Petitioners are physicians who perform a surgical procedure through which they remove, isolate, and then reimplant a patient's own stem cells to promote natural healing. Claiming authority under the Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (FDA) filed an enforcement action to prevent Petitioners from undertaking the procedure. The question presented is whether 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.

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