Warning Letter to Darwins includes Blatant Regulatory Bias

Warning Letter to Darwins includes Blatant Regulatory Bias


No, No, No FDA. Raw pet food is held to ‘food’ law, but others are considered feed and allowed to violate ‘food’ law. Outright regulatory bias (and illegal).

The FDA issued a Warning Letter to Darwin’s Pet Food on April 2, 2018 citing testing revealing the raw pet food was “contaminated with Salmonella, Listeria, and/or Shiga toxin-producing Escherichia coli O128.” The Warning Letter provided information that multiple samples of unopened Darwin’s pet food – provided by (what appears to be) multiple customers tested positive for dangerous bacteria.

Overall, this FDA Warning Letter is a bit different than any other pet food Warning Letter (at least to my knowledge). The issues FDA seems to be addressing with Darwin’s is a concern that the same strain of bacteria was found in multiple different products – “which may suggest pathogen contamination in your facility.” And that Darwin’s utilizes bacteriophages; FDA states this concern:

…we have concerns about the use of these bacteriophage because we are unaware that they are generally recognized as safe, as described in Title 21, Code of Federal Regulations (21 CFR) 570.30, or the subject of a food additive regulation published in 21 CFR Part 573, describing food additives permitted in animal foods.

Ok, fair enough for what is mentioned above in the FDA Warning Letter. If Darwin’s has a pathogen contamination within their manufacturing facility – as FDA alludes – it should be addressed.

But, there are some concerns with the FDA Warning Letter…

Testing time frames

FDA appears to be very concerned over the potential of “pathogen contamination” in the Darwin’s facility. But their testing of pet food samples provided by consumers was certainly not rushed.

FDA sample 441268 and FDA sample 441268 was collected by FDA on November 15, 2017 from a Darwin’s customer – but the testing was not performed until November 29th and 27th respectively; two weeks after the sample was collected.

Another sample (#1031923) was collected on January 24th, and tested a week later February 1, 2018.

And another sample (#1042721) was collected by FDA on February 28, 2018, but this sample was not tested until about 3 weeks later March 19, 2018.

Why was some testing performed promptly (1 week) and other testing took weeks to complete? If FDA is so concerned about “pathogen contamination”, why wait 3 weeks to test?

Blatant Regulatory Bias

In the first paragraph of the Warning Letter to Darwin’s is the following sentence:

Your raw pet food products are food under section 201(f) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(f)], because they are articles used for food for animals.

Note that within this Warning Letter from FDA to Darwin’s – a raw pet food company – the FDA openly cites the federal definition of food – “201(f) of the Federal Food, Drug, and Cosmetic Act”. The FDA openly tells a raw pet food company pet food products “are food…under the Federal Food, Drug and Cosmetic Act”. 

BUT…on other pages of the FDA website the agency talks out of the other side of their mouth allowing pet “food” products to violate these EXACT SAME LAWS – allowing pet “food” products to be considered feed, not “food“.

So for small raw pet food manufacturers the FDA is attempting to enforce food laws. But for multi-billion dollar a year kibble and can pet food manufacturers the FDA says…

CPG Sec. 675.400 Rendered Animal Feed Ingredients

“POLICY: No regulatory action will be considered for animal feed ingredients resulting from the ordinary rendering process of industry, including those using animals which have died otherwise than by slaughter, provided they are not otherwise in violation of the law.”

“CPG Sec. 690.300 Canned Pet Food”

“POLICY: Pet food consisting of material from diseased animals or animals which have died otherwise than by slaughter, which is in violation of 402(a)(5) will not ordinarily be actionable, if it is not otherwise in violation of the law. It will be considered fit for animal consumption.”

So…according to public information found on the FDA website – some styles of pet food are considered “food” and are held to food law, while other styles of pet food are considered “feed” and are openly allowed to violate “food” law.

Is it coincidence that the small manufacturers are the ones being held to food law and the multi-billion dollar a year pet food manufacturers are allowed to violate food law? Or is this collusion?

My opinion: it’s collusion. The FDA (and AAFCO and each State Department of Agriculture) openly colludes with Big Pet Feed enabling billions in profits to be made from illegal products.

If Darwin’s has a manufacturing problem as the FDA indicates, it most certainly should be corrected. But the FDA cannot continue to have two separate standards for pet “food”. One law abiding, one illegal. This is regulatory bias – blatant regulatory bias.

This MUST stop.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
Association for Truth in Pet Food

Warning Letter to Darwins includes Blatant Regulatory Bias
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Warning Letter to Darwins includes Blatant Regulatory Bias

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