According to the FDA’s Investigations Operations Manual 2024, the definition of a recall is: “a company’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 will initiate legal action (eg, seizure).”
Recalls are classified by the FDA into one of three options:
CLASS I RECALL
“A Class I Recall is a situation where there is a reasonable possibility that use of, or exposure to, an infringing product will cause serious adverse health effects or death.“
CLASS II RECALL
“A Class II Recall is a situation where use of, or exposure to, an infringing product may cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health effects is remote..”
CLASS III RECALL
“A Class III Recall is a situation where use of, or exposure to, an infringing product is unlikely to cause adverse health effects..”
According to federal law, “an ad hoc committee of Food and Drug Administration scientists” determine the classification of a recall based on the risk and consequence of the issue. The recall classifications seem clear, but in real life, the FDA appears to classify recalls in ways that suit their needs or preferences. Just like…
In the FDA Enforcement Report notes for the week of June 19, 2024 (for the Veterinary category), we found these two reports of pet foods being recalled for the same reason – “potential metal contamination“.
Two identical reasons for recall; “metal contamination”. But there are two different classifications of these pet foods.
One pet food is Pedigree dog food, a product of Mars Petcare. The reason for recall stated in the enforcement report is “potential metal contamination“. FDA scientists have classified this pet food recall as Class II – “the possibility of serious adverse health effects is remote“.
The other pet food is a raw pet food, TDBBS green tripe product. Again, the reason for this recall as stated in the implementation report is “Contamination by foreign material (metal).“. But the FDA scientists classified this pet food return in a different way, as a Class I remember – “an infringing product will cause serious adverse health effects or death.“
Similar causes of relapse are classified very differently. Why do FDA scientists classify metal contamination in these two pet foods differently? Perhaps the FDA classifies them differently because of who the manufacturers are – and what would be required in a Class I recall.
The big difference between Class I and Class II recalls is the public press release – which is only required for Class I.
In other words, the raw pet food metal contamination then required to issue a public recall statement because it was classified as Class I. But, because the FDA classified the Pedigree kibble dog food metal contamination recall as Class II – Mars Petcare didn’t have to say publicly that they recalled the dog food.
The TDBBS recall notice was sent to public news outlets directly from the FDA. But since the Mars Petcare Pedigree recall was Class II – Mars Petcare was allowed to keep their recall quiet (for the same reason).
If pet owners want to track these special/unannounced recalls – the easiest way to watch what’s happening in 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 specific weeks in each month. To narrow the results to pet products only, once you’ve opened the records for that particular week, select the ‘Veterinary’ option under Product Type.
Wishing you and your pet(s) the best,
Susan Thixton
Pet Food Safety Advocate
TruthaboutPetFood.com
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