Whether stem cells used in surgical procedures are 'drugs' subject to FDA regulation under the FDCA and whether the FDA had a lawful basis for its enforcement action given its own 'Same Surgical Procedure' exception

is w hether the stem cells used in Petitioners’ surgical procedure are “drugs” subject to regulation under the FDCA and, even if they are “drugs” subject to such regulation, whether the FDA had a lawful basis for its enforcement action given the FDA’s own “Same Surgical Procedure ” exception to the FDCA. ii PARTIES TO THE P ROCEEDING Petitioners California Stem Cell Treatment Center, Inc., Cell Surgical Network Corporation, Dr. Elliot B. Lander, and Dr. Mark Berman were the defendants in the district court and the appellees in the court of appeals. Respondent United States of America was the plaintiff in the district court and the appellant in the court of appeals.