Posted: 26 Jan 2016 09:17 AM PST
By Riëtte van Laack & John R. Fleder –
In hockey parlance, a player gets a “hat trick” when the player scores three goals in one game. In the FDA enforcement world, a “hat trick” – and perhaps a “Gordie Howe hat trick” – would be the use of FDA’s three traditional enforcement mechanisms in one matter: a criminal prosecution, an injunction action and a civil seizure. In a case announced late last week, we saw the government come very close to scoring a hat trick with regard to cheese products that were connected to a Listeria outbreak in 2014.
FDA and the Department of Justice (DOJ) have an arsenal of methods for dealing with alleged violations of the Federal Food, Drug, and Cosmetic Act (FDC Act). The government typically uses one of those remedies against a company. Although, in the past, it has on numerous occasions used multiple enforcement methods against the same company, as far as we can recall, it has never used three remedies against the same company in the same matter. While the East Coast was getting ready for a historical snowstorm, DOJ did just that. On January 22, 2016, it filed a civil Complaint and proposed Consent Decree for Permanent Injunction. It also filed a separate criminal Information, which includes as part of the remedy sought “forfeiture” (which is akin to a civil seizure action) of adulterated food products. Seeking a forfeiture of allegedly violative products regulated by FDA in a criminal case is highly unusual but not unprecedented.
The government announced a guilty plea involving the company, Roos Foods, Inc. (Roos) to the Information and the other actions taken by the government.
The civil Complaint, criminal Information, and previous announcements by FDA suggest that Roos had a history of non-compliance issues. Allegedly, Roos manufactured and distributed several varieties of ready-to-eat cheese, including ricotta, queso fresco and fresh cheese curd and sold and distributed its products to wholesale customers in Maryland, New Jersey, Virginia and Washington D.C. In 2014, investigations by FDA (together with CDC and state authorities) linked Roos cheese products, contaminated with Listeria monocytogenes (L.m.), to a multi-state outbreak of listeriosis. Allegedly, a subsequent inspection of the facility revealed numerous deficiencies in good manufacturing practice and the presence of Listeria monocytogenes in various environmental samples.
Roos issued a recall and, in March 2014, FDA suspended the facility’s registration. Facility suspension is a relatively new enforcement power which gives FDA the authority to suspend the registration of a facility when FDA determines that a food manufactured, processed, packed, received, or held by a facility has “a reasonable probability of causing serious adverse health consequences or death to humans,” and “the facility created, caused, or was otherwise responsible for such reasonable probability.” Because a food facility registration is required for the legal manufacture of food for consumption in the United States, the suspension of the facility registration effectively put the company out of business for the duration of the suspension.
It is not clear what, if anything, happened since March 2014. According to the civil Complaint, the government believes that the permanent injunction is required because without it, Roos will continue to violate the law. Although, the facility suspension should prevent any further violations by the facility, the proposed Permanent Injunction is broader as it includes the owners.
According to both the Complaint and the Information, the 2014 inspection was not the first time that FDA identified violations of GMP and sanitation requirements involving Roos. According to those documents, FDA inspections in 2010 and 2013 revealed similar violations. Both times, “FDA investigators issued a Report of Investigational Observations . . . and discussed . . . the observations with” Roos management. According to the civil Complaint, Roos did not respond in writing to the Form 483s FDA issued in 2010 and 2013. Yet, as far as we know, FDA did not take any further action until 2014.
One wonders why the agency did not take earlier enforcement action as a result of 2010 and 2013 violative inspections. In fact, the Complaint alleges that FDA’s observations in the 2010 and 2013 inspections were, in some instances, the same as or similar to the observations made by FDA in its February-March 2014 inspection.
As mentioned above, as far as we can recall, the government has never before filed criminal and civil charges against a company and also sought the forfeiture of violative products against a company.
It is also noteworthy that the civil Complaint alleges that Roos Foods and the individual owners violated the FDC Act by, among other things, introducing or delivering for introduction into interstate commerce articles of food that were adulterated in that the food was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. The criminal Information, however, is directed only at the company. Does this mean that the government worked out a deal where no individuals would be criminally prosecuted? Or, does it mean that the government is still investigating to determine if it should file criminal charges, presumably against the individual defendants in the civil case? We cannot determine the answer to these questions because the Plea Agreement between the company and the government is not yet public.
In hockey parlance, a player gets a “hat trick” when the player scores three goals in one game. In the FDA enforcement world, a “hat trick” – and perhaps a “Gordie Howe hat trick” – would be the use of FDA’s three traditional enforcement mechanisms in one matter: a criminal prosecution, an injunction action and a civil seizure. In a case announced late last week, we saw the government come very close to scoring a hat trick with regard to cheese products that were connected to a Listeria outbreak in 2014.
FDA and the Department of Justice (DOJ) have an arsenal of methods for dealing with alleged violations of the Federal Food, Drug, and Cosmetic Act (FDC Act). The government typically uses one of those remedies against a company. Although, in the past, it has on numerous occasions used multiple enforcement methods against the same company, as far as we can recall, it has never used three remedies against the same company in the same matter. While the East Coast was getting ready for a historical snowstorm, DOJ did just that. On January 22, 2016, it filed a civil Complaint and proposed Consent Decree for Permanent Injunction. It also filed a separate criminal Information, which includes as part of the remedy sought “forfeiture” (which is akin to a civil seizure action) of adulterated food products. Seeking a forfeiture of allegedly violative products regulated by FDA in a criminal case is highly unusual but not unprecedented.
The government announced a guilty plea involving the company, Roos Foods, Inc. (Roos) to the Information and the other actions taken by the government.
The civil Complaint, criminal Information, and previous announcements by FDA suggest that Roos had a history of non-compliance issues. Allegedly, Roos manufactured and distributed several varieties of ready-to-eat cheese, including ricotta, queso fresco and fresh cheese curd and sold and distributed its products to wholesale customers in Maryland, New Jersey, Virginia and Washington D.C. In 2014, investigations by FDA (together with CDC and state authorities) linked Roos cheese products, contaminated with Listeria monocytogenes (L.m.), to a multi-state outbreak of listeriosis. Allegedly, a subsequent inspection of the facility revealed numerous deficiencies in good manufacturing practice and the presence of Listeria monocytogenes in various environmental samples.
Roos issued a recall and, in March 2014, FDA suspended the facility’s registration. Facility suspension is a relatively new enforcement power which gives FDA the authority to suspend the registration of a facility when FDA determines that a food manufactured, processed, packed, received, or held by a facility has “a reasonable probability of causing serious adverse health consequences or death to humans,” and “the facility created, caused, or was otherwise responsible for such reasonable probability.” Because a food facility registration is required for the legal manufacture of food for consumption in the United States, the suspension of the facility registration effectively put the company out of business for the duration of the suspension.
It is not clear what, if anything, happened since March 2014. According to the civil Complaint, the government believes that the permanent injunction is required because without it, Roos will continue to violate the law. Although, the facility suspension should prevent any further violations by the facility, the proposed Permanent Injunction is broader as it includes the owners.
According to both the Complaint and the Information, the 2014 inspection was not the first time that FDA identified violations of GMP and sanitation requirements involving Roos. According to those documents, FDA inspections in 2010 and 2013 revealed similar violations. Both times, “FDA investigators issued a Report of Investigational Observations . . . and discussed . . . the observations with” Roos management. According to the civil Complaint, Roos did not respond in writing to the Form 483s FDA issued in 2010 and 2013. Yet, as far as we know, FDA did not take any further action until 2014.
One wonders why the agency did not take earlier enforcement action as a result of 2010 and 2013 violative inspections. In fact, the Complaint alleges that FDA’s observations in the 2010 and 2013 inspections were, in some instances, the same as or similar to the observations made by FDA in its February-March 2014 inspection.
As mentioned above, as far as we can recall, the government has never before filed criminal and civil charges against a company and also sought the forfeiture of violative products against a company.
It is also noteworthy that the civil Complaint alleges that Roos Foods and the individual owners violated the FDC Act by, among other things, introducing or delivering for introduction into interstate commerce articles of food that were adulterated in that the food was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. The criminal Information, however, is directed only at the company. Does this mean that the government worked out a deal where no individuals would be criminally prosecuted? Or, does it mean that the government is still investigating to determine if it should file criminal charges, presumably against the individual defendants in the civil case? We cannot determine the answer to these questions because the Plea Agreement between the company and the government is not yet public.
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