United States: FDA Kicks Enforcement Into Higher Gear In FYs 2010 And 2011

A review of FDA's published enforcement statistics from fiscal years 2009 through 2011 shows that it has ramped up its enforcement activities in several categories, especially warning letters. The following table compares the numbers by type of enforcement activity over this three year period:

Consistent with one of the FDA's main missions to ensure that information about the products it regulates is truthful and not misleading, it should be noted that the dramatic increase in warning letters is largely attributable to the FDA's Center for Tobacco Products (CTP). The CTP issued 1,040 warning letters in FY 2011, far more than it had in the past. This is not surprising given that the FDA was first given jurisdiction over tobacco products in 2009. Even without the CTP's letters, however, the data would show an impressive 43 percent increase in warning letters from 2011 over 2009. The FDA takes other types of enforcement actions, but directly comparable data were not readily available for all three years because of a change in the reporting format.

In light of the volume of U.S. commerce regulated by FDA, estimated to be over 25 percent of U.S. gross domestic product, these numbers may appear modest. Nonetheless, the increase in enforcement activity suggests that companies in FDA-regulated industries should increase their compliance efforts.

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