Author - Savannah Wiseman*
*Admitted only in the State of Texas. Practice supervised by principals of the firm admitted in DC.

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 November 14th and December 14th.

Warning Letters issued to six dairies

The FDA issued Warning Letters to six 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 animals with unsafe levels of various drugs present in the animal's tissue into the food supply.

Warning Letters issued to six seafood processing facilities

FDA issued Warning Letters to six seafood processing facilities for selling adulterated products under the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

Under the HACCP regulation, a seafood processing facility must have an annually signed and dated HACCP plan. The HACCP plan must contain appropriate "critical limits" that are measured and verified. These would include, for example, temperature control measures that are monitored with calibrated instruments, a list of the food safety hazards of pathogens caused by time and temperature abuse, and undeclared allergens. A food safety hazard is defined as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption."

Facility violations included: (1) failure to have an HACCP plan for all products; (2) failure to record compliance with the facility's HACCP plan; (3) failure to set temperatures in the HACCP plan that are sufficient to prevent pathogenic bacteria grown or toxin formation; (3) failure to include all ingredients on product labels; and (4) failure to include critical limits for brining or cooling in the facility's HACCP plan.

The FDA recommended to one facility that in addition to providing the cooking temperature, the facility should include other parameters that affect the cooking process, such as the minimum cooking time for each type of product, as well as the maximum batch and portion size to ensure that each piece receives an adequate scheduled cook process.

Warning Letters issued to five food processing facilities

FDA issued Warning Letters to five food processing facilities for manufacturing adulterated food products in violation of the Current Good Manufacturing Procedures (CGMP) for Human Food and/or for misbranding food products in violation of the FDCA.

Violations of the CGMP included: (1) failure to exclude pests from food processing areas; (2) failure to clean equipment, containers, and utensils as frequently as necessary to protect against contamination; (3) failure to chlorinate water used in heating and cooling processes; (4) failure to inadequately clean and sanitize floors; and (5) failure to provide hand washing facilities near food processing areas.

Misbranding violations included (1) failure to declare caloric content and serving size,  (2) incorrectly labeling products as "smoked" when the products did not go through a smoking process; (3) labeling a chocolate-covered coconut product as "healthy" when such a statement is misleading; (4) and failure to declare the common name of an ingredient.