The law requires FDA to adjust its civil monetary penalties at least one time every 4 years to account for inflation, and FDA last adjusted these penalties in 2004. While the increases do not affect the new civil penalty authority granted FDA under FDAAA in 2007, the Notice does list the nine (9) new civil penalties created by FDAAA, which we previously described.The resulting new 21 C.F.R. § 17.2 may now have sufficient heft to warrant more FDA enforcement resources, especially because of coincidental timing that nevertheless almost compels one to speculate about the enforcement priorities of an Obama administration FDA. The FDA’s Rule was published as a direct final rule, which means that FDA did not believe notice and comment rulemaking was necessary under the Administrative Procedure Act.