FDA Maintains Strong Enforcement Stance on Drug Residues in Food Animals

The Food and Drug Administration (FDA) has issued a dozen Warning Letters to dairy farms across the country.

In recent weeks, the Food and Drug Administration (FDA) has issued approximately 12 Warning Letters to dairy farms in the US due to the presence of illegal drug residues found in food from slaughtered cattle from those farms. In each case, the FDA tested animal tissue samples, which confirmed the presence of residues of either unapproved new drugs (e.g., sulfamethoxazole) or residues of approved drugs (e.g., penicillin, neomycin, sulfamethazine, etc.) at limits that exceed the FDA’s applicable drug residue tolerance. While it is not uncommon for the FDA to issue Warning Letters for these types of violations, it is clear that the FDA has recently been maintaining a strong enforcement stance concerning the presence of illegal drug residues in food-producing animals.

Each of the farms that received an FDA Warning Letter was charged with offering for sale an animal that, when slaughtered, was found to have edible tissues containing amounts of drugs that violated the law. The selling of adulterated food is a violation of Sec. 301 of the Federal Food, Drug and Cosmetic Act. In addition, the FDA found in some instances that the farms had failed to have a system to control administration of drug treatments to their animals and that they failed to maintain complete treatment records. While this type of enforcement action is generally resolved by the farm instituting practices and procedures to prevent a recurrence of the adulteration, violations of the act can lead to the imposition of penalties, as well as possible prosecution for continuing violations of the law.

Over the past few years, the FDA has expanded its enforcement activities in the food area under the authority of the Food Safety Modernization Act, and we expect the Agency to continue to maintain a relatively high level of enforcement targeting foods over the foreseeable future. Thus, we recommend that farm operations evaluate their procedures in light of this enforcement climate.

If you have any questions about this alert, please contact James R. Ravitz, Georgia C. Ravitz, or Wayne H. Matelski, or the Arent Fox professional who handles your matters.


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