Warning Letter Summary, First Quarter 2010, Part 1

J0386036Note:  After this posting was originally published on the morning of April 7, the FDA posted additional NOV and Warning letters to its site that were issued in the month of March.  The numbers were changed to reflect the new numbers and the posting was re-published. 

Today the Washington Post carried a story "FDA Inspections of Food Plants, Enforcement Down, Officials Say" that carried the news that despite the fact that food safety has risen as a priority in the wake of several high profile public health problems, the number of inspections and enforcement actions between 2004 and 2008 plummeted.  The article quoted FDA's Deputy Commissioner for Food Safety as saying that this demonstrates the need for new legislation, though that does not address why enforcement is down under existing legislation.

This January, there were articles heralding a new enforcement era at the FDA's DDMAC – in particular Reuters reporting that ad enforcement was set to double.  Technically, they are sort of rack.  Here are the numbers:

In January, DDMAC issued 8 letters;

In February DDMAC issued 3 letters;

In March, DDMAC issued 4 letters

At that rate, DDMAC is on track to issue a total of 60 letters for the year, which would be more than double last year's anemic rate, but still well below historic levels, so it all depends on how one views progress here.  Here is a chart that demonstrates what 2010 would look like if this projection holds out.  

Warning and Untitled Letters 1st QU 2010

It is also worth recalling that 2009 includes the (what I regard as) anomaly of the 14 NOV letters issued on April 2.  

In a subsequent posting, we'll examine the substance of the violations cited in the letters.  

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