Do FDAs tobacco regulations apply to sales of cigarettes and smokeless tobacco on Indian reservations?
As a general rule, statutes that by their terms apply to everyone generally are presumed to apply to Indian reservations. This general rule can be altered by specific treaties with individual tribes. FDA’s Compliance Policy Guide provides that “FDA considers Indian Reservations to be possessions of the United States within the meaning of [the Act].” Therefore, FDA presumes that the tobacco regulations apply to sales of cigarettes and smokeless tobacco on Indian reservations unless a specific treaty with an individual tribe alters FDA’s jurisdiction over such sales. Although this guidance document does not confer any rights for or on any person and does not operate to bind FDA or the public, it does represent the agency’s current thinking on the regulations involving the sale and distribution of cigarettes and smokeless tobacco in order to protect children and adolescents at 21 CFR Part 897. Alternative methods that comply with the tobacco regulations are acceptable. If a regulated comp