United States Files Enforcement Action Against Michigan Sandwich Company and Co-Owner to Stop Distribution of Adulterated Products
A civil complaint was filed in federal court in Michigan against Scotty’s Incorporated of Detroit and its co-owner and manager, Sandra Jackson, to prevent the distribution of adulterated sandwiches, the Department of Justice announced today.
According to the complaint, Scotty’s Incorporated, which does business as Bruce Enterprises and Bruce’s Fresh Products, prepares and distributes ready-to-eat (RTE) sandwiches, including RTE tuna sandwiches. The complaint alleges that the company’s sandwiches are manufactured in insanitary conditions, and that the company’s procedures are inadequate to ensure the safety of its products. Moreover, the company has failed to implement a written Hazard Analysis and Critical Control Point (HACCP) plan for handling seafood and minimizing the potential for harmful contamination in the company’s RTE tuna sandwiches. The Justice Department filed the injunction action in the Eastern District of Michigan at the request of the U.S. Food and Drug Administration (FDA).
“Seafood poses well-known risks when it is transported from ship to shore, but these risks can be effectively mitigated if companies handling seafood take proper precautions,” said Acting Assistant Attorney General Joyce R. Branda of the Justice Department’s Civil Division. “The Department of Justice will take all appropriate measures to protect the safety of the seafood consumers eat.”
According to the complaint, the FDA has performed five inspections of the defendants’ facility since 2006 and documented insanitary practices and/or seafood HACCP violations every time. These inspections revealed that the company’s RTE sandwiches are adulterated within the meaning of the Food, Drug, and Cosmetic Act because they are prepared, packed or held under insanitary conditions in which they may have become contaminated with filth or rendered injurious to health. The complaint alleges, for example, that since 2006, the company was repeatedly told to develop a written HACCP plan recognizing the inherent risks of toxin formation in tuna and enumerating plans to take corrective action when tuna is not properly handled.
Tuna that is not chilled rapidly or stored at sufficiently lower temperatures is at increased risk for the formation of scombrotoxin. The toxin can be adequately controlled when tuna is chilled after death and maintained at a cold temperature throughout storage and distribution. In the event that the tuna is not properly maintained, scombrotoxin readily forms and cannot be removed or destroyed through subsequent washing, freezing or cooking of the tuna. Consumption of fish containing high levels of scombrotoxin may cause scombrotoxin poisoning, the symptoms of which may include burning sensations in the mouth or throat, dizziness, nausea, vomiting, headaches, diarrhea, rashes, hives, a drop in blood pressure, constriction of the air passage, heart palpitations and respiratory distress.
According to the complaint, the FDA’s most recent inspection was conducted between January 14 and February 6. At the inspection, according to the complaint, the FDA found that the defendants failed to have and implement an HACCP plan for food safety hazards reasonably likely to occur. There were also no sanitation control records documenting the safety of, among other things, water used at the facility; the cleanliness of surfaces, utensils and equipment coming into contact with food; maintenance of hand-sanitizing machines and bathrooms; exclusion of pests from the facility; and control of employee health conditions such as the wearing of jewelry, hair nets or beard covers.
The government is represented by Trial Attorney Dan Baeza of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Peter Caplan of the Eastern District of Michigan, with the assistance of Assistant Chief Counsel for Enforcement Christopher Fanelli of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.