Two Warning Letters to Raw Pet Food – Truth about Pet Food


Two and a half months into 2023, the FDA has issued two Warning Letters to pet food manufacturers – and they just happen to be raw pet food. On February 16th the agency issued a Warning Letter to Arrow Reliance (Darwin’s Pet Food) and on February 21st the agency issued a Warning Letter to Primal Pet Food.

Darwin’s Pet Food

The Darwin’s Warning Letter is part of a year’s long battle FDA seems to be having with this pet food company. And the FDA hasn’t been shy about their opinion of this pet company.

FDA issued a Warning Letter to Darwin’s in April 2018.

In March of 2019, the FDA issued a public statement warning consumers about Darwin’s pet food. FDA’s argument to support the public statement was that Darwin’s did not issue a public press release for a recall. BUT, Darwin’s is sold direct to consumer and the company verified with FDA they notified all customers.

(To the contrary of how FDA handled Darwin’s – I asked FDA why a public press release was not issued for a Spot and Tango Pet Food recall in September 2022. The FDA responded: “Spot & Tango opted to directly notify each of their customers about the Salmonella issue by using the contact information provided by customers when they ordered the recalled products. Since these products were sold directly to consumers from the company (without further distribution), as long as the firm can prove that the direct notifications are successful, the firm has fulfilled its public notification obligation under current federal requirements.” In other words, the FDA allowed Spot and Tango to notify customers directly – but the agency DID NOT allow Darwin’s the same opportunity.)

In August 2022 the FDA issued another public statement warning consumers about Darwin’s pet food. The FDA stated in this public statement 3 kittens “developed diarrhea” after eating Darwin’s.

(In February 2023 we received a Freedom of Information Act request from FDA of all pet food adverse event reports received by the agency from 2010 through 2022. Within the many pages of documents there were hundreds, perhaps thousands of reports of pets that ‘developed diarrhea’. However, to our knowledge, Darwin’s is the only company the FDA issued a public notice about. To our knowledge the FDA ignored the hundreds to thousands of other pet food related diarrhea reports.)

And the FDA issued another Warning Letter to Darwin’s in February 2023. This Warning Letter is directly linked to the August 2022 public statement issued by FDA and again mentions the 3 kittens (no other pet adverse events were mentioned). The only new issue FDA mentions in the February 2023 Warning Letter is the use of the antimicrobial “peroxyacids“. This bacteria control method is approved for use in human meats, but the FDA states it is not approved for use in pet foods.

Primal Pet Food

FDA issued a Warning Letter to Primal pet food on February 21, 2023. This FDA Warning is directly linked to a recall issued by the pet food company on July 6, 2022. Per the FDA Enforcement Report, Primal recalled “2,376 pounds” of pet food due to contamination with pathogenic bacteria.

(As comparison, the FDA also issued a Warning Letter to Midwestern Pet Food directly related to their aflatoxin recall in January 2021 and their pathogenic bacteria recall in March 2021. Per the FDA Enforcement Report, Midwestern recalled “6,509,819 pounds” of pet food due to pathogenic bacteria.)

The Primal Warning Letter discusses another issue that could be a concern. The FDA appears to be saying that Primal testing of their products indicated an excess vitamin D issue in a freeze dried dog food – and it appears to state that Primal ignored the laboratory testing and distributed the pet food.

The lab report numbered 21-124-9881 with a sample received date of April 23, 2021, for the product Canine Turkey & Sardine Formula Freeze Dried (lot W10031394) reported Vitamin D3 levels, based on dry weight, as 3,410 IU/kg. Your firm’s Standard Operating Procedure (SOP), SOP-722, “Sampling Protocol for Thiamine and Vitamin D,” identifies a maximum vitamin D3 level of (b)(4) IU/kg based on dry weight. Your corrective actions inSOP-722 state, “If the levels of vitamin D exceed the requirements the product will be destroyed.” However, your firm distributed the Canine Turkey & Sardine Formula Freeze Dried (lot W10031394) on April 22, 2021. Additionally, you distributed this food before the lab had even received the samples, making it impossible for you to have destroyed the food in accordance with SOP-722.”

And the Primal Warning Letter appears to be saying some of the companies cat foods were thiamine deficient.

Although you told the Investigator that you utilize the AAFCO Food Nutrient Profiles, the table on page 2 of your SOP-722 identified a minimum thiamine level of (b)(4) mg/kg based on a dry weight in feline diets. The AAFCO Food Nutrient Profiles for thiamine in feline diets identifies a minimum level of 5.6 mg/kg. As a result, your prerequisite program is insufficient to manage a thiamine deficiency hazard. For example, the lab report numbered 21-029-9570 with a sample received date of January 14, 2021, for the product Feline Chicken & Salmon Formula Freeze Dried (lot W10022504), reported thiamine levels based on dry weight as 3.96 mg/kg. Your firm distributed the Feline Chicken & Salmon Formula Freeze Dried (lot W10022504) with a low thiamine level on January 11, 2021.”

Opinion and Disclosure: Darwin’s Pet Food is included in my 2023 List of pet foods I would trust to give my own pets. The FDA Warning Letter does not cause me to question the quality of the pet food.

We do not condone pathogenic bacteria in any pet food. However, we personally acknowledge that pathogenic bacteria is a risk common to ALL foods – from lettuce to meat. We believe that every consumer needs to be incredibly diligent when handling any food – not solely pet food.

Because of our own personal awareness of the risk of pathogenic bacteria in ANY food, we believe the FDA in partnership with the USDA should deeply investigate why pathogenic bacteria has become common in almost all foods. Prevention at the cause should be their focus, NOT after-the-contamination warnings.

As well, we believe the FDA should focus the same regulatory attention to pet food issues that result is serious illness or death in our pets. Such as close monitoring of vitamin/mineral premixes, and aflatoxins. The FDA appears to be very focused on pathogenic bacteria and only pathogenic bacteria (and most significantly in raw pet food). We believe that limited focus becomes a dangerous outcome to pets.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
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