Roos Foods pleads guilty to FD&C Act violation in connection with 2014 Listeria outbreak.

• Thanks to the FDA Food Safety Modernization Act (FSMA), FDA now has the authority to suspend a food facility’s registration where there is a “reasonable probability” (of which the facility is or should be aware) that exposure to food will cause serious adverse health consequences or death to humans or animals.  A suspension effectively shuts down a food facility.  In March 2014, FDA suspended the registration of Roos Foods when their cheeses were linked to Listeria monocytogenes and where insanitary conditions (e.g., leaking roof, standing water) existed in the facility.  The Department of Justice (DOJ) eventually brought criminal charges against the company in connection with its distribution of tainted cheeses in interstate commerce.

• Roos Foods has now pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act by introducing adulterated food into interstate commerce.  Should the company wish to re-open in the future, it is subject to numerous stringent conditions under a consent decree, such as obtaining support from third-party experts and labs to develop a remedial food safety plan aimed at dealing with Listeria.  The facility also would need to allow FDA to make unannounced inspections at any time and must bear the costs of these inspections.

• The disposition of the Roos Foods case shows the significant potential long-term impact that food safety issues can have on a company.  In particular, DOJ recently indicated that a key area of increased focus for the Department is food safety.  The guilty plea in this case is further evidence of FDA’s/DOJ’s power to target and prosecute facilities for food safety violations.