They applied first to the FDA, stating that while the drugs to be involved in the lethal injection had been approved, the manner in which they were going to be used had not, in violation of the Food, Drug, and Cosmetic Act's prohibition against "misbranding".
They first approached the FDA with their proposal, stating that although the medications intended for use in lethal injection had received regulatory approval, the manner in which they would be administered was not compliant with the Food, Drug, and Cosmetic Act's regulations regarding truthful labeling.