The FDA Just Set A Precedent

Disclosure: Darwin’s Pet Food has been on my annual ‘List’ of pet foods I trust to give my own pets for many years. The company sources human grade ingredients and provides verification to that. As long as the company continues to be transparent with me (and pet owners), provides me all verification documents, they will remain on my List of pet foods I trust to give my own pets.

The FDA has opened a big can of worms.

The United States Justice Department – on behalf of the FDA Center for Veterinary Medicine – has filed a complaint “seeking to permanently enjoin” (force to stop manufacturing) Darwin’s Pet Food company. 

Why is the US DOJ doing this?

In part the DOJ complaint states “unless enjoined [Darwin’s Pet Food] will continue to violate, 21 U.S.C. § 331(a) by introducing or causing to be introduced, or delivering or causing to be delivered for introduction, into interstate commerce, articles of pet food that are adulterated within the meaning of 21 U.S.C. § 342(a)(4).”

In other words, the FDA seeks to shut down Darwin’s Pet Food alleging the company has repeatedly sold adulterated pet food – and unless they are legally prevented (enjoined) from manufacturing pet food the company will continue to do so.

“Every American pet owner deserves confidence that the food they feed their animals is safe and will not pose health risks to their families,” Timothy Schell, Ph.D., director of FDA’s Center for Veterinary Medicine.

The complaint discusses Darwin’s manufacturing history from 2017 through 2025.

With this action, the FDA appears to be taking a very strong stance against what they believe are ‘repeat offenders’.

Speaking of repeat offenders…

Within the same time frame (2017 through 2025), below are recalls issued by some other repeat offenders (more frequent offenders than Darwin’s).

Smuckers

7/3/20 – JM Smucker Natural Balance – canned – elevated levels of choline chloride.
12/5/19 – JM Smucker/Special Kitty Cat Food – can – not disclosed.
2/14/18 – Smuckers (Gravy Train, Kibbles n Bits, Skippy) – can – pentobarbital.
12/7/18 – JM Smucker 9 Lives – wet/canned – low thiamine.
1/03/17 – JM Smucker 9 Lives, EverPet, Special Kitty – can – low thiamine.
1/06/17 – JM Smucker 9Lives, EverPet, Special Kitty – can – low thiamine.

If FDA is truly interested in protecting the public (as the lawsuit claims), then pet owners should expect another enjoinment action to be filed against the JM Smucker company.

Sunshine Mills
11/2/18 – Natural Life (manufactured by Sunshine Mills) – dry – excess Vitamin D.
11/2/18 – Nutrisca (manufactured by Sunshine Mills) – dry – excess Vitamin D.
11/6/18 – Orlando Brand (manufactured by Sunshine Mills) – dry – excess Vitamin D.
11/9/18 – Natural Life Pet Products (manufactured by Sunshine Mills) – dry – excess Vitamin D.
11/27/18 – Sunshine Mills – dry – excess Vitamin D.
11/28/18 – ANF Pet Foods (manufactured by Sunshine Mills) – dry – excess Vitamin D.
11/29/18 – Elm Pet Foods (manufactured by Sunshine Mills) – dry – excess Vitamin D.
12/5/18 – Abound (Kroger) (manufactured by Sunshine Mills) – dry – excess Vitamin D.
12/5/18 – Abound (King Soopers and City Market stores) (manufactured by Sunshine Mills) – dry – excess Vitamin D.
8/26/20 – Sunshine Mills Nature’s Menu – dry – Salmonella.
9/3/20 – Sunshine Mills Family Pet, Heartland Farms, and Paws Happy Life – dry – aflatoxin.
7/29/21 – Sunshine Mills (Triumph, Evolve, Wild Harvest, Nurture Farms, Heart to Tail, and Elm pet food) – dry – aflatoxin.
6/4/21 – Sunshine Mills (Sportsman’s Pride, Sprout, Intimidator, and FRM Gold Select) – dry – Salmonella. 

Again, based on this FDA precedent – pet owners should expect another enjoinment action to be filed against the JM Smucker company, a proven repeat offender.

The FDA/DOJ Complaint regarding Darwin’s Pet Food cites a very significant federal law as foundation for their enjoinment action; the Federal Food Drug and Cosmetic Act definition of an adulterated food (“21 U.S.C. § 342(a)(4)”). Specifically, the legal action quotes “342(a)(4)” – “A food shall be deemed to be adulterated- (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. “

Using this new FDA precedent, there are more repeat offenders to consider. Pet Food ingredients are also considered pet food. 

Based on the EXACT same law, we can assume that all rendering facilities will soon be enjoined too. In no uncertain terms, the following examples of rendering company images are pet food ingredients “held under insanitary conditions whereby it may have become contaminated with filth”.

And rendering companies are certainly repeat offenders, producing pet food ingredients for decades in the same insanitary, filthy conditions. 

Since the FDA has opened the can of worms (established the legal precedent of forcing closure of repeat violators in pet food), there is another law to consider. 21 U.S.C. § 342(a)(5). Adulterated Food: “(5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter.”

Because the FDA should not publicly evidence the agency is bias in any way (which would evidence mismanagement of federal funds and abuse of power), based on the precedent FDA just established by attempting to enjoin Darwin’s, pet owners should expect perhaps hundreds of other enjoinment actions to be filed against every pet food manufacturer that sources rendered ingredients, sources diseased animals and animals that have died other than by slaughter. 

Unless the FDA is going to confirm to the public they are openly bias and abusing their power, within the next few days, pet owners SHOULD see DOJ/FDA filings against many pet food repeat offenders.

But if we don’t…

The FDA Center for Veterinary Medicine will evidence to everyone (including members of Congress and the Government Accountability Office) the agency is abusing its authority, mismanaging federal funds and not consistently enforcing law across the pet food industry. 

If we don’t promptly see multiple enjoining cases filed in federal courts against the many repeat offenders in pet food, we will file a formal complaint with the Government Accountability Office providing undeniable evidence the FDA Center for Veterinary Medicine is in violation of their official duties.

Susan Thixton
Pet Food Consumer Advocate
TruthaboutPetFood.com
Association for Truth in Pet Food

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