Saturday, June 7, 2008

FDA Warning Letters Decline

Article in the Wall Street Journal -- FDA Warning Letters to Companies Decline Sharply, by Jared Favole.  Here's an excerpt:

The number of Food and Drug Administration warning letters sent to companies dropped by half in the past 10 years, highlighting a change in enforcement tactics at an agency facing criticism about its policing of the food and drug industries.

In 2002, the FDA changed its policies and required that all warning letters go through the agency's chief counsel's office, a move it said was designed to strengthen the letters and make them legally consistent and credible.

In fiscal 2001, the year before this change took effect, the agency issued 1,032 warning letters. In 2006, the FDA sent 538 letters, and in 2007 sent 471, according to agency data. The FDA sends warning letters for an array of reasons, from the mislabeling of chocolate-chip cookies to the improper manufacturing of blood bags.


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