Dairy farmers, and other food animal producers, should be ever-vigilant in their use of medications to treat their herds and flocks, otherwise they may be at risk of violating certain federal laws.  Following through with its promise to increase its enforcement activities, FDA has already issued more warning letters to dairy farmers, for misuse of medications, in the first two months of 2014, than they had in all of 2013. (See FDA’s website).

A warning letter from the FDA requires an expedited written response-within 15 days-outlining the steps the farmer taken to come into compliance.  Farmers, who fail to respond timely or sufficiently, risk facing the threatened regulatory action of seizure or injunction.

The violations recently cited by the FDA in warning letters to dairy farmers resulted from:

  1. the presence of drugs approved for use in food animals, but identified in tissues at slaughter at levels which exceed those established by FDA; or
  2. the presence of drugs not approved for use in food animals and identified in tissues at slaughter.

The use of drugs in a manner that is not indicated on the label is considered an “extralabel use” and is only permitted under limited circumstances in food animals, and only “by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.”

If drug residues are identified at slaughter, FDA usually sends investigators to the farm to inspect the farming operation and interview farmers and their employees.  These unannounced on-farm investigations often occur months after the treated animal has been tested, and can result in additional violations cited.

To ensure that farm operations are in compliance with the law, dairy farmers should consult with their veterinarians about the proper use of medications approved for use in cattle, including the appropriate route of administration, dosage, documentation of treatment, separation of treated animals, and withholding times required to ensure that residues in meat and milk products will not exceed permitted levels.