California Stem Cell Treatment Center, Inc. v. United States

(1) Whether stem cells removed, isolated, and then reimplanted in a patient’s own stem cells to promote natural healing via surgical procedure are “drugs” subject to regulation under the Food Drug and Cosmetic Act; and (2) whether, if so, the Food and Drug Administration had a lawful basis for an enforcement action to prevent prevent physicians from undertaking the procedure given the FDA's own “same surgical procedure” exception to the Act.