FDA Warning Letter alerts us to MORE Pentobarbital in Pet Food – Truth about Pet Food

January 7, 2020 Kar-Bay-Inc 0 Comments

Valley Proteins – one of the largest rendering companies – told FDA that pentobarbital is an “unavoidable contaminant.”

The FDA issued a Warning Letter to Valley Proteins on November 18, 2019. Though the Warning is cryptic, it is evidence of several concerning problems in pet food AND apparently a new (bad) attitude from FDA.

FDA stated “On February 5 and 6, and April 3 and April 22, 2019 the U.S. Food and Drug Administration (FDA or “we”) conducted an inspection of your rendering plant located at 1635 Indian Hollow Road, Winchester, Virginia 22603. Your rendering plant produces animal food ingredients distributed to animal food manufacturers.”

The Warning Letter states that pentobarbital was found in fat ingredients produced by Valley Proteins. FDA warned Valley Proteins (bold added for emphasis) “the presence of pentobarbital in your animal fat products causes these products to be adulterated because the animal food contains an unsafe new animal drug. The drug is unsafe because it was not used in conformance with the drug approval, which does not have a tolerance established for the presence of pentobarbital in the edible tissues of animals.”

Note the FDA warned Valley Proteins – a rendering company that turns dead animals into ‘food’ (but actually feed) ingredients – about pentobarbital because the drug was not “used in conformance with the drug approval“. This is a distinct change in FDA language regarding pentobarbital in pet food – a very concerning distinct change in language.

As example of FDA’s change in pentobarbital language, in February of 2018 FDA warned the public about the potential of pentobarbital in numerous Smuckers manufactured pet foods. Within this warning FDA stated “any detection of pentobarbital in pet food is a violation of the Federal Food, Drug, and Cosmetic Act.” This warning is the accurate warning that should be declared by FDA on ANY pentobarbital warning. The Federal Food, Drug and Cosmetic Act clearly states ANY food (the legal definition of food includes animal/pet food) is adulterated (illegal) “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.” A pentobarbital euthanized animal is ‘an animal which has died otherwise than by slaughter’. This 2018 warning accurately cites law as the foundation for the adulterated pet food.

BUT…this new Warning Letter to Valley Proteins completely revises the previous FDA warning about pentobarbital. Now the FDA is publicly ignoring federal law in the Valley Proteins Warning stating ONLY that pentobarbital was not used properly (“in conformance with the drug approval“). This is extremely concerning language from FDA as it indicates that FDA is positioning themselves to further defend their allowed use in pet food of diseased animals and animals that have died other than by slaughter.

Another serious concern of the Warning Letter is a statement from Valley Proteins to FDA. Valley Proteins told FDA “that pentobarbital is an ‘unavoidable contaminant not known to present a health hazard‘.” Valley Proteins as well completely ignores federal law that clearly states any food is adulterated if it is sourced from “an animal which has died otherwise than by slaughter.”

The Valley Proteins website states “Valley Proteins, Inc. has grown to become one of the largest rendering companies in the United States with several hundred million dollars in annual sales. On average, the company currently processes three million tons of raw materials, and manufactures over one million tons of value-added animal feed ingredients annually, which are marketed throughout the world.” For a company of this size, processing millions of tons of animal material all over the world to have an attitude that “pentobarbital is an unavoidable contaminant not known to present a health hazard” is EXTREMELY concerning.

And then this Warning Letter discusses one more concerning issue. FDA stated to Valley Proteins “Our investigation revealed that once you became aware of the pentobarbital contamination on December 18, 2018, you did not take immediate action to notify customers or recall the product, which are actions specified in your “9.12 Recall Plan” written procedure. On February 11, 2019; April 3, 2019; April 16, 2019; and April 22, 2019, FDA inquired whether you planned to recall the animal food product contaminated with pentobarbital. You stated you did not plan to do so and did not provide FDA with requested information regarding the amount of potentially affected product that was distributed by your firm before you learned of the positive FDA test result.”

The FDA knew products sold by Valley Proteins were adulterated, but FDA did not force the company to recall. Valley Proteins told the FDA ‘No’ – we won’t recall, and we’re not going to tell you more. And FDA just accepted their response. This issue has been going on for almost 1 full year – beginning December 18, 2018 – and only now did FDA take some action by issuing this Warning Letter (a very weak response from FDA).

To read the full Warning Letter, Click Here.

This is very concerning and completely unacceptable behavior from FDA and Valley Proteins. Pet owners don’t know where these adulterated ingredients ended up – don’t know if their pet is consuming an illegal adulterated pet food right now. Beyond absurd.

Note: We will be filing Freedom of Information Act requests for more information, when FDA provides the information it will be shared. Unfortunately, FDA takes their time providing such requests – often up to 2 years.

Wishing you and your pet(s) the best,

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