While five antibiotics found in sample tissues are approved as new animal drugs under specified conditions, no legal tolerances have been approved for the use of these animal drugs in calves, says the injunction. (See pages 5-7 of the consent decree.) In addition, two sulfa drugs found in tissue samples have not been approved for use in any animals. Most residues found in the calves were considerably higher than the normal amounts allowed for adult beef cattle.
The decree prevents the defendants from purchasing or selling any animals for use as food unless and until they take certain actions to assure animals with illegal drug residues do not enter the food supply, according to an FDA statement.
The decree, filed by the US Department of Justice’s Office of Consumer Protection Litigation and the US Attorney’s Office for the Eastern District of California, requires the defendants to keep written records to identify which animals have been medicated and to segregate medicated and non-medicated animals.
According to the FDA, previous inspections of the defendants’ operations found recurring violations of the Federal Food, Drug, and Cosmetic Act that the defendants failed to correct.
Ingesting food containing excessive levels of antibiotics and other drugs, even at very low levels, can cause severe adverse reactions among the general population and can harm consumers who are sensitive to antibiotics.
“The FDA continues to take strong enforcement actions against companies that put consumers’ health at risk,” says FDA’s Associate Commissioner for Regulatory Affairs, Dara A. Corrigan. “The actions we took are necessary to ensure that these foods don’t contain illegal residues of drugs.”
