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According to Dr. Joseph Mercola at Mercola.com, the FDA is considering withdrawing the approval for carbadox, a popular antibiotic used in pigs over concerns it could be linked to cancer. Mercola writes:
Livestock raised in confined animal feeding operations (CAFOs) are routinely given a range of veterinary drugs to prevent disease, and some of those drugs could potentially impact the health of those who eat their meat.
November 7, 2023, the U.S. Food and Drug Administration announced it is considering withdrawing approval for the antibiotic carbadox1 (brand name Mecadox), which is added to pig feed to prevent infections and fatten up the animals, due to cancer concerns. As noted in the Federal Register:2
“The Food and Drug Administration … Center for Veterinary Medicine (CVM), is proposing to withdraw approval of all new animal drug applications (NADAs) providing for use of carbadox in medicated swine feed …
This action is based on CVM’s determination that there is no approved regulatory method to detect the residue of carcinogenic concern in the edible tissues of the treated swine.”
How a Carcinogen Ended Up Being Used for Decades
Under the Delaney Clause in Section 512 of the Federal Food, Drug, and Cosmetic Act, an animal drug cannot gain FDA approval if it has been found to “induce cancer when ingested by man or animal.” In the case of carbadox, the drug was known to cause liver cancer3 and birth defects4 in lab animals.
CVM still approved it under an exception to the Delaney Clause, known as the Diethylstilbestrol “DES” Proviso, which allows a carcinogenic drug to be approved if, under the conditions for use, the drug is found to not have an adverse effect on the animals being treated, and if no drug residues can be found “by an approved regulatory method in any edible tissues of, or food from, the animal.”5 As explained by the FDA:6
“In 1998, the FDA’s Center for Veterinary Medicine (CVM) approved the most recent testing method for carbadox based on information available to CVM at that time.
The method relied on measuring the noncarcinogenic residue quinoxaline-2-carboxylic acid (QCA) as a marker to demonstrate when the residue of carcinogenic concern in the edible tissue of carbadox-treated animals dropped to a level that satisfied the DES Proviso.
However, subsequent information showed that carcinogenic residues of carbadox persist longer than previously known. This means that noncarcinogenic QCA is not a reliable marker …
Specifically, because there is no established relationship between noncarcinogenic QCA measured by the 1998-approved method and the residue of carcinogenic concern, the 1998-approved method does not allow FDA to determine whether the residue of carcinogenic concern can be found in any edible tissue of, or food derived from, the treated animals.
Accordingly, in November 2023, FDA revoked the 1998-approved method. There is currently no approved method for carbadox. Without an approved method, the second prong of the DES Proviso exception to the Delaney Clause, which requires that ‘no residue of such drug will be found …, in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animals,’ is not met.”
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