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.
The FDA issued Warning Letters to eight 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 insanitary conditions whereby it may have been rendered injurious to health. The recipient dairies were found to have introduced animals into the food supply with unsafe levels of various drugs present in the animal’s tissue.
Three of the dairies received letters due to the fact that they sold an animal that tested positive for penicillin, which is allowable for use in animals for slaughter but was present at a level above the allowable level, as defined by FDA.
Four of the 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.
Six of the dairies were found to have adulterated the administered drugs because they failed to use the drugs as directed by approved labeling. Such use of a drug is an extralabel use, which is allowed under the FD&C Act only if the extralabel 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.
Seven of the warned dairies were 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.
Seafood processing facilities
Eight seafood processing facilities and importer establishments were issued Warning Letters for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, codified at 21 C.F.R. § 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). Facility violations included: failure to monitor the temperature of crawfish that were thawing in a water bath; failure to annually sign and date the facility’s HACCP plan; failure to properly control histamine (a foodborne pathogenic microorganism); failure to have a HACCP that outlines controls for each food safety hazard reasonably likely to occur; failure to monitor sanitation conditions; and failing to monitor pathogen growth and toxin formation.
Juice processing facilities
Two juice processing facilities received Warning Letters for selling adulterated juice products. Under the juice HACCP regulation, all juice processors must have and must implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of Part 120. Failure to do so renders the juice products adulterated.
One of the juice processing facilities failed to include control measures that ensure reduction of certain microorganisms. The facility’s HACCP plan also failed to list all food safety hazards that are reasonably likely to occur, specifically the pertinent food safety hazards of foreign objects and microbiological hazards common to juice products packaged in plastic bottles of the type the facility produces.
The second juice processing facility similarly failed to address the presence of microorganisms. The facility also did not have HACCP plan specific to each type of juice produced by the processor. Finally, the facility did not monitor conditions and practices during processing to the extent required to conform with the current good manufacturing practice regulations for food processors.
Other food processing facilities
The FDA issued Warning Letters to one shell egg processing facility for violations of the Egg Safety Rule, codified at 21 C.F.R. 118. The FDA found that the facility had not properly implemented legally required measures meant to prevent Salmonella Enteritidis (SE). Additional draft guidance regarding the Egg Safety Rule, meant to provide additional guidelines for compliance with the Rule, was proposed in August of 2013.
A Warning Letter was also issued to a food storage facility for violations of 21 CFR 110, Current Good Manufacturing Practice (CGMP) regulations. Live birds were observed flying throughout the facility and dead birds were observed trapped in netting suspended in the facility. Rodent activity, measured by the number of rodent excreta pellets, was also observed. The condition of the facility caused the foods therein to be adulterated under Section 402(a)(4) [21 United State Code (USC) 342(a)(4)] of the FD&C Act because the food had been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth.