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 (“FDCA”).
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. The 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 published between January 18th and February 22th.
Warning Letters issued to twelve dairies
The FDA issued Warning Letters to twelve dairies for selling animals for slaughter that were adulterated. Under 402(a)(2)(C)(ii) of the FDCA, 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 FDCA, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FDCA, 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, including desfuroylceftiofur, penicillin, oxyphenylbutazone, and neomycin, present in the animal’s tissue.
Investigations also revealed that some of the facilities improperly administered human or animal drugs to livestock, for example, by not following approved labeling. The FDA allows extralabel use of approved animal and human drugs in animals if the extralabel use complies with certain regulations, including that extralabel uses are by or on the order of a licensed veterinarian within the context of a veterinarian/client/patient relationship. These facilities were found to improperly administer drugs to animals without the required veterinary supervision. There facilities also failed to maintain complete treatment for their livestock.
Warning Letters issued to one food processing facility
FDA issued Warning Letters to one food processing facility for manufacturing adulterated food products in violation of the Current Good Manufacturing Procedures (CGMP) for Human Food.
This facility was warned a second time for failing to exclude pests from food processing areas and for failing to provide adequate screening or other protection against pests after receiving an FDA warning letter.
*Savannah Wiseman is admitted only in Texas. Practice supervised by principals of the firm admitted in the District of Columbia.
