It is FDA's practice to issue Warning Letters in order to provide individuals and companies an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. The agency's position is that it issues Warning Letters only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act ("the FD&C Act").
Companies in receipt of a Warning Letter have 15 days to respond to the agency in writing to explain the steps taken to correct the violations. FDA evaluates the responses and, if needed, can take regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures.
Below is a brief synopsis of recent food-related Warning Letters, all of which have been issued to dairy operations. View the 2014 Warning Letters.
The FDA issued Warning Letters to seven dairies for selling animals for slaughter that were adulterated. Under 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under unsanitary conditions whereby it may have been rendered injurious to health. The recipient dairies were found to have introduced into the food supply animals with unsafe levels of various drugs present in the animal's tissue.
Five of the seven dairies received letters due to the fact that they sold an animal with drugs that are allowable for use in animals for slaughter but that were present at a level above the allowable level, as defined by FDA. These drugs included ampicillin and desfuroylceftiofur, both antibiotics, and flunixin, a non-steroidal anti-inflammatory drug.
The remaining two dairies were found to have used drugs in pre-ruminating (also known as bob veal) calves that are approved for use in cattle but are not allowable for use in veal calves. These drugs included sulfamethazine and dihydrostreptomycin, both antibiotics. Because these drugs are not allowable for use in veal calves, the presence of any level of this drug in a bob-veal calf causes the produced food to be adulterated.
While one of the dairies in receipt of a Warning Letter had written to FDA and addressed the observations made by the agency during its inspection of their farm, FDA stated that the farm’s letter was not an adequate response. The dairy’s response failed to include completed treatment records, did not state if the dairy had implemented a procedure for tracing animals sent for slaughter, and did not address how the dairy will monitor the expiration dates of medications used by the facility to ensure that expired medications are not being used to treat animals.
Each warned dairy was also found to have failed to maintain treatment records for their cows. The FDA asserted that this inadequate monitoring caused it to be more likely that medicated animals bearing potentially harmful drug residues would enter the food supply. Finally, most of the warned dairies were also found to have administered drugs to cattle without a lawful order of a licensed veterinarian.