When prescription drugs switch to over-the-counter status, regulatory oversight of their advertising shifts to the Federal Trade Commission (FTC), potentially leading to reduced focus on warnings about risks and side effects, a new report suggests. While the FDA regulates prescription drug advertising, including requirements to provide consumers with a “fair balance” of risks and benefits, the FTC holds drug advertisements to the same standards as any consumer product: not requiring any balancing of potential benefits and harms. In a recently published letter (JAMA; 308(10):973-5), Jeremy A. Greene, MD, PhD, et al. shed light on how the changes in direct-to-consumer pharmaceutical advertising are following shifts from prescription-only to over-the-counter status. The authors note that such a shift may be associated with changes in content.