The FDA considers Indian Reservations to be possessions of the United States within the meaning of section 20l(a)(2) of the Federal Food, Drug, and Cosmetic Act. Consequently, FDA has complete jurisdiction over products within the purview of the Act that are manufactured on an Indian reservation. The products are in interstate commerce within the meaning of section 20l(b) of the Act at all times.
*Under the Food, Drug and Cosmetic Act, the FDA has the same authority on a reservation as it does anywhere else, to inspect, to take official samples, and to initiate regulatory actions.*
*Material between asterisks is new or revised*
Revised: 10/1/80, 9/1/87
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.