FDA: a gentle giant or a brewing beast?

There has been a great deal of media coverage surrounding FDA’s new enforcement initiatives under the Food Safety Modernization Act (“FSMA”).  With the new regulations going into effect, the agency has also adjusted its approach as it relates to other areas of enforcement.  Although FDA leadership implored last week that the agency is here to “help food companies enhance their existing food safety programs,” and to “educate before it regulates,” those statements stand in stark contrast to ongoing reports of: (1) FDA and DOJ criminal investigations initiated against companies such as Chipotle, Blue Bell, Dole and others; (2) FDA’s new strategy to conduct routine microbiological “swab-a-thons” in all registered food facilities (and then force expansive recalls based only upon environmental test results); and (3) FDA’s recent use of armed U.S. Marshals to seize millions of pounds of milk products from a major dairy cooperative in Virginia. The statements from FDA regarding its interest in gently helping the food industry to do a better job also stand in opposition to the agency’s decision to bestow all of its FDA inspectors with the fear-inducing title of “FDA INVESTIGATORS.”   Now, what were commonly referred to as routine “FDA inspections,” are incresingly characterized as “FDA investigations.”  When asked about the meaning and connotation of the title "investigator," some ageny employees confirmed that the title is used to “give them more power.”  If an FDA employee is told that he or she is an “investigator,” however, and that he or she must “go investigate a food facility,” isn’t the hypothesis being tested that the food company has already committed crime?