Exclusive: FDA Dings Raw Pet Food, Company Hits Back
"Mighty Raw" responds to exhaustive warning letter from FDA, alleging "bias" against raw food; unfair treatment
Answers, parent company of “Mighty Raw”, was lashed for “poisonous or deleterious substance[s]”; “contaminated with filth”; Salmonella; Listeria.
Despite numerous cutbacks and spending freezes, the FDA’s Center for Veterinary Medicine has continued to function in 2025, and has been especially active in its oversight of raw pet food, as evidenced by an exhaustive warning letter issued on June 18 to Pennsylvania-based raw pet food purveyor Keith Hill, owner of Lystn LLC which sells Answers pet food brand Might Raw, available online through retailers such as Chewy as well as in brick and mortar stores such as Petco around the country. Mr. Hill did not return TCR’s email request for a response to the FDA’s letter. In our inquiry, we also asked Mr. Hill whether he believed that he had been treated unfairly by regulators—and, we asked if he believed the FDA’s letter contained any inaccuracies. [Note: Following publication, Mr. Hill responded by email and included what he is describing as a “draft” response to FDA regulators which dismisses the letter and alleges bias against raw pet food. See below.]
The letter offers two points of contact: Compliance Officer Andrew J. Howard and Director of Food Compliance Isaac K. Carney at the Office of Surveillance and Compliance. Neither Mr. Howard nor Mr. Carney returned email or voice mail requests for comment, including requests to confirm whether they remained employed at HHS. The warning letter was dated June 18.
Pet food regulators at the FDA’s Center for Veterinary Medicine have been actively monitoring raw pet diets: Earlier this year, the FDA told manufacturers of these diets that they would be required to come up with safety protocols surrounding the H5N1 Bird Flu epidemic. The agency also warned consumers to exercise additional caution when feeding raw pet diets.
The warning letter to Mr. Hill’s cites findings from onsite inspections and samples taken at those inspections of his raw pet food manufacturing facility in Elizabethville, Pennsylvania. The letter describes “evidence of significant violations of FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements…which cause your products to be adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.”
The letter goes on to explain that FDA Investigators also purchased samples of Answers already on store shelves from a store in Nevada – in response to consumer complaints. The findings revealed “all four sampled lots contained Salmonella and/or Listeria monocytogenes, as described below. Therefore, your Answers Pet Food Raw Beef Detailed Formula, lot May 06 2026, Answers Pet Food Raw Beef Straight Formula, lot Jan 31 2026, and your Answers Pet Food Straight Chicken Formula, lots Jan 02 2026 and Mar 11 2026, are adulterated in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.4 FDA issued a public advisory on September 23, 2024. At the close of the inspection, you were issued a Form FDA 483….”
Mr. Hill’s earlier response to regulators was also deemed insufficient, according to the letter. “In your October 18, 2024 response you state that the observations will be discussed with your staff, addressed and documented through CGMPs, and added to your SOPs. However, your response does not include supporting documentation to demonstrate that any corrections have been completed and are adequately and consistently implemented. Therefore, we are unable to fully evaluate the adequacy of your response. We encourage you to provide documentation of your corrective actions in follow-up correspondence.”
“You manufacture raw pet food and the practices described above are ways in which the pet food you manufacture could become contaminated by undesirable microorganisms,” the letter continues. Undesirable microorganisms include microorganisms that are pathogens, that subject animal food to decomposition, that indicate that animal food is contaminated with filth, or that otherwise may cause animal food to be adulterated.”
The letter concludes by instructing Mr. Hill to respond within 15 working days with “specific steps that you have taken to correct any violations.”
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When asked about the employment status of the two individuals whose names were signed to the warning letter, Andrew Nixon, the head spokesperson for the Trump administration’s Departments of Health and Human Services, did not respond. In the same email, asked whether there was any backlog in the warning letters due to cutbacks, Mr. Nixon wrote: “There is no backlog due to staffing, that is false.” However, Mr. Hill’s warning letter addresses communications, materials, and events occurring mostly one year ago, over last summer 2024, with one inspection and some emails in November 2024.
Update
Following publication, Mr. Hill responded by email: “Yes, there are inaccuracies and misrepresentations in the FDA WARNING LETTER that will be responded to in detail. From our response we also provide background on why the WARNING LETTER was unwarranted and why we feel ANSWERS Pet Food has not been treated fairly.” Here is the “draft” response Mr. Hill told TCR he planned to issue to FDA regulators, which he provided to TCR Thursday morning. The letter is not signed, but Mr. Hill copied six additional individuals with Answers or parent company Lystn LLC email addresses.
