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 initially submitted their application to the FDA, asserting that while the drugs destined for lethal injection had been sanctioned, the method of administration was unapproved, violating the Food, Drug, and Cosmetic Act's prohibition on misleading labeling.