Doctor concerned with health care law

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Health Law Daily, May 13, 2016

Stray cats rejoice: tuna sandwich company forced to cease operations, destroy ingredients

By Kayla R. Bryant, J.D.

A company that distributes ready-to-eat (RTE) tuna sandwiches has been enjoined from preparing and distributing its products until it complies with the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.) as well as current good manufacturing practice (CGMP) requirements for food. The injunction follows FDA inspections that revealed the unsanitary conditions in which the food was prepared as well as a civil complaint filed by the Department of Justice (DOJ) (U.S. v. Scotty’s Inc., May 12, 2016, Cleland, R.).

Inspections and complaint. The FDA inspected Scotty’s, based in Detroit, and found that the company’s sandwiches were adulterated (see Michigan ready-to-eat tuna sandwiches could be toxic, DOJ warns, November 24, 2014). The DOJ’s complaint alleged that Scotty’s failed to create and implement a Hazard Analysis and Critical Control Point (HACCP) plan for handling seafood, and it lacked control records documenting various safety measures. Although Scotty’s argued that it was not subject to HACCP regulations and that it had addressed the FDA’s safety concerns, the district court was not convinced of the company’s ability to comply with regulations and granted the injunction (see Company’s tuna salad processing smells fishy to FDA, injunction granted, March 30, 2016).

Injunction. The government was required to supply the form of injunction it desired by April 1, 2016. The court ultimately entered an order of permanent injunction against Scotty’s, preventing the company from distributing its sandwiches from any locations until the company retains an independent expert to assist it in complying with the FDC act and CGMP. The company must develop and implement a written sanitation control program, comply with HACCP regulations, and develop employee training programs. The expert must inspect Scotty’s facility and establish procedures to ensure that all controls are administered properly.

The company must seek FDA approval of its plans and programs. Under FDA supervision, Scotty’s must destroy all RTE sandwiches and ingredients in the company’s possession at the time of the order. The company must bear the FDA’s costs of inspection and oversight. The company may not resume operations until the FDA notifies it in writing that it is in compliance with all of the requirements.

The case is 2:14-cv-14450-RHC-RSW.

Attorneys: Ann Entwistle, U.S. Department of Justice, for the United States of America. Jerome A. Moore (Jerome A. Moore, Attorney at Law) for Scotty's Inc.

Companies: United States of America; Scotty's Inc.

MainStory: TopStory CaseDecisions FDCActNews AdulterationNews InspectionNews FoodSafetyNews FoodStandardsNews MichiganNews

Back to Top

Health Law Daily

Introducing Wolters Kluwer Health Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.


A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.