What Does FDA’s Regulation of Spinach Have in Common with its Regulation of Nanotechnology?

More than one might guess.  On September 26, 2008, the Government Accountability Office (“GAO”) released a report, titled "Food Safety:  Improvements Needed in FDA Oversight of Fresh Produce."  As the title suggests, the report is somewhat critical in tone, although it does acknowledge FDA’s efforts to address fresh produce safety.  Some observations and conclusions in the report are that: (1) federal spending on food safety oversight has not kept pace with the volume of goods (particularly imports) moving in commerce or the increase in FDA’s other food safety responsibilities; (2) FDA’s science base has eroded to the point where it can not conduct or fund the research needed to collect the data needed to devise appropriate solutions; (3) FDA’s efforts are hampered by its inability to get information from industry; (4) FDA has to cannibalize other programs to fund its fresh produce safety activities; and (5) FDA is in a reactive mode, with much of FDA’s attention being diverted to address counterterrorism and outbreaks of foodborne illness.  The report recommends that FDA focus on its research and information-gathering activities, update its guidance and regulations, and seek additional statutory authorities.

Now for the fun, if disturbing, part of the exercise.  One can substitute “nanotechnology” for “fresh produce/food/food safety” in the preceding paragraph and end up with a series of true statements.  That is a hint to the systemic nature of the challenges facing FDA as it seeks to stay ahead of the curve on issues that range from the seemingly humble (getting a salad to the consumer’s table) to the more exotic (evaluating the safety of an article that crosses the boundaries between drugs, biologics, and devices).  In light of those challenges, it seems a bit curious that GAO would recommend that FDA issue new regulations.  While true that a preventive approach is generally more efficient than a reactive one, it’s not clear how FDA could hope to effectively and efficiently regulate a problem that it does not yet fully understand.  In fact, it was not until October 3, 2008 that FDA announced OMB approval of the Agency’s proposal to survey domestic and foreign FDA-registered food manufacturing and processing facilities to obtain more information about their current manufacturing practices.   

By Ricardo Carvajal