This trend has continued since announcement of the aggressive enforcement strategy. FDA data indicates that between 2003 and 2006 (the last year for which statistics are available), convictions stemming from OCI investigations increased from 206 to 279. During this time, the number of FDA product recalls decreased from 4,627 to 4,266, while the number of FDA warning letters decreased from 582 to 528. These numbers suggests that, despite a decreasing number of potentially actionable FD&C violations, FDA chose to rely more often on criminal prosecutions than the other enforcement techniques available.
Despite these increases, a look at recent OCI-instituted prosecutions indicates FDA reserves criminal prosecutions for the most egregious or high-profile FD&C violations, including the most serious threats to public health; incidents with the potential to affect a large number of citizens; or violations accompanied by some evidence of culpable intent. For example, in 2006, FD&C prosecuted the supplier of a non-FDA approved flu vaccine during the 2004 flu vaccine shortage; Internet vendors of the drug DXM whose products lead to five purchasers’ deaths; and an individual who tampered with infant formula by removing the product and filling the empty packages with common wheat flour.
The ChemNutra indictment fits this model of FD&C violations chosen for prosecution by FDA and OCI. Like those listed above, the violations leading to this indictment involved a highly-publicized and wide-ranging recall, as well as claims of widespread injury and death among affected pets. Moreover, although ChemNutra owners were not alleged to have intended or been aware of the purported adulteration of the wheat gluten, they both claimed to have been knowledgeable that the product had not been inspected upon export and to have not revealed this fact.
It is a simple reality that FDA and OCI do not have the resources to investigate for prosecution each one of the thousands of FD&C violations alleged each year, nor does the Department of Justice have the tools necessary to prosecute each one. Although the FD&C is broad in scope and strict in its application, FDA enjoys significant discretion in deciding which violations should be prosecuted. Examination of a handful of recent prosecutions suggests that FDA and OCI will concentrate their efforts where they are likely to have the most effect: high-profile violations leading to death or widespread injury, or involving particularly egregious conduct. By doing so, FDA and OCI can uphold the mantle of “aggressive enforcement” by sending a message of toughness and publicly demonstrating their commitment to prosecuting violations.
Although the indictment of ChemNutra and its owners may be surprising because it does not involve allegations of an intentional or knowing violation, it fits within the category of cases usually chosen by FDA for prosecution. While this situation should not be seen as a sign of an even more aggressive zero-tolerance policy, it is an important reminder of the high cost that can result from even unintentional violations of the FD&C.
Richard Fama is a member of the food liability practice group of Cozen O’Connor. He represents major food processors, manufacturers and distributors (including Fortune 100 companies) in products liability matters, in addition to advising manufacturers and distributors regarding country of origin labeling issues. Reach him at rfama@cozen.com.
Russell Wheeler is an associate in the general litigation department of Cozen O’Connor. He has experience in criminal defense and commercial litigation matters, including in the defense of consumer class actions. He can be reached at rwheeler@cozen.com.