When FDA Openly ‘Takes Care’ of Their Friends

According to the FDA’s Investigations Operations Manual 2024, the definition of a recall is: “a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which it would initiate legal action (e.g., seizure).”

Recalls are classified by FDA in one of three options:

CLASS I RECALL
“Class I Recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.“

CLASS II RECALL
“Class II Recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

CLASS III RECALL
“Class III Recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”

Per federal law, “an ad hoc committee of Food and Drug Administration scientists” determine the classification of a recall based on risk and consequences of the issue. It appears recall classifications are clear-cut, but in real life the FDA appears to classify recalls in ways that suit their needs or wants. Such as…

In the FDA Enforcement Report records for the week of June 19, 2024 (for the category Veterinary), we find these two reports of pet foods that are recalled due to the same cause – “potential metal contamination“.

Two identical causes for recall; “metal contamination”. But two very different classifications with these pet food recalls.

One pet food is Pedigree dog food, a Mars Petcare product. The reason for recall stated on the enforcement report is “potential metal contamination“. The FDA scientists classified this pet food recall as Class II – “the probability of serious adverse health consequences is remote“.

The other pet food is a raw pet food, TDBBS green tripe product. Again, the reason for this recall as stated on the enforcement report is “Foreign material (metal) contamination“. But the FDA scientists classified this pet food recall differently, as a Class I recall – “a violative product will cause serious adverse health consequences or death.“

Identical recall causes classified very differently. Why did FDA scientists classify metal contamination differently in these two pet foods? Perhaps FDA classified them differently because of who the manufacturers were – and what would be required of a Class I recall.

The big difference between a Class I and Class II recall is the public press release – which is only required for a Class I.

In other words, the raw pet food metal contamination was required to issue a public recall press release because it was classified as Class I. But, because the FDA classified the Pedigree kibble dog food metal contamination recall as a Class II – Mars Petcare was not required to tell the public they recalled the dog food.

TDBBS’s recall notice was sent out publicly to news outlets directly from FDA. But because the Mars Petcare Pedigree recall was Class II – Mars Petcare was allowed to keep their recall (for the same cause) quiet.

If pet owners would like to keep track of these special/unannounced recalls – the easiest way to watch the on-goings of the industry is through the Enforcement Report records. These FDA records are updated weekly.

Go to this FDA page: https://www.accessdata.fda.gov/scripts/ires/index.cfm

On this FDA page you can open records for months, and then particular weeks through each month. To narrow the results to only pet products, once you open a particular week’s records, choose the option ‘Veterinary’ under Product Type.

Wishing you and your pet(s) the best,

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

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