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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).

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
TruthaboutPetFood.com
Association for Truth in Pet Food


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11 Comments

11 Comments

  1. Sherrie Ashenbremer

    April 6, 2018 at 5:22 pm

    Ok the FDA needs to back of. They are getting way to nosey. They will start regulating raw pet foods and soon it will be gone. Big companies (Purina, Mars etc) has Government in the back pockets. Just wait, they will stop raw food if we don’t stop them

  2. tinab158

    April 6, 2018 at 5:29 pm

    I made this same comment (ok, maybe not as eloquently as you said it) on another blog yesterday.

    It’s clear to see the FDA is actively going after raw food companies (aka: The Little Fish in a Big Pond), while giving kibble companies (aka: The Big Money Fish in the Big Pond) carte blanche to do whatever they want to do, and use whatever they choose to use, in their pet food products.

    🙁

  3. Jane

    April 6, 2018 at 6:03 pm

    I recently heard a veterinarian on our local public radio station say that bigger companies have more safety protocols in place and so their pet food would likely be safer. This sounds like it’s the opposite – bigger companies are more likely to get a pass on using bad ingredients!

    This is a little off-topic, but what exactly would constitute being “otherwise in violation of the law” when using dead/down/diseased animals doesn’t count as a violation? Does it have to result in illness or death for them to take any action?

  4. paponypal

    April 6, 2018 at 6:08 pm

    Money corrupts all who live in the swamp. Big pharma. NRA, FDA, AFFCO, EIEIO…and the honest citizens doing things correctly are slapped with fines and slander. I agree if Darwins’ food needs addressing but the double standards speak volumes/

  5. Ian

    April 6, 2018 at 6:28 pm

    Thank you as always for shining a light into dark corners.

  6. Marilyn Evans

    April 6, 2018 at 6:28 pm

    Thank you, Susan, for this article. I have been a Darwin’s customer for 6 years and am beyond satisfied with the product quality and the customer service. There must be a way for raw feeders to rise up and demand the end to a double standard in the treatment of pet food by AAFCO and the FDA. Sadly, however, I’ve read your reports of shoddy treatment by these agencies, and it’s very discouraging.

    • Sharon Testa

      May 3, 2018 at 6:25 am

      Any pet owner who feeds their pet,Darwins,and are satisfied with Darwin’s will NOT buy this nonsense from AAFCO!! We know what is good and we know that most pet food industries is garbage so screw whatever AAFCO says they back up the nasty Mars,Colgate,Purina,and the rest of them and why Because they get a huge kick back just like all the veterinaries !!

  7. Pingback: Warning Letter to Darwins includes Blatant Regulatory Bias - Pet News Hound

  8. gemee

    April 7, 2018 at 4:52 am

    Let the FDA try to halt pet owners from simply making raw food for their pets at home. It’s simple with additives; https://www.thespruce.com/top-raw-food-diet-supplements-555079

  9. Reader

    April 7, 2018 at 5:03 pm

    Within a rotational diet, I do feed raw and understand its advantages. But it is always a risk.

    However the FDA may be looking at the situation in this way. Canned PF is one category which is safer (of course, only when a quality source of protein is being used to reduce endotoxins). We know the FDA is not proactively looking into this problem, and only reacts to a PF crisis when a pet gets sick (and will not acknowledge endotoxins).

    Then there is animal-livestock-pet dry feed (kibble, pellets, etc.). Raw food is not (usually) fed in a raw state to livestock-animals although it is to dogs and cats, and therefore functions as a unique class. It does appear there is bias against raw, when comparing the number of raw food brands recalled, per class. However, there is a more concentrated segment of manufacturers producing raw food, compared to several hundreds and hundreds of brands producing kibble. Perhaps it is understood by the FDA that kibble is not salmonella free, but the format of the food is relatively less hazardous than raw, meaning the defects of raw require more emphasis! We know that even if owners fed hamburger (sold for human consumption) that the raw meat would still contain pathogens. And I’ve also read that even using HPP on raw meat only suspends pathogens (temporarily), but when the meat is left unattended, the will resume its contamination process. Therefore the sourcing (and all the handling steps) of raw meat are extremely important! So I believe raw food manufacturers should be under particular scrutiny!

    What worries me about raw isn’t just salmonella (which a dog can handle, but to a degree) are the other more serious pathogens which can be dangerous. There is also the recurring “handling” factor among pet owners. Knowledgeable and experienced owners using raw will sterilize dishware and surfaces. But the average pet owner who’s used to serving a dry PF may not clean up “Fido’s” dish, or the holding places of that raw food regularly. I can see the FDA’s alarm. However, it doesn’t mean they shouldn’t be equally alarmed and diligent about ANY form of PF which is a danger to pets, and is making them sick, or puts a family at risk!

  10. D

    June 25, 2018 at 11:23 am

    Darwin’s has never lead me astray. I will continue supporting them because they have proven true to being committed to quality, honesty and care (Can’t say the same about the FDA)

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