Significant federalism concerns are raised when state products liability actions are preempted by federal regulatory schemes. For example, the FDA has recently taken the position that its approval of the labels on prescription drugs preempts civil tort claims grounded in a manufacturer’s failure to warn. Using the FDA’s recent stance on the issue of preemption, this Article demonstrates that federal agencies can engage in “strategic characterization” by pointing to Congress as the source of preemption, rather than the agency itself. In doing so, agencies avoid political and judicial scrutiny of agency action. This Article proposes that courts use a more realistic, totality of the circumstances approach when deciding whether Congress or an agency is the source of preemption. Further, the Article demonstrates that properly identifying a case as one of preemption by the agency can result in a type of “hard-look” review of the agency’s decision to preempt. Use of a hard-look review can serve as a proxy - in cases of agency preemption - for the “presumption against preemption” which is used in all other categories of preemption analysis.