additives, to control ‘harmful bacteria’; this is beyond their established intended use. As FDA moves forward with implementing preventive controls for food for animals within the Food Safety Modernization Act, firms will be required to validate any method to control a known or foreseeable hazard requiring a preventive control.”
FDA says Lystn also failed to file a Reportable Food Report within 24 hours as required by the Food, Drug and Cosmetic Act.
If Lystn does not “take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur,” the result may be regulatory action “without further notice such as seizure and/or injunction,” FDA said.
In a report, Lystn officials said they believe they have addressed FDA’s concerns and that FDA declined to address its follow-up questions.
The US Department of Agriculture allows a limited amount of Salmonella in poultry and other food consumed by humans, Jacqueline C. Hill, the company’s vice president of operations, product development and sales, said in a report.
“But we’re not regulated by the USDA but by the FDA, and it says pet food can’t contain any Salmonella,” Hill said. “We’re a small family company trying to make dogs and cats healthier.”