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").  Below is a brief synopsis of recent food-related Warning Letters.

Warning Letters issued to dairies

The FDA issued Warning Letters to ten dairies for selling animals for slaughter that were adulterated.  The New York District Office issued six of these warnings.  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 animals with unsafe levels of various drugs, including desfuroylceftiofur, flunixin, and sulfamethoxazole present in the animal's tissue into the food supply.

Each dairy was also found to generally hold its animals under conditions that were inadequately monitored.  Specifically, all warned dairies were 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, all dairies to which warning letters were issued were found to have used pharmaceuticals in their cows in a manner not allowed by regulations.  The extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.  Most of the dairies were found to have administered drugs to cows without the supervision of a veterinarian.

Warning Letters issued to food-processing facilities

Three food-processing facilities were found by FDA inspectors to have violated the Current Good Manufacturing Procedures (CGMP) for Human Food, Title 21, Code of Federal Regulations, Part 110.  The products, which included cheese, read-to-eat sandwiches, and almond butter, among other products, were deemed adulterated under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] in that they have been "prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health."  Violations include the failure of employees to properly wash their hands or change protective gloves between tasks, failing to sanitize production surfaces, and utilizing cardboard "with heavy filth buildup" in the food production process.

Warning Letters issued to seafood processing facilities

Four seafood processing facilities were issued Warning Letters for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, codified in 21 CFR § 123: Because these facilities failed to properly implement their HACCP plans, their seafood products were rendered adulterated within the meaning of Section 402(a)(4) of the FD&C Act, 21 USC. § 342(a)(4).   The facilities' HACCP plans lacked required procedures, or, for certain products, did not exist at all.  Additionally, the facilities failed to properly follow certain procedures listed in their HACCP plan.

Warning Letters issued to processor of acidified foods

The FDA issued a Warning Letter to a manufacturer of acidified foods due to its failure to schedule processes with FDA for foods produced, as required by the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR 114).  For those processes that the FDA did have on file, the firm failed to follow them in its production of its hot sauce, in addition to other products.  Due to these violations, the agency found that the food and acidified food products were adulterated within the meaning of section 402(a) of the Act (21 U.S.C. 342(a)(4)).  Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available here.

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.

Erin Close*
*Admitted only in the State of New York. Practice supervised by principals of the firm admitted in DC