OBJECTIVES: To investigate FDA regulatory actions against drug company’s health economic promotions from 2002 through mid 2011 to understand the types of economic promotions the Agency considers false or misleading. METHODS: We reviewed all warning letters and notices of violation (“untitled letters”) issued by the FDA’s Division of Drug Marketing Advertising and Communications (DDMAC) to pharmaceutical companies between January 2002 and August 2011.  We searched for and analyzed letters containing a violation related to “health economic promotions,” defined according to one of several categories (e.g., implied claims of cost-savings due to work productivity; economic claims containing unsupported statements about effectiveness or safety).  We also collected information on other factors, such as the indication involved, and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act (FDAMA), which created a different evidentiary standard for health economic promotions made to formulary committees. RESULTS: Of 280 DDMAC letters sent to pharmaceutical companies during the study period, 34 (12%) cited an economic violation.  The most common type (found in 20 letters) was an unsupported implied claim of cost-savings due to work productivity or functioning.  The next most frequent types included an economic claim containing an unsubstantiated comparative statement of effectiveness, safety, or interchangeability (5 letters) and implied claims of cost-savings to broader audiences than applicable (4 letters).  Economic violations have covered various indications, mostly commonly psychiatric disorders (7 letters), pain (5 letters), and cancer (4 letters).  No DDMAC letter pertained to FDAMA Section 114. CONCLUSIONS:  The FDA continues to regulate health economic promotions and express concern about certain inappropriate practices, particularly unsupported work productivity claims and hidden clinical claims (i.e., about effectiveness or safety) embedded in health economic information.  More guidance from the Agency would help clarify what level of substantiation is required for health economic promotions.