The US Food and Drug Administration ("FDA") issued over 600 Warning Letters in 2013. About 230 of those Warning Letters, more than 35 percent, were related to food. Below is an overview of this year's Warning Letters.
Almost half8 of the 230 food-safety-related Warning Letters issued over the last year addressed violations of the Current Good Manufacturing Practices (CGMP) in Manufacturing, Packing, or Holding Human Food. Food produced in a facility that is in violation of the CGMP is considered adulterated in that the food has been manufactured, prepared, packed, or held under such conditions that it is rendered unfit for food and/or injurious to health.
Almost 40 percent of this year's letters addressed illegal drug residue. Typically addressed to dairies, such letters are issued when an illegal amount of drug residue is found in the tissue of an animal sold for slaughter. Under section 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. While the legal amount for drug presence varies (from zero to a specified percentage point), dairies are expected to hold their animals under conditions that are adequately monitored, and maintain treatment records so that animals bearing potentially harmful drug residues do not enter the food supply.
Almost one third of letters in 2013 alleged violations of the Seafood Hazard Analysis and Critical Control Points (HACCP) regulation, codified at 21 CFR Part 123. The Seafood HACCP is a preventive system of hazard control that can be used by processors to ensure the safety of their products to consumers. The Seafood HACCP requires that all Seafood production and importer facilities have in place a HACCP plan that identifies the hazards that are reasonably likely to occur during the production of each firm's products, and thus must be controlled for during production. The FDA Warning Letters that address the Seafood HACCP typically address weaknesses or failings within a firm's HACCP plan, or a firm's failure to follow its established HACCP. Multiple letters were also issued for violations of the juice HACCP regulation, codified at 21 C.F.R. Part 120.
The agency has shown no signs of an intent to slow its issuance of food-related Warning Letters. Food manufacturers and facilities should expect continued scrutiny in the coming year. All Warning Letters issued during 2013 can be found here.
Author Erin Close*
*Admitted only in the State of New York. Practice supervised by principals of the firm admitted in DC